The International Journal Of Risk & Safety In Medicine[JOURNAL]
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200 papers
Examination and therapeutic evaluation of individuals afflicted with profound thrombocytopenia triggered by tirofiban: A retrospective cohort study.
Guo SJ, Luo H, Gao R … +3 more , Fan RJ, Zhou YM, Jing R
Medicine (Baltimore) · 2026 Jun · PMID 42363542 · Full text
This study aimed to characterize the clinical features of severe tirofiban-induced thrombocytopenia (TIT) and evaluate the efficacy of immunosuppressive therapy in accelerating platelet recovery. We conducted a retrospec...
This study aimed to characterize the clinical features of severe tirofiban-induced thrombocytopenia (TIT) and evaluate the efficacy of immunosuppressive therapy in accelerating platelet recovery. We conducted a retrospective analysis of 29 patients who developed severe thrombocytopenia (platelet count < 50 × 109/L) following tirofiban administration at our hospital between September 2008 and September 2021. Patients were categorized by age (≥60 vs <60 years) and treatment (immunosuppressants: glucocorticoids and/or intravenous immunoglobulin; no immunosuppressants: control). Primary outcomes included platelet recovery time (>100 × 109/L) and bleeding events during thrombocytopenia. Among elderly patients, those receiving immunosuppressive therapy (n = 10) exhibited a significantly shorter platelet recovery time (mean: 3.2 ± 1.1 days) compared to the control group (n = 8, mean: 5.6 ± 1.8 days; P < .05), despite no difference in baseline (82.3 vs 79.6 × 109/L, P = .67) or nadir platelet counts (31.5 vs 28.4 × 109/L, P = .42). In contrast, no such benefit was observed in the nonelderly subgroup. Importantly, no significant differences in major or clinically relevant nonmajor bleeding events were observed between any groups, including in elderly patients receiving immunosuppressive therapy (10.0% vs 12.5%, P > .99). Although severe TIT presents similarly in elderly and nonelderly patients, our findings reveal a distinct age-dependent therapeutic response to immunosuppression. The significantly accelerated platelet recovery observed in elderly patients receiving glucocorticoids and/or intravenous immunoglobulin suggests that immunomodulatory strategies are particularly effective in this population. This differential efficacy may be attributed to immunosenescence, which potentially heightens the susceptibility of older adults to antibody-mediated platelet destruction. Notably, this therapeutic benefit was achieved without increasing the risk of bleeding, addressing a critical concern in anticoagulated patients. These results suggest that age-specific management strategies for severe TIT may be warranted, although validation in larger prospective studies is needed. In elderly patients with severe TIT, immunosuppressive therapy is associated with faster platelet recovery without increasing bleeding risk. These findings support the potential safety and efficacy of immunomodulatory strategies in this population, though validation in larger prospective studies is warranted.
An analysis of digoxin serum concentrations and influencing factors: A cross-sectional study from a tertiary hospital in China.
Huang W, Dong Z, Chen G
Medicine (Baltimore) · 2026 Jun · PMID 42260860 · Full text
The digoxin drug has a narrow therapeutic window that requires regular blood concentration monitoring in a tertiary hospital. The concentration of a drug varies due to several factors. The factors may include physiologic...
The digoxin drug has a narrow therapeutic window that requires regular blood concentration monitoring in a tertiary hospital. The concentration of a drug varies due to several factors. The factors may include physiological and biochemical factors, comorbidities, and concomitant medications. The purpose of this study was to analyze the monitoring data of serum digoxin concentration (SDC) using logistic regression and to find the SDC correlated factors. SDC with a cutoff value of 0.9 ng/mL, which corresponds to the proposed safety upper limit by international heart failure recommendations (ACCF/AHA). This cross-sectional study retrospectively analyzed data from 178 patients at Jiande First People's Hospital, including SDC, demographic characteristics, biochemical parameters, comorbidities, and medication use. Patients were stratified into 2 groups based on an SDC cutoff of 0.9 ng/mL (<0.9 vs ≥0.9 ng/mL) to describe population characteristics and perform comparative analyses, including univariate logistic regression. Variables with P < .1 in the univariate analysis were included in a stepwise regression model. Factors with P < .05 which remained in the final model. Among 178 patients, those with SDC < 0.9 ng/mL accounted for 43.26%, while patients with SDC ≥ 0.9 ng/ml comprised 56.74%. The median SDC was 1.05 ng/ml (IQR: 0.54, 1.60). Univariate analysis revealed several factors significantly associated with SDC levels. The results of multivariate logistic regression indicated that age (odds ratio [OR] = 1.10, 95% confidence interval [CI]: 1.05-1.15, P < .001), chloride ion (Cl-) (OR = 0.87, 95% CI: 0.81-0.94, P < .001), high-density lipoprotein cholesterol (HDLC) (OR = 0.08, 95% CI: 0.02-0.30, P < .001), blood urea nitrogen (BUN) (OR = 1.15, 95% CI: 1.07-1.25, P < .001), Deslanoside (OR = 5.41, 95% CI: 1.39-21.15, P = .015), and hypoglycemic drugs (OR = 0.30, 95% CI: 0.10-0.89, P = .030) were all significantly associated with SDC levels. Age, Cl-, HDLC, BUN, Deslanoside, and hypoglycemic drugs are independent factors influencing SDC. These findings provide valuable references for the rational clinical use of digoxin.
Adverse event mining for Breztri and Trelegy Ellipta based on the three international pharmacovigilance databases.
Wang J, Chen K, Yun L … +1 more , Xu D
Medicine (Baltimore) · 2026 Jun · PMID 42260824 · Full text
This study aimed to identify adverse drug reaction (ADR) risk signals associated with budesonide/glycopyrrolate/formoterol (Breztri) and fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta) to support clinical d...
This study aimed to identify adverse drug reaction (ADR) risk signals associated with budesonide/glycopyrrolate/formoterol (Breztri) and fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta) to support clinical decision-making and risk management. ADR reports related to Breztri and Trelegy Ellipta from the FDA Adverse Event Reporting System (FAERS) database, Japanese Adverse Drug Event Report (JADER) database and Canada Vigilance Adverse Reaction database (Q3 2004 to Q2 2024) were analyzed. After deduplication, reports were categorized using Medical Dictionary for Regulatory Activities (MedDRA) to obtain System Organ Class (SOC) and preferred terms (PTs). Disproportionality analysis was conducted using reporting odds ratio (ROR) and proportional reporting ratio methods. Analysis of 394 Breztri and 18,866 Trelegy Ellipta FAERS reports (predominantly consumer-submitted, U.S.-originated) identified 47 signals across 11 SOCs for Breztri (e.g., "Drug delivery system issue" ROR = 411.16, "Intentional device misuse" ROR = 410.69) and 160 signals across 15 SOCs for Trelegy (e.g., "Chronic eosinophilic rhinosinusitis" ROR = 187.65, "Foreign body in mouth" ROR = 107.67), revealing unlabeled risks like administration errors and packaging confusion. JADER data reinforced respiratory risks (Breztri: Chronic obstructive pulmonary disease (COPD) ROR = 516.8; Trelegy: gastrointestinal fungal infection ROR = 413.11) and device-independent safety signals (e.g., Trelegy urinary retention ROR = 28.81), while CVARD highlighted region-specific concerns including Trelegy-associated vasculitis (pulmonary vasculitis n = 29) and Breztri hypertension (ROR = 7.82). Cross-database convergence confirmed core anticholinergic/cardiopulmonary risks, yet divergent signals, FAERS' device errors, JADER's infection prominence, and CVARD's immunological events, underscore geographic heterogeneity in adverse reaction profiles, necessitating tailored risk management strategies for inhaler therapies. Inhalation device-related ADRs were observed, with Breztri showing higher incidence than Trelegy Ellipta, likely due to its more complex device usage. These findings highlight the need for enhanced patient education by healthcare providers to ensure proper device use in COPD treatment. Although core respiratory and anticholinergic risks are globally relevant, infection profiles, device complications, and rare immunological events exhibit significant geographic heterogeneity, necessitating tailored risk mitigation strategies aligned with regional pharmacovigilance patterns.
Triple oral therapy combining metformin, SGLT-2 and DPP-4 inhibitors versus dual therapy in type 2 diabetes mellitus: A systematic review and meta-analysis.
Malik AF, Kashish F, Shivani F … +8 more , Kumar S, Kumari V, Haseeb A, Mujtaba A, Raheem A, Ali SMS, Saleh U, Ahmad TKF
Medicine (Baltimore) · 2026 May · PMID 42216339 · Full text
BACKGROUND: Triple oral therapy combining metformin, sodium-glucose cotransporter 2 inhibitor, and a dipeptidyl peptidase-4 inhibitor has been proposed as a synergistic approach to intensify glycemic control in patients...
BACKGROUND: Triple oral therapy combining metformin, sodium-glucose cotransporter 2 inhibitor, and a dipeptidyl peptidase-4 inhibitor has been proposed as a synergistic approach to intensify glycemic control in patients with type 2 diabetes mellitus. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of triple therapy compared to dual therapy (metformin plus either sodium-glucose cotransporter 2 or dipeptidyl peptidase-4 inhibitor). METHODS: Following preferred reporting items for systematic review and meta-analysis guidelines, we searched PubMed, Embase, Scopus, and Web of Science through January 2026. Studies included randomized controlled trials comparing triple versus dual therapy in adults with type 2 diabetes mellitus. Outcomes included hemoglobin A1c (HbA1c), fasting plasma glucose, body weight, achievement of HbA1c < 7%, and adverse events (AEs). Pooled standardized mean differences (SMDs) and risk ratios (RRs) were calculated using random-effects models. RESULTS: Eight studies encompassing 2606 participants were included. Findings indicate triple therapy significantly reduced HbA1c levels compared to dual therapy, with a SMD of - 0.54 (95% confidence interval [CI]: -0.92 to -0.16; P = .005). Triple therapy resulted in greater reduction in fasting plasma glucose, with an SMD of -0.30 (95% CI: -0.62 to 0.01; P = .06). Patients on triple therapy were more likely to achieve HbA1c levels below 7% (RR: 2.02; 95% CI: 1.55-2.63; P < .0001). Weight reduction was modest, with an SMD: -0.14 (95% CI: -0.22 to -0.07; P = .0002). No significant differences were found in total AEs (RR = 0.97; P = .69) or hypoglycemia (RR = 1.32; P = .32), although there was higher discontinuation due to AEs (RR = 2.62; P = .03). CONCLUSION: Triple therapy offers superior glycemic control over dual therapy without major safety trade-offs, though tolerability may affect long-term adherence.
An international multidisciplinary consensus statement on laparoscopic liver biopsy.
Lei SY, Han Y, Rockey DC … +46 more , Alswat K, Wong VW, Jumaev N, Toro-Huamanchumo CJ, Taha S, El-Kassas M, George J, Muthiah M, Ghanem O, Yoneda M, Hang DV, Sebastiani G, Papatheodoridis G, Abu-Abeid A, Robertson AG, Kim SH, Weiner R, Mahawar K, Shabbir A, Kermansaravi M, Rajan R, Seki Y, Taskin HE, Shikora S, Oliveros E, Parmar C, Cheng Q, Thaher O, Ruiz-Úcar E, Oviedo R, Ribeiro R, Musella M, Ramos AC, Ryu SW, Abdelbaki T, Lee WJ, Chan MP, Garcia Flores JE, Skinovsky J, Madkhali A, Weiner S, Tacke F, Yang W, Neuberger J, Zheng MH, International Obesity Society Working Group on Steatotic Liver Disease
Cell Rep Med · 2026 Jun · PMID 42173098 · Full text
Laparoscopic liver biopsy (LLB) provides a way to obtain liver tissue samples under direct visual inspection of the liver surface. It complements percutaneous liver biopsy (PLB) for complex or high-risk cases where PLB c...
Laparoscopic liver biopsy (LLB) provides a way to obtain liver tissue samples under direct visual inspection of the liver surface. It complements percutaneous liver biopsy (PLB) for complex or high-risk cases where PLB cannot be performed. Clinical practices for LLB vary across centers due to the lack of international standards. To improve the procedural quality and diagnostic efficiency of LLB, a multidisciplinary panel of 45 international experts from 6 continents, including hepatology, hepatobiliary surgery, gastrointestinal surgery, and metabolic and bariatric surgery, developed this consensus statement through three rounds of a modified Delphi process. This consensus covers clinical application scenarios, high-risk clinical scenarios, preoperative preparation, surgical procedures, complication management, and discharge and quality management. It aims to promote the standardization, safety, and rational clinical application of LLB; support the management of complex cases; and facilitate the appropriate implementation of this important diagnostic procedure.
Persistent thrombocytosis in β-thalassemia post-splenectomy: A STROBE-compliant retrospective cohort study at a Jordanian referral center.
Alesufi A, Abu Lehyah NAA, Abu Nasrieh D … +7 more , Banihani HA, Aburumman S, Zibara Z, Fakih N, Al-Karmi L, Al Nawaiseh MA, Shersheer Q
Medicine (Baltimore) · 2026 May · PMID 42152419 · Full text
Beta-thalassemia is a prevalent autosomal recessive hematological disorder characterized by defective β-globin chain production. Splenectomy is commonly performed in severe cases to alleviate transfusion dependency, but...
Beta-thalassemia is a prevalent autosomal recessive hematological disorder characterized by defective β-globin chain production. Splenectomy is commonly performed in severe cases to alleviate transfusion dependency, but persistent post-splenectomy thrombocytosis poses significant clinical challenges. This Strengthening the Reporting of Observational Studies in Epidemiology-compliant retrospective cohort study included β-thalassemia major patients who underwent splenectomy at Al-Bashir Hospital between 2018 and 2024. Hematologic and biochemical parameters before and 1 year after surgery were compared using paired t tests after verifying data normality with the Shapiro-Wilk test (P > .05). A P value < .05 was considered statistically significant. Persistent thrombocytosis was observed in all patients, with mean platelet counts of 965.36 ± 413.50 × 109/L immediately after surgery, decreasing slightly to 843.23 ± 320.08 × 109/L at the 1-year follow-up. Hemoglobin levels significantly increased from 8.91 ± 0.96 g/dL pre-splenectomy to 9.65 ± 1.49 g/dL post-splenectomy. Blood transfusion requirements decreased by 42.49%, and transfusion intervals lengthened significantly, confirming the procedure's effectiveness in reducing transfusion burden. Ferritin levels declined, reflecting improved iron overload management. Nevertheless, adherence to postoperative medications, including aspirin and hydroxyurea, was suboptimal, potentially elevating thrombotic risk. Splenectomy in β-thalassemia major is associated with sustained hematologic improvement but persistent thrombocytosis. These findings underscore the importance of long-term platelet monitoring and strict adherence to antithrombotic prophylaxis to ensure optimal safety and clinical outcomes. Further multicenter studies are warranted to establish standardized monitoring and management protocols for this population.
The impacts of introducing online postal self-sampling for sexually transmitted infections on the sustainability and equity of sexual health systems: lessons learned from a multi-method UK-wide realist evaluation.
Sheringham J, Wong G, Spence T … +17 more , Stirrup O, Tostevin A, Howarth A, Copas A, Crundwell D, Jackson L, Mercer CH, Mohammed H, Apea V, Day S, Ross JDC, Sullivan A, Tittle V, Winter A, Dewsnap C, Gibbs J, Burns F
BMC Med · 2026 May · PMID 42151930 · Full text
BACKGROUND: Online postal self-sampling (OPSS) for sexually transmitted infections and blood borne viruses (STI/BBVs) has been introduced in several countries, because it may lower costs, and increase access for service...
BACKGROUND: Online postal self-sampling (OPSS) for sexually transmitted infections and blood borne viruses (STI/BBVs) has been introduced in several countries, because it may lower costs, and increase access for service users. There are gaps in the evidence on the equitable delivery to underserved populations beyond men who have sex with men, the implementation and maintenance of programmes and its impact on wider health systems. This study synthesised evidence from the ASSIST research programme, which evaluated the implementation, equity, impacts and economic consequences of OPSS in England (2015-2022), with a focus on understanding how and why unintended consequences may emerge in other contexts. METHODS: A synthesis using a realist logic of analysis was undertaken across multiple sources of evidence from ASSIST workstreams. Context-mechanism-outcome configurations were developed from a systems perspective. They were iterated through comparisons with initial programme theory and through feedback obtained from sexual health providers, funders, researchers and service users. RESULTS: In England, OPSS appears convenient and achieved higher testing uptake for lower costs per diagnosis. However, there were unintended consequences, principally: (1) difficulties in containing demand for OPSS could result in higher total costs than planned; (2) the introduction of OPSS affected wider sexual health system sustainability, particularly when the context changed; (3) inequalities in sexual health may widen after the introduction of OPSS in part due to missed presentation opportunities. These challenges prompted adaptive responses in health systems, leading to a rebalancing between OPSS and clinic-based services. CONCLUSIONS: While the introduction of OPSS in the context of reducing sexual health budgets offers some clear advantages to entirely clinic-based sexual health services, excessive demand and difficulties in access and use risk destabilising sexual health systems and worsening inequalities. Strategic rebalancing of OPSS and clinic-based provision is essential to mitigate unintended effects and ensure equitable, resilient service delivery. PROTOCOL: https://doi.org/10.1136/bmjopen-2022-067170.
Predictive factors for the development of urethral stricture in patients undergoing holmium laser enucleation of the prostate: A retrospective study.
Efendioğlu F, Özcan C, Tokatli Z
Medicine (Baltimore) · 2026 Apr · PMID 41995549 · Full text
This study aimed to determine the incidence and predictors of urethral stricture after holmium laser enucleation of the prostate (HoLEP) and to assess the safety of the procedure. We retrospectively reviewed data from 20...
This study aimed to determine the incidence and predictors of urethral stricture after holmium laser enucleation of the prostate (HoLEP) and to assess the safety of the procedure. We retrospectively reviewed data from 202 patients who underwent HoLEP. Patients were divided into 2 groups: those with urethral stricture (group 2) and those without (group 1). Preoperative prostate-specific antigen (PSA), uroflowmetry with post-void residual (PVR), and International Prostate Symptom Score (IPSS) were evaluated. Multivariate logistic regression analysis was performed to identify independent predictors of urethral stricture. Perioperative complications were classified according to the Clavien-Dindo system. The mean age was 67.0 ± 7.6 years in group 1 and 68.4 ± 7.3 years in group 2 (P = .335). Urethral stricture developed in 6.4% of patients. Multivariate analysis revealed that preoperative prostatitis (odds ratio [OR]: 116.81; 95% confidence interval [CI]: 1.32-10,330; P = .047) and the use of general anesthesia (OR: 269.07; 95% CI: 7.30-9912.74; P = .047) were independent predictors of stricture formation. Preoperative prostatitis and general anesthesia significantly increase the risk of urethral stricture after HoLEP.
Minimally invasive treatments for benign prostatic hyperplasia: A narrative review.
Zhang X, Liang T, Dong Y … +1 more , Gao H
Medicine (Baltimore) · 2026 Mar · PMID 41870215 · Full text
Benign prostatic hyperplasia-related lower urinary tract symptoms are highly prevalent in middle-aged and older men. Compared to traditional transurethral resection of the prostate (TURP), minimally invasive surgical the...
Benign prostatic hyperplasia-related lower urinary tract symptoms are highly prevalent in middle-aged and older men. Compared to traditional transurethral resection of the prostate (TURP), minimally invasive surgical therapies (MISTs) aim to provide meaningful symptom relief. This review evaluated the efficacy, safety, and procedural characteristics of 5 representative MISTs: water vapor thermal therapy (WVTT), prostatic urethral lift (PUL), prostatic artery embolization (PAE), temporary implantable nitinol device (iTIND), and Aquablation. A systematic literature search was conducted in PubMed (2018-2023), supplemented by backward citation tracking. Clinical studies reporting International prostate symptom score (IPSS), quality of life (QoL), and/or maximum flow rate (Qmax) were included, with higher-level evidence prioritized. Long-term data show that WVTT and PUL provide durable symptom improvement, achieving 48% IPSS reduction and 35% IPSS improvement, respectively, at 5 years. Aquablation has a lower rate of retrograde ejaculation than TURP. Importantly, no new sexual dysfunction has been reported after WVTT or PUL. The long-term retrograde ejaculation rate with iTIND is 4%. Most MISTs can be performed in an outpatient setting under local anesthesia. For prostates >80 cm3, PAE achieved >44% volume reduction. In summary, MISTs offer personalized treatment options for benign prostatic hyperplasia, though evidence strength varies. Aquablation has the strongest evidence for larger prostates, while WVTT and PUL are guideline-recommended for medium-sized glands. PAE is suitable for older/high-risk patients, and iTIND shows promise but requires more long-term data. Future research should focus on comparative trials to optimize patient selection.
The efficacy of acupuncture combined with Chinese herbal medicine in the treatment of gastric ulcer: A systematic review and meta-analysis.
Liang YF, Qu WW, Zhu MD … +5 more , Liu GF, Zheng X, Jiang Q, Han YL, Wang Q
Medicine (Baltimore) · 2026 Mar · PMID 41824820 · Full text
BACKGROUND: This study aimed to evaluate the efficacy of acupuncture combined with Chinese herbal medicine in the treatment of gastric ulcers (GU) through a meta-analysis. METHODS: A comprehensive search was conducted in...
BACKGROUND: This study aimed to evaluate the efficacy of acupuncture combined with Chinese herbal medicine in the treatment of gastric ulcers (GU) through a meta-analysis. METHODS: A comprehensive search was conducted in Chinese databases (CNKI, VIP, and Wanfang) and international databases (PubMed, Embase, and the Cochrane Library) to identify available randomized controlled trials (RCTs) published from the inception of each database through January 2025. The primary outcomes considered included overall efficacy rate, Helicobacter pylori (Hp) eradication rate, recurrence rate, gastrin levels, and adverse events. The quality of each included study was assessed using the Cochrane Collaboration's Risk of Bias Tool, and data were analyzed using RevMan 5.3 software. RESULTS: A total of 1288 articles were initially identified, of which 17 RCTs involving 1632 patients were ultimately included. The meta-analysis demonstrated that acupuncture combined with Chinese herbal medicine was superior to non-acupuncture combined with Chinese herbal medicine in terms of clinical efficacy (OR = 4.83, 95% confidence intervals [CI] = 3.36-6.93, P < .00001), Hp eradication rate (OR = 3.94, 95% CI = 2.35-6.6, P < .00001), recurrence rate (OR = 0.19, 95% CI = 0.1-0.35, P < .00001), and gastrin levels (MD = -18.39, 95% CI = -20.68 to -16.11, P < .00001). Due to the small sample size and low quality of the RCTs included, the overall certainty of the evidence is low. CONCLUSION: Compared with the control intervention measures, acupuncture combined with traditional Chinese medicine therapy may be an effective complementary therapy for treating GU. It has shown good clinical efficacy, significantly improving the eradication rate of Hp, gastrin levels, and having a relatively low recurrence rate. No increase in adverse events has been reported, suggesting a favorable safety profile in clinical practice. However, further high-quality, large-scale studies are needed to confirm these results.
Intravenous thrombolysis versus standard medical therapy in minor stroke patients with large vessel severe stenosis or occlusion: a systematic review and meta-analysis.
Zhang T, Tong L, Xu L … +6 more , Liu R, Xie L, Jiang L, Du M, Yuan H, Liang Z
BMC Med · 2026 Mar · PMID 41792788 · Full text
BACKGROUND: Patients with mild stroke (National Institutes of Health Stroke Scale [NIHSS] ≤ 5) and severe intracranial stenosis or occlusion represent a high-risk subgroup for early neurological deterioration (END) and a...
BACKGROUND: Patients with mild stroke (National Institutes of Health Stroke Scale [NIHSS] ≤ 5) and severe intracranial stenosis or occlusion represent a high-risk subgroup for early neurological deterioration (END) and are strong predictors of poor 3-month functional outcomes. The effectiveness of intravenous thrombolysis (IVT) in patients with minor stroke and large vessel severe stenosis or occlusion (LVSSO) remains uncertain. This study aims to assess the comparative efficacy and safety of IVT versus standard medical therapy (SMT) through a systematic review and meta-analysis of both randomized and observational studies. METHODS: A systematic search of PubMed, Embase, Cochrane Library, and Web of Science was conducted to identify studies evaluating IVT in minor stroke with LVSSO from database inception through March 13, 2025. The primary outcome was defined as an excellent functional outcome (modified Rankin Scale [mRS] 0-1) at 90 days. Pooled analyses were performed using odds ratios (ORs) with 95% confidence intervals (CIs) for the overall population and prespecified subgroups. The study protocol was prospectively registered in the PROSPERO international registry (CRD42025637459). RESULTS: A total of five studies were included, comprising 1090 patients with mild ischemic stroke and LVSSO treated with IVT and 3501 patients treated with SMT. Compared with SMT, IVT significantly improved the 90-day excellent functional outcome (mRS 0-1) (OR, 1.58 [95% CI, 1.16-2.15]). In the large vessel occlusion subgroup, IVT was also significantly associated with an excellent 90-day functional outcome (OR, 1.52 [95% CI, 1.03-2.23]). No significant differences were observed between groups in 90-day favorable functional outcome (mRS 0-2), symptomatic intracranial hemorrhage (sICH), 90-day mortality, or 90-day stroke recurrence. CONCLUSIONS: These findings suggest that IVT may be associated with improved 90-day excellent functional outcomes in patients with mild acute ischemic stroke (AIS) and LVSSO, without increasing the risk of sICH.
Anti-CD19 chimeric antigen receptor T-cell therapy for relapsed or refractory Philadelphia chromosome-positive B cell acute lymphoblastic leukemia: a multicenter retrospective study.
Yu J, Song F, Zhang M … +10 more , Zhao M, Sang W, Jiang S, Wang L, Wang X, Tu S, Li Y, Huang H, Hu Y, Wei G
BMC Med · 2026 Mar · PMID 41776492 · Full text
BACKGROUND: Although chemotherapy-free regimens have improved initial remission rates in patients with newly diagnosed Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph + B-ALL), outcomes for relap...
BACKGROUND: Although chemotherapy-free regimens have improved initial remission rates in patients with newly diagnosed Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph + B-ALL), outcomes for relapsed or refractory (R/R) Ph + B-ALL remain poor. This study reports the efficacy and safety of CD19 chimeric antigen receptor (CAR) T-cell therapy in R/R Ph + B-ALL. METHODS: This study retrospectively analyzed 93 patients with R/R Ph + B-ALL who received CD19 CAR T-cell therapy across China between August 2015 and March 2024. We evaluated the overall response rates, long-term efficacy, safety, and prognostic factors associated with CD19 CAR T-cell therapy. RESULTS: Complete remission (CR) or CR with incomplete hematologic recovery rate was 87.1% (81/93), with 96.3% (78/81) of responders achieving minimal residual disease negativity by flow cytometry. Molecular response rate was 78.5% (73/93), including 63.4% achieving complete molecular remission and 15.1% major molecular remission. Twenty patients underwent consolidative allogeneic hematopoietic stem cell transplantation (allo-HSCT). After a median follow-up of 25.4 months (range, 0.1-68.5), the median overall survival (OS) was 20.8 months, and the median leukemia-free survival (LFS) was 8.1 months. Better Eastern Cooperative Oncology Group performance status and absence of adverse genetic features were associated with improved OS and LFS. In contrast, consolidative allo-HSCT following CAR T-cell therapy was not independently associated with improved OS or LFS. Grade ≥ 3 cytokine release syndrome and neurotoxicity occurred in 14.0% and 2.2% of patients, respectively. The most common and predictable adverse events were hematologic, primarily cytopenias, which were manageable with supportive care. CONCLUSIONS: CD19 CAR T-cell therapy can achieve high response rates and long-term clinical benefits for patients with R/R Ph + B-ALL, with a manageable safety profile. STATEMENT OF PRIOR PRESENTATION: The preliminary study was presented as a poster presentation (Publication Number: 4201) at the 66th American Society of Hematology Annual Meeting, San Diego, CA, on December 7-10, 2024.
ADHD and adherence to antihypertensive medication treatment: a multinational cohort study.
Yao H, Zhou Y, Li L … +20 more , Gillies MB, Brikell I, Gao L, Wimberley T, Xie T, Zhang-James Y, Astrup A, Dalsgaard S, Semark BD, Engeland A, Faraone SV, Klungsøyr K, Larsson H, Man KKC, Snieder H, Wong ICK, Yuen ASC, Zoega H, Hartman C, Chang Z
BMC Med · 2026 Feb · PMID 41721349 · Full text
BACKGROUND: Adherence to antihypertensive medication, alongside lifestyle modifications, is fundamental to managing hypertension and reducing the risk of cardiovascular disease. Attention-deficit/hyperactivity disorder (...
BACKGROUND: Adherence to antihypertensive medication, alongside lifestyle modifications, is fundamental to managing hypertension and reducing the risk of cardiovascular disease. Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder associated with a range of cardiovascular diseases, including hypertension. ADHD medication has also been associated with hypertension. However, the influence of ADHD and ADHD medication on discontinuation and adherence to antihypertensive treatments is unknown. METHODS: We conducted a multinational cohort study using electronic health databases from seven countries, which included adults who initiated antihypertensive medication between 2010 and 2020. ADHD was identified by a diagnosis of ADHD or dispensation of ADHD medications. The outcomes were (1) time to the first discontinuation of antihypertensive medication and (2) poor adherence, defined as the proportion of days covered (PDC) below 80% during 1-, 2-, and 5-year follow-up periods. We used Cox proportional hazards models and logistic regression to estimate associations, adjusting for age, sex, and calendar year of antihypertensive medication initiation. We pooled results from different countries via random-effects meta-analysis. RESULTS: We identified 12,174,321 adults who initiated antihypertensive medication during the study period, including 320,691 (2.6%) with ADHD. In the pooled analysis across all countries, ADHD was associated with an increased rate of discontinuation in 5-year follow-up of antihypertensive medication (hazard ratio [HR] 1.14; 95% CI, 1.02-1.27). In age-stratified analyses, ADHD was associated with a higher rate of antihypertensive medication discontinuation in middle-aged (HR, 1.11; 95% CI, 1.01-1.23) and older adults (HR, 1.14; 95% CI, 1.01-1.29), but not in young adults. Individuals with ADHD also had higher odds of poor adherence across 1 year after treatment initiation (odds ratio [OR] 1.45, 95% CI 1.26-1.67) to 5 years (OR 1.64, 95% CI 1.34-2.00). Among those with ADHD, use of ADHD medications was associated with lower odds of poor adherence (1 year OR 0.66, 95% CI 0.60-0.73; 5 years OR 0.58, 95% CI 0.46-0.72). CONCLUSIONS: Adults with ADHD are more likely to discontinue antihypertensive treatment and exhibit poor medication adherence. However, ADHD medication use appears to be associated with better adherence among individuals with ADHD.
The effect of prenatal balanced energy and protein supplementation on small vulnerable newborn types in low- and middle-income countries: A systematic review and meta-analysis of individual participant data.
Wang D, Partap U, Liu E … +32 more , Costa JC, Cliffer IR, Wang M, Nookala SK, Subramoney V, Briggs B, Ahmed I, Argaw A, Ariff S, Bhandari N, Chowdhury R, Dailey-Chwalibóg T, Hanley-Cook GT, Huybregts L, Jehan F, Krebs NF, Lachat C, Manandhar DS, McClure EM, Moore SE, Muhammad A, Nisar MI, Prentice AM, Roberfroid D, Saville NM, Shafiq Y, Shrestha BP, Sonko B, Soofi S, Taneja S, Toe LC, Fawzi WW
PLoS Med · 2026 Feb · PMID 41701774 · Full text
BACKGROUND: Small vulnerable newborn (SVN) types, defined by combinations of being born too soon or too small, have distinct determinants, health consequences, and prevention strategies. The effects of prenatal balanced...
BACKGROUND: Small vulnerable newborn (SVN) types, defined by combinations of being born too soon or too small, have distinct determinants, health consequences, and prevention strategies. The effects of prenatal balanced energy and protein (BEP) supplementation on SVN types remain unknown. METHODS AND FINDINGS: We conducted a systematic review and meta-analysis of individual participant data from eight randomized controlled trials of prenatal BEP supplements (N = 10,252, with 5,164 in the BEP arm and 5,088 in the control arm) in low- and middle-income countries were used. The control arms varied across studies and included context-specific standards of care, iron and folic acid supplements, or multiple micronutrient supplements. Newborns were classified into 10 groups through the combinations of preterm birth, small for gestational age (SGA) birth, and low birthweight (LBW), such as term-appropriate-for-gestational-age (AGA)-nonLBW, preterm-SGA-LBW, preterm-large-for-gestational-age-LBW, term-SGA-LBW, preterm-AGA-nonLBW, and other permutations. Newborns were also analyzed using a four-group categorization that included term-nonSGA, preterm-nonSGA, term-SGA, and preterm-SGA. Log-binomial models were used to estimate study-specific risk ratios (RRs), which were pooled using meta-analyses. Subgroup analyses were conducted by maternal age, parity, gestational age at enrollment, early pregnancy body mass index, and maternal anemia status. In the 10-group categorization of SVNs, on average, prenatal BEP supplementation led to a 30% lower risk of preterm-SGA-LBW (RR: 0.70; 95% CI [0.53, 0.91]; P = 0.009), a 25% lower risk of preterm-AGA-LBW (RR: 0.75; 95% CI [0.60, 0.93]; P = 0.009), and a 20% lower risk of term-SGA-LBW (RR: 0.80; 95% CI [0.72, 0.90]; P < 0.001). In the four-group categorization, prenatal BEP supplementation led to a 31% lower risk of preterm-SGA (RR: 0.69; 95% CI [0.52, 0.91]; P = 0.008) and a 12% lower risk of term-SGA (RR: 0.88; 95% CI [0.81, 0.96]; P = 0.005). The protective effect of prenatal BEP supplementation on preterm-SGA was stronger among multiparous women and women without anemia. The protective effects on all three SVN types under the four-group categorization were stronger among women enrolled before 20 weeks of gestation. The main limitations of the study included the absence of some BEP trials and the small event numbers for some SVN types. CONCLUSIONS: Prenatal BEP supplementation reduces the risk of SVNs to varying extents. Further research is needed to determine the optimal targeting approach for providing BEP supplements to vulnerable pregnant women who are most likely to benefit from the supplementation.
Physical activity patterns and cardiovascular disease risk in adults with overweight or obesity: a prospective cohort study.
Mu K, Qiao Y, Lin R … +4 more , Yu Y, Zhao M, Magnussen CG, Xi B
BMC Med · 2026 Feb · PMID 41692732 · Full text
BACKGROUND: Cardiovascular disease (CVD) is a major global health burden, particularly among overweight and obese individuals. We aimed to investigate associations between different physical activity patterns (concentrat...
BACKGROUND: Cardiovascular disease (CVD) is a major global health burden, particularly among overweight and obese individuals. We aimed to investigate associations between different physical activity patterns (concentrated activity vs. regularly active) and incident CVD, and to compare their effects in this specific population. METHODS: Data were from the UK Biobank, with 49,368 overweight and obese individuals (63.50 ± 7.73 years; 51.4% women) included in this study from 2006-2010. Participants were categorized into three physical activity patterns: inactive (< 150 min/week of moderate-to-vigorous physical activity (MVPA)), regularly active (≥ 150 min/week of MVPA, with ≥ 50% of activity distributed over > 2 days/week), and concentrated activity (≥ 150 min/week of MVPA, with ≥ 50% concentrated on 1-2 days/week). RESULTS: In fully adjusted models, both the concentrated activity and regularly active patterns had a similar magnitude of CVD risk reduction compared with inactive individuals, overall CVD (concentrated activity: HR [95% CI]: 0.79 [0.74-0.85]; regularly active: 0.76 [0.70-0.83]), myocardial infarction (concentrated activity: 0.77 [0.67-0.88]; regularly active: 0.64 [0.53-0.76]), atrial fibrillation (concentrated activity: 0.81 [0.73-0.89]; regularly active: 0.84 [0.75-0.94]), heart failure (concentrated activity: 0.60 [0.52-0.70]; regularly active: 0.61 [0.50-0.73]), and stroke (concentrated activity: 0.79 [0.66-0.94]; regularly active: 0.81 [0.65-1.00]). CONCLUSIONS: Concentrated MVPA over 1-2 days (the concentrated activity pattern) was associated with reduced CVD risk in individuals with overweight or obesity, with a magnitude of risk reduction similar to that observed for regularly distributed activity.
Acceptability and safety of one versus three months of rifapentine and isoniazid to prevent tuberculosis in people exposed in the household or workplace in Brazil: The Ultra-Curto randomized controlled trial.
Durovni B, Cordeiro-Santos M, Cavalcante SC … +11 more , Spener-Gomes R, Garcia J, Cohn S, Saraceni V, Kohler B, Moulton LH, Brito da Souza A, Berihun A, Marzinke M, Chaisson RE, Ultra Curto Study Team
PLoS Med · 2026 Feb · PMID 41666121 · Full text
BACKGROUND: Short-course tuberculosis preventive therapy with isoniazid and rifapentine (HP) is widely recommended, but the acceptability and safety of one month of daily HP (1HP) compared to three months of weekly HP (3...
BACKGROUND: Short-course tuberculosis preventive therapy with isoniazid and rifapentine (HP) is widely recommended, but the acceptability and safety of one month of daily HP (1HP) compared to three months of weekly HP (3HP) is uncertain. We compared treatment with these two regimens in people with a positive latent tuberculosis infection test and without HIV infection. We hypothesized that 1HP would have greater treatment completion and fewer targeted safety events than 3HP. METHODS AND FINDINGS: We conducted a Phase 4 randomized trial of 1HP versus 3HP in adolescents and adults without HIV infection with recent tuberculosis exposure and a positive latent tuberculosis infection test in two sites in Brazil. The primary outcomes were successful completion of >90% of medication as ascertained by self-report, pill counts, and pharmacologic monitoring, and safety. Treatment safety was defined as occurrence of Grade >2 targeted events or discontinuation of treatment for side effects. We randomized 500 individuals to 1HP (249) and 3HP (251); 193 males and 307 females, with a median age of 39 years. Treatment completion was 89.6% for 1HP recipients versus 84.1% for 3HP recipients (site-adjusted risk difference 5.2%, [95% CI: [-0.1%, 11.2%], p = 0.10). Targeted >Grade 2 adverse safety events or treatment discontinuation occurred in 16.1% of 1HP recipients and 10.4% of 3HP recipients (site-adjusted risk difference 6.1%, [95%CI: [-0.04%, 12.3%], p = 0.05). The proportions who discontinued treatment for any side effect were 7.2% for 1HP and 4.4% for 3HP. The risk difference for the primary safety outcome adjusted for site and baseline demographic and clinical covariates was 3.4% (95% CI [-2.3,9.1%], p = 0.24). The trial was not designed to ascertain efficacy. CONCLUSION: Both 1HP and 3HP had high rates of treatment success. Participants assigned to 1HP had more targeted safety events, mostly low-grade. Neither regimen was superior to the other. These results will inform global guidelines for tuberculosis preventive therapy. NCT04703075 (clinicaltrials.gov).
Comparative efficacy and safety of acupuncture and moxibustion in the treatment of postprostatectomy urinary incontinence: A systematic review and network meta-analysis.
Tang Y, Cai Y, Xu F … +5 more , Wang X, Ding J, Qiao R, Cheng P, Gao Z
Medicine (Baltimore) · 2026 Jan · PMID 41559977 · Full text
BACKGROUND: To compare the efficacy and safety of different acupuncture and/or moxibustion methods in the treatment of postprostatectomy urinary incontinence using frequency-based network meta-analysis (NMA) method. METH...
BACKGROUND: To compare the efficacy and safety of different acupuncture and/or moxibustion methods in the treatment of postprostatectomy urinary incontinence using frequency-based network meta-analysis (NMA) method. METHODS: Randomized controlled trials (RCTs) on acupuncture and/or moxibustion for postprostatectomy urinary incontinence published from database inception to September 1, 2024, were identified through computerized searches of PubMed, Embase, Cochrane Library, CNKI, SinoMed, Wanfang Data, and VIP databases. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. NMA was conducted using Stata 16.0 software. RESULTS: A total of 17 RCTs involving 9 methods and 1286 patients were included. The NMA showed that needling-warm moxibustion was the most effective in improving the total effective rate, gentle moxibustion (GM) was the most effective in reducing International Consultation on Incontinence Questionnaire-Short Form, and standard acupuncture was the most effective in improving Incontinence Quality of Life Questionnaire. Electroacupuncture had the highest incidence of adverse events. Considering International Consultation on Incontinence Questionnaire-Short Form and Incontinence Quality of Life Questionnaire, GM may be the most ideal choice. CONCLUSION: Based on NMA, GM, needling-warm moxibustion, and standard acupuncture were found to have the highest probability of being the best therapies. Due to the limitations of this study, these results should be confirmed by detailed RCTs.
Oral Chinese patent medicines for herpangina in children: A network meta-analysis.
Wang Y, Chen B, Li M … +5 more , Tian Y, Zhang X, He M, Huo Y, Liu X
Medicine (Baltimore) · 2025 Dec · PMID 41465969 · Full text
INTRODUCTION: Herpangina, primarily caused by Enterovirus A71 and Coxsackievirus A, is characterized by fever, oropharyngeal pain, and ulcers. The prognosis is generally favorable. However, some severe cases may lead to...
INTRODUCTION: Herpangina, primarily caused by Enterovirus A71 and Coxsackievirus A, is characterized by fever, oropharyngeal pain, and ulcers. The prognosis is generally favorable. However, some severe cases may lead to complications such as febrile seizures and myocarditis. In recent years, clinical studies have demonstrated that combining oral Chinese patent medicines with conventional Western medicine can improve treatment efficacy. OBJECTIVE: To compare the efficacy and safety of oral Chinese patent medicines combined with conventional treatment for pediatric herpangina using network meta-analysis. METHOD: We systematically searched major Chinese and international databases from inception to January 1, 2024. Two researchers independently screened studies, extracted data, and assessed risk of bias (Cochrane tool). Statistical analysis was performed using Stata 16.0 and Review Manager 5.3 software. A network meta-analysis was conducted using a random-effects model. The odds ratio, and its 95% confidence interval (CI), were used as the effect measure for binary outcomes. The mean difference (MD), and its 95% CI, were used as the effect measure for continuous variables. Differences in efficacy and safety among interventions were compared and ranked independently. RESULT: 11 oral Chinese patent medicines, 61 studies, and 6805 patients were included. The antipyretic time was ranked from best to worst as XiaoerShuangjinqingre Oral Liquid (SJQR), Lianhuaqingwen Granules (LHQW), Pudilan Anti-inflammatory Oral Liquid (PDL), XiaoerNiuhuangqingxin Powder (NHQX), Lanqin Oral Liquid (LQ), XiaoerQingyan Granules (QY), Shuanghuanglian Oral Liquid (SHL), XiaoerChaiguituire Granule (CGTR), XiaoerChiqiaoqingre Granules (CQQR), Kouyanqing Granules (KYQ), and Shufengjiedu Capsules (SFJD). The herpes regression time was ranked from best to worst as SJQR, KYQ, PDL, CQQR, SHL, NHQX, LHQW, LQ, QY, SFJD, and CGTR. The incidence of adverse reactions was ranked from lowest to highest as CQQR, PDL, LQ, CGTR, LHQW, NHQX, SJQR. CONCLUSION: Combining oral Chinese patent medicines with conventional treatment effectively shortens the time of fever and herpes in children. Additionally, no increase in adverse events was observed in terms of safety when oral Chinese patent medicines were combined with conventional treatment. This study has been registered in the International Prospective Register of Systematic Reviews (PROSPERO), with a registration number CRD42024503831.
Efficacy and safety of acupoint catgut embedding for knee osteoarthritis: A systematic review and meta-analysis.
Zhao H, Liu Y, Yang C … +2 more , Lee J, Han CH
Medicine (Baltimore) · 2025 Dec · PMID 41431000 · Full text
BACKGROUND: Acupoint catgut embedding (ACE) is a therapeutic method for pain management that involves inserting a thread or catgut into the body with anti-hyperalgesic effect. This study aims to systematically review and...
BACKGROUND: Acupoint catgut embedding (ACE) is a therapeutic method for pain management that involves inserting a thread or catgut into the body with anti-hyperalgesic effect. This study aims to systematically review and comprehensively compare the effectiveness of ACE with that of each comparator in the treatment of knee osteoarthritis (OA). METHODS: We searched 11 databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, Chinese Biomedical Literature Database, Chinese Scientific Journal Database, WanFang Database, China National Knowledge Infrastructure, Oriental Medicine Advanced Searching Integrated System, Science-On, and KoreaMed) from their inception through August 1, 2023, without language limitations. Additionally, 2 registration platforms - ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry - were searched for ongoing trials. The primary outcomes were assessed using a visual analog scale (VAS) and the Western Ontario and McMaster Universities OA Index. The secondary outcomes included the total effective rate, Lysholm score, and adverse effects. The risk of bias was assessed using the Cochrane handbook. The meta-analysis was performed using review manager, while the quality of evidence was evaluated using GradePro. RESULTS: A total of 28 randomized controlled trials were included in the present study, encompassing 2120 participants. The most frequently used acupoint was GB34. The overall risk of bias was unclear. According to the meta-analysis results, the combination of ACE and conventional treatments showed higher effectiveness in term of the VAS, Western Ontario and McMaster Universities OA Index, total effectiveness, and Lysholm scores. Moreover, compared with the sham ACE control, the results showed that the combination of ACE and conventional treatments was more beneficial in term of the VAS, Western Ontario and McMaster Universities OA Index, and total effectiveness. CONCLUSION: Despite some potential improvement, the current evidence regarding the effectiveness of ACE for the treatment of knee OA is inconclusive due to the poor quality of the available evidence. Future well-designed randomized controlled trials are needed to confirm ACE's effectiveness for treating knee OA.
Research and practice on key drug safety monitoring under the normalization of centralized procurement: A case study of 13 selected drugs in a Province.
Ding G, Ding J
Medicine (Baltimore) · 2025 Dec · PMID 41398809 · Full text
The National Centralized Volume-Based Procurement policy for drugs has effectively reduced drug prices but has raised concerns regarding quality and safety. To address these issues, adverse drug reactions (ADR) are monit...
The National Centralized Volume-Based Procurement policy for drugs has effectively reduced drug prices but has raised concerns regarding quality and safety. To address these issues, adverse drug reactions (ADR) are monitored through a national system. As the policy stabilizes, real-world data (RWD) may improve, making ongoing monitoring crucial for studies and assessments. This study monitored 13 drug types from batches 1 to 8 across 39 provincial hospitals, supplied by 12 marketing authorization holders. We compared tracking data with the "National Adverse Drug Reaction Monitoring System" to analyze reporting rates of ADR and identify risk signals for rational drug use in practice. The monitoring period was from May to December 2023, and routine data from 2019 to 2022 were analyzed using descriptive statistics and comparative methods. A safety evaluation of 13 drug types across 39 hospitals revealed ADR rates ranging from 0 to 4.58% and serious reactions ranging from 0 to 1.97%, with 4 identified risk signals. In comparison, routine monitoring indicated lower rates: 0 to 1.20% for ADR and 0 to 0.80% for serious reactions, with one risk signal. Despite these differences, the ADR risks associated with all drugs were manageable, with no unexpected events exceeding label listings. These findings suggest that the safety of domestic generic drugs is comparable to that of originator drugs, supporting the effectiveness of China's centralized procurement policy. This study aims to enhance coordination among the healthcare, insurance, and pharmaceutical sectors by improving the supervision of drug procurement and RWD research. It emphasizes the need for rigorous monitoring to address safety concerns.
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