Dong PTX, Pham VTT, Nguyen LT
… +7 more, Le AV, Nguyen TT, Vu HD, Nguyen HTL, Nguyen HT, Hua S, Li SC
J Clin Pharm Ther
· 2022 Dec · PMID 36543256
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WHAT IS KNOWN AND OBJECTIVE: Unintentional medication discrepancies (UMDs) are common in geriatric patients during care transitions, resulting in frequent undesirable consequences. Medication reconciliation could be a us...WHAT IS KNOWN AND OBJECTIVE: Unintentional medication discrepancies (UMDs) are common in geriatric patients during care transitions, resulting in frequent undesirable consequences. Medication reconciliation could be a useful practice to prevent or ameliorate UMD. However, this practice in Vietnamese hospitals has not been well established or standardized. This study aims to determine the effect of pharmacist-initiated educational interventions on improving medication reconciliation practice. METHODS: This prospective 6-month pre-and post-study was conducted in two internal medicine wards in a Vietnamese 800-bed public hospital. Pharmacists provided training and short-term support to physicians on medication reconciliation. Primary outcome measures were the proportions of patients with at least one UMD at admission. Secondary outcome measures were the proportions of patients with preventable adverse drug events (pADEs) score ≥0.1 due to these UMDs. Odds ratio and 95% confidence intervals were assessed based on a multivariate logistic regression model. RESULTS AND DISCUSSION: One hundred fifty-two patients were recruited in the pre-intervention phase, and 146 in the post-intervention phase. Following the intervention, the proportion of geriatric patients with ≥1 UMD at admission significantly decreased from 55.3 to 25.3 % (ORadj 0.255, 95% CI: 0.151-0.431). Similarly, the proportion of patients with a pADE ≥0.1 at admission reduced from 44.1 to 11.6% [ORadj 0.188, 95% CI: 0.105-0.340] post-intervention. WHAT IS NEW AND CONCLUSION: Our pharmacist-initiated educational interventions have demonstrated the ability to produce substantial improvement in medication reconciliation practice, reducing UMDs and potential harm. Our approach may provide an alternate option to implement medication reconciliation for jurisdictions with limited healthcare resources.
WHAT IS KNOWN AND OBJECTIVE: Retinal vein occlusion (RVO) is one of the most common causes of vision loss. Anti-vascular endothelial growth factor (anti-VEGF) drugs, ranibizumab and aflibercept, and corticosteroid implan...WHAT IS KNOWN AND OBJECTIVE: Retinal vein occlusion (RVO) is one of the most common causes of vision loss. Anti-vascular endothelial growth factor (anti-VEGF) drugs, ranibizumab and aflibercept, and corticosteroid implants are approved treatment options for RVO-related macular edema (ME) in Turkey. To the best of our knowledge, there is no data regarding the off-label use of these drugs for RVO in English literature. We aimed to evaluate the clinical and demographic characteristics of off-label drug use applications in Turkey for RVO. METHODS: Applications made to the Turkish Medicines and Medical Devices Agency between January 1 and December 31, 2018, for the use of off-label drugs (ranibizumab, aflibercept, dexamethasone implant) for the diagnosis of RVO from hospitals across Turkey were retrospectively analysed. Data of the applications, such as demographic characteristics, previous treatment regimens, reasons for applications, applicant hospitals and their regions, were recorded. RESULTS: There were 291 approved applications for RVO. The mean age of the patients was 64.88 ± 10.78 years, 48.8% were male, and 51.2% were female. Of these applications, 44.7% were for aflibercept, 35.7% for ranibizumab and 19.6% for dexamethasone implant. No application was made for bevacizumab since it could be used without needing for an application. The most common reasons for applications were due to dose limitations, failure to complete loading doses, and glaucoma, respectively. In terms of the distribution of the applicant hospitals, public university hospitals ranked first with 72.5%, training and research hospitals ranked second with 14.7% and foundation university hospitals ranked third with 13.1% rates. WHAT IS NEW AND CONCLUSION: The practice of drug use in RVO in Turkey has changed as of the beginning of 2019. Stepwise therapy has been accepted by the drug regulatory agency Turkish Medicines and Medical Devices Agency. Utilization of licensed drugs, aflibercept, ranibizumab and dexamethasone has been allowed only after administration of 3 doses of intravitreal bevacizumab. After 3 doses of bevacizumab, the physician may continue either with bevacizumab again or a dexamethasone implant. If there is a reason such as the presence of glaucoma, the physician may skip dexamethasone and switch to aflibercept and ranibizumab, but in this case, dexamethasone cannot be administered to the patient for life. The evaluation of the off-label treatments of RVO, which is one of the most frequently followed diseases in retina clinics, not only contributes to the literature but also provides information regarding the most frequently applied treatments and the physicians' off-label drug preferences for RVO.
Rahmani E, Lemelle T, Sharp H
… +2 more, Smarbafzadeh E, Kablinger A
J Clin Pharm Ther
· 2022 Dec · PMID 36543254
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WHAT IS KNOWN AND OBJECTIVE: Traumatic brain injury (TBI) is a major cause of disability, and it has been associated with agitation and aggression. In a previous study, we reviewed the literature to identify evidence-bas...WHAT IS KNOWN AND OBJECTIVE: Traumatic brain injury (TBI) is a major cause of disability, and it has been associated with agitation and aggression. In a previous study, we reviewed the literature to identify evidence-based pharmacological agents for treatment of agitation in TBI. Based on the results of our previous study that summarizes the findings of several systematic reviews, the use of haloperidol and benzodiazepines is not supported by the available evidence while the use of amantadine, beta blockers, antiepileptics and methylphenidate is supported by the limited available evidence. In this study, we describe the psycho-pharmacological agents that were administered to patients with agitation and/or aggression in the context of TBI in inpatient facilities of a private, non-profit health care system in southwest Virginia. We will also compare the psycho-pharmacological agents ordered before and after psychiatric consultation. METHODS: Adult patients who were admitted to Carilion Clinic's inpatient facilities from March 30, 2013, to March 30, 2018, had a diagnosis of TBI, and received psychiatric consultation for agitation and/or aggression were enrolled in this study. A retrospective review of electronic medical records was conducted by researchers and data were collected on the following measures: ordered psycho-pharmacological agents, frequency, dosing and duration of orders, whether each administered psycho-pharmacological agent was started before or after psychiatric consultation, and psycho-pharmacological agents prescribed upon discharge. RESULTS AND DISCUSSION: About 68% of patients were started on benzodiazepines and/or typical antipsychotics and 23% of patients were subsequently discharged on these medication categories. Only 23% of patients were ordered to receive medications supported by the evidence such as amantadine, beta blockers or antiepileptics. The percentage of patient-days with an order to receive typical antipsychotics significantly decreased following psychiatric consultation (p = 0.0056), but the percentage of patient-days with an order to receive benzodiazepines significantly increased following psychiatric consultation (p = 0.0001). This finding remained statistically significant after excluding patients with active or unclear alcohol/benzodiazepine withdrawal (p < 0.0001). WHAT IS NEW AND CONCLUSION: This study demonstrates the widespread use of typical antipsychotics and benzodiazepines in the management of agitation in TBI and the importance of multidisciplinary collaboration, research and education of providers to improve patient care.
WHAT IS KNOWN AND OBJECTIVE: Low treatment persistence and adherence in patients with dementia results in a rapid loss of disease control. This pilot study evaluated the impact of pharmacist-provided caregiver counsellin...WHAT IS KNOWN AND OBJECTIVE: Low treatment persistence and adherence in patients with dementia results in a rapid loss of disease control. This pilot study evaluated the impact of pharmacist-provided caregiver counselling on treatment persistence, adherence, quality of life (QoL) in patients with dementia, as well as caregiver's knowledge of dementia, and caregiver burden. METHODS: This prospective, randomized controlled study was performed at a hospital-based pharmacist-managed clinic from December 2017 to December 2019. Patients with mild-to-moderate Alzheimer's disease (AD), initiating cholinesterase inhibitors within 3 months, and coming with their caregivers were included and randomized 1:1 to intervention or control group. The intervention group received pharmacist counselling and education sheets about AD, whereas the control group only received standard of care. Patients' treatment persistence and adherence were assessed at months 3, 6, 9, and 12; QoL, and caregiver burden were assessed at baseline and month 12. Caregiver's knowledge of dementia was assessed at baseline and 2 weeks after counselling in the intervention group. Nonparametric statistics and generalized estimating equation models were used for statistical analysis. RESULTS AND DISCUSSION: A total of 40 patients and 40 caregivers were included, with 20 pairs for each group. One-year medication persistence (16/20 vs. 16/20) and adherence rates (87%-99%) were high in both groups without significant differences. Dementia knowledge scores improved significantly after counselling in the intervention group (77.5 vs. 95.8, p < 0.01). Although the change of caregiver burden was non-significant between groups, the score decreased in the intervention group (-0.89; p = 0.78) but increased in the control group (+6.01; p = 0.07). WHAT IS NEW AND CONCLUSION: In this pilot study, pharmacist's counselling for patients with dementia and their caregivers is feasible and can enhance caregiver knowledge of dementia. Further study with larger scale is needed to confirm the impact on these outcomes.
WHAT IS ALREADY KNOWN AND OBJECTIVE: Sedation is routinely provided for patients undergoing gastrointestinal endoscopy. Remimazolam tosilate is a novel and short-acting sedative agent that has been used for sedation duri...WHAT IS ALREADY KNOWN AND OBJECTIVE: Sedation is routinely provided for patients undergoing gastrointestinal endoscopy. Remimazolam tosilate is a novel and short-acting sedative agent that has been used for sedation during endoscopic procedures. The optimal dose of remimazolam in gastrointestinal endoscopy for patients with liver cirrhosis has not been elucidated. BACKGROUND: To determine the effective dose of remimazolam tosilate with adjuvant sufentanil for sedation in patients with liver cirrhosis undergoing oesophagogastric varices screening endoscopy. MATERIAL AND METHODS: Patients aged 18-65 years with liver cirrhosis undergoing screening endoscopy for oesophagogastric varices were recruited. Sufentanil 0.15 μg/kg was given intravenously at 2 min before administration of remimazolam tosilate. The initial dose of remimazolam was 0.1 mg/kg and adjusted by 0.025 mg/kg as a step size, based on the Dixon and Massay up-and-down sequential method. Inclusion of patients was stopped after eight crossovers and the calculated median effective dose (ED ) of remimazolam for successful endoscopy was obtained by calculating the mean of midpoint of all crossovers. Furthermore, a probit regression was applied to establish the dose-response curve of remimazolam and further assess the 95% effective dose (ED ) of remimazolam. RESULTS: The calculated ED of remimazolam for successful endoscopy using the mean of midpoint of all crossovers was 0.097 mg/kg (95% CI, 0.004-0.099 mg/kg). Using the probit regression analysis, the ED and ED of remimazolam for successful endoscopy was 0.097 mg/kg (95% CI, 0.004-0.099 mg/kg) and 0.107 mg/kg (95% CI, 0.103-0.336 mg/kg), respectively. No adverse events were observed throughout the study period. CONCLUSIONS: This pilot study suggests that the ED and ED of remimazolam tosilate with adjuvant sufentanil for sedation in liver cirrhosis patients undergoing oesophagogastric varices screening endoscopy was 0.097 and 0.107 mg/kg, respectively.
WHAT IS KNOWN AND OBJECTIVE: Immune disorder is a key trigger of recurrent spontaneous abortion (RSA); meanwhile, tumour necrosis factor inhibitor (TNFi) is a fundamental therapeutic for multiple immune and inflammatory...WHAT IS KNOWN AND OBJECTIVE: Immune disorder is a key trigger of recurrent spontaneous abortion (RSA); meanwhile, tumour necrosis factor inhibitor (TNFi) is a fundamental therapeutic for multiple immune and inflammatory diseases. Hence, this real-world study aimed to explore the efficacy and safety of TNFi combined with intravenous immunoglobin (IVIG) and heparin therapy in RSA patients. METHODS: A total of 105 RSA patients who received TNFi+IVIG+Heparin (enoxaparin) (n = 48) or IVIG+Heparin (enoxaparin) (n = 57) were retrospectively included in this two-centre cohort study. RESULTS AND DISCUSSION: The live birth rate of RSA patients in the TNFi+IVIG+heparin group was 72.9% (95% confidence interval [CI]: 69.6%-85.9%). Besides, the live birth rate in the IVIG+heparin group was 52.6% (95% CI: 42.8%-62.4%). By comparison, the live birth rate was higher in the TNFi+IVIG+heparin group compared to the IVIG+heparin group (p = 0.033). After adjustment by the multivariate logistic regression model using the enter method, TNFi+IVIG+Heparin was also superior to IVIG+Heparin regarding increased live birth rate (odds ratio [OR] = 2.941, p = 0.015). Moreover, TNFi+IVIG+Heparin (vs. IVIG+Heparin) also served as an independent factor for increased live birth rate (OR = 2.423, p = 0.035) by the forward stepwise method in the multivariate analysis. Gestational weeks at delivery (38.3 ± 1.3 vs. 37.7 ± 2.0 weeks, p = 0.155), newborn weight (3123.9 ± 332.1 vs. 3056.6 ± 287.4 g, p = 0.390), Apgar score of newborns (9.8 ± 0.5 vs. 9.7 ± 0.7, p = 0.271) were of no difference between TNFi+IVIG+Heparin and IVIG+Heparin groups. In terms of safety profile, the adverse events were of no difference between the TNFi+IVIG+Heparin and the IVIG+Heparin groups (all p > 0.05), either. WHAT IS NEW AND CONCLUSION: TNFi combined with IVIG and heparin therapy improves the live birth rate but does not elevate the adverse events compared to IVIG and heparin therapy in RSA patients.
WHAT IS KNOWN AND OBJECTIVE: Individuals with medication adherence challenges or a preference for long-acting medications may benefit from extended-release naltrexone (XR-NTX) for treatment of alcohol use disorder (AUD)....WHAT IS KNOWN AND OBJECTIVE: Individuals with medication adherence challenges or a preference for long-acting medications may benefit from extended-release naltrexone (XR-NTX) for treatment of alcohol use disorder (AUD). Individuals on therapeutic anticoagulation were excluded from XR-NTX studies and its safety in this population has not been reported. CASE SUMMARY: We conducted structured retrospective chart review of six individuals who received XR-NTX for AUD while on therapeutic anticoagulation between November 2019 and Deccember 2020. We found no documented complications among six individuals who received up to 11 doses of XR-NTX while on therapeutic anticoagulation. WHAT IS NEW AND CONCLUSION: XR-NTX may be safely tolerated by patients on therapeutic anticoagulation. We need larger studies evaluating XR-NTX administration in patients on therapeutic anticoagulation and those with coagulopathies, including individuals with alcohol-related liver disease, to better quantify risks and benefits for shared decision-making.
OBJECTIVE: The current study aimed to comprehensively evaluate the potential effects of mulberry consumption on cardiometabolic risk factors in adults. METHODS: Relevant articles published up to January 2021 were systema...OBJECTIVE: The current study aimed to comprehensively evaluate the potential effects of mulberry consumption on cardiometabolic risk factors in adults. METHODS: Relevant articles published up to January 2021 were systematically retrieved from SCOPUS, PubMed/MEDLINE, EMBASE, and Web of Science databases. We included all randomized controlled trials (RCTs) investigating the impact of mulberry consumption on various cardiometabolic risk factors. RESULTS: The quantitative meta-analysis of 12 eligible RCTs demonstrated a significant reducing effect of mulberry consumption on haemoglobin A1c (HbA1c) (weighted mean difference [WMD]: -0. 55, 95% CI: -1.08, -0.02, p = 0.044), serum total cholesterol (TC) (WMD: -13.13 mg/dl, 95% CI: -19.06, -7.20, p < 0.001), low-density lipoprotein levels (LDL-C) (WMD: -8.84 mg/dl, 95% CI: -13.26, -4.42, p < 0.001), triglycerides (TG) (WMD: -19.67 mg/dl, 95% CI: -30.13, -9.22, p < 0.001) and C-reactive protein (CRP) (WMD: -1.60, mg/L, 95% CI: -3.07, -0.12, p = 0.034). Also, >300 mg daily intake of mulberry exhibited a favourable effect on serum high-density lipoprotein levels (HDL-C). However, there were no significant differences between mulberry intervention and control groups for other factors. CONCLUSION: The current systematic review and meta-analysis revealed that incorporating mulberry into the diet may favourably affect several cardiometabolic risk factors.
WHAT IS KNOWN AND OBJECTIVE: Programmed cell death protein-1 (PD-1) inhibitors synergize apatinib for anti-tumour effect by regulating tumour microenvironment, vascular endothelial growth factor, hypoxia condition, immun...WHAT IS KNOWN AND OBJECTIVE: Programmed cell death protein-1 (PD-1) inhibitors synergize apatinib for anti-tumour effect by regulating tumour microenvironment, vascular endothelial growth factor, hypoxia condition, immune response, etc. This study aimed to investigate the treatment efficacy and safety of camrelizumab (PD-1 inhibitor) plus apatinib as third-line or above therapy in metastatic colorectal cancer (mCRC) patients. METHODS: Totally, 64 unresectable mCRC patients receiving camrelizumab plus apatinib (N = 31) and apatinib (N = 33) were retrospectively enrolled. RESULTS: Disease control rate (80.6% vs. 57.6%) (P = 0.047) was elevated in camrelizumab plus apatinib group compared to apatinib group; however, objective response rate (22.6% vs. 6.1%) (P = 0.078) only showed an increasing trend but did not achieve statistical significance. Besides, the median (95% confidence interval [CI]) progressive-free survival (PFS) and overall survival (OS) were 6.9 (3.7-10.1) and 11.5 (7.7-15.3) months in camrelizumab plus apatinib group; meanwhile, the median (95% CI) PFS and OS were 3.6 (1.7-5.5) and 6.7 (5.0-8.4) months in the apatinib group. Additionally, PFS (P = 0.017) and OS (P = 0.006) were prolonged in camrelizumab plus apatinib group compared with apatinib group, which was confirmed by further multivariate Cox's proportional hazards regression analysis (hazard ratio [HR] = 0.340, P < 0.001 for PFS; HR = 0.271, P < 0.001 for OS). The incidence of total, grade 1-2, and grade 3-4 adverse events did not differ between groups (all P > 0.05). CONCLUSION: Camrelizumab (PD-1 inhibitor) plus apatinib achieves a better treatment efficacy than apatinib as third-line or above therapy with a good safety profile in mCRC patients.
WHAT IS KNOWN AND OBJECTIVE: To Investigate the pharmacokinetic/pharmacodynamic (PK/PD) parameters of high-dose tigecycline in plasma and sputum of patients with hospital-acquired pneumonia (HAP), and provide a therapeut...WHAT IS KNOWN AND OBJECTIVE: To Investigate the pharmacokinetic/pharmacodynamic (PK/PD) parameters of high-dose tigecycline in plasma and sputum of patients with hospital-acquired pneumonia (HAP), and provide a therapeutic regimen of multidrug-resistant bacteria (MDRB) infections. METHODS: Blood/sputum samples were collected at intervals after tigecycline had reached a steady-state. Tigecycline concentrations in specimens were determined by high-performance liquid chromatography (HLPC), PK parameters were evaluated by WinNonlin software using a non-compartment model. The probability of target attainments (PTAs) at different minimal inhibitory concentrations (MICs) were calculated for achieving the PK/PD index with Crystal Ball software by 10,000-patient Monte Carlo Simulation. RESULTS: In plasma, the maximum concentration (C ) and area under the concentration-time curve from 0 to 12 h (AUC ) were 2.21 ± 0.17 mg/L and 15.29 ± 1.13 h mg/L, respectively. In sputum, they were 2.48 ± 0.21 mg/L and 19.46 ± 1.82 h mg/L, respectively. The mean lung penetration rate was 127.27%. At the MIC ≤4 mg/L, the PTAs in plasma and sputum were 100.00%. When the MIC increased to 8 mg/L, the PTAs in plasma and sputum mostly were < 90.00% according to two criteria. WHAT IS NEW AND CONCLUSION: In this study, we explored PK/PD of high-dose tigecycline in plasma and sputum. From a PK/PD perspective, high-dose tigecycline had greater therapeutic outcomes in HAP treatment caused by MDRB. Antimicrobial-drug concentrations should be determined to optimize their clinical use.
WHAT IS KNOWN AND OBJECTIVE: Daratumumab, an anti-CD38 monoclonalantibody, is a safe and effective antibody used in the treatment of multiple myeloma (MM), which is rarely reported to cause severe pulmonary complications...WHAT IS KNOWN AND OBJECTIVE: Daratumumab, an anti-CD38 monoclonalantibody, is a safe and effective antibody used in the treatment of multiple myeloma (MM), which is rarely reported to cause severe pulmonary complications. CASE SUMMARY: A 58-year-old man diagnosed with MM and preexisting interstitial lung disease developed a high fever and severe dyspnea after administering Daratumumab and bortezomib-containing regimen. Chest CT showed bilaterally and diffused ground-glass opacities and consolidations. A quick improvement was achieved in both clinical symptoms and chest imaging findings through the administration of large doses of methylprednisolone, followed by oral prednisolone. WHAT IS NEW AND CONCLUSION: This is the first case reporting Daratumumab and bortezomib-containing regimen-induced lung injury characterized by preexisting interstitial lung disease.
WHAT IS KNOWN AND OBJECTIVE: The study aimed to assess acceptability and patient experience of Certolizumab (CZP) self-injection with AVA® and clarify patient device preference after switching CZP from the syringe or aut...WHAT IS KNOWN AND OBJECTIVE: The study aimed to assess acceptability and patient experience of Certolizumab (CZP) self-injection with AVA® and clarify patient device preference after switching CZP from the syringe or auto-injection pen to AVA® in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) patients. METHOD: A multicentre open-label, cross-sectional and prospective study among four Spanish hospitals was performed. Adult RA, PsA, axSpA patients treated for at least 6 months with the CZP syringe or pen were recruited. At the first visit, patients completed Pre-AVA® questionnaire. Patients were instructed on proper administration of CZP by AVA®. After 2 and 6 months of CZP self-injections using the AVA®, patient experience, adherence, preference and safety of each administration was assessed using post-AVA® questionnaire. RESULTS AND DISCUSSION: Thirty four patients were included (28 women). All patients self-administered CZP AVA® the full dose of CZP was injected. Patients reported >90% adherence to CZP AVA® assessed with the injection log. Pain at the injection site was reduced after switching to AVA®. Twenty nine patients preferred CZP AVA® and five patients preferred the CZP pen. No safety-related findings related to AVA® CZP administration were identified. WHAT IS NEW AND CONCLUSION: The AVA® is an advantageous delivery option for CZP in patients with RA, PsA, axSpA.
WHAT IS KNOWN AND OBJECTIVE: Posaconazole is the second-generation triazole antifungal agent with widespread clinical application. Posaconazole exposure is influenced by various factors such as drug interactions, disease...WHAT IS KNOWN AND OBJECTIVE: Posaconazole is the second-generation triazole antifungal agent with widespread clinical application. Posaconazole exposure is influenced by various factors such as drug interactions, disease state and diet, resulting in a high interindividual variability in many patients and failure to ensure therapeutic efficacy. Therefore, it is necessary to conduct individualized therapy on posaconazole to ensure the efficacy and safety of treatment. METHODS: Articles were identified through PubMed using the keywords such as "posaconazole," "therapeutic drug monitoring" and "Population pharmacokinetics" from 1 January 2001 to 30 April 2022. RESULTS AND DISCUSSION: In this paper, we review the individualized treatment studies of posaconazole from the three aspects of therapeutic drug monitoring, population pharmacokinetic study and Monte Carlo simulation to provide reference for in-depth individualized posaconazole dosing studies. WHAT IS NEW AND CONCLUSION: This review suggests that therapeutic drug monitoring should be performed in patients taking posaconazole to adjust the dosage and assess the efficacy and cost-effectiveness of posaconazole under different clinical conditions and different dosing regimens through Monte Carlo simulations. In the future, a more detailed delineation and comprehensive examination of posaconazole PPK for specific populations requires further study.
WHAT IS KNOWN AND OBJECTIVE?: The latest published guidelines advocate for the area under the concentration-time curve to minimal inhibitory concentration (AUC /MIC) estimated with bayesian calculations. This recommended...WHAT IS KNOWN AND OBJECTIVE?: The latest published guidelines advocate for the area under the concentration-time curve to minimal inhibitory concentration (AUC /MIC) estimated with bayesian calculations. This recommended pharmacokinetic monitoring transition is not based on randomized controlled prospective data. METHODS: In this open-label feasibility RCT, patients were assigned to have their vancomycin dosing adjusted based on bayesian-guided AUC /MIC or trough levels. Primary outcomes were consent rate, number of patients recruited per month, compliance with blood sampling schedule and compliance with bayesian software recommendations. Secondary outcomes focused on target attainment, safety and operational impacts. RESULTS AND DISCUSSION: Forty-five patients underwent randomization (23 bayesian, 22 trough). Consent rate was 37,5% for an average of 9.8 patients recruited per month meeting pre-specified objectives of 30% (p = 0.073) and 10 (p = 0.74) respectively. A 74.8% compliance with blood sampling schedule was below the pre-specified objective of 80% (p = 0.038). There was no statistically significant difference between the 83.7% compliance with bayesian software recommendations and the pre-specified objective of 90% (p = 0.21). Although exploratory, key clinical results were significant increases in the bayesian group for proportion of levels at target (RR 1.32; 95% CI 1.01-1.72; P = 0.038), number of blood samplings for patients (p = 0.036) and pharmacists' time spent on monitoring (p < 0.0001). A tendency towards a reduced incidence of nephrotoxicity in the Bayesian group was observed (RR 0.57; 95% CI 0.16-2.12; p = 0.46). WHAT IS NEW AND CONCLUSIONS?: This trial demonstrates that it would be feasible to conduct a properly sized RCT comparing vancomycin Bayesian-guided AUC /MIC to trough level monitoring. Although exploratory, this trial also showed a tendency towards reduced incidence of nephrotoxicity and an increased proportion of dosages at therapeutic targets with Bayesian monitoring.
WHAT IS KNOWN AND OBJECTIVE: Many patients with acute ischemic stroke (AIS) develop early neurological deterioration (END), leading to disabilities or death. Thus, this study aimed to investigate the efficacy and safety...WHAT IS KNOWN AND OBJECTIVE: Many patients with acute ischemic stroke (AIS) develop early neurological deterioration (END), leading to disabilities or death. Thus, this study aimed to investigate the efficacy and safety of intravenous tirofiban in treating patients with AIS and END who missed the thrombolysis time window. METHODS: A total of 123 AIS-END patients participated in the study between January 2021 and December 2021. Patients were randomized into the tirofiban group (n = 63) and the control group (n = 60) based on whether a tirofiban injection was administered. The National Institute of Health Stroke Scale (NIHSS) was used to assess neurological function at the 48th hour and on the 7th day after intervention, and the modified Rankin Scale (mRS) was used to assess neurological recovery 90 days after AIS. Adverse reactions during the intervention were recorded for safety analysis. RESULTS AND DISCUSSION: The 7th day NIHSS and 90th day post-AIS mRS scores of the tirofiban group were significantly lower than those of the control group (p < 0.05), while the 90th day good prognosis (mRS ≤ 2) rate of the tirofiban group was significantly higher (84.13% vs. 65.00%, p < 0.05). Logistic regression demonstrated a protective effect of tirofiban for good prognosis in AIS patients with END (OR = 4.675, 95% CI [1.012-21.605], p < 0.05). No cases of intracranial haemorrhage transformation or death were observed during the treatment in either group. WHAT IS NEW AND CONCLUSION: Tirofiban injection exhibited a high safety profile and significantly improved the prognosis of AIS-END patients who missed the intravenous thrombolysis time window.
WHAT IS KNOWN AND OBJECTIVES: Present study evaluated the safety profile and efficacy of G-Rup® syrup (100 mg/ml ginger extract plus 150 mg/ml honey) in symptomatic treatment of knee osteoarthritis (OA). METHODS: Patient...WHAT IS KNOWN AND OBJECTIVES: Present study evaluated the safety profile and efficacy of G-Rup® syrup (100 mg/ml ginger extract plus 150 mg/ml honey) in symptomatic treatment of knee osteoarthritis (OA). METHODS: Patients diagnosed with knee OA were randomly assigned (1:1) to receive either of a 30 ml twice daily regimen of G-Rup® syrup or placebo over a 12-week period. Primary endpoints of the study comprised of an improvement in the joint's stiffness, physical functioning and pain score, assessed by WOMAC questionnaire and the visual analog scale (VAS). Secondary objectives comprised of safety and tolerability of the syrup by patients. RESULTS AND DISCUSSION: The 30 ml twice-daily regimen of G-Rup® syrup was safe and well tolerated by patients. Moreover, in whole studied time points, treatment with G-Rup® syrup could significantly Power the VAS score (p < 0.001) whereas improving WOMAC total score (p < 0.001) and pain (p < 0.001), physical functioning (p < 0.001), and stiffness sub-scores (p = 0.006) compared to the placebo receiving group. WHAT IS NEW AND CONCLUSION: Based on obtained results, the G-Rup® syrup, composed of a combination of honey and ginger, may be a proper supplementary choice, along with routine therapeutic regimens, for improvement of symptomatic treatment of OA.
WHAT IS KNOWN AND OBJECTIVE: The management of biological agents during pregnancy poses challenges as maternal and infant safety must be addressed. This study aims to compare the recommendations of existing guidelines on...WHAT IS KNOWN AND OBJECTIVE: The management of biological agents during pregnancy poses challenges as maternal and infant safety must be addressed. This study aims to compare the recommendations of existing guidelines on managing the use of biologics during pregnancy, lactation for patients with inflammatory bowel disease, and the influence on neonatal vaccination. METHODS: The PubMed, EMBASE, China National Knowledge Infrastructure, Wanfang database, China Science and Technology Journal Database and China Biomedical Database were systematically searched from the inception date to 11 May 2022, to screen all relevant guidelines. Quality assessment was performed using the guideline methodology reporting tool AGREE II. RESULTS AND DISCUSSION: Fourteen guidelines and consensus statements with detailed recommendations were included. All guidance documents cover management comments during pregnancy, and most consider that biologics can be given safely during pregnancy but require suspension at the right time to protect the foetus. However, the roles of vedolizumab and ustekinumab are disputed. Five documents guide lactation and the use of most biologics during lactation is safe, but no guidelines recommend vedolizumab. Six papers provide recommendations for newborns' vaccination, suggesting a delay in infants' live vaccination schedule if their mothers are treated with biologics. WHAT IS NEW AND CONCLUSION: Our study concluded that future guidelines could consider incorporating newer, more robust evidence to update recommendations. The development of future guidelines needs to consider the involvement of multidisciplinary experts, adequately report on the evidence retrieval process, and provide strategies for implementation. Besides, more research is needed to explore the use of biologics during pregnancy and lactation in patients with inflammatory bowel disease.
WHAT IS KNOWN AND OBJECTIVE: Antiestrogen agents have been reported to enhance the anticoagulant activity of warfarin. The use of tamoxifen with warfarin has been contraindicated. However, warfarin in combination with to...WHAT IS KNOWN AND OBJECTIVE: Antiestrogen agents have been reported to enhance the anticoagulant activity of warfarin. The use of tamoxifen with warfarin has been contraindicated. However, warfarin in combination with toremifene has not been reported. We report a case in which warfarin was combined with toremifene and applied warfarin dose prediction models to predict the dose of warfarin. CASE SUMMARY: We report the case of a 50-year-old woman with a history of breast cancer, who underwent long-term toremifene therapy after mastectomy. The patient was treated with warfarin after prosthetic valve replacement and had a fluctuating international normalized ratio (INR) following the concomitant administration of toremifene. We applied the warfarin dose prediction model to adjust the warfarin dose during treatment. Finally, her INR stabilized with a lower dose of warfarin, and there was no serious bleeding during the 1-year follow-up. WHAT IS NEW AND CONCLUSION: Warfarin does not have a serious interaction with toremifene in this case, but it needed about 37.5% dose reduction which was comparable to the interaction of some common antibiotics with warfarin.
WHAT IS KNOWN AND OBJECTIVE: Tietze syndrome is a rare form of chest wall costochondritis with joint swelling which can cause significant chest pain and decline in ability of daily activities. There is no standardized tr...WHAT IS KNOWN AND OBJECTIVE: Tietze syndrome is a rare form of chest wall costochondritis with joint swelling which can cause significant chest pain and decline in ability of daily activities. There is no standardized treatment protocol. The aim of this study was to assess the efficacy of adding oral steroids in addition to other non- steroidal treatment in improvement of pain and quality of life (QOL) in patients with Tietze syndrome. METHODS: Forty patients with Tietze syndrome were randomly divided into two treatment groups: (1) One week of prednisolone 40 mg daily followed by 1 week of prednisolone 20 mg daily followed by 1 week of 10 mg with 3 weeks of non-steroidal anti-inflammatory drug (NSAID) treatment (n = 20); (2) three weeks of NSAID treatment only (n = 20). A symptom questionnaire was used to rate the major symptoms of Tietze syndrome and costochondritis: Numeric rating scale (NRS) for pain on a scale of 0 (no pain) to 10 (severest pain); the resulting global symptom score was used to evaluate the efficacy of treatment with assessment of joint swelling resolution. The EQ-5D-5L instrument for measurement of QOL was used. Assessments were made on intention to treat basis at baseline and at 1, 2 and 3 weeks followed by a medium term follow period after treatment cessation. The trial was registered at www.isrctn.com ISRCTN11877533. RESULTS AND DISCUSSION: There was a significant drop in mean NRS pain scores between the groups at 1, 2 and 3 weeks in favour of the steroid group (46.8% vs. 17.7%; p < 0.001, 56.3% vs. 35.8% p < 0.001 and 65.4% vs. 46.7% p < 0.001 respectively). There was a 25.8% (95% CI 13.2-38.8) difference in mean NRS score drop at a median of 6.5 months after treatment cessation in favour of the steroid group over the NSAID only group. Only three cases of mild GIT upset in the steroid group and two cases of mild nausea were reported in the NSAID group. There was an improvement in QOL using the median EQ-5D-5L scoring at 3 weeks in favour of the steroid group 7 (7, 8) versus 10 (8.5-11), (p < 0.001). The improvement in pain scoring and QOL did not correlate with improvement in joint swelling at 3 weeks after treatment with 2/20 (10%) in the steroid arm versus 1/20 (5%) in NSAID arm having an obvious improvement (p = 0.393). WHAT IS NEW AND CONCLUSION: In this study, addition of short-term oral corticosteroids showed a clear benefit for use at 1, 2 and 3 weeks in improvement of pain and QOL in patients with Tietze syndrome. This difference was maintained at mid-term follow up after treatment cessation. This facilitates the advantage of using steroids as well as excluding their side effects for an accepted timeframe.
WHAT IS KNOWN AND OBJECTIVE: As the incidence of postoperative pain in patients with biliary and pancreatic diseases has gradually increased, how to control postoperative pain has received increasing research attention....WHAT IS KNOWN AND OBJECTIVE: As the incidence of postoperative pain in patients with biliary and pancreatic diseases has gradually increased, how to control postoperative pain has received increasing research attention. By reading pain management guidelines and multidisciplinary communication and cooperation, clinical pharmacists designed multi-mode analgesia regimens based on surgical types, in order to provide strong evidence for the effectiveness and safety of postoperative analgesia regimens and better serve patients. METHODS: Data from biliary or pancreatic surgery performed at Nanjing Drum Tower Hospital from 2019 to 2021 were collected. Take October 2020 as the time point to compare the outcomes before and after the implementation of the path-based postoperative analgesic regimens. The primary outcomes were NRS pain scores, sleep quality, and incidence of adverse reactions. Length of stay was a secondary outcome. RESULTS AND DISCUSSION: A total of 268 and 239 patients were enrolled in the study and control groups, respectively. Four path-based postoperative analgesic management regimens significantly reduced patients' static and dynamic NRS scores in the 24 h (p < 0.05). The patients' sleep quality were better than controls (p > 0.05). The incidence of adverse reactions and the length of stay in the study group were numerically lower than controls. Moderate analysis indicated that four analgesia regimens are more precise and better meet actual clinical needs. WHAT IS NEW AND CONCLUSION: Effective and safe postoperative pain management is particularly important for clinical purposes. Path-based postoperative analgesia regimens based on different types of surgery overcome the disadvantages of overly broad and generalized traditional guidelines, which play an important role in providing personalized and precise clinical services. Further, study findings provide evidence that four path-based analgesic regimens can reduce postoperative pain and reduce the length of hospital stay, which may provide a better direction for clinical postoperative pain management.