J Clin Pharm Ther [JOURNAL]
Sun
200 papers
The effectiveness of esketamine and propofol versus dezocine and propofol sedation during gastroscopy: A randomized controlled study.
Xu Y, Zheng Y, Tang T … +3 more , Chen L, Zhang Y, Zhang Z
J Clin Pharm Ther · 2022 Sep · PMID 35488787 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Propofol is widely used in painless gastroscopy. However, sedation with propofol alone might increase the risk of respiratory and circulatory complications. This randomized clinical study com...
WHAT IS KNOWN AND OBJECTIVE: Propofol is widely used in painless gastroscopy. However, sedation with propofol alone might increase the risk of respiratory and circulatory complications. This randomized clinical study compares the efficacy and safety of esketamine or dezocine combined with intravenous (IV) propofol in patients undergoing gastroscopy. METHODS: A total of 102 patients were enrolled in this study and randomized into two groups. All patients were adults aged 18-64 years who underwent upper gastrointestinal gastroscopy. Patients were randomly assigned to two groups to receive esketamine (0.3 mg/kg) combined with propofol (group E) or dezocine (0.05 mg/kg) combined with propofol (group D). In both groups, the drugs were administered intravenously. The primary outcome was the dose of propofol which provided a satisfactory sedative effect, both to the endoscopist and the patients. Secondary outcomes included recovery time, side effects (such as hypotension, nausea and vomiting and agitation), and the number of adverse circulatory and respiratory events. RESULTS: Data of 83 patients were analysed in the present study. Dosage of propofol required in group E (1.44 mg/kg ± 0.67 mg/kg) was significantly lower compared with that in group D (2.12 mg/kg ± 0.37 mg/kg) (p < 0.0001). There was no statistically significant difference in recovery time, side effects, and the frequency of sedation-related adverse events between the two groups. WHAT IS NEW AND CONCLUSION: The study indicates that intravenous injection of propofol and esmketamine is more effective for gastroscopy. Use of esketamine reduces the total amount of propofol required in ASA I-II patients undergoing gastroscopy compared with single use of dezocine. It also provides more stable hemodynamics, without affecting the recovery time and side effects such as respiratory and circulatory adverse events. TRIAL REGISTRATION: The study was registered at the Chinese Clinical Trial Registry (www.chictr.org.cn; registration number: ChiCTR2100051814) on 05/10/2021.
ABCB1 gene polymorphisms impact the effect of high-dose intravenous methylprednisolone therapy on optic neuritis associated with AQP4-IgG-positive neuromyelitis optica spectrum disorder.
Dai Y, Ni S, Wu F … +3 more , Guo S, Zhao X, Wang J
J Clin Pharm Ther · 2022 Sep · PMID 35488449 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Patients with optic neuritis (ON) have significant individual differences in their response to high-dose intravenous methylprednisolone (HIMP) therapy. This study aims to evaluate the associa...
WHAT IS KNOWN AND OBJECTIVE: Patients with optic neuritis (ON) have significant individual differences in their response to high-dose intravenous methylprednisolone (HIMP) therapy. This study aims to evaluate the association between gene polymorphisms and the efficacy of HIMP therapy in Chinese Han patients with ON mediated by aquaporin-4 immunoglobulin G antibody (AQP4-IgG) -positive neuromyelitis optica spectrum disorder (NMOSD) or multiple sclerosis (MS). METHODS: Chinese Han patients with AQP4-IgG NMOSD-ON or MS-ON were genotyped for four candidate genes: ABCB1 (rs1045642, rs1128503, rs2032582), NR3C1 (rs41423247), TBX21 (rs9910408, rs16947078) and VDR (rs731236, rs1544410, rs7975232, rs2228570). Patients were divided into glucocorticoid resistance (GR) and glucocorticoid sensitivity (GS) groups based on vision acuity (VA) improvement after HIMP treatment. Intergroup comparisons were performed on clinical characteristics, allele and genotype frequencies and haplotype distributions. RESULTS: A total of 267 patients completed the follow-up, including 120 patients with AQP4-IgG NMOSD-ON and 147 patients with MS-ON. We observed a significant association between the ABCB1 G2677T/A (rs2032582) polymorphism and glucocorticoid response in AQP4-IgG NMOSD-ON patients. Changes in VA scores in patients with the GG genotype were significantly lower than those in patients with the T/A T/A genotype (1.07 ± 1.20 vs. 1.77 ± 1.31, p = 0.026). In the GS group, the G allele had a lower frequency than the T/A allele (32.03% vs. 60.16%, p = 0.001). Logistic regression analysis showed that the G2677T/A GG and G T/A genotypes could increase the GR risk 3.53 and 2.67 times compared with the T/A T/A genotype, respectively (OR = 3.534, 95% CI: 1.186-10.527, p = 0.023; OR = 2.675, 95% CI: 1.005-7.123, p = 0.049). In addition, haplotype analysis showed that AQP4-IgG NMOSD-ON patients with the TAT/TTT haplotype (ABCB1 C3435T-G2677T/A-C1236T) were only 0.54 times more likely to develop GR than those with other haplotypes (OR = 0.542, 95% CI: 0.315-0.932, p = 0.026). However, we did not observe intergroup differences in the MS-ON population. WHAT IS NEW AND CONCLUSION: Our findings suggest that the G > T/A polymorphism of ABCB1 G2677T/A and the TAT/TTT haplotype played a protective role in HIMP treatment of AQP4-IgG NMOSD-ON but not MS-ON.
The role of the genetic variant FECH rs11660001 in the occurrence of anti-tuberculosis drug-induced liver injury.
Zhang M, Zhu J, Wang N … +6 more , Liu W, Lu L, Pan H, He X, Yi H, Tang S
J Clin Pharm Ther · 2022 Aug · PMID 35470464 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The pathogenic mechanism of anti-tuberculosis drug-induced liver injury (AT-DILI) is still largely unknown. Recent studies have indicated that rifampicin and isoniazid cotreatment causes the...
WHAT IS KNOWN AND OBJECTIVE: The pathogenic mechanism of anti-tuberculosis drug-induced liver injury (AT-DILI) is still largely unknown. Recent studies have indicated that rifampicin and isoniazid cotreatment causes the accumulation of endogenous protoporphyrin IX in the liver through the haem biosynthesis pathway. Alanine synthase 1 (ALAS1) and ferrochelatase (FECH) are the rate-limiting enzymes in the production of haem. The present study aimed to investigate the genetic contribution of the ALAS1 and FECH genes to the risk of AT-DILI in an Eastern Chinese Han population. METHODS: A 1:4 matched case-control study was conducted, and eight SNPs in the ALAS1 and FECH genes were detected and assessed. A multivariate conditional logistic regression model was used to estimate the association between genotypes and the risk of AT-DILI by the odds ratios (ORs) with 95% confidence intervals (CIs), with liver disease history, hepatoprotectant use, smoking and drinking history as covariates. RESULTS AND DISCUSSION: Overall, 202 AT-DILI cases and 808 controls were included in this study. The female patients carrying polymorphisms of rs11660001 in FECH had an increased risk of AT-DILI under the dominant and additive models (OR = 1.831, 95% CI: 1.014-3.307, p = 0.045; OR = 1.673, 95% CI: 1.015-2.760, p = 0.044, respectively). The peak aspartate transaminase level was significantly higher in female patients carrying the GA+AA genotype of rs11660001 than in those with the GG genotype during anti-TB treatment (p = 0.032). WHAT IS NEW AND CONCLUSION: Based on this 1:4 individual matched case-control study, SNP rs11660001 in the FECH gene may be associated with susceptibility to AT-DILI in Chinese female anti-TB treatment patients. Further studies in larger varied populations are needed to validate our findings.
Analysis of drug adverse events in elderly patients based on the Japanese Adverse Drug Event Report Database.
Okada A, Sera S, Taguchi M … +2 more , Yamada H, Nagai N
J Clin Pharm Ther · 2022 Aug · PMID 35470461 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Compared with the general adult population, pharmacokinetics and changes in drug responsiveness occur to a greater extent in the elderly. Interactions may occur between drugs used in combinat...
WHAT IS KNOWN AND OBJECTIVE: Compared with the general adult population, pharmacokinetics and changes in drug responsiveness occur to a greater extent in the elderly. Interactions may occur between drugs used in combination to treat various diseases and may cause adverse events (AEs). We conducted a cross-sectional risk assessment of AEs in elderly patients based on information gathered from Japanese medical practices with the goal of obtaining information that will contribute to optimizing pharmacotherapy. METHODS: The Japanese Adverse Drug Event Report database was used to determine the incidence of AEs in elderly patients (aged 80 years or older) compared with patients aged less than 80 years old by evaluating the reporting odds ratio using the data obtained from reports. RESULTS AND DISCUSSION: Hypnotics and anxiolytics, as well as anticoagulants and theophylline, were identified as groups of drugs that warrant special attention in the elderly. Hypnotics and anxiolytics, especially those that are short-acting, tend to cause delirium and geriatric syndromes including falls and fractures. With respect to anticoagulants, no increase in the risk of bleeding was evident and the dose was believed to be properly adjusted; however, there was an increased risk of anemia. Theophylline toxicity tended to occur more frequently in the elderly, suggesting the need for drug monitoring. WHAT IS NEW AND CONCLUSION: Based on these cross-sectional studies, the evaluation of the risk of AEs for drugs commonly used in the elderly based on near real-world information was achieved.
Clinical characteristics and treatment of terlipressin-induced ischemic skin necrosis: A synthesis of 35 literature reported cases.
Zhou Y, Zeng J, Song L … +1 more , Wang C
J Clin Pharm Ther · 2022 Aug · PMID 35460093 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The clinical features of terlipressin-induced ischemic skin necrosis are unknown. The purpose of this study is to explore the clinical features of terlipressin-induced skin necrosis. METHODS:...
WHAT IS KNOWN AND OBJECTIVE: The clinical features of terlipressin-induced ischemic skin necrosis are unknown. The purpose of this study is to explore the clinical features of terlipressin-induced skin necrosis. METHODS: We searched Chinese and English databases to collect case reports of terlipressin-induced skin necrosis for retrospective analysis. RESULTS AND DISCUSSION: A total of 42 patients (31 males and 11 females) from 35 studies were included, with a median age of 54 years (range 0.17-84). The onset of skin ischemia ranged from a few hours to 21 days. The most common clinical manifestations were bulla (15 cases, 35.7%), cyanosis (12 cases, 28.6%), necrosis (11 cases, 26.2%), and purpura (10 cases, 23.8%). The following were often affected: the legs (26 cases), 61.9%), abdomen (13, 31.0%), scrotum (10 cases, 23.8%), feet (10 cases, 23.8%), upper extremities (8 cases, 19.0%), and hands (7 cases, 16.7%). Skin biopsy showed fibrin thrombus (7 cases, 38.9%), nonspecific inflammation (6 cases, 33.3%), and necrosis (10 cases, 55.6%). After discontinuation of terlipressin, skin symptoms improved in most patients. WHAT IS NEW AND CONCLUSION: Ischemic skin necrosis is a rare and serious adverse effect of terlipressin. Patients receiving terlipressin therapy should be monitored closely for terlipressin-related ischemic complications. Terlipressin should be discontinued immediately if ischemic complications occur.
Successful treatment of a case with synchronous follicular lymphoma and gastric adenocarcinoma with CD19 CAR T cells and literature review.
Liu J, Cao F, Li Z … +7 more , Gao H, Zhang C, Du T, Li Z, Song Y, Zhu J, Ying Z
J Clin Pharm Ther · 2022 Sep · PMID 35437775 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Anti-CD19 CAR-T cell therapy is effective in B-cell lymphoma. However, it is rarely used in lymphoma combined with other malignant tumours. CASE DESCRIPTION: A relapsed/refractory follicular...
WHAT IS KNOWN AND OBJECTIVE: Anti-CD19 CAR-T cell therapy is effective in B-cell lymphoma. However, it is rarely used in lymphoma combined with other malignant tumours. CASE DESCRIPTION: A relapsed/refractory follicular lymphoma (r/r FL) patient underwent anti-CD19 CAR-T cell therapy and achieved complete response to lymphoma. However, gastric adenocarcinoma (GAC) was diagnosed during the cellular therapy. After infusion of CAR-T cells, he received curative treatment for GAC, and maitained complete response in both r/r FL and GAC after the treatment. WHAT IS NEW AND CONCLUSION: Anti-CD19 CAR-T therapy is an effective treatment for r/r FL, also provided opportunity for the sequential therapy of GAC, and remained significant quality of life afterwards.
Use of histamine-2 receptor antagonists and risk of inflammatory bowel diseases: A systematic review and meta-analysis of observational studies.
D'sa FF, Fernandes EZ, Kesarkar SV … +6 more , Swaminathan L, Kunhikatta V, Rashid M, Thunga G, Chandran VP, Nair S
J Clin Pharm Ther · 2022 Aug · PMID 35403222 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The effect of histamine-2 receptor antagonists (H2RAs) use causing inflammatory bowel diseases (IBD) has been reported in few isolated observational studies; however, pooled estimation of IBD...
WHAT IS KNOWN AND OBJECTIVE: The effect of histamine-2 receptor antagonists (H2RAs) use causing inflammatory bowel diseases (IBD) has been reported in few isolated observational studies; however, pooled estimation of IBD risk has not been done. The present study was conducted to estimate the risk of IBD [Crohn's disease (CD), ulcerative colitis (UC) and microscopic colitis (MC)], among H2RAs users. METHODS: Databases such as MEDLINE/PubMed, Scopus and Cochrane Library were searched from inception to January 2021. A bibliographic search of selected articles, random search in Google Scholar and ResearchGate were also performed for any additional studies. The observational studies which assessed the incidence or risk of IBD in H2RA users published in the English language were considered. Modified Downs and Black Checklist was used for quality assessment. Two independent reviewers were involved in study selection, data extraction and quality assessment; any discrepancies were settled through consensus or by consulting a third reviewer. RESULTS: Four studies out of 2,658 articles were included for this meta-analysis. The meta-analysis of 4 studies with 8939 participants revealed a significantly higher risk of IBD (OR: 2.27; 95% CI: 1.70-3.02; p < 0.0001) in H2RA users compared to non-users. Similar significant relationships were observed in the subgroup analysis of adults (p < 0.0001) and paediatrics (p = 0.04). The quality of included studies was observed to be fair to good. WHAT IS NEW AND CONCLUSION: Our findings indicate a significantly higher IBD risk among those who used H2RA compared to non-users both in adults and in paediatrics. Further observational studies involving large populations are required to strengthen these results and to generalize these findings.
Efficacy, safety and prognostic factors of camrelizumab plus carboplatin and pemetrexed chemotherapy in advanced lung adenocarcinoma patients.
Lv J, Zhang W, Deng R … +18 more , Chen Y, Liu M, Zhang Z, Wang Q, He Y, Liu Y, Wang F, Lv Z, Zhou H, Li C, Zhang T, Fu Y, Zhao X, Bao Q, Miao Y, Wang L, Huang M, Zhang C
J Clin Pharm Ther · 2022 Aug · PMID 35397125 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Camrelizumab is a recently developed PD-1 inhibitor in China applied in treating different cancers including lung cancer. This study is designed to evaluate the efficacy, safety and prognosti...
WHAT IS KNOWN AND OBJECTIVE: Camrelizumab is a recently developed PD-1 inhibitor in China applied in treating different cancers including lung cancer. This study is designed to evaluate the efficacy, safety and prognostic factors for camrelizumab plus carboplatin and pemetrexed (CP) chemotherapy in treating patients with advanced lung adenocarcinoma. METHODS: Of 51 advanced lung adenocarcinoma patients with negative driver genes who received camrelizumab plus CP chemotherapy were recruited. These patients received four cycles of camrelizumab plus CP chemotherapy in a 21-day cycle. Then, camrelizumab, pemetrexed or camrelizumab plus pemetrexed was administered as maintenance therapy. RESULTS AND DISCUSSION: The rates of complete response, partial response, stable disease and progressive disease were 2.0%, 56.8%, 19.6% and 5.9%, respectively; while treatment response of 15.7% of patients was missing or not evaluable. The objective response and disease control rates were 58.8% and 78.4%, respectively. With a median follow-up period of 14.9 months (the follow-up duration ranged from 3.9 months to 24.3 months), 41 (83.4%) cases of disease progression and 22 (43.1%) cases of death were recorded. The median progression-free survival (PFS) was 10.5 months (95% confidence interval (CI): 8.4-12.6 months) with a 1-year PFS rate of 36.3% and a 2-year PFS rate of 7.5%. In addition, the median overall survival (OS) was 18.7 months (95% CI: 16.4-21.0 months) with a 1-year OS rate of 79.1% and a 2-year OS rate of 30.4%. In consideration of safety, the most frequent adverse events were peripheral neuropathy (37.3%), neutropenia (37.3%), alopecia (35.3%), etc. and most of them were grade 1-2 and could be controlled. WHAT IS NEW AND CONCLUSION: Camrelizumab plus CP chemotherapy achieves favourable efficacy and tolerable adverse events in advanced lung adenocarcinoma patients.
High-Dose Clopidogrel versus Ticagrelor in CYP2C19 intermediate or poor metabolizers after percutaneous coronary intervention: A Meta-Analysis of Randomized Trials.
Sheng XY, An HJ, He YY … +3 more , Ye YF, Zhao JL, Li S
J Clin Pharm Ther · 2022 Aug · PMID 35396752 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: For patients after percutaneous coronary interventions (PCI), clopidogrel combined with aspirin is a conventional dual antiplatelet therapy (DAPT) method. Because the genetic polymorphism of...
WHAT IS KNOWN AND OBJECTIVE: For patients after percutaneous coronary interventions (PCI), clopidogrel combined with aspirin is a conventional dual antiplatelet therapy (DAPT) method. Because the genetic polymorphism of CYP2C19 gene leads to clopidogrel resistance, guidelines for antiplatelet recommendations in CYP2C19 of ultrarapid metabolizers (UM), extended metabolizers (EM) and poor metabolizers (PM) are clear. However, there is no clear recommendation as to whether ticagrelor or double dose clopidogrel is the best antiplatelet regimen for CYP2C19 of intermediate metabolizers (IM). To evaluate the efficacy and safety of ticagrelor (combined with aspirin) and high-dose clopidogrel (combined with aspirin) in patients after PCI with CYP2C19 loss-of-function (LOF) alleles. METHODS: We searched the following databases to select RCTs of comparing ticagrelor with high-dose clopidogrel in patients after PCI with CYP2C19 LOF alleles: CNKI, Wanfang Data, PubMed, Clinical trials, Cochrane, Web of Science and Embase. Major adverse cardiovascular events (MACEs), platelet function and TIMI bleeding event were defined as the outcomes. revman 5.3 software was used to perform meta-analysis. RESULTS AND DISCUSSION: A total of 14 RCTs with 2351 patients were enrolled. Meta-analysis showed that compared with high-dose clopidogrel, ticagrelor had reduced incidence of MACEs (OR = 0.32, 95% Cl: 0.23-0.44, p < 0.00001), stent thrombosis (OR: 0.24, 95%CI: 0.13-0.44, p < 0.00001), myocardial infarction OR: 0.42, 95%CI: 0.22-0.80, p = 0.008), revascularization (OR: 0.29, 95%CI: 0.10-0.82, p = 0.02) and unstable angina (OR: 0.47, 95%CI: 0.29-0.77, p = 0.003) in patients after PCI with CYP2C19 LOF alleles. A subgroup analysis showed that ticagrelor reduced the risk of MACEs compared with high-dose clopidogrel regardless of the type of metabolizer. Compared with high-dose clopidogrel, ticagrelor significantly reduced the risk of MACE with longer follow-up period (more than 3 months) without increasing the risk of bleeding (OR: 0.89, 95%CI: 0.53-1.49, p = 0.30), while elevated dyspnoea (OR: 5.62, 95%CI: 3.07-10.28, p < 0.00001). WHAT IS NEW AND CONCLUSIONS: For patients carrying CYP2C19 LOF alleles after PCI, ticagrelor may be better than high-dose clopidogrel in reducing the risk of MACEs, while dyspnoea incidents should be alerted.
Comparison of cold spray and shotblocker to reduce intramuscular injection pain: A randomized controlled trial.
Gürdap Z, Cengiz Z
J Clin Pharm Ther · 2022 Aug · PMID 35385141 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: It is important to identify effective, easy-to-use and cost-effective non-pharmacological methods in the management of pain caused by medical interventions. The purpose of this study is to co...
WHAT IS KNOWN AND OBJECTIVE: It is important to identify effective, easy-to-use and cost-effective non-pharmacological methods in the management of pain caused by medical interventions. The purpose of this study is to compare the effects of cold spray and ShotBlocker on pain in adults in reducing pain caused by intramuscular injection in the adult emergency department. METHODS: This is a randomized controlled trial with two experimental groups, two placebo groups and a control group. The study was conducted on 195 adults who received diclofenac sodium injections. In the study, the injection procedure was performed by following the same injection protocol in all five groups. In the injection process, cold spray or ShotBlocker was used in the intervention groups based on the group, and cold spray with distilled water or the smooth surface of the ShotBlocker was used in the placebo groups. Following the injection, the pain caused by the injection was evaluated using the Visual Analog Scale. RESULTS AND DISCUSSION: The study was completed with the remaining 195 patients. In the study, the average pain scores due to injection of the individuals in the cold spray group were lower than those of the control group (p < 0.05). There was no statistically significant difference between the pain score averages due to injection of the individuals in the ShotBlocker group and cold spray, control, ShotBlocker placebo and cold spray placebo groups. WHAT IS NEW AND CONCLUSION: The routine use of a fast-acting, cost-effective and easy-to-use method, cold spray, to reduce pain in the intramuscular injection will be beneficial in increasing patient satisfaction and quality of care.
Characteristics of hospitals that report adverse drug reactions: Results of a nationwide survey in Japan.
Tsuchiya M, Kikuchi D, Hatakeyama S … +4 more , Tasaka Y, Uchikura T, Funakoshi R, Obara T
J Clin Pharm Ther · 2022 Aug · PMID 35362208 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Adverse drug reactions (ADRs) are one of the primary reasons for hospitalization. The spontaneous reporting of ADRs by healthcare professionals is important for issuing post-marketing drug sa...
WHAT IS KNOWN AND OBJECTIVE: Adverse drug reactions (ADRs) are one of the primary reasons for hospitalization. The spontaneous reporting of ADRs by healthcare professionals is important for issuing post-marketing drug safety measures. The Japanese Society of Hospital Pharmacists (JSHP) conducts a nationwide survey annually. Using data from this large-scale survey, we identified the characteristics of hospitals that reported ADRs to regulatory authorities and pharmaceutical companies. METHODS: Data were obtained from annual surveys conducted by JSHP from 2015 to 2020. All variables were expressed as categorical variables and tabulated. The Chi-square test was used to compare the categorical variables. The Cochran-Armitage trend test was used to identify significant trends in the proportion of hospitals reporting ADRs. RESULTS AND DISCUSSION: From 2015 to 2020, 22,362 responses were recorded. There was a significant increase in the proportion of hospitals that reported ADRs with an increase in number of beds and pharmacists (p < 0.0001). The proportion of hospitals reporting ADRs to regulatory authorities was also significantly higher in those charging an additional fee for pharmacist-performed ward operations and in those with an ADR data management section than in hospitals without these attributes (p < 0.0001). WHAT IS NEW AND CONCLUSION: Hospitals that submitted ADR reports to the regulatory authorities and pharmaceutical companies charged an additional fee for pharmacist-performed ward operations, had a central ADR data management section, and had fewer beds per pharmacist. This trend was similar, regardless of the size of the hospital.
No apparent pharmacokinetic interactions were found between henagliflozin: A novel sodium-glucose co-transporter 2 inhibitor and glimepiride in healthy Chinese male subjects.
Que L, Huang K, Xiang X … +3 more , Ding Y, Chu N, He Q
J Clin Pharm Ther · 2022 Aug · PMID 35362180 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Henagliflozin is a novel selective sodium-glucose co-transporter 2 (SGLT2) inhibitor with similar inhibitory effect to ertugliflozin. Glimepiride is widely used to treat type 2 diabetes melli...
WHAT IS KNOWN AND OBJECTIVE: Henagliflozin is a novel selective sodium-glucose co-transporter 2 (SGLT2) inhibitor with similar inhibitory effect to ertugliflozin. Glimepiride is widely used to treat type 2 diabetes mellitus (T2DM) with few cardiovascular side effects. In the present study, we aimed at evaluating the pharmacokinetic (PK) interactions between henagliflozin and glimepiride. METHODS: An open-label, single-centre, single-arm, 3-period, 3-treatment, self-control study was conducted in twelve healthy Chinese male subjects. During each study period, subjects received a single oral dose of glimepiride 2 mg, multiple oral doses of henagliflozin 10 mg or a combination of the two drugs. Serial blood samples were collected 24 h post-dosing for PK analyses. Finger-tip blood glucose was also tested for safety evaluation. RESULTS AND DISCUSSION: Co-administration of henagliflozin with glimepiride did not affect their plasma PK profiles. For henagliflozin, the 90% confidence intervals for the geometric mean ratio (GMR) for the maximum plasma concentrations at steady-state (C ) and the area under the plasma concentration-time curve during a dosing interval at steady-state (AUC ) of combination therapy to henagliflozin alone were 1.00 (0.93-1.08) and 1.00 (0.98-1.02), respectively. For glimepiride, the corresponding values of combination therapy to glimepiride alone were 1.00 (0.88-1.13) for maximum plasma concentrations (C ), 0.91 (0.84-0.99) for the area under the plasma concentration-time curve from 0-24 h (AUC ) and 0.91 (0.83-1.00) for the plasma concentration-time curve from 0 h to infinite (AUC ), respectively. All values fell within the equivalence range of 0.8-1.25. All monotherapies and combination therapy led to no serious adverse events and were well tolerated. WHAT IS NEW AND CONCLUSION: Multiple doses of henagliflozin did not exert a significant change on glimepiride PK profiles and a single dose of glimepiride had little effect on henagliflozin blood concentration. Thus, henagliflozin can be co-administered with glimepiride without dose adjustment of either drug.
Pharmacokinetics of piperacillin and tazobactam in critically Ill patients treated with continuous kidney replacement therapy: A mini-review and population pharmacokinetic analysis.
Selig DJ, DeLuca JP, Chung KK … +5 more , Pruskowski KA, Livezey JR, Nadeau RJ, Por ED, Akers KS
J Clin Pharm Ther · 2022 Aug · PMID 35352374 · Full text
WHAT IS KNOWN AND OBJECTIVE: Timely and appropriate dosing of antibiotics is essential for the treatment of bacterial sepsis. Critically ill patients treated with continuous kidney replacement therapy (CKRT) often have p...
WHAT IS KNOWN AND OBJECTIVE: Timely and appropriate dosing of antibiotics is essential for the treatment of bacterial sepsis. Critically ill patients treated with continuous kidney replacement therapy (CKRT) often have physiologic derangements that affect pharmacokinetics (PK) of antibiotics and dosing may be challenging. We sought to aggregate previously published piperacillin and tazobactam (pip-tazo) pharmacokinetic data in critically ill patients undergoing CKRT to better understand pharmacokinetics of pip-tazo in this population and better inform dosing. METHODS: The National Library of Medicine Database was searched for original research containing piperacillin or tazobactam clearance (CL) or volume of distribution (V) estimates in patients treated with CKRT. The search yielded 77 articles, of which 26 reported suitable estimates of CL or V. Of the 26 articles, 10 for piperacillin and 8 for tazobactam had complete information suitable for population pharmacokinetic modelling. Also included in the analysis was piperacillin and tazobactam PK data from 4 critically ill patients treated with CKRT in the Military Health System, 2 with burn and 2 without burn. RESULTS AND DISCUSSION: Median and range of literature reported PK parameters for piperacillin (CL 2.76 L/hr, 1.4-7.92 L/hr, V 31.2 L, 16.77-42.27 L) and tazobactam (CL 2.34 L/hr, 0.72-5.2 L/hr, V 36.6 L, 26.2-58.87 L) were highly consistent with population estimates (piperacillin CL 2.7 L/hr, 95%CI 1.99-3.41 L/hr, V 25.83 22.07-29.59 L, tazobactam CL 2.49 L/hr, 95%CI 1.55-3.44, V 30.62 95%CI 23.7-37.54). The proportion of patients meeting pre-defined pharmacodynamic (PD) targets (median 88.7, range 71%-100%) was high despite significant mortality (median 44%, range 35%-60%). High mortality was predicted by baseline severity of illness (median APACHE II score 23, range 21-33.25). Choice of lenient or strict PD targets (ie 100%fT >MIC or 100%fT >4XMIC) had the largest impact on probability of target attainment (PTA), whereas presence or intensity of CKRT had minimal impact on PTA. WHAT IS NEW AND CONCLUSION: Pip-tazo overexposure may be associated with increased mortality, although this is confounded by baseline severity of illness. Achieving adequate pip-tazo exposure is essential; however, risk of harm from overexposure should be considered when choosing a PD target and dose. If lenient PD targets are desired, doses of 2250-3375 mg every 6 h are reasonable for most patients receiving CKRT. However, if a strict PD target is desired, continuous infusion (at least 9000-13500 mg per day) may be required. However, some critically ill CKRT populations may need higher or lower doses and dosing strategies should be tailored to individuals based on all available clinical data including the specific critical care setting.
Real-life contemporary vitamin K antagonist is still associated with very low time in therapeutic range despite strict international normalized ratio monitoring: Results of big data analysis.
Goudot FX, Martins-Meune E, Chenevier-Gobeaux C … +2 more , Mourad JJ, Meune C
J Clin Pharm Ther · 2022 Aug · PMID 35352367 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: This study aimed to determine the results of INR monitoring in patients on vitamin K antagonists (VKAs) and the time in therapeutic range (TTR) in 'real-world' settings. METHODS: Retrospectiv...
WHAT IS KNOWN AND OBJECTIVE: This study aimed to determine the results of INR monitoring in patients on vitamin K antagonists (VKAs) and the time in therapeutic range (TTR) in 'real-world' settings. METHODS: Retrospective analysis of 836,857 INR measurements performed in adults from February 2010 to August 2015 in two districts in the French Brittany region. RESULTS: Of the 836,857 INR measurements, 94.9% were ordered by general practitioners and 2.0% by cardiologists. The number of tests increased by 10-year age categories up to the age-group of 80-90 years. The number of INR measurements increased from 169,636 in 2011 to 176,184 in 2012, but then decreased slightly to 162,597 in 2013 and 164,427 in 2014. Mean coefficient of variation of INR was 19.0%, and mean TTR was 29.0%. TTR was higher in women than in men (31% vs. 18%), in older than in younger patients (19.1% at 40 years and 38.6% at 100 years) and in patients with arrhythmias than in those with deep vein thrombosis/pulmonary embolism (44.4% versus 19.4%) (p < 10 for each comparison). Median interval between INR measurements was 14 days [7-28]; it was prolonged in men vs women, rural vs urban regions, older vs younger patients and when requested by GPs vs cardiologists. The interval was shorter for patients with INR outside the therapeutic range versus patients with INR within the therapeutic range (9 days [5-21] vs. 18 days [10-29], p < 10 ). WHAT IS NEW AND CONCLUSION: VKAs are still frequently prescribed in this era of direct oral anticoagulants. The low TTR cannot be explained by inadequate INR monitoring.
Pharmacokinetics of cefoperazone/sulbactam in critically Ill thrombotic thrombocytopenic purpura patients undergoing therapeutic plasma exchange.
Li H, Gao C, Lin L … +3 more , Zhang G, Fan S, Hai X
J Clin Pharm Ther · 2022 Aug · PMID 35347732 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVES: The aim of this study was to investigate the pharmacokinetics (PK) of cefoperazone (CFP) and sulbactam (SUL) in critically ill thrombotic thrombocytopenic purpura (TTP) patients undergoing t...
WHAT IS KNOWN AND OBJECTIVES: The aim of this study was to investigate the pharmacokinetics (PK) of cefoperazone (CFP) and sulbactam (SUL) in critically ill thrombotic thrombocytopenic purpura (TTP) patients undergoing therapeutic plasma exchange (TPE). METHODS: Critically ill TTP patients receiving a dose of 3 g CFP/SUL (2.0 g/1.0 g) intravenously every 8 h were included in the study. TPE session began 10 min after the end of CFP/SUL infusion. Serial blood samples were collected at 0, 1, 2, 3, 4, 6 and 8 h at the fourth infusion with TPE and the sixth infusion without TPE. Effluent samples were collected at the effluent port of plasma eliminated at the end of TPE. Concentrations of CFP and SUL in plasma and effluent were measured using LC-MS/MS. PK parameters were calculated based on two-compartment open model. RESULTS: Five critically ill TTP patients receiving CFP/SUL monotherapy were enrolled. T of CFP and SUL with TPE was 0.62 and 1.30 h, respectively. For CFP, T with TPE were significantly higher than those without TPE (5.85 ± 3.16 vs. 4.41 ± 2.74, p = 0.016). V with TPE were significantly higher than those without TPE (7.23 ± 0.89 vs. 5.24 ± 0.80 L, p = 0.024). AUC with TPE were significantly lower compared with those without TPE (1380.98 ± 411.99 vs. 1581.61 ± 500.22 mg*h/L, p = 0.011). Relatively, CL with TPE were significantly higher than those without TPE (1.56 ± 0.46 vs. 1.37 ± 0.44 L/h, p = 0.010). For SUL, V and CL were higher significantly with TPE than those without TPE (28.11 ± 8.42 vs. 18.87 ± 6.45 L, p = 0.002; 10.74 ± 2.01 vs. 8.60 ± 2.10 L/h, p = 0.048). Mean Q of CFP and SUL were 344.42 ± 55.37 and 34.65 ± 10.09 mg, respectively. Mean fe% of CFP and SUL were 17.22 ± 2.77% and 3.46 ± 1.01%, respectively. WHAT IS NEW AND CONCLUSION: TPE enhances the clearance of CFP and SUL in critically ill TTP patients. CFP is more likely to be removed than SUL due to its a low V and high Pb. TPE is suggested to begin 1-2 h after the end of CFP/SUL infusion. Plasma concentration monitoring is advised when CFP/SUL must be administered during TPE.
Status of medication literacy and its related factors among undergraduate students in Shanxi Province, China: A cross-sectional study.
Li X, Duan T, Lai Y … +8 more , Wang X, Yang L, Su X, Wang H, Guo Y, Zhu L, Jia M, Wu Y
J Clin Pharm Ther · 2022 Aug · PMID 35347725 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Medication safety problem has always been the focus of healthcare providers and public health community scholars. As the backbone of the future society, the mastery of college students' knowl...
WHAT IS KNOWN AND OBJECTIVE: Medication safety problem has always been the focus of healthcare providers and public health community scholars. As the backbone of the future society, the mastery of college students' knowledge to use medicine will directly affect the level of medication literacy (ML) of the public in the future. The purpose of this study was to investigate the current ML of college students in Shanxi Province and to identify its related factors. METHODS: A cluster random sampling method was utilized to select 800 college students from 10 universities in Shanxi province as participants from 21 March to 10 April 2020. After quality control, 763 valid questionnaires were collected (effective rate 95.4%). This study applied the ML scale adapted from the 14-item health literacy scale (HLS-14) to estimate ML, which contains functional ML, communicative ML and critical ML dimensions to estimate the ML situation. Then, we used structural equation modelling (SEM) to test the hypothesized relationship among three dimensions of ML, self-evaluated health status and safety medication science popularization activities on campus. RESULTS AND DISCUSSION: The results showed that the reliability and validity of the ML scale were good. The average score of ML level of college students in Shanxi Province was 44 points, and the interquartile range was 40-48 points (full score is 65 points). The proportion of high ML level was estimated at as low as 26.7%. 73.1% participants had an average level, and only 1 participant (0.1%) had a low level of ML. Univariate analysis showed that the ML level was significantly influenced by gender, universities, field of study, academic performance and ethnic group (p < 0.05). SEM showed that functional ML (λ = 0.01) and communicative ML (λ = 0.75) had a direct positive association with critical ML. Meanwhile, the model also had a mediating effect. Functional ML had an indirect positive association with critical ML through the mediating effect of communicative ML (λ = 0.11). In addition, both self-evaluated health status and safety medication science popularization activities on campus had an indirect positive association with critical ML through the mediating effect of functional ML and communicative ML. WHAT IS NEW AND CONCLUSION: The study revealed that the ML of most college students in Shanxi Province was at the average level. Among them, medical college student (including pharmacy, nursing, public health, preventive medicine, basic medicine and clinical medicine students), the Han nationality students (the students of China's majority ethnic group), students of good self-evaluated health status, and students who were more exposed to safety medication science popularization activities had a relatively higher ML level. Moreover, it highlighted the importance of self-evaluated health status and safety medication science popularization activities on campus to ML.
Analysis of clinical features of tacrolimus-induced optic neuropathy.
Lei H, Zeng J, Liu X … +2 more , Li Z, Wang C
J Clin Pharm Ther · 2022 Aug · PMID 35342971 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Tacrolimus is associated with optic neuropathy. The clinical features of tacrolimus-induced optic neuropathy (TION) are unclear. The purpose of this article is to explore the clinical feature...
WHAT IS KNOWN AND OBJECTIVE: Tacrolimus is associated with optic neuropathy. The clinical features of tacrolimus-induced optic neuropathy (TION) are unclear. The purpose of this article is to explore the clinical features of TION. METHODS: TION-related case reports were collected and analysed by searching Chinese and English databases from 1989 to 31 December 2021. RESULTS AND DISCUSSION: Twelve males and 7 females were included, with a median age of 54 years (range 23-66). TION onset time ranged from 2 months to 16 years after administration, and the main clinical features were blurred vision (4 cases), decreased visual acuity (7 cases), decreased visual acuity (5 cases), grey films (3 cases), visual field damage (3 cases) and headache (2 cases). Fifteen patients developed bilateral optic neuropathy. Ophthalmological examination showed visual acuity ranging from 20/25 to blindness, pupillary examination revealed relative afferent pupillary defect in 9 patients and marked decrease in colour vision in 15 eyes. The optic disc showed pallor (10 cases), oedema (8 cases), atrophy (4 cases) and haemorrhage (2 cases). After discontinuation or dose reduction of tacrolimus, symptoms improved in 10 patients, 1 patient recovered completely, and 4 patients did not recover. WHAT IS NEW AND CONCLUSION: TION presents diverse clinical manifestations. TION should be promptly identified and treated to prevent severe and permanent vision loss.
Rapid clearance of tacrolimus blood concentration triggered by variant pharmacogenes.
Šimičević L, Canjuga I, Zibar L … +3 more , Borić-Bilušić A, Ganoci L, Božina N
J Clin Pharm Ther · 2022 Sep · PMID 35342959 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Tacrolimus (TAC) is an immunosuppressant with large interpatient pharmacokinetic variability and a narrow therapeutic index. We report a case of acute cellular rejection (ACR) type IB with in...
WHAT IS KNOWN AND OBJECTIVE: Tacrolimus (TAC) is an immunosuppressant with large interpatient pharmacokinetic variability and a narrow therapeutic index. We report a case of acute cellular rejection (ACR) type IB with insufficient TAC blood concentrations (TAC C ). CASE SUMMARY: ACR developed on the eighth postoperative day of kidney transplantation. During this period, TAC C were insufficient. This referred pharmacogenetic assessment disclosed the patient as a CYP3A5 expresser and CYP3A4*1B carrier. According to the genotype, higher doses of TAC, 15 mg twice daily, were administered and targeted TAC C were achieved. WHAT IS NEW AND CONCLUSION: Our case presents an association of TAC rapid clearance and two alleles modifying greater CYP3A enzyme activity.
A systematic review on the impact of pharmacist-provided services on patients' health outcomes in Arab countries.
El-Awaisi A, Al-Shaibi S, Al-Ansari R … +2 more , Naseralallah L, Awaisu A
J Clin Pharm Ther · 2022 Jul · PMID 35332557 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The pharmacist's role has evolved dramatically over the last few decades and shows considerable impact globally. The aim of this systematic review was to describe the nature and extent of stu...
WHAT IS KNOWN AND OBJECTIVE: The pharmacist's role has evolved dramatically over the last few decades and shows considerable impact globally. The aim of this systematic review was to describe the nature and extent of studies evaluating the impact of pharmacist-provided services on clinical, humanistic and economic outcomes in different healthcare settings across the Arab world. METHODS: A systematic literature search was conducted using the following databases from their inception until June 2020: Cochrane, Embase, MEDLINE, PubMed, ScienceDirect and Scopus. Reporting was done according to PRISMA guidelines, and the quality assessment utilized the Mixed Methods Appraisal Tool. RESULTS AND DISCUSSION: Thirty-five eligible studies were included in this review, the majority of which were randomized controlled trials (RCT) (n = 26) conducted in hospital settings (n = 26). Most of the studies involved patients with specific medical conditions (n = 29) and pharmacist's interventions involved mainly medication therapy management (n = 32), counselling and education (n = 29), and medication therapy recommendations (n = 12). Several studies showed a positive impact (i.e., a statistically and/or clinically significant difference in favour of pharmacist-provided care or intervention) of pharmacist-provided services on clinical (n = 28), humanistic (n = 6) and economic (n = 5) outcomes. Conversely, five studies showed neutral or mixed effect of pharmacist interventions on clinical and humanistic outcomes. WHAT IS NEW AND CONCLUSION: The findings of this systematic review demonstrate a positive impact of pharmacist-provided services on clinical, humanistic and economic outcomes across diverse settings in the Arab world. Most of the included studies evaluated clinical outcomes and were from hospital setting. Directed approaches are needed to advance pharmacy practice across various healthcare settings in the Arab world.
Qualitative exploration of the experiences of community pharmacists delivering the Diabetes MedsCheck service.
Gargya D, Mirkazemi C, Curtain C
J Clin Pharm Ther · 2022 Aug · PMID 35322454 · Full text
WHAT IS KNOWN AND OBJECTIVE: The Diabetes MedsCheck (DMC) pharmacist service improves patient medication use and provides education on diabetes self-management. The original 2012 program evaluation identified barriers an...
WHAT IS KNOWN AND OBJECTIVE: The Diabetes MedsCheck (DMC) pharmacist service improves patient medication use and provides education on diabetes self-management. The original 2012 program evaluation identified barriers and facilitators in implementation. There are no recent studies exploring pharmacists' experiences with the DMC service. This pilot study may contribute to achieving an optimal diabetes management service in Australia. To explore the experiences of community pharmacists in providing the DMC service. METHODS: A purposive sampling approach was used to recruit practising Australian community pharmacists from July to December 2019. Inclusion criteria included provision of DMC service for more than 1 year and having delivered the service within 3 months of recruitment. Semi-structured interviews elicited pharmacists' experience with the DMC service. RESULTS AND DISCUSSION: Twelve interviews of community pharmacist owners, managers and employees (including three who had additional medication review and diabetes qualifications), resulted in four primary themes: benefit of and need for training in diabetes management, challenges of service delivery and implementation, the challenge of patients' diabetes management and the positive effect of DMC on pharmacists' professional satisfaction from the positive impact on patient interactions and diabetes management. Pharmacists highlighted the need for continuous training on diabetes management and patient communication, and a dedicated time and space for service provision for optimal implementation and delivery of DMC. DMC helped to fulfil pharmacists' desires to provide health care. Pharmacists perceived through patient engagement and patient feedback that DMC benefits patient health care. WHAT IS NEW AND CONCLUSION: Positively, the implementation of the DMC service has promoted engagement with other health professionals while also contributing to pharmacists' professional satisfaction. Patient satisfaction and awareness of the health knowledge that pharmacists provide promotes pharmacist capabilities to the public. To ensure that accessible diabetes care in community pharmacy is optimized for greatest patient care, pharmacists delivering DMC should be supported by provision of contemporary diabetes management training and communication skills. Additional investment in community pharmacy operational set-up, such as dedicated pharmacist time, dedicated consulting space, upskilling of staff and investment in technology is also required to support optimal delivery of DMC.
About
- Frequency
- Sun
- Papers found
- 200
- RSS feed
- Subscribe