International journal of clinical pharmacology and therapeutics最新文献_第3页

Skin toxicity associated with immune checkpoint inhibitors based on the FDA adverse event reporting system 2011 - 2023 data. 基于FDA不良事件报告系统2011 - 2023年数据的免疫检查点抑制剂相关皮肤毒性

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-22 DOI: 10.5414/CP204739

Xiao-Yan Qiu, Zhang-Yong Fu, Ai-Feng Wu

{"title":"Skin toxicity associated with immune checkpoint inhibitors based on the FDA adverse event reporting system 2011 - 2023 data.","authors":"Xiao-Yan Qiu, Zhang-Yong Fu, Ai-Feng Wu","doi":"10.5414/CP204739","DOIUrl":"10.5414/CP204739","url":null,"abstract":"Purpose: To evaluate skin toxicity associated with immune checkpoint inhibitors (ICIs) using data mining and the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).Materials and methods: Data on skin toxicity associated with the use of ICIs were retrieved for the period January 2011 to September 2023. Analysis was done using various methods, including reporting odds ratio (ROR) estimates, proportional reporting ratios (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker estimates (MGPS). Mortality and hospitalization data were also assessed.Results: A total of 8,129 skin toxicity reports concerning \"ICIs\" as the \"primary suspected cause\" were documented, accounting for 18.89% of all reported adverse events. Anti-PD-1 agents showed the highest incidence of skin toxicity, whereas anti-CTLA-4 monotherapy was associated with the most significant changes in ROR, PRR, empirical Bayesian geometric mean (EBGM), and information component (IC) values. The median onset of toxicity was 17 days after commencement of ICI treatment, consistent across sexes, age groups, and ICI types. The highest mortality rate occurred with anti-PD-1 treatment (11.37%), and there was a significant difference in mortality rates between different ICI treatments (monotherapy vs. combination therapy) (p = 0.03).Conclusion: Differences are present between ICI regimens in the pattern of skin toxicity with anti-PD-1 therapies exhibiting the highest incidence of skin toxicity and mortality rates, while anti-CTLA-4 therapies showed the most marked signals.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

High expression of EFNA3 in adrenocortical carcinoma and its association with prognosis. 肾上腺皮质癌中EFNA3的高表达及其与预后的关系。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-22 DOI: 10.5414/CP204767

Caihong Cao, Xiao Li, Xing Feng, Yansha Wang

引用次数: 0

Bioequivalence of tamsulosin 0.4 mg film-coated sustained-release tablet formulations in healthy subjects under fasting conditions. 空腹条件下坦索罗辛0.4 mg膜包膜缓释片在健康人体内的生物等效性

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-15 DOI: 10.5414/CP204708

Raymond R Tjandrawinata, Danang Agung Yunaidi, Yantirta Indra Kurniawan, Clarasintha Nindyatami, Ismail Dwi Saputro, Syifa Anugriani Aziswan, Vicky Achmad Ginanjar, Liana W Susanto

{"title":"Bioequivalence of tamsulosin 0.4 mg film-coated sustained-release tablet formulations in healthy subjects under fasting conditions.","authors":"Raymond R Tjandrawinata, Danang Agung Yunaidi, Yantirta Indra Kurniawan, Clarasintha Nindyatami, Ismail Dwi Saputro, Syifa Anugriani Aziswan, Vicky Achmad Ginanjar, Liana W Susanto","doi":"10.5414/CP204708","DOIUrl":"10.5414/CP204708","url":null,"abstract":"This open-label, randomized, single-dose, 4-period, 2-sequence, fully replicated study was conducted to evaluate the bioequivalence of tamsulosin 0.4 mg sustained-release film-coated tablet manufactured by PT Dexa Medica, Indonesia, and Harnal OCAS 0.4 mg prolonged-release tablet manufactured by Astellas Pharma Europe B.V., the Netherlands, imported by PT Combiphar, Indonesia, under fasting conditions in 28 healthy adult Indonesian males. Subjects were randomly assigned to receive the test formulation (1 single tablet of 0.4 mg) or the reference formulation (1 single tablet of 0.4 mg) orally in each of the 4 study periods, according to the full replicate design. Therefore, over the 4 complete periods, each subject received 2 administrations of the test formulation and 2 administrations of the reference formulation, with each administration separated by a 7-day washout period. The plasma concentration of tamsulosin from the blood samples was analyzed using validated ultra-performance liquid chromatography with tandem mass spectroscopy detection (UPLC-MS/MS), and pharmacokinetic parameters (AUC0-t, AUC0-∞, Cmax, tmax, and T1/2) were calculated. The 90% confidence interval (CI) for the test/reference geometric mean ratio (GMR) of the AUC0-t was 80.2 - 98.4%, and for AUC0-∞ it was 80.5 - 120.1%. The 90% CI GMR of Cmax was 89.3 - 107.7%. All parameters were within the 90% CI GMR acceptance criteria of 80.0 - 125.0%. The T1/2 and tmax of the 2 test drugs and the 2 reference drugs were not statistically different. There was no adverse effect observed during the study. Based on the study results, it was concluded that both tamsulosin formulations were bioequivalent and well tolerated.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Cardiovascular toxicity associated with sedative drug use: Post-market pharmacovigilance study with disproportionality analysis. 与镇静药物使用相关的心血管毒性：上市后药物警戒研究与歧化分析。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-15 DOI: 10.5414/CP204796

Pei Ye, Hewei Zhang, Qiang Lyu, Wangzheqi Zhang, Yidi Xu, Xiaofei Ye, Xiaojing Guo

{"title":"Cardiovascular toxicity associated with sedative drug use: Post-market pharmacovigilance study with disproportionality analysis.","authors":"Pei Ye, Hewei Zhang, Qiang Lyu, Wangzheqi Zhang, Yidi Xu, Xiaofei Ye, Xiaojing Guo","doi":"10.5414/CP204796","DOIUrl":"10.5414/CP204796","url":null,"abstract":"Objective: To compare the toxicity of sedatives in critically ill intensive care unit patients and investigate safety concerns using the United States Food and Drug Administration Adverse Event Reporting System and VigiBase databases.Materials and methods: Disproportionality analysis was used to assess the relationships among midazolam, propofol, and dexmedetomidine and suspected adverse drug reactions. Adverse drug reactions related to sedation in the intensive care unit were identified through systematic organ classification and assessed using Standardized Regulatory Activities Medical Dictionary Analysis Queries.Results: A total of 12,102 adverse drug reactions were identified with midazolam, propofol, or dexmedetomidine as the primary suspected drug. The cardiovascular system accounted for a significant proportion of the drug reaction systems with strong signals. The strongest preferred term was neonatal hypertension (N = 9; information component = 7.11 (95% confidence interval: 5.97 - 7.87)), propofol infusion syndrome (N = 482; information component = 10.88 (95% confidence interval: 10.73 - 10.99)), and the trigemino-cardiac reflex (N = 7; information component = 10.36 (95% confidence interval: 9.06 - 11.21)) for midazolam, propofol, and dexmedetomidine, respectively. The Standardized Regulatory Activities Medical Dictionary Analysis Queries with the strongest signal across all sedatives were torsade de pointes and shock-associated conditions (N = 679; information component = 4.24 (95% confidence interval: 4.12 - 4.34)).Conclusion: These findings highlight the need for clinicians to consider cardiovascular toxicity when administering sedatives in the intensive care unit, as different sedatives exhibit different adverse reaction profiles.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Neurodegenerative protection with Orgaheal medium-chain triglycerides oil: Evidence from cell cultures, enzyme inhibition studies, and measurement of antioxidant and lipid-lowering properties. 有机中链甘油三酯油的神经退行性保护作用：来自细胞培养、酶抑制研究以及抗氧化和降脂特性测量的证据。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-11 DOI: 10.5414/CP204742

Rajendran Aanaimuthu, Sudesh Raj Rajendran, Tejas Mudharaikal, Jayakumar Sivasamy, Reethi Suresh, Sneha Srinivasan

{"title":"Neurodegenerative protection with Orgaheal medium-chain triglycerides oil: Evidence from cell cultures, enzyme inhibition studies, and measurement of antioxidant and lipid-lowering properties.","authors":"Rajendran Aanaimuthu, Sudesh Raj Rajendran, Tejas Mudharaikal, Jayakumar Sivasamy, Reethi Suresh, Sneha Srinivasan","doi":"10.5414/CP204742","DOIUrl":"10.5414/CP204742","url":null,"abstract":"Neurodegenerative diseases such as Alzheimer's and Parkinson's are marked by neuronal loss due to oxidative stress, neuro inflammation, and lipid dysregulation. Medium-chain triglyceride (MCT) oil, particularly rich in caprylic acid (C8, 56%) and capric acid (C10, 43%), has shown potential neuroprotective effects through its antioxidant properties, cholinesterase inhibition, and lipid-lowering benefits.Objectives: This study aims to evaluate the neuroprotective effects of ORGAHEAL medium-chain triglyceride (MCT) oil by assessing its antioxidant activity, cholinesterase inhibition, and lipid-lowering effects in vitro.Materials and methods: Antioxidant activity was measured using 2, 2-diphenyl-1-picrylhydrazyl (DPPH) and nitric oxide scavenging assays. Cholinesterase inhibition was studied through enzyme kinetics with Lineweaver-Burk and Dixon plots. Lipid-lowering effects were analyzed in 3T3-L1 adipocytes using Oil Red O staining and triglyceride quantification.Results: MCT oil exhibited antioxidant activity in DPPH and nitric oxide assays (IC50: 6.15 mg/mL and 29.87 mg/mL) and non-competitive inhibition of acetylcholinesterase and butyrylcholesteraseE (Ki: 31.01 mg/mL and 24.86 mg/mL). It reduced lipid accumulation and triglyceride levels in 3T3-L1 cells, potentially enhancing neuronal health by lowering oxidative damage.Conclusion: MCT oil, with caprylic acid (C8) and capric acid (C10), offers neuroprotective benefits through its antioxidant, cholinesterase inhibitory, and lipid-lowering properties. Further in vivo studies are needed to confirm its therapeutic potential.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Treatment of delirium in intensive care patients with sepsis using daily intravenous infusions with omega-3 fatty acids. 每日静脉输注omega-3脂肪酸治疗重症脓毒症患者谵妄。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-11 DOI: 10.5414/CP204791

De-Qiang Wang, Fang-Bao Hu, Wen Wang, Hong-Jie Dou, Lin Ling, Cong-Bo Zheng, Yong Guo

{"title":"Treatment of delirium in intensive care patients with sepsis using daily intravenous infusions with omega-3 fatty acids.","authors":"De-Qiang Wang, Fang-Bao Hu, Wen Wang, Hong-Jie Dou, Lin Ling, Cong-Bo Zheng, Yong Guo","doi":"10.5414/CP204791","DOIUrl":"10.5414/CP204791","url":null,"abstract":"Background: The development of delirium is closely linked to inflammatory processes. Omega-3 fatty acids can modulate the immune response and may contribute to reducing the incidence of sepsis-associated delirium (SAD).Aims: To investigate the effects of omega-3 fatty acids on delirium in patients with sepsis.Materials and methods: In a single-center clinical trial, 220 intensive care patients diagnosed with sepsis were randomly assigned to receive daily intravenous infusions of either an omega-3 fish oil emulsion or a placebo. Delirium was assessed twice daily using the Richmond Agitation-Sedation Scale (RASS) and the Confusion Assessment Method (CAM). The primary outcome was the duration of delirium during the first 10 days of admission. Secondary outcomes included the duration of mechanical ventilation, length of intensive care unit (ICU) stay, and mortality.Results: Compared to the control group, the omega-3 group exhibited significantly fewer days with delirium episodes (p = 0.010), shorter ICU stays (p = 0.008), and fewer mechanical ventilation days (p = 0.001). However, there was no statistically significant difference in mortality between the two groups.Conclusion: Omega-3 fatty acids may effectively reduce the risk of delirium in sepsis patients, highlighting their potential as a therapeutic intervention in this population.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608303","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Potentiation of paclitaxel-induced apoptosis in a non-small cell lung cancer model using the traditional Chinese drug huaier: Network pharmacology analysis, experimental verification, and clinical impact. 中药怀尔增强紫杉醇诱导的非小细胞肺癌细胞凋亡：网络药理学分析、实验验证及临床影响

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-01 DOI: 10.5414/CP204745

Wanrong Zheng, Fobao Lai

引用次数: 0

Severe autoimmune hemolytic anemia associated with glucose-6-phosphate dehydrogenase deficiency as a complication of nivolumab treatment: A case report. 作为纳武单抗治疗并发症的严重自身免疫性溶血性贫血与葡萄糖-6-磷酸脱氢酶缺乏相关：1例报告

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-01 DOI: 10.5414/CP204756

Roberto Lozano, María-Esther Franco, Carina Bona

引用次数: 0

Immune-mediated hepatitis caused by toripalimab: A case report. 托帕利单抗致免疫介导肝炎1例。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2025-06-01 DOI: 10.5414/CP204647

Taoyan Lin, Ping Zheng, Yilei Li, Jing Cai

引用次数: 0

Prediction of hyperkalemia occurrence in patients using co-trimoxazole: Clinical adjustment of a Markov model. 预测复方新诺明患者高钾血症的发生：马尔可夫模型的临床调整。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2025-05-01 DOI: 10.5414/CP204681

Fumiya Watanabe, Toshinori Hirai, Chihiro Shiraishi, Ken Tasaka, Takuya Iwamoto, Kazuhiko Hanada

{"title":"Prediction of hyperkalemia occurrence in patients using co-trimoxazole: Clinical adjustment of a Markov model.","authors":"Fumiya Watanabe, Toshinori Hirai, Chihiro Shiraishi, Ken Tasaka, Takuya Iwamoto, Kazuhiko Hanada","doi":"10.5414/CP204681","DOIUrl":"10.5414/CP204681","url":null,"abstract":"Objective: Predicting the occurrence of hyperkalemia in patients undergoing co-trimoxazole treatment for Pneumocystis pneumonia is critical. However, other factors besides drug exposure affect serum potassium levels, and various interventions are often used to treat hyperkalemia in clinical practice. Therefore, we aimed to develop a Markov model to predict the risk of hyperkalemia under various intervention conditions.Materials and methods: This was a retrospective, observational study. Information on daily dose of co-trimoxazole and hyperkalemia events was obtained from adult patients administered oral co-trimoxazole between 2015 and 2020 at Mie University Hospital (Mie, Japan). A Markov model with an intermediate layer was applied using NONMEM. The drug-effect model was assumed to have a maximum effective model. Bootstrapping and visual predictive checks were used to assess model validity.Results: A total of 271 patients with 4039 observations of potassium levels were included. Baseline serum potassium level was a significant covariate of drug response. The successful bootstrap completion rate was 99.5%, and each parameter estimate was consistent with the bootstrap median; therefore, the model was sufficiently robust.Conclusion: The Markov model, including an intermediate layer, provides a robust framework for predicting the risk of hyperkalemia, even in datasets where post-onset interventions vary from patient to patient. Thus, it is postulated that higher baseline potassium levels increase hyperkalemia.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"190-196"},"PeriodicalIF":0.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143596964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0