European Journal of Clinical Pharmacology最新文献

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Population pharmacokinetics of bedaquiline: a systematic review. 贝达喹啉的群体药代动力学:系统综述。
IF 2.4 3区 医学
European Journal of Clinical Pharmacology Pub Date : 2025-01-08 DOI: 10.1007/s00228-024-03788-1
Jie Jin, Jie Cao, Ruoying Zhang, Lifang Zheng, Xinjun Cai, Jinmeng Li
{"title":"Population pharmacokinetics of bedaquiline: a systematic review.","authors":"Jie Jin, Jie Cao, Ruoying Zhang, Lifang Zheng, Xinjun Cai, Jinmeng Li","doi":"10.1007/s00228-024-03788-1","DOIUrl":"https://doi.org/10.1007/s00228-024-03788-1","url":null,"abstract":"<p><strong>Background and objectives: </strong>Bedaquiline (BDQ) plays a critical role in the treatment of multidrug-resistant tuberculosis (MDR-TB). However, the large pharmacokinetic (PK) variability of BDQ presents a significant challenge in its clinical use. This study aimed to summarize the population PK characteristics of BDQ and to identify significant covariates affecting the PK variation of BDQ.</p><p><strong>Methods: </strong>The PubMed and Web of Science databases were systematically searched from their inception to October 1, 2023. Population pharmacokinetics (PPK) studies on BDQ were searched and identified in this review. The PK characteristics of included studies and the significant covariates were systematically summarized.</p><p><strong>Results: </strong>Eight studies conducted in adults and one in children and adolescents were included in this review. A three disposition compartments with dynamic absorption transport chamber model was the commonly used structural model for BDQ. Body weight, race, albumin, and concomitant medication were significant covariates affecting BDQ PK variation. With the increase of weight and albumin levels, the clearance (CL) of BDQ was gradually increased. The average CL value per body weight in children was 1.49-fold higher than that in adults. Black race patients had an 84% higher CL than other populations. Moreover, combined with rifampicin and rifapentine, BDQ had 378% and 296% higher clearance rates, respectively.</p><p><strong>Conclusions: </strong>Body weight, race, albumin level, and concomitant medication may be important factors affecting patients' exposure differences. Further PPK studies of BDQ are needed to facilitate optimal dosing regimens.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Association of obesity with ropivacaine and sufentanil EC50 in labor analgesia: a single-center prospective study. 妊娠镇痛中肥胖与罗哌卡因和舒芬太尼EC50的关系:一项单中心前瞻性研究。
IF 2.4 3区 医学
European Journal of Clinical Pharmacology Pub Date : 2025-01-08 DOI: 10.1007/s00228-024-03800-8
Zunyi Liu, Xuelan Zhou, Jiang Zhu
{"title":"Association of obesity with ropivacaine and sufentanil EC50 in labor analgesia: a single-center prospective study.","authors":"Zunyi Liu, Xuelan Zhou, Jiang Zhu","doi":"10.1007/s00228-024-03800-8","DOIUrl":"https://doi.org/10.1007/s00228-024-03800-8","url":null,"abstract":"<p><strong>Objective: </strong>In part I, measure the EC50 of sufentanil in obese and non-obese parturients combined with 0.1% ropivacaine and compare the differences. Similarly, in part II, measure the EC50 of ropivacaine in obese and non-obese parturients combined with 0.5 µg/ml sufentanil and compare the differences.</p><p><strong>Methods: </strong>This study comprises two parts, with an initial intention to enroll 120 full-term primiparous women who underwent vaginal delivery and sought epidural analgesia. Each part includes an obese group (OA group, Obese Adults, defined as prepartum BMI≥29 kg/m<sup>2</sup>) and a non-obese group (CON group, Control group, defined as 18.5<prepartum BMI<28 kg/m<sup>2</sup>), with 30 participants in each. Both parts, for both obese and non-obese women, utilized an initial concentration of 0.1% ropivacaine with 0.5 µg /ml sufentanil. The initial concentration of sufentanil is 0.5 µg/ml. When the NRS score is ≤3 within 30min after analgesia, it is considered effective analgesia, and the concentration of sufentanil in the next parturients decreases by 0.05 µg/ml. Otherwise, the concentration of sufentanil in the next parturient will increase by 0.05 µg/ml. The second part uses the same method to measure the EC50 of ropivacaine (increase or decrease by 0.01%) in the OA group and CON group combined with 0.5 µg/ml sufentanil, with 30 participants in each group. EC50 measurements were performed through up-and-down sequential allocation, with effective analgesia defined as an NRS score ≤3, 30 min post-analgesia.</p><p><strong>Results: </strong>In part I, the EC50 of epidural sufentanil in the OA group was 0.090 µg/ml (95% CI, 0.061~0.115µg/ml), and in the CON group, it was 0.170µg/ml (95% CI, 0.117~0.219µg/ml). In part II, the EC50 of epidural ropivacaine in the OA group was 0.048% (95% CI, 0.041~0.053%), and in the CON group, it was 0.070% (95% CI, 0.064~0.075%). The secondary outcomes in both parts of the study showed no statistically significant differences.</p><p><strong>Conclusion: </strong>Obese parturients exhibited significantly lower EC50 values for ropivacaine and sufentanil compared to non-obese parturients. Lower concentrations of both agents can be considered for labor analgesia in obese parturients.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Correlation of cyclosporine A blood concentration with kidney injury for pediatric patients after hematopoietic stem cell transplantation: a retrospective cohort study. 环孢素A血药浓度与儿童造血干细胞移植后肾损伤的相关性:一项回顾性队列研究。
IF 2.4 3区 医学
European Journal of Clinical Pharmacology Pub Date : 2025-01-07 DOI: 10.1007/s00228-024-03792-5
Wei Shi, Xin Qiu, Liang Huang, Linan Zeng, Runxin Lu, Hailong Li, Kun Zou, Zhijun Jia, Guo Cheng, Qin Yu, Limei Zhao, Lingli Zhang
{"title":"Correlation of cyclosporine A blood concentration with kidney injury for pediatric patients after hematopoietic stem cell transplantation: a retrospective cohort study.","authors":"Wei Shi, Xin Qiu, Liang Huang, Linan Zeng, Runxin Lu, Hailong Li, Kun Zou, Zhijun Jia, Guo Cheng, Qin Yu, Limei Zhao, Lingli Zhang","doi":"10.1007/s00228-024-03792-5","DOIUrl":"https://doi.org/10.1007/s00228-024-03792-5","url":null,"abstract":"<p><strong>Background: </strong>The potential nephrotoxicity of cyclosporine A (CsA) has been a problem for treating graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the relationship between CsA blood concentration and acute kidney injury (AKI) in pediatric patients after allo-HSCT remains unclear.</p><p><strong>Methods: </strong>We performed a retrospective study including pediatric patients who received allo-HSCT in West China Second Hospital of Sichuan University from 2000 to 2022 and collected their clinical data. Included patients' CsA blood concentration were divided into three cohorts according to the guideline. Multivariate logistic regression was used to estimate the relationship between AKI and CsA blood concentration and other factors. And the maximum cut-off value for the safe blood concentration range of CsA was obtained by the receiver operating characteristic (ROC) curve.</p><p><strong>Results: </strong>Seventy-nine patients (average age 6.75 ± 4.25) were included. The incidence of kidney injury for three CsA blood concentration cohorts (< 200 ng/ml, 200-300 ng/ml, > 300 ng/ml) were 21.30%, 23.50%, and 66.70%, respectively. A multivariate logistic regression identified CsA blood concentration (> 300 ng/ml) and infection were risk factors for AKI (OR <sub><200 ng/ml</sub>: 0.115, 95% CI: 0.029-0.458; OR <sub>200-300 ng/ml</sub>: 0.184, 95% CI: 0.036-0.929; OR <sub>infection</sub>: 5.006, 95% CI: 1.491-16.810). Meanwhile, the maximum cut-off value for the safe blood concentration range of CsA is 276.85 ng/ml with an AUC value of 0.684 (P = 0.010).</p><p><strong>Conclusion: </strong>In conclusion, clinical treatment for the pediatric patients after allo-HSCT may be considered to control the blood concentration of CsA in 200-276.85 ng/ml and closely monitoring patients who have infections.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Pharmacogenetics of opioid medications for relief of labor pain and post-cesarean pain: a systematic review and meta-analysis. 缓解分娩疼痛和剖宫产后疼痛的阿片类药物的药物遗传学:系统回顾和荟萃分析。
IF 2.4 3区 医学
European Journal of Clinical Pharmacology Pub Date : 2025-01-07 DOI: 10.1007/s00228-024-03798-z
Martina Giacon, Sarah Cargnin, Maria Talmon, Salvatore Terrazzino
{"title":"Pharmacogenetics of opioid medications for relief of labor pain and post-cesarean pain: a systematic review and meta-analysis.","authors":"Martina Giacon, Sarah Cargnin, Maria Talmon, Salvatore Terrazzino","doi":"10.1007/s00228-024-03798-z","DOIUrl":"https://doi.org/10.1007/s00228-024-03798-z","url":null,"abstract":"<p><strong>Objective: </strong>Several studies have attempted to identify genetic determinants of clinical response to opioids administered during labor or after cesarean section. However, their results were often contrasting. A systematic review and meta-analysis was conducted to quantitatively assess the association between gene polymorphisms and clinical outcomes of opioid administration in the treatment of labor pain and post-cesarean pain.</p><p><strong>Methods: </strong>A comprehensive search was performed up to December 2023 using PubMed, Web of Knowledge, Cochrane Library, and OpenGrey databases. The clinical endpoints of interest were pain score after opioid treatment, total opioid consumption, patient's analgesic satisfaction, and incidence of opioid side effects. Random-effects meta-analyses were conducted when data were available in at least three studies.</p><p><strong>Results: </strong>Twenty-six studies enrolling 7765 patients were included in the systematic review. Overall, a total of 12 candidate polymorphic genes (OPRM1, COMT, CYP2D6, CYP3A4, ABCB1, ABCC3, UGT2B7, CGRP, OPRK1, OPRD1, KCNJ6, KCNJ9) were considered by the included studies, among which the most investigated variant was OPRM1 rs1799971. Overall pooled results indicated that individuals carrying the G allele of OPRM1 rs1799971 required higher opioid doses for pain management in comparison to rs1799971 AA subjects (standardized mean difference: 0.26; 95% CI: 0.09-0.44; P = 0.003). Such an association was confirmed in the subgroups of patients with labor pain and post-cesarean pain.</p><p><strong>Conclusion: </strong>The present meta-analysis provides strong evidence of an association between OPRM1 rs1799971 and opioid dose requirement for relief of labor pain or post-cesarean pain. However, given the insufficient evidence for other polymorphic gene variants, large studies are still needed to investigate the impact of genetic variability on the efficacy and safety of opioid medications for relief of labor pain and post-cesarean pain (INPLASY Registration No. 202410040).</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Drug safety during pregnancy: a challenging and ever moving field. 妊娠期用药安全:一个充满挑战和不断变化的领域。
IF 2.4 3区 医学
European Journal of Clinical Pharmacology Pub Date : 2025-01-03 DOI: 10.1007/s00228-024-03793-4
M Conijn, B Cuppers-Maarschalkerweerd, F O'Shaughnessy, M Berlin, U Nörby, M H M van Tuyl
{"title":"Drug safety during pregnancy: a challenging and ever moving field.","authors":"M Conijn, B Cuppers-Maarschalkerweerd, F O'Shaughnessy, M Berlin, U Nörby, M H M van Tuyl","doi":"10.1007/s00228-024-03793-4","DOIUrl":"https://doi.org/10.1007/s00228-024-03793-4","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142921265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Effectiveness of macrolides as add-on therapy to beta-lactams in community-acquired pneumonia: A meta-analysis of randomized controlled trials. 大环内酯类药物作为β-内酰胺类药物的附加疗法对社区获得性肺炎的疗效:随机对照试验荟萃分析。
IF 2.4 3区 医学
European Journal of Clinical Pharmacology Pub Date : 2025-01-01 Epub Date: 2024-11-18 DOI: 10.1007/s00228-024-03775-6
Vitória Martins Prizão, Otavio Cosendey Martins, Beatriz Austregésilo de Athayde de Hollanda Morais, Beatriz Ximenes Mendes, Maria Luiza Rodrigues Defante, Mariana de Moura Souza
{"title":"Effectiveness of macrolides as add-on therapy to beta-lactams in community-acquired pneumonia: A meta-analysis of randomized controlled trials.","authors":"Vitória Martins Prizão, Otavio Cosendey Martins, Beatriz Austregésilo de Athayde de Hollanda Morais, Beatriz Ximenes Mendes, Maria Luiza Rodrigues Defante, Mariana de Moura Souza","doi":"10.1007/s00228-024-03775-6","DOIUrl":"10.1007/s00228-024-03775-6","url":null,"abstract":"<p><strong>Purpose: </strong>This study aims to evaluate whether adding macrolides (MAC) to beta-lactam (BL) monotherapy in the treatment of community-acquired pneumonia (CAP) offers clinical benefits that justify the potential disadvantages or side effects.</p><p><strong>Methods: </strong>We systematically searched PubMed, Embase, and Cochrane for randomized controlled trials (RCTs) comparing BL monotherapy to combination therapy with BL and MAC for the in-hospital treatment of CAP. We pooled mean differences (MD) for continuous outcomes and risk ratio (RR) for binary outcomes, with 95% confidence intervals (CI).</p><p><strong>Results: </strong>Six RCTs with 2661 participants (52% receiving combination therapy), revealed no significant difference in in-hospital mortality (RR 0.99; 95% CI 0.78 to 1.25; p = 0.94; I2 = 0%), 90-day mortality (RR 1.03; 95% CI 0.82 to 1.29; p = 0.83; I2 = 13%), or 30-day mortality (RR 0.90; 75% CI 0.63 to 1.29; p = 0.58; I2 = 54%). Additionally, no significant differences were observed in the length of hospital stay (MD 0.51; 95% CI - 0.50 to 1.51; p = 0.33; I2 = 63%) or respiratory insufficiency (RR 0.63; 95% CI 0.29 to 1.35; p = 0.24; I2 = 74%). However, combination therapy significantly improved the treatment success rate (RR 1.17; 95% CI 1.04 to 1.32; p = 0.009; I2 = 0%).</p><p><strong>Conclusion: </strong>Our findings suggest that BL + MAC therapy should not be used in all cases of hospitalized patients with CAP.</p><p><strong>Prospero id: </strong>CRD42024516383 - Data of registration: 03/03/2024.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"83-91"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Curcumin as a complementary treatment in oncological therapy: a systematic review. 姜黄素作为肿瘤治疗的辅助疗法:系统综述。
IF 2.4 3区 医学
European Journal of Clinical Pharmacology Pub Date : 2025-01-01 Epub Date: 2024-10-19 DOI: 10.1007/s00228-024-03764-9
Lisa C Gutsche, Jennifer Dörfler, Jutta Hübner
{"title":"Curcumin as a complementary treatment in oncological therapy: a systematic review.","authors":"Lisa C Gutsche, Jennifer Dörfler, Jutta Hübner","doi":"10.1007/s00228-024-03764-9","DOIUrl":"10.1007/s00228-024-03764-9","url":null,"abstract":"<p><strong>Purpose: </strong>Curcumin, the active ingredient in turmeric, is employed by numerous cancer patients to support conventional cancer therapy. This systematic review aims to summarize the existing clinical evidence and to provide an overview of the potential benefits and risks associated with curcumin supplementation.</p><p><strong>Methods: </strong>In January 2024, we conducted a systematic search of five electronic databases (Embase, Cochrane, PsycInfo, CINAHL, and Medline) using a complex search strategy. We included randomized controlled trials on the use, effectiveness, and potential harm of additional curcumin therapy in adult patients under cancer treatment. The risk of bias was assessed using Cochrane revised Risk of Bias Tool 2.0.</p><p><strong>Results: </strong>This systematic review included 34 randomized controlled trials involving 2580 patients out of 11143 search results. Included patients were primarily diagnosed with head and neck cancer, followed by breast, prostate, and colorectal cancer. Therapy concepts encompassed topical or systemic curcumin administration. The studies reported heterogeneous results concerning oral and skin symptoms, pain, weight alteration and changes in body composition, survival, and disease progression. Significant findings were reported for oral mucositis and weight loss. Considering risk of bias, all studies had moderate to high risk of bias. Regarding side effects, one study reported significantly more vomiting in the curcumin group.</p><p><strong>Conclusion: </strong>Although the results suggest promise in reducing mucositis and weight loss, a clear statement regarding the effectiveness of curcumin therapy on cancer patients cannot be made due to heterogeneous results and methodological limitations of the involved studies. Further investigations of higher quality are necessary to derive a definite recommendation for action.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1-33"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11695395/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Risk prediction models for adverse drug reactions and adverse drug events in older adults-a systematic review and meta-analysis. 老年人药物不良反应和药物不良事件的风险预测模型--系统综述和荟萃分析。
IF 2.4 3区 医学
European Journal of Clinical Pharmacology Pub Date : 2025-01-01 Epub Date: 2024-11-18 DOI: 10.1007/s00228-024-03774-7
Nicole Cosgrave, Sooad Saleh, Woei Shan Ong, Juliane Frydenlund, David J Williams, Caitriona Cahir
{"title":"Risk prediction models for adverse drug reactions and adverse drug events in older adults-a systematic review and meta-analysis.","authors":"Nicole Cosgrave, Sooad Saleh, Woei Shan Ong, Juliane Frydenlund, David J Williams, Caitriona Cahir","doi":"10.1007/s00228-024-03774-7","DOIUrl":"10.1007/s00228-024-03774-7","url":null,"abstract":"<p><strong>Background: </strong>Adverse drug reactions (ADRs) are common and result in significant morbidity, mortality, and associated hospital costs. Models predicting ADRs in older adults were previously found to lack reliability and validity. This systematic review and meta-analysis aim to provide an updated, comprehensive quality assessment and analysis of ADR-risk prediction tools in older adults.</p><p><strong>Methods: </strong>Standard databases and citations were searched (2012 to 2023) and studies which developed and/or validated an ADR prediction model for use in older adults were included. Four studies from a previous systematic review were also included. The TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) checklist was used to evaluate each study. Random effects models were used to derive a pooled discrimination estimate (area-under-the-receiver-operation curve; AUROC) for model development and validation studies.</p><p><strong>Results: </strong>Eight studies, describing 6 ADR-risk prediction models met the inclusion criteria). In the meta-analysis, the pooled AUROC was 0.75 (95% CI 0.57, 0.87; I-squared = 96.88%) for model development studies and 0.73 (95% CI 0.52, 0.87; Isquared = 90.19%) for externally validated studies. Studies had poor adherence (range 34-50%; median 46.5%; IQR 12%) to TRIPOD guidelines.</p><p><strong>Conclusion: </strong>The studies identified through this systematic review exhibit poor adherence to TRIPOD guidelines which may question the investigational rigor and the usability of the models. This underscores the urgent need to develop a validated, robust, and reliable tool worthy of implementation and testing in a real-world setting to gauge its impact and usability effectively.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"93-110"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142667597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Evaluating the impact of loperamide on irinotecan-induced adverse events: a disproportionality analysis of data from the World Health Organization pharmacovigilance database (VigiBase). 评估洛哌丁胺对伊立替康引发的不良事件的影响:对世界卫生组织药物警戒数据库(VigiBase)数据的比例失调分析。
IF 2.4 3区 医学
European Journal of Clinical Pharmacology Pub Date : 2025-01-01 Epub Date: 2024-10-23 DOI: 10.1007/s00228-024-03767-6
Tomoaki Akagi, Hirofumi Hamano, Hirotaka Miyamoto, Tatsuaki Takeda, Yoshito Zamami, Kaname Ohyama
{"title":"Evaluating the impact of loperamide on irinotecan-induced adverse events: a disproportionality analysis of data from the World Health Organization pharmacovigilance database (VigiBase).","authors":"Tomoaki Akagi, Hirofumi Hamano, Hirotaka Miyamoto, Tatsuaki Takeda, Yoshito Zamami, Kaname Ohyama","doi":"10.1007/s00228-024-03767-6","DOIUrl":"10.1007/s00228-024-03767-6","url":null,"abstract":"<p><strong>Purpose: </strong>SN-38, the active metabolite of irinotecan, may cause adverse events necessitating treatment discontinuation and management. Diarrhea, which is treated with loperamide, is one such event. However, loperamide may delay SN-38 elimination, causing more adverse events. Therefore, understanding the adverse events caused by symptomatic drugs is crucial for safe drug therapy. This study aimed to assess the association between loperamide and irinotecan-induced adverse events.</p><p><strong>Methods: </strong>We analyzed data up to December 2022 from VigiBase, the World Health Organization's adverse event database. The study used reporting odds ratios (RORs) to evaluate the associations between concomitant medications and irinotecan-induced adverse events. Fisher's exact probability test was used to analyze the adverse events. Logistic regression analysis was performed to identify associated adverse event signals.</p><p><strong>Results: </strong>Of the 32,520,983 cases analyzed, 57,454 involved the use of irinotecan. Among these, 1589 (2.8%) patients were co-treated with loperamide. Signals for neutropenia (ROR 1.37, 95% confidence interval (CI) 1.20-1.57, p < 0.001), anemia (ROR 1.81, 95% CI 1.43-2.30, p < 0.001), and alopecia (ROR 1.89, 95% CI 1.30-2.74, p < 0.01) were detected with concomitant loperamide. Multivariate logistic regression analysis confirmed that concomitant loperamide use was associated with signals for neutropenia, anemia, and alopecia.</p><p><strong>Conclusion: </strong>Our results suggest that loperamide increases the risk of irinotecan-induced adverse events and enhances irinotecan toxicity. The study methodology may be useful for predicting adverse event risk when choosing symptomatic therapy drugs during irinotecan use.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"129-137"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Effects of olanzapine in the improvement of body weight and appetite in patients with cancer or receiving chemotherapy: a systematic review and meta-analysis. 奥氮平在改善癌症患者或化疗患者体重和食欲方面的作用:系统综述和荟萃分析。
IF 2.4 3区 医学
European Journal of Clinical Pharmacology Pub Date : 2025-01-01 Epub Date: 2024-10-29 DOI: 10.1007/s00228-024-03770-x
Lu Yuan, Xin-Yu Li, Lu Xu, Si-Jie Quan, Yan-Bing Huang, Hui Zheng
{"title":"Effects of olanzapine in the improvement of body weight and appetite in patients with cancer or receiving chemotherapy: a systematic review and meta-analysis.","authors":"Lu Yuan, Xin-Yu Li, Lu Xu, Si-Jie Quan, Yan-Bing Huang, Hui Zheng","doi":"10.1007/s00228-024-03770-x","DOIUrl":"10.1007/s00228-024-03770-x","url":null,"abstract":"<p><strong>Objective: </strong>We aimed to assess the effects of olanzapine in the improvement of body weight and appetite in patients with cancer or receiving chemotherapy through a systematic review and meta-analysis.</p><p><strong>Methods: </strong>We searched the following databases from their inception to April 23, 2024: Embase, PubMed, Web of Science, and the Cochrane Library. The mean difference (MD) and risk ratios were used to calculate by random effects models. The primary outcome was the proportion of patients with > 5% weight gain.</p><p><strong>Results: </strong>Seventeen studies with 3457 participants were included. For primary outcomes, 1 study with 124 participants showed olanzapine increased the proportion of patients with > 5% weight gain compared with placebo (60% vs. 9%, P < 0.001). Versus active controls (3 studies, 439 participants), no significant difference in the proportion of patients with > 5% weight gain (RR = 1.69, 95%CI: 0.91 to 3.13, I<sup>2</sup> = 27%, P = 0.10), with moderate-quality evidence. Olanzapine increased appetite scores compared to both placebo (1 study, 112 participants; MD = 3, 95%CI: 2.3 to 3.7, P < 0.001) and active controls (2 studies, 106 participants; MD = 4.96, 95%CI: 4.61 to 5.30, I<sup>2</sup> = 0%, P < 0.01). For mean weight change, olanzapine showed no significant differences versus placebo (2 studies, 164 participants, MD = 2.78 kg, 95%CI: - 1.60 to 7.17, I<sup>2</sup> = 48%, P = 0.21) or active controls (2 studies, 480 participants, MD = 0.44 kg, 95%CI: - 1.04 to 1.91, I<sup>2</sup> = 58%, P = 0.56).</p><p><strong>Conclusions: </strong>Olanzapine appears to be a potential option for improving appetite and weight gain in cancer patients. Future trials need to focus on the optimal target dose and use durations of olanzapine. Registered: https://archive.org/details/osf-registrations-kpv4h-v .</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"45-63"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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