摘要
目的:利用中国医院药物警戒系统(CHPS)评估白蛋白结合型紫杉醇超说明书使用的安全性情况,分析发生不良反应的影响因素,为合理用药提供参考。方法:采用回顾性分析,选取2022年9月1日到2023年12月31日深圳市第二人民医院超说明书使用白蛋白结合型紫杉醇的251例肿瘤患者作为研究对象,利用CHPS建立白蛋白结合型紫杉醇的自动监测方案,研究其药品不良反应(ADR)发生率,并对其ADR相关因素进行分析。结果:系统共监测病例196例,白细胞减少、中性粒细胞减少、血小板减少、贫血、胃肠道反应及肝肾功能异常的不良反应占比分别为16.46%、12.80%、8.54%、23.78%、15.24%、6.70%。相关因素分析表明,患者体质量指数(BMI)和治疗周期对白蛋白所致的血液系统ADR影响较大。结论:白蛋白结合型紫杉醇超说明书使用发生不良反应最多的为血液系统反应,而这些与患者的BMI及治疗周期相关,对低体质量且用药周期较多的患者应该加强监测。
Objective To evaluate the safety of off-label use of albumin-bound paclitaxel by using the China Hospital Pharmacovigilance System(CHPS),analyze the influencing factors of adverse drug reactions(ADRs),and provide references for rational drug use.Methods A retrospective analysis was conducted on 251 tumor patients who received off-label use of albumin-bound paclitaxel at Shenzhen Second People's Hospital from September 1,2022 to December 31,2023.An automatic monitoring plan for albumin-bound paclitaxel was established using CHPS to study the incidence of ADRs and analyze the related factors.Results A total of 196 cases were monitored.The proportions of adverse reactions such as leukopenia,neutropenia,thrombocytopenia,anemia,gastrointestinal reactions,and abnormal liver and kidney functions were 16.46%,12.80%,8.54%,23.78%,15.24%,and 6.70%,respectively.The analysis of related factors indicated that the body mass index(BMI)of patients and the treatment cycle had a significant impact on hematological ADRs caused by albumin-bound paclitaxel.Conclusion The most common ADRs of off-label use of albumin-bound paclitaxel are hematological reactions,which are related to the BMI and treatment cycle of patients.For patients with low BMI and a longer treatment period,enhanced monitoring should be implemented.
作者
龙书可
陈钦榜
李璐
郑安泰
王金平
LONG Shuke;CHEN Qinbang;LI Lu;ZHENG Antai;WANG Jinping(Pharmacy Department,Shenzhen Second People's Hospital,Guangdong Shenzhen 518035;Department of Pharmacy,Medical College of Jiaying University,Guangdong Meizhou 514031)
出处
《深圳中西医结合杂志》
2025年第10期10-14,I0007,共6页
Shenzhen Journal of Integrated Traditional Chinese and Western Medicine
基金
广东省药学会肿瘤领域超说明书用药评价研究基金(2023ZLCS35)。
