药品集中采购政策背景下仿制药与原研药有效性和安全性对比的系统综述

Clinical efficacy and safety between generic and original drugs under the centralized drug procurement policy:a systematic review

目的梳理药品集中带量采购(集采)政策背景下仿制药与原研药有效性和安全性对比的原始研究,为集采中选仿制药临床评价提供参考。方法系统性检索2018年1月—2021年12月中国知网、万方、PubMed和Cochrane数据库中关于我国仿制药与原研药疗效与安全性对比文献。提取作者、药品、研究方法及结果信息,使用ROB2.0和ROBINS-I偏倚风险评估工具进行文献质量评价。结果共纳入91篇文献。其中,77篇文献偏倚风险为高至极高;93.4%的入选文献表明仿制药与原研药有效性一致;86.2%的入选文献表明仿制药与原研药安全性一致。抗感染药、抗肿瘤及免疫用药、心血管系统药、血液和造血器官药、消化系统和代谢系统药是多数的研究药物类型,入选文献研究主要集中在慢性病治疗领域。结论大多数仿制药临床研究数据不足,尤其是急性病治疗药物。多数入选的文献存在高偏倚风险,报告质量需提高。医疗机构药师参与的真实世界研究可以为仿制药临床研究提供参考和思路。

Objective To sort out original studies on the clinical efficacy and safety between generic drugs and original drugs,and provide reference for the selection of generic drugs for the National Centralized Drug Procurement Policy.Methods From January 2018 to December 2021,CNKI,WanFang,PubMed and Cochrane Library were retrieved to collect clinical studies comparing the efficacy and safety of generic drugs with original drugs.The authors,drugs,research methods and results were collected and analyzed.Bias risk was analyzed for included studies with ROB2.0 or ROBINS-I.Results Totally 91 publications were included,77 of which had high to extremely high risk of bias.93.4%of the enrolled studies indicated no significant differences in efficacy between generic drugs and original drugs;86.2%of the enrolled studies indicated no significant differences in safety between generic drugs and original drugs.Antiinfection drugs,anti-tumor and immunological drugs,cardiovascular drugs,blood and hematopoietic organs drugs,digestive and metabolic drugs were the main drug types studied.Drugs for chronic diseases were the main types of drugs studied.Conclusion Clinical data for most generic drugs are lacking,especially drugs for acute diseases.Most included randomized clinical trials have a high risk of bias,and the quality of the reports needs improvement.Real-world studies involving pharmacists in medical institutions can provide new clinical evidence for generic drugs.