国内贝伐珠单抗超说明书用药现状及分析

Current Situation and Analysis of Bevacizumab Over Instruction in China

目的:对贝伐珠单抗在国内超说明书用药情况进行汇总、分析,为规范超说明书用药行为提供循证依据与参考。方法:以“贝伐珠单抗”“超说明书”为关键词检索自贝伐珠单抗上市到2021年12月发表的相关报道,按照纳入与排除标准筛选文献,对贝伐珠单抗的适应证、用法用量等超说明书应用情况进行整理分析。结果:该研究共纳入826篇文献,19种超适应证使用情况,文献数占比为27.8%,有9种非静脉滴注的给药途径。另外贝伐珠单抗在结直肠癌治疗中应用文献数量最大,未发现其超说明书适应证用药情况,存在2021CSCO指南及说明书推荐的联合用药治疗方案。超说明书用药的疗效相比于对照组基本都具有显著优势,不良反应与对照组相比绝大部分差异无统计学意义,但高血压在乳腺癌、胸膜间皮瘤、胸腹腔积液及胃癌中比对照组发生率高,差异有统计学意义,值得关注。结论:目前贝伐珠单抗超说明书用药在国内各大型综合医院存在较为普遍,应结合已经通过的《中华人民共和国医师法》关于超说明书用药法条对其进行合理管控,进一步促进临床合理用药,降低用药风险。

Objective:The off-label use of bevacizumab in China was summarized and analyzed to provide evidence-based basis and reference for standardizing off-label use behavior.Methods:With"bevacizumab"and"off-label"as keywords,relevant reports published from the marketing of bevacizumab to 2021 December were retrieved,literatures were screened according to inclusion and exclusion criteria,and the off-label application of bevacizumab such as indications,usage and dosage were sorted out and analyzed.Results:A total of 826 articles were included in this study,including 17 off-label uses(27.8%)and 9 non-intravenous delivery routes.In addition,bevacizumab has been used in the treatment of colorectal cancer in the largest number of literatures,and no off-label drug use was found,but there were combined drug treatment regiments not recommended by 2021CSCO guidelines and instructions.Compared with the control group,the efficacy of off-label drug use basically had significant advantages,and most of the adverse reactions had no statistical difference compared with the control group.However,the incidence of hypertension in breast cancer,pleural mesothelioma,pleuroperitoneal product and gastric cancer was higher than that in the control group,and the incidence was statistically significant,which deserved attention.Conclusion:At present,the off-label use of bevacizumab is relatively common in large general hospitals in China,and it should be rationally controlled in accordance with the provisions on off-label use of bevacizumab in the Medical Law of the People's Republic of China,to further promote rational drug use in clinical practice and reduce the risk of drug use.