贝伐珠单抗注射液等4种单抗类抗肿瘤药上市后安全性比较研究

Comparative study on post-marketing safety of four monoclonal anti-tumor drugs including bevacizumab injection

关键词:  单抗类抗肿瘤药  药品不良反应  信号检测  安全性比较

Key words:  monoclonal anti-tumor agents  adverse drug reaction  signal detection  security comparison

摘要:

目的 对贝伐珠单抗注射液等4种单抗类抗肿瘤药开展上市后安全性比较研究,供临床掌握其安全风险特征,促进合理用药水平提升。方法：使用《监管活动医学词典(MedDRA)》对药品不良反应进行编码；采用综合标准法(MHRA)开展信号检测和回顾分析法对不良反应从人口学因素、不良反应特征、不良反应信号和不良反应转归等方面进行比较。结果 本项研究中各品种的不良反应多发于50岁以上患者,贝伐珠单抗注射液的女性ADR患者占比高于男性,利妥昔单抗注射液、注射用卡瑞利珠单抗和信迪利单抗注射液的男性ADR患者占比高于女性；各品种在其主要不良反应临床表现方面存在差异；不同品种对同一系统器官的影响存在差异；不同品种的不良反应信号发生时间存在差异；不同品种的不良反应转归情况均较好。结论 本项研究中各品种的临床使用风险可控；建议关注贝伐珠单抗注射液40岁以上女性患者和利妥昔单抗注射液、注射用卡瑞利珠单抗以及信迪利单抗注射液50岁以上男性患者；建议结合不良反应分析和信号检测情况,针对不同品种在不同时间段的不同ADR有侧重地开展监测工作。

Abstract:

OBJECTIVE To conduct a post-marketing safety comparison study of four monoclonal antibody anti-tumor drugs including bevacizumab injection, so as to understand their safety risk characteristics and promote the improvement of rational drug use. METHODS Use the Medical Dictionary of Regulatory Activities (MedDRA) to code adverse drug reactions; the comprehensive standard method (MHRA) was used to carry out signal detection and retrospective analysis to compare the demographic factors, adverse reaction characteristics, adverse reaction signals and adverse reaction outcomes. RESULTS In this study, adverse reactions of various varieties were more common in patients over 50 years of age. The proportion of female ADR patients with bevacizumab injection was higher than that of male patients, and the proportion of male ADR patients with rituximab injection, carrellizumab injection and sindillizumab injection was higher than that of female patients; there were differences in the clinical manifestations of the main adverse reactions; the effects of different varieties on organs of the same system were different; the occurrence time of adverse reaction signal was different in different varieties; the adverse reaction outcome of different varieties was good. CONCLUSION The clinical use risk of each variety in this study is controllable; it is recommended to pay attention to female patients over 40 years old for bevacizumab injection and male patients over 50 years old for rituximab injection, carrellizumab for injection and sindillizumab injection; it is suggested that combining adverse reaction analysis and signal detection, the monitoring work should be focused on different ADRs of different varieties in different time periods.