由4种抗肿瘤靶向药物不良反应调查探讨加强不良反应监测的重要性

Importance of Strengthening ADR Monitoring Oriented Adverse Drug Reaction Survey of 4 Targeted Anticancer Drugs

目的探讨我国药品不良反应监测中存在的问题和解决方法。方法对2011-01～2012-06中山大学肿瘤防治中心使用过利妥昔单抗、曲妥珠单抗、贝伐珠单抗、厄洛替尼的患者ADR发生情况进行抽查,并将抽查结果与该院以及广东地区ADR监测结果进行对比分析。结果 4种靶向药物在本院ADR上报率为0.0%～1.4%,抽查结果显示4种靶向药物在本院发生率为6.7%～30.0%;约18.9%患者可能发生与靶向药物相关ADR,而仅0.5%的ADR引起临床注意并上报。结论不良反应监测存在漏报现象,应从立法、处罚、报告制度、人才培养等方面进一步加强我国不良反应监测工作。

OBJECTIVE To investigate the problems and solutions of adverse drug reaction monitoring in China. METHODS A spot-check of ADR occurrence was conducted in hospitalized patients who were treated by rituximab, trastuzumab, bevacizumab and erlotinib in Sun Yat-sen University Cancer Center （SYSUCC） from January 2011 to June 2012. Then the incidence condition of adverse reaction of 4 targeted anticancer drugs was analyzed in these cases and the results were compared with the actually ADR monitoring results in SYSUCC and Guangdong region. RESULTS The reporting rate of ADR of 4 targeted anticaneer agents was 0.0%- 1.4%, and the incidence of ADR of these 4 drugs was 6.7%-30.0% based on this survey,which means the side effects may occurred in about 18.9% patients administrated with targeted therapy while only 0.5% ADR got clinic attention and was reported. CONCLUSION Under-reporting of ADRs occurred in ADR reporting systems,and the ADR monitoring in China should be strengthened.