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目的统计长春市食品药品安全监测中心收集的顺铂导致的药品不良反应报告数据,对其进行回顾性分析,总结顺铂引起不良反应的表现特点和影响因素。方法导出2014年1月1日至2017年7月31日长春市食品药品安全监测中心收集到的430例顺铂导致的不良反应报告,对数据进行统计分析。结果 430例报告中45岁以上年龄段人群占89.8%;430份报告中主要给药途径为静脉滴注;原患疾病为肺恶性肿瘤占63.3%;49.3%的不良反应报告出现胃肠系统损伤,46.7%的不良反应报告出现血液系统损伤。93.4%严重不良反应病例临床用药时有合并用药,而430例报告中合并用药只占比61.6%。结论顺铂的不良反应主要集中发生在中老年群体中;一些不良反应症状在说明书中并未提及;合并用药会增加顺铂发生严重不良反应的概率。
OBJECTIVE: To analyze the data of adverse drug reactions caused by cisplatin collected by Changchun Food and Drug Safety Monitoring Center, retrospectively analyze the characteristics and the influencing factors of cisplatin-induced adverse reactions. Methods A total of 430 cisplatin-induced adverse reactions collected in Changchun Food and Drug Safety Monitoring Center from January 1, 2014 to July 31, 2017 were derived and the data were analyzed statistically. Results Among the 430 reports, 89.8% of the population was over 45 years of age. The main route of administration for the 430 reports was intravenous infusion. The original disease was 63.3% of lung malignancies. 49.3% of the adverse reactions reported gastrointestinal injury , 46.7% of the adverse reactions reported blood system damage. 93.4% of serious adverse reactions were combined with clinical medication, while the merger of 430 cases accounted for only 61.6%. Conclusions The adverse reactions of cisplatin mainly occur in middle-aged and elderly people. Some symptoms of adverse reactions are not mentioned in the manual. The combination therapy may increase the probability of serious adverse reactions of cisplatin.