奈达铂与其他铂类制剂药物不良反应的临床比较研究

Compare Nedaplatin with Other Platinum Agents in Clinical Studies of Adverse Drug Reaction

目的调查分析奈达铂和其它铂类制剂药物不良反应(Adverse Drug Reaction,ADR)发生情况,为临床选用铂类制剂和预防铂类制剂ADR提供参考。方法随机抽取2009年1月～2010年12月间使用铂类制剂病例共224例,其中使用奈达铂112例,其它铂类制剂(包括顺铂、卡铂、奥沙利铂,按4:2:4抽取)112例为对照组,采用回顾性分析方法进行统计。结果奈达铂和其它铂类制剂组ADR发生率分别为62.5%,66.07%,无明显统计学意义,其中骨髓抑制奈达铂发生率高于其他铂类制剂,有统计学意义(P<0.05),肝肾功能损害发生率明显低于其他铂类制剂(P<0.05)。约95%ADR能治愈;约65%ADR为严重级;ADR男女发生率分别为61.81%、38.19%,有统计学意义,ADR发生年龄主要为58～72岁患者。结论奈达铂发生骨髓抑制高于其他铂类制剂,而对肝肾功能损害比其他铂类制剂低。

Objective Compared adverse drug reaction ofnedaplatin with other platinum agents to provide the references information in clinical application. Methods 224 cases of platinum agents collected from January 2009 to December 2010 were analyzed using retrospective study method. Among them,112 used nedaplatin, 112 used other platinum agents （Cisplatin： Carboplatin ：Oxaliplatin=4：2：4）. Results The adverse drug reaction rates of Nedaplatin and other platinum agents ware 62.5%, 66.07%,which showed no significant difference. The incidence of bone marrow restrain was higherthan other platinum agents（P 〈0.05）. Liver and kidney dysfunction was significantly lower than other platinum agents （P 〈0.05）. There were about 95% patients could be cured and 65% AD1K cases reported were severe, AD1K proportions of men and women were 61.81%, 38.19%, It shows significant difference（P 〈0.05）. The majority of reported AD1K were 58-72years old. Conclusion Nedaplatin is higher than the other platinum agents on bone marrow suppression, lower than the other platinum agents on liver and kidney dysfunction.