托泊替康的临床应用与药物利用评价

Drug Utilization Evaluation of Topotecan in the Clinic

目的:评价某院妇科盐酸托泊替康的使用合理性。方法:对该院妇科2010年1月-2011年10月69例住院患者应用盐酸托泊替康的情况进行回顾性统计、分析,并参照国家食品药品监督管理局、美国食品与药物管理局(FDA)批准的适应证、药品说明书与美国国立综合癌症网络(NCCN)临床实践指南,对其使用的合理性进行评价。结果:69例住院患者中应用盐酸托泊替康符合国家食品药品监督管理局批准适应证者47例(68.12%);另22例住院患者中12例(17.39%)符合美国FDA说明书适应证与NCCN临床实践指南推荐,10例(14.49%)无说明书与指南支持。结论:该院妇科盐酸托泊替康的临床应用有85.51%的病例有说明书或指南支持,14.49%的病例仅有文献支持。

OBJECTIVE： To evaluate the rationality of topotecan hydrochloride in gynecology department of a hospital. METH- ODS： The use of topotecan hydrochloride in 69 inpatients from gynecology department of the hospital was analyzed statistically dur- ing the period of Jan. 2010--Oct. 2011. The rationality of drug use was evaluated according to package insert and National Compre- hensive Cancer Network （NCCN） guidelines recommends. RESULTS： Among 69 inpatients, 47 patients met indications approved by SFDA （68.12%） ; among other 22 inpatients, 12 patients met the indications approved by FDA or NCCN guidelines recom- mends （17.39%）, and other 10 patients were off-label use （14.49%）. CONCLUSIONS： 85.51% of clinical use of topotecan hydro- chloride in gynecology department in the hospital meet package insert or guidelines, and other 14.49% only have literatures support.