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目的:探讨如何完善中成药药物说明书和减少中成药退药现象的发生。方法:收集浙江省义乌市妇幼保健院目前应用的138种中成药的说明书,同时选取2010年6月~2013年6月间于浙江省义乌市妇幼保健院退药的198例中成药门诊退药记录作为研究对象,分别对中成药说明书的描述情况和退药处方进行分析。结果:妇幼保健院中成药说明书关于临床试验、药理毒理、如有问题可与生产厂家联系和药物的相互作用等情况没有标注的分别占81.16%、80.43%、60.14%和50.72%;不良反应、药证不符和服药禁忌是导致妇保院中成药退药的前三位原因。结论:中成药说明书还存在不完善的地方,应规范中成药说明书,针对中成药退药的具体原因加强改进,最终减少中成药退药现象的发生。
OBJECTIVE: To explore how to improve the proprietary Chinese medicines and reduce the occurrence of the withdrawal of proprietary Chinese medicines. Methods: The instructions of 138 kinds of Chinese patent medicines currently used in Maternal and Child Health Hospital of Yiwu City of Zhejiang Province were collected. At the same time, 198 Chinese patent medicines were withdrawn from the pharmacies in Yiwu Maternal and Child Health Hospital of Zhejiang Province from June 2010 to June 2013 Records as the research object, respectively, the descriptions of proprietary Chinese medicine manual description and withdrawal prescription analysis. Results: There were 81.16%, 80.43%, 60.14% and 50.72% of unmarked cases concerning the clinical trial, pharmacology and toxicology, the contact with the manufacturer and the interaction of drugs if there was any problem; the adverse reactions , Incompatible drug certificates and medication taboo is the first three reasons leading to the withdrawal of proprietary Chinese medicines in MCH. Conclusion: There are still some defects in the manual of proprietary Chinese medicines. The specification of proprietary Chinese medicines should be regulated. The specific reasons for the withdrawal of proprietary Chinese medicines should be improved to reduce the occurrence of the withdrawal of proprietary Chinese medicines.