上市后中成药说明书安全性信息修订证据体的构建:以消渴安胶囊为例

Construction of Evidence Body for Revision of Safety Information on Package Inserts of Chinese Patent Medicines in Post-marketing:Taking Xiaoke'an Capsules as an Example

目的:以消渴安胶囊说明书安全性信息修订为例,构建上市后说明书安全性信息修订证据体,为上市后中药说明书修改提供参考与借鉴。方法:证据体构建以中医理论与《已上市后中药说明书安全信息项内容修订技术指导原则》为指导,以八大类、25个具体项目为证据体主体,进行信息纳入、整合、筛选、完善,并进行专家论证,最后根据药品审评中心意见进行修改,完成消渴安胶囊说明书的安全项信息修订。结果:消渴安胶囊【不良反应】修订为“监测数据显示,本品可见以下不良反应:个例低血糖反应报告”。【禁忌】修订为“对本品及所含成份过敏者禁用”。【注意事项】修订为“(1)孕妇慎用。(2)老年人用药,请咨询医师。(3)脾虚湿滞、脾胃虚寒或食少泻泄者慎用。(4)本品含有人参,不宜与含有藜芦、五灵脂的中药方剂或成药同时服用。(5)用药期间注意进行监测血糖。(6)服药期间出现其他不适,应及时就诊”。警示语修订为“孕妇慎用。注意定期监测血糖”。结论:按照说明书安全性信息修订证据体构建内容与流程,完成了消渴安胶囊说明书安全性信息的修订工作,为临床合理安全用药提供有力依据。

Objective:To construct the evidence body for revision of safety information on package inserts of Chinese patent medicines in post-marketing by taking Xiaoke'an capsules as an example,so as to provide reference for the revision of instructions of Chinese patent medicines in post-marketing.Method:The construction of the evidence body was guided by the theory of traditional Chinese medicine(TCM)and the Technical Guiding Principles for Revision of Safety Information Items in Instructions for TCMs After Marketing,and 8 categories and 25 specific items were taken as the main body of the evidence body,and information inclusion,integration,screening and improvement were carried out,then expert demonstrations were conducted,and finally modifications were made based on the opinions of the Center for Drug Evaluation to complete the revision of the safety information in the instructions of Xiaoke'an capsules.Result:[Adverse reactions]of Xiaoke'an capsules was revised to"monitoring data show that the following adverse reactions can be seen with this product:individual hypoglycemic reaction reports".[Contraindications]was revised to"contraindicated for those allergic to this product and its ingredients".[Precautions]was revised to"(1)pregnant women should use with caution,(2)elderly people should consult a physician,(3)people with spleen deficiency and dampness,spleen and stomach deficiency and cold,or those who eat less and have diarrhea should use with caution,(4)this product contains ginseng,should not be taken at the same time with TCM prescriptions or patent medicines containing veratrum and Wulingzhi,(5)pay attention to monitoring blood sugar during medication,(6)if any other discomfort occurs during medication,you should seek medical attention in time".The warning was revised to"use with caution by pregnant women,and pay attention to regular monitoring of blood sugar".Conclusion:In accordance with the content and process of the evidence body for the revision of safety information in the instructions,the revision of the safety information in the instructions of Xiaoke'an capsules has been completed,providing a strong basis for the rational and safe use of medication in the clinic.