上海地区云南白药胶囊临床安全性监测报告

Clinical safety monitoring report of Yunnan Baiyao capsules in Shanghai area

目的:探究云南白药胶囊在实际临床应用过程中的群体安全性,寻找可能诱发云南白药胶囊不良反应的危险因素,为临床合理用药和降低不良反应的发生率提供依据。方法:通过对2015年6月—2016年12月上海地区8家医院的骨科、消化科、耳鼻喉科、妇科、外科和眼科等科室接受云南白药胶囊治疗的患者共1 496例进行跟踪研究,对云南白药胶囊治疗期间出现的不良事件进行详细记录,并分析其与云南白药胶囊之间的因果关系。结果:整个研究过程中共收集到不良反应事件47例,最终判定出4例与云南白药胶囊有关,包括胃肠道不适2例,恶心呕吐1例,皮肤过敏1例,不良反应发生率为0. 267%,属偶见级别。结论:云南白药胶囊在上海地区8家医院内使用不良反应发生率低、安全性高,值得临床进一步推广使用。

Objective : To explore the group safety of Yunnan Baiyao capsules in real clinical application and find out the risk factors to providing basis for using the drug rationally and reducing the incidence of adverse reactions in clinical practice. Methods: A total of 1 496 patients taking Yunnan Baiyao capsules in the departments of orthopedics, digestive , ear-nose-throat, gynaecology, surgery and ophthalmology in 8 hospitals of Shanghai area were tracked during the period of June 2015 to December 2016. The adverse events were recorded in details, and the causality was analyzed. Results: In the whole study, 47 cases of adverse events were collected , and 4 cases of adverse reactions related to Yunnan Baiyao capsules were determined , in eluding 2 cases of gastrointestinal discomfort, 1 cases of nausea and vomiting, 1 cases of skin allergy. The incidence of adverse reactions was 0. 267%, belonging to occasional rank. Conclusion : Yunnan Baiyao capsules had high safety and low incidence of adverse reactions in the 8 hospitals in Shanghai area, which is worthy of further promotion in clinic.