重庆地区云南白药胶囊临床应用安全性再评价

Re-Evaluation of Clinical Safety of Yunnan Baiyao Capsules in Chongqing

目的全面认识云南白药胶囊在临床使用中的安全性。方法选取2015年6月至2016年12月重庆地区9家医院内接受云南白药胶囊治疗的患者1 653例,分析出现的药品不良反应(ADR)/药品不良事件(ADE)类型及其发生率、严重程度等。结果共收集到ADR/ADE 108例,被认定为与云南白药胶囊有关的共7例,其中轻度4例,中度3例,均为合并用药,合并用药ADR/ADE发生率为0. 47%,末次用药后14 d随访,ADR/ADE均消失;未发现新的和罕见的ADR/ADE。结论云南白药胶囊单用未见ADR/ADE,合并用药时ADR/ADE发生率低,多为程度较轻的过敏反应、胃肠道反应等,经停药、减量服用或采取其他措施后均消失,对原患疾病的治疗几乎无影响。且整个研究中未发现新的和严重的ADR/ADE,临床使用较安全。

Objective To fully understand the safety of Yunnan Baiyao Capsules in clinical use. Methods Totally 1 653 patients treated with Yunnan Baiyao Capsules in 9 hospitals in Chongqing from June 2015 to December 2016 were selected. The types of adverse drug reactions/adverse drug events( ADR/ADE) and their incidence and severity were analyzed. Results A total of 108 cases of ADR/ADE were collected,and 7 cases were identified to be related to Yunnan Baiyao Capsule,of which 4 cases were mild and 3 cases were moderate,all of which were combined with other medicine,the incidence of ADR/ADE induced by combined medication was 0. 47%.14 d after the last administration,the ADR/ADE disappeared,and no new or rare ADR/ADE was found. Conclusion No ADR/ADE is found in Yunnan Baiyao Capsules when used alone. The incidence of ADR/ADE in combination is low,most of them are mild allergic reactions and gastrointestinal reactions,which disappear after discontinuation,reduction or other measures,and have little effect on the treatment of the original diseases. And no new or serious ADR/ADE is found in the study,which is safe for clinical use.