注射用硫普罗宁不良反应文献分析

Literature Review on Adverse Drug Reactions of Tiopronin Injection

目的:分析注射用硫普罗宁不良反应(ADR)的规律、相关影响因素及预防救治措施,为其临床合理应用提供参考。方法:通过回顾文献中的病历资料,对1989~2015年报道的115例ADR案例按患者信息、用药信息、文献信息等几个方面分类,建立数据库,并进行描述性统计分析。结果:73.04%的患者为男性;52.17%为41~60岁;63.48%的患者ADR发生在30 min之内;99.13%的患者预后痊愈或者好转,1例患者死亡;过敏史不详的占比46.09%。结论:注射用硫普罗宁ADR机制仍需研究,其应用时应综合考虑患者性别、年龄、过敏史、给药速度及浓度、药物联用等因素,合理用药以确保患者用药安全。

Objective ：To provide reference for rational clinical application of tiopronin injection by analyzing the regularity of its adverse drug reactions （ADR）,the related influencing factors and the prevention and treatment measures. Methods ：We reviewed the literature by searching the database published in Chinese from 1989 to 2015, and 115 adverse drug reactions reports were included in this analysis according to patient information,medication information and literature information. Results ：Most patients experiencing adverse drug reactions were males which accounting for 73.04%. 52.17% patients with ADR were at age between 41 and 60. 63.48% patients with ADRs occurred in 30 minutes after injection,and 99.13% of the patients got recovered or exhibited better prognosis, but 1 patient died eventually. There were 46.09% patients had unknown allergy history records. Conclusion ： There were various clinical symptoms of ADRs and allergic reaction was the most significant one. The major potential risk factor that may be related to ADRs included male gender and elder age. Our study suggested that some factors,such as gender,age,allergy history,drug administration speed and concentration,drug combination should be taken into consideration when administration of tiopronin to be rational used andensure the safety of the patient′s medication.