10029例感染性疾病患者常用中药注射剂安全性医院集中监测分析

Safety Analysis of Commonly Used TCM Injections in 10029 Centralized Monitoring Hospitalized Patients With Infectious Diseases

目的探讨喜炎平注射液、热毒宁注射液、痰热清注射液3种感染性疾病常用中药注射剂上市后在广泛人群中使用的临床安全性。方法采用前瞻性、多中心、大样本、注册登记式医院集中监测形式,监测2012年9月至2013年10月使用3种中药注射剂的10029例感染性疾病患者,对出现不良反应(ADR)的患者临床特征及怀疑药品情况进行详细记录。结果 10029例感染性疾病患者出现26例ADR,ADR发生率为0.26%。ADR患者均为首次报告,24例患者为一般不良反应,1例严重不良反应,1例新发不良反应。ADR患者年龄以9岁以下婴幼儿及儿童为主,原患疾病主要为呼吸系统为主,其发生多在用药后0.5h,主要以腹痛、腹泻、高热多见。其中6例患者在使用本研究注射剂前使用了其他注射剂,20例患者在使用本研究注射剂后使用了其他注射剂。结论喜炎平注射液、热毒宁注射液、痰热清注射液ADR发生率较低,其原因可能与临床用药规范及合并用药情况有关。

Objective To study the clinical safety of Yanxiping Injection, Reduning Injection and Tanreqing Injection in extensive population. Methods A prospective, multicentral, and large sample post-market safety monitoring was conducted. Totally 10029 hospitalized patients with intectious diseases used the above 3 TCM injections were centrally monitored from September 2012 to October 2013. The clinical features and suspected drugs in patients with adverse reactions （ADRs） were recorded in detail. Results The incidence of ADRs was 0.26% （26/ 10029）. All ADRs were first reported. There were 24 cases of general ADRs, one ease of severe ADR and one ease of new-onset ADR. Most of the patients with ADRs aged under 9, mainly infants and children, mainly with respiratory diseases as the primery disease, occurred in 0.5 h after treatment and with main symptoms of abdominal pain, diarrhea and fever common. There were 6 patients used other injections before this study and 20 patients used other injections after this study. Conclusion Yanxiping Injection, Reduning Injection and Tanreqing Injection are safe in extensive population with a lower incidence of ADR. The occun＇ence of the ADRs may be relevant to medication standard and combined medication.