2014年至2018年重庆市4家二甲医院中药注射剂不良反应分析

Analysis on the Adverse Reactions Induced by Traditional Chinese Medicine Injections in 4 Second-Class Level-A Hospitals in Chongqing from 2014 to 2018

目的为临床合理使用中药注射剂提供参考。方法对重庆市不同区域4家二级甲等医院2014年至2018年发生的中药注射剂药品不良反应(ADR)进行统计及分析。结果210例中药注射剂ADR患者中,男女比例为1∶1.47,多为40岁以上;13例(6.19%)明确既往有药物过敏史,138例(65.71%)明确无药物过敏史;涉及的30种中药注射剂中引发ADR最多的为痰热清注射液(41例,19.52%);95例ADR由心脑血管疾病治疗药物引起,涉及15个药品;124例(59.05%)为一般ADR,85例(40.48%)为新的一般ADR,1例(0.48%)为严重ADR;103例(49.05%)累及器官/系统为皮肤及其附件;65例(30.95%)治愈,140例(66.67%)好转。结论中药注射剂ADR的发生与患者个体差异、药物本身及医务人员的操作规范性有关,因此临床使用中药注射剂时应详细了解患者情况,合理用药、规范操作,同时应加强ADR的监测。

Objective To provide reference for the rational use of traditional Chinese medicine(TCM)injections in clinic.Methods Statistics and analysis were made on the adverse drug reaction(ADR)of TCM injections from 2014 to 2018 in 4 second-class level-A hospitals in different regions of Chongqing.Results Among the 210 patients with ADR of TCM injections,the ratio of male to female was 1∶1.47,and most patients were over 40 years old;13 cases(6.19%)confirmed that there was a history of drug allergy,and 138 cases(65.71%)had no history of drug allergy;among the 30 kinds of TCM injections,the most induced ADR was Tanreqing Injection(41 cases,19.52%);95 cases ADR is caused by cardiovascular and cerebrovascular disease drugs,involving 15 drugs;124 cases(59.05%)were general ADR,85 cases(40.48%)were new general ADR,1 case(0.48%)was severe ADR;103 cases(49.05%)of the affected organs/systems were skin and its accessories;65 cases(30.95%)were cured,and 140(66.67%)cases were improved.Conclusion The occurrence of ADR of TCM injections is related to the individual differences of patients,the drug itself and the standardization of the operation of medical personnel.Therefore,when using TCM injections,we should understand the patients’situation in detail,rationally use drugs,and standardize the operational steps.Meanwhile,we should also strengthen the ADR monitoring.