中药注射剂不良反应发生的原因分析

Analysis on Causes of ADR Associated with Traditional Chinese Medicine Injections

目的了解中药注射剂不良反应(ADR)发生的原因。方法通过跟踪随访和病例回顾的方式对对照组(100例)及ADR组(93例),在药物、患者、处方及护理因素方面进行单因素和多因素分析。结果与结论中药注射剂致不良反应的主要原因为给药剂量过大、联合用药、输液距配液时间过长、用药前没有进行肝肾功能检查、适应证不合理、说明书中用法用量不详细、没有药理作用的说明。改进处方及护理行为对提高临床用药的安全性具有重要意义。

OBJECTIVE. To comprehend the causes for adverse drug reactions （ADR） associated with the traditional Chinese medicine injections in order to improve therapeutic safety. METHODS .Through tracking visits and retrospective study of patient cases, 100 control cases and 93 ADR cases are analyzed in terms of medicine, patient, prescribing and nursing, both by single factor and multi - factor approach. RESULTS： The main causes of ADR associated with traditional Chinese medicine injections are. overdosing, combined administration of drugs, longer-than- required time gap between dispensing and transfusion, failure to do pre- dosing liver or kidney function checkup, irrelevance of indication, lack of detailed instruc- tion about way of administration and dosing, and lack of remarks on pharmacological action. CONCLUSION： It＇s vitally important to improve prescribing and nursing behaviors for the sake of enhanced safety of clinical use of drugs.