97例硫辛酸注射液不良反应报告及相关因素分析

Analysis of 97 Cases of Adverse Drug Reactions Induced by Thioctic Acid Injection and Its Related Factors

目的分析97例硫辛酸注射液所致药品不良反应(ADR)及相关因素,预防或减少ADR发生,促进临床安全用药。方法对2014年5月-2017年4月本院97例使用硫辛酸注射液发生ADR的病例进行调查并统计分析。结果ADR累及系统-器官以皮肤及其附件损害(45.57%)最常见,其次为注射局部损害(17.09%)、消化系统(17.09%)、中枢和外周神经系统(9.49%);ADR主要发生在用药的第1天,大多数经停药观察或对症治疗于60 min后好转。ADR的发生与患者食物药物过敏史,超说明书用药(包括适应证、用法用量、输注速度)、硫辛酸注射液杂质和辅料存在一定的关系。结论建议临床严格按照说明书推荐的适应证、日剂量、溶媒、浓度、滴速、避光规范使用,生产厂家进一步纯化硫辛酸注射液,从而减少ADR的发生。

Objective To analyze 97 cases of adverse drug reactions（ADRs） and related factors in thioctic acid injection,prevent or reduce the incidence of ADRs and promote the safety of clinical medication. Methods 97 cases of ADRs induced by thioctic acid injection from May 2014 to April 2017 in our hospital were retrospectively investigated and analyzed. Results ADR mainly affected the skin and its appendages（45.57%）, followed by local injection damage（17.09%）, digestive system（17.09%） and central and peripheral nervous system（9.49%）. The ADRs mainly occurred on the first day of medication and most improved after 60 minutes with discontinuation or symptomatic treatment.ADRs were related to the patient＇s food and drug allergy history, off-label uses（including indications, usage, dosage,speed of infusion）, the impurities and excipients of thioctic acid injection. Conclusion It is recommended that clinicians should strictly follow the instructions of thioctic acid injection in terms of indications, daily dose, solvent,concentration, drip rate and light avoidance, and the manufacturers should purify thioctic acid injection further so as to reduce the occurrence of ADRs.