陈　蕾，孙佳瑜，单爱云(深圳市福田区中医院药剂科，广东 深圳　518034)



深圳市福田区中医院183例中药注射剂不良反应报告分析

陈蕾*，孙佳瑜，单爱云(深圳市福田区中医院药剂科，广东 深圳518034)

摘要目的：探索深圳市福田区中医院(以下简称“我院”)中药注射剂不良反应(adverse drug reaction, ADR)发生的原因与特点，为临床合理用药提供参考。方法：对我院2010年1月—2015年6月上报的183例中药注射剂ADR报告进行回顾性统计分析。结果：我院183例ADR患者主要集中在60岁以上人群(占30.60%)；引起ADR的主要药物为清热解毒类和心血管类(占87.98%)；涉及的器官和(或)系统主要是皮肤及其附件损害(占48.63%)；ADR通常发生在给药后5～30 min内(占46.45%)；2例新的严重的ADR临床表现分别是血尿、肝功能异常；与溶剂及其他药物联合使用的病例数为159例(占86.89%)。结论：中药注射剂ADR的发生与患者因素、剂量、滴速、溶剂、联合用药等有关，应加强临床合理用药，减少ADR的重复发生，促进中药注射剂的安全、合理使用。

关键词中药注射剂； 不良反应； 分析； 合理用药

Analysis on 183 Cases of Adverse Drug Reaction induced by TCM injection in Shenzhen Futian District Traditional Chinese Medicine Hoapital

CHEN Lei, SUN Jiayu, SHAN Aiyun(Dept.of Pharmacy, Shenzhen Futian District Traditional Chinese Medicine Hoapital, Guangdong Shenzhen 518034, China)

ABSTRACTOBJECTIVE：To probe into the causes and characteristics of adverse drug reaction(ADR) induced by traditional chinese medicine(TCM) in Shenzhen Futian District Traditional Chinese Medicine Hoapital of Traditional Chinese Medicine(hereinafter referred to as “our hospital”), and to provide reference for the rational drug use in clinic. METHODS: Statistically retrospective analysis was conducted on 183 cases of ADR induced by TCM injection reported from Jan. 2010 to Jun. 2015. RESAULTS: Of the 183 cases, the incidence rate of ADR was higher in patients aged over 60 (30.60%). ADR-inducing drugs mainly focus on heat-clearing detoxifying drugs and cardiovascular drugs(87.98%). Organs and (or) systems involved in ADR mainly were lesion of skin and its appendants(48.63%). The time of ADR occurrence was centralized from 5 to 30 min(46.45%). The clinical manifestations of two new and severe ADR were respectively hematuria and hepatic dysfunction. The combination of solvent and drugs were 159 cases (86.89%). CONCLUSIONS: ADR induced by TCM injection is correlated with the factors of patients, dosage, drip speed, solvent and drug combination, etc. It is necessary to strengthen the rational drug use in clinic, reduce the repeated occurrence of ADR, so as to promote rational and safe use of TCM injection.

KEYWORDSTCM injection; ADR; Analysis; Rational drug use

中药注射剂是在中医药传统用药和验方、单方的基础上，根据药材性质所含成分和临床需要，采用现代科学技术与方法加工制备的灭菌制剂，主要用于急、重症的临床治疗。但随着中药注射剂的广泛应用，其药品不良反应(adverse drug reaction,ADR)也随之增加，引起了社会的强烈关注。本调查对圳市福田区中医院(以下简称“我院”)中药注射剂的ADR发生情况进行了调查，分析中药注射剂ADR发生的原因，为临床合理应用提供参考。

1资料与方法

资料来源于2010年1月—2015年6月我院上报至广东省ADR监测中心的所有ADR，共计183例，分别对患者的年龄、性别、用药品种及症状表现进行统计分析。……