活血化瘀中药注射剂不良反应分析

Analysis of Adverse Drug Reactions of Traditional Chinese Medicine Injection for Eliminating the Stagnant and Activating the Blood

目的:研究活血化瘀中药注射剂药品不良反应的规律和特点。方法:对一家三级甲等中医院2006年7月至2010年6月住院患者使用活血化瘀中药注射剂发生的不良反应进行统计分析。结果:93例活血化瘀中药注射剂不良反应中,有既往药物过敏史患者26例(28.1%)。不良反应发生率最高品种为红花注射液(12.5%),最低为注射用血栓通(0.13%)。丹红注射液的不良反应以循环、呼吸、神经系统为主(占总数的60%),注射用血塞通的不良反应以药物热为主(占总数的55%),刺五加注射液不良反应以静脉炎为主(占38%),疏血通注射液不良反应以血液系统为主(占20%)。丹红注射液的不良反应发生与疗程相关,用药后症状发生时间均≥7d。结论:成分和适应证相同或相似的活血化瘀中药注射剂应根据其安全性来选择用药,既往存在过敏史的患者,发生不良反应的可能性很大。不同品种的活血化瘀中药注射剂的不良反应存在各自的特点,在临床中应有针对性的防治其不良反应发生。

OBJECTIVE： To study the regularity and characteristic of adverse drug reactions （ADR） of traditional Chinese medicine （TCM） injection for eliminating the stagnant and activating the blood. METHODS： ADR of TCM injection in the inpatients of a grade A class three hospital from Jul. 2006 to Jun. 2010 were analyzed statistically. RESULTS： Of 93 ADR cases, 26 cases had allergy history, accounting for 28.1%. Most of ADR cases were induced by Carthamus tinctorius injection （12.5%） and The fewest ADR cases were induced by Xueshuantong injection （0.13%）. The main ADR of Danhong injection was in circulation system, respiratory system and nervous system, accounting for 60%; The major ADR of Xuesaitong for injection was drug fever, accounting for 55% ; The main ADR ofAcanthopanax senticosus injection was phlebitis, accounting for 38%. ADR related to hematological system took up 20% in Shuxuetong injection. The ADR of Danhong injection was related to the duration of treatment, since all the symptoms of ADR cases appeared 7 days after administration. CONCLUSION： The choice of TCM injection for eliminating the stagnant and activating the blood with same or similar components and indications should base on their safety in practice. The patients with allergy history are more susceptible to ADR than those without. Different kinds of TCM injection for eliminating the stagnant and activating the blood has its unique ADR manifestations, so the prevention and treatment should also be specialized according to the characteristics of different TCM injections.