林石思 姚帆

【摘 要】 目的：调查我院活血化瘀类中药注射剂不良反应（ADR）发生的规律及特点，为临床合理用药提供参考，减少ADR的发生。方法：采用回顾性分析的方法，收集阳江市中医医院上报的61例活血化瘀类中药注射剂发生的ADR报告进行统计分析。结果：本次统计的61例ADR个案中，涉及9个中药注射剂品种，不良反应发生率最高品种为红花注射液（32.79%）；男女构成比分别为45.90%和54.10%；60岁以上患者发生ADR比例最高，占60.66%，平均年龄为（61.72±21.84）岁；用药后30 min内发生ADR占47.06%；ADR累及器官/系统以全身性损害为主（占44.09%），主要表现为寒战、发热；严重的ADR报告共有3例，占4.92%。结论：应加强活血化瘀类中药注射剂不良反应的监测，提高临床合理用药水平，尽可能的减少ADR的发生，保障患者用药安全、有效。

【关键词】 中药注射剂；活血化瘀；药物不良反应；分析

【中图分类号】R944.1 【文献标志码】 A【文章编号】1007-8517（2018）13-0126-05

Abstract：Objective To investigate the regularity and characteristics of adverse drug reactions（ADR）induced by traditional Chinese medicine（TCM）injections for activating the blood and eliminating the stagnant in our hospital so as to provide references for clinical rational use of drugs and reduce or avoid adverse drug reactions. Methods 61 cases of ADR induced by TCM injections for activating the blood and eliminating the stagnant in YangJiang Hospital Of TCM were selected and analyzed Statistically. Results Of the 61 cases of ADR，9 different kinds of TCM injections were involved.Most of ADR cases were related to Honghua injection（32.79%）；The incidence of ADR was 45.90% in the male and 54.10% in the female；The patients aged over 60 years had the highest occurrence rate of ADR （60.66 %）， and the average age was （61.72±21.84） years old；The incidence of ADR which occurred within half an hour was 47.06%；The main ADR damages were systemic cases，accounting for 44.09%，the most common symptoms were the chills and fever；There were 3 cases of sever ADR reports，accounting for 4.92%. Conclusion The surveillance of ADR of TCM injections for activating the blood and eliminating the stagnant should be strengthened to improve the rationality of clinical application，as much as possible to reduce the occurrence of ADR and to ensure the safety and efficiency of the patients medication.

Keywords：Traditional Chinese Medicine Injection； Activating the Blood and Eliminating the Stagnant； Adverse Drug Reaction；Analysis

活血化瘀藥是一类能疏通血脉、祛除瘀血，临床用于治疗血瘀证的药物[1]。而活血化瘀类中药注射剂是根据传统的中医药理论，结合现代生产工艺经过提取、纯化等途径制成的注射剂型[2]。活血化瘀类中药注射剂具有很好的祛瘀生新、活血行气、调理脏腑的功能，临床应用极其广泛。但是在临床中，活血化瘀类中药注射剂治疗也可能会出现不良反应[3]。随着活血化瘀类中药注射剂被广泛应用于临床以及药监部门对ADR监测力度的加大，此类注射剂不良反应报告例数也在逐年增多，其安全性受到了一定的关注。为了进一步了解……