活血化瘀类中药注射剂不良反应61例报告分析

Analysis of 61 Adverse Drug Reactions Induced by TCM Injections for Activating the Blood and Eliminating the Stagnant

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。

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 patient s medication.