124例中药注射剂致不良反应报告

124 Cases of Adverse Drug Reaction Reports Induced by Traditional Chinese Medicine Injections

目的:探讨中药注射剂发生药品不良反应(adverse drug reaction,ADR)情况,为临床合理使用中药注射剂提供参考。方法:对2013年1月—2016年8月上报国家ADR监测中心的124例中药注射剂致ADR报告进行回顾性分析。结果:124例中药注射剂致ADR报告中,男性患者53例(占42.74%),女性患者71例(占57.26%);ADR在各年龄段男性和女性患者中无明显规律,但40岁以上的中老年患者ADR发生率最高(71.77%,89/124);累及皮肤及其附件105例,占84.68%,所占比例最高,其次为循环系统和全身性损害;ADR涉及药物包括活血通络类、扶正补益类和清热解毒类中药注射剂,其中活血通络类中药注射剂发生ADR例次数占比最高,为73.56%(103例次/140例次);注射用红花黄色素发生ADR例次数最多,共52例次,占中药注射剂发生ADR总例次数(140例次)的37.14%。结论:中药注射剂发生ADR与多因素有关,临床上应严格掌握适应证、正确使用中药注射剂,同时加强ADR监测,保障患者用药安全。

OBJECTIVE： To probe into the adverse drug reactions（ ADR） induced by traditional Chinese medicine（ TCM） injections,so as to provide reference for the rational application of TCM injections in clinic. METHODS： 124 cases of ADR induced by TCM injections reported to National Adverse Drug Reaction Monitoring Center by the First People＇s Hospital of Dali（ hereinafter referred to as ＂our hospital ＂） from Jan. 2013 to Aug. 2016 were analyzed retrospectively. RESULTS： Of the 124 cases,males were 53 cases（ 42. 74%）,females were 71 cases（ 57. 26%）.ADR occurred in both men and women of all ages ratio had no obvious regularity,but the elderly over the age of 40 years old had the highest incidence of ADR（ 71. 77%,89 /124）. ADR involved skin and its appendages took the lead,totally 105 cases（ 84. 68%）, followed by circulatory system and systemic damage. ADR-inducing drugs were huoxuetongluo,fuzhengbuyi and qingrejiedu injections; among which the ratio of number of ADR cases induced by huoxuetongluo injections dominate the first place,accounting for 73. 56%（ 103 cases /140 cases）; meanwhile,the number of ADR cases induced by carthamin yellow injections took the lead,totally 52 cases,accounting for 37. 14%of the total number of ADR cases（ 140 cases） induced by TCM injections. CONCLUSIONS： ADR can be induced by various factors,therefore,the clinic should strictly grasp indications,proper application methods of TCM injections and strengthen the ADR monitoring to ensure the medication safety for patients.