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[目的 ]了解中药制剂引起不良反应的情况 ,促进中药制剂不良反应的监测。 [方法 ]对近年来上报的中药制剂所引起不良反应的报告表进行统计分析。 [结果 ]中药制剂引起的不良反应有 10 2例 ,其中最多是双黄连粉针剂 (30例 ) ,其次是茵栀黄针剂 (14例 )、葛根素针剂 (13例 )。 ADR表现主要是皮肤损害 ,其次是全身性的损害如畏寒、发热等 ;较严重的 ADR有溶血性贫血 3例 ,过敏性休克 3例 ,呼吸困难 2例 ,呼吸骤停 1例 ,高热 12例。 [结论 ]中药制剂引起的不良反应中 ,有的病情较严重 ,不及时抢救可危及生命 ,因此加强其不良反应的监测是很必要的
[Objective] To understand the adverse reactions caused by TCM preparations and to promote the monitoring of adverse reactions of TCM preparations. [Methods] Statistical analysis was conducted on the reports of adverse reactions caused by Chinese medicine preparations reported in recent years. [Results] There were 102 cases of adverse reactions caused by TCM preparations, of which Shuanghuanglian powder injection (30 cases) was the most, followed by Yinzhihuang injection (14 cases) and Puerarin injection (13 cases). ADR manifested mainly in skin damage, followed by systemic damage such as chills, fever, etc.; more severe ADR had hemolytic anemia in 3 cases, anaphylactic shock in 3 cases, dyspnea in 2 cases, respiratory arrest in 1 case, and high fever12 example. [Conclusion] Among the adverse reactions caused by TCM preparations, some are in serious condition and failure to rescue them in time can endanger life. Therefore, it is necessary to strengthen the monitoring of adverse reactions.