99例中药注射剂不良反应分析

Analysis of 99 reports on adverse drug reactions associated with traditional Chinese medicine injections

目的探讨中药注射剂不良反应发生的特点与规律,为临床合理使用中药注射剂提供参考。方法对本院2011年1月～2012年7月上报的99例中药注射剂不良反应,从患者的年龄、性别、药品名称、发生时间、不良反应累及器官系统、临床表现、关联性评价等方面进行统计、分析。结果 99例报告中,60岁以上患者(30.30%)和5岁以下的婴幼儿患者(27.27%)发生不良反应的比例较高。药品共涉及3大类14个品种,其中,活血化瘀类较多(51.52%)。不良反应累及器官系统以皮肤及附件最常见,临床表现主要为皮疹和瘙痒(42.42%)。结论加强对中药注射剂使用监管有助于减少和避免ADR的发生,保障患者用药安全。

Objective To investigate the characteristic and regularity of the adverse drug reactions included by injectable preparations of traditional Chinese medicine,in order to provide some references for the use of traditional Chinese medicine injections in the clinic.Methods Ninety nine case reports on adverse reactions associated with traditional Chinese medicine injections,which were submitted by our hospital from January 2011 to July 2012,were collected and analyzed in the following aspects such as patients＇ age,gender,drug name,the occurrence time of the adverse reactions,the involved organs,the clinical manifestations,relevance evaluation,etc.Results Patients which were more than 60 years old （30.30%） and less than 5 years old （27.27%） had a higher proportion of adverse reactions in the 99 reports.The involved drugs covered 3 kinds including 14 varieties.They were mainly drugs of promoting blood circulation to remove blood stasis （51.52%）.The most common involved organs were skin and accessories.The clinical manifestations were mainly rash and itch （42.42%）.Conclusion It is important to strengthen the supervision of the use of traditional Chinese medicine injection in order to reduce and avoid the occurrence of adverse drug reactions as well as ensure the medication safety in patients.