中药注射剂药品不良反应的临床表现及其相关因素分析

Analysis of Adverse Drug Reaction of Traditional Chinese Medicinal Injection

目的了解江苏省常州市中医医院2004-2005年中药注射剂药品不良反应(ADR)的临床表现及其相关因素,给医生和药师提供科学的参考依据,尽量预防和避免药品不良反应的重复发生。方法由国家不良反应监测中心数据库收集江苏省常州市中医医院2004-2005年中药注射剂的ADR病例共164例,运用SPSS统计软件,分别按患者的性别、年龄、发生时间、临床表现、受损器官、药品种类等项目进行描述性的统计分析。结果在164例报告中,男女构成比分别为52.4%和47.6%,中药注射剂ADR临床表现多样,以用药部位损害为主,主要表现为用药部位疼痛,其次为皮肤及其附件损害表现为红肿、皮疹等,ADR构成比较高的前3个为注射用七叶皂苷钠、注射用血塞通(主含三七总皂苷)、参麦注射液。结论中药注射剂易发生不良反应,临床应引起重视,做好预防和监测工作,提高安全性。

Objective To study the condition and related factors for adverse drug reaction induced by traditional Chinese medicinal injection in the Chinese medical hospital in the years of 2004 - 2005, providing the references of science for the doctors in order to prevent from and avoid the drugs repetition occurrence of bad reaction . Methods Collected traditional Chinese medicinal injection of ADR of total 164 in the Chinese medical hospital in the years of 2004 - 2005, by the SPSS statistics soft ware,in terms of the sufferer＇s sex, age and take place time, clinic performance, damaged organ, the drugs category etc. The statistic analysis of description was conducted. Results Those ADR of clinic performance showed diversity, mainly including the attention to this, and pain in injection site, red, swollen and rash in skin and its enclosure. The first three kinds of medicine that the ADR occurrence rate is high are injection Kakkonein etc. Conclusion The ADR occurrence rate of traditional Chinese medicinal injection is high, in clinic so it should be payed more attention.