141例中药制剂不良反应的回顾性分析及预防对策简

目的：了解医院中药制剂药物不良反应（ADRs）的发生特点,提出预防对策,促进临床合理用药.方法：采用回顾性研究方法对2008-2012年上海中医药大学附属曙光医院141例中药制剂的ADRs报告进行分类统计分析.结果：60岁以上病人、静脉滴注给药方式、祛瘀剂等引起的ADRs所占比例最高,分别为71例（50.35％）、131例（92.91％）和82例（82/175,46.86％）.严重的ADRs共5例（3.55％）,新的ADRs有12例（8.51％）.ADRs常见表现为皮肤及附件的损害（85/164,51.83％）.结论：引发中药制剂ADRs的因素包括病人本身、药品本身及药物使用方法不当等.临床应加强ADRs的监控,及时发现并上报,以提高临床用药的安全性和有效性.

Retrospective analysis of 141 cases of adverse drug reactions induced by Chinese herbal preparations and related preventive countermeasures

Objective： To investigate features of adverse drug reactions （ADRs） induced by Chinese herbal preparations in the hospital and put forth preventive countermeasures, so as to promote rational application of drugs clinically. Methods： One hundred and forty-one cases of ADRs induced by Chinese herbal preparations in the Shuguang Hospital Affiliated to Shanghai Traditional Chinese Medical University from 2008 to 2012 were retrospectively analyzed. Results： ADRs occurred in patients older than 60 years, and ADRs induced by intravenous drip as well as agents used for promoting blood circulation and removing blood stasis constituted the highest percentage, accounting for 71 cases （50. 35%）, 131 cases （92. 91%） and 82 cases （82/175, 46.86%）, respectively. There were 5 cases displaying serious ADRs cases （3.55%） and another 12 new ADRs cases （8.51%）. Common manifestations of ADRs were skin and appendix lesion. Conclusion： Factors associated with the occurrence of ADRs induced by Chinese herbal preparations were： susceptibility of patients, the drug itself, improper application of drugs, etc. Efforts should be made to strengthen monitoring of ADRs, and cases of ADRs should be identified and reported to the superior, so as to promote safety and efficiency of clinical medication.