世界中医药

目的：分析中药制剂导致的不良反应类型及特点，探讨中药制剂用药管理对策。方法：随机选取2013年1月至2015年12月我院发生的180例中药制剂不良反应检测报告，回顾性分析中药制剂导致不良反应的相关因素（性别、年龄、发生时间、中药剂型、给药途径、不良反应累及器官或系统），针对导致不良反应的原因制定相应的管理措施。结果：通过回顾性分析180例中药制剂不良反应检测报告发现，女性患者不良反应发生率高于男性，但差异不具有统计学意义（P>0.05）；11～20岁（27.2%）和61岁及以上（28.3%）的老年患者不良反应发生率明显高于其他年龄段患者，差异具有统计学意义（P<0.05）；不良反应发生时间主要集中在1 h以内（78.9%），差异与其他时间段有统计学意义（P<0.05）；导致不良反应发生率较高的中药剂型是静脉注射剂（53.9%）和中药口服制剂（17.8%），与其他中药剂型相比，差异具有统计学意义（P<0.05）；静脉给药（66.1%）途径，不良反应发生率明显高于口服制剂、外用制剂等其他给药方式，差异具有统计学意义（P<0.05）；中药制剂不良反应主要累及的器官或系统是皮肤及附件（38.3%）、消化系统（26.1%），其不良反应发生率明显高于循环系统、呼吸系统、循环系统等，差异具有统计学意义（P<0.05）。结论：临床上对中药不良反应及用药安全性依然缺乏深入研究和全面的认识，应重视中药制剂的不良反应监测，合理使用中药制剂，提高临床中药制剂的用药安全性。

English Summary:

Analysis of the types and characteristics of adverse reactions caused by traditional Chinese medicine preparations, to explore the management countermeasures of traditional Chinese medicine preparations. Methods:One hundred and eighty adverse reactions reports of traditional Chinese medicine preparation of patients who received treatment from January 2013 to December 2015 in the hospital were randomly selected. Related factors of the adverse reactions to Chinese medicine preparation were retrospectively analyzed, including gender, age, medicine form, administration and the involved the organs or systems) and management measures were suggested according to corresponding adverse reactions factors. Results:The incidence of adverse reactions occurred in female patients was higher than that in male with no statistically significant difference (P>0.05). Patients of 11 to 20 years old (27.2%) and above the age of 61 (28.3%) may much easier been attacked compared with patients in other age group with statistically significant differences (P<0.05); adverse reactions mainly occured within 1 hours after medicine administration (78.9%), and the difference was statistically significant (P<0.05). Intravenous injection (53.9%) and oral preparation of traditional Chinese medicine (17.8%) are the most common formulations caused adverse reactions of Chinese medicine, compared with other forms of Chinese medicine, with statistically significant difference (P<0.05). The incidence of adverse reactions of intravenous administration (66.1%) was significantly higher than that of oral preparations, topical preparations and other ways of administration, which showed statistically significant difference (P<0.05). The main Chinese medicine adverse reactions involved organs or systems are the skin (38.3%) and digestive system (26.1%) and their incidences of adverse reactions was significantly higher than that of the circulatory system, respiratory system, circulatory system, etc., statistically significant difference (P<0.05). Conclusion:there is still a lack of in-depth research and comprehensive understanding on adverse reaction of traditional Chinese medicine and medication safety in clinic. More attention should be paid to the monitoring of adverse reactions and rational use of traditional Chinese medicine preparation to improve the medication safety of clinical Chinese medicine preparation.

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