目的分析吲哚美辛栓所致不良反应的临床特征、相关因素,为临床药物治疗中药品不良反应的防治提供参考依据。方法检索1986年-2009年中国生物医学文献系统吲哚美辛栓的不良反应资料,并加以分析研究。结果得到符合标准的患者24例,不良反应报告中男性多于女性;不良反应以全身性损害最多(12例,50.00%),其次为皮肤及附件损害(2例,8.33%)、循环系统损害(2例,8.33%)、消化系统损害(2例,8.33%);不良反应较为严重。结论患者的年龄、性别等因素能影响不良反应的发生,临床应特别注意吲哚美辛栓引起的休克。 Objective To analyze the clinical characteristics and related factors of adverse reactions induced by indometacin suppository and provide references for the prevention and treatment of adverse reactions of traditional Chinese medicines in clinical drug treatment. Methods The data of adverse reactions of indometacin in Chinese biomedical literature system from 1986 to 2009 were retrieved and analyzed. Results A total of 24 patients were eligible. More adverse reactions were reported in males than females. Adverse reactions were systemic injury (12 cases, 50.00%), followed by skin and accessory lesions (2 cases, 8.33%), circulatory damage (2 cases, 8.33%), digestive system damage (2 cases, 8.33%); adverse reactions were more serious. Conclusion The patient’s age, gender and other factors can affect the occurrence of adverse reactions, clinical special attention should be indometacin suppository-induced shock.