目的探讨骨瓜提取物在临床应用中发生的不良反应表现以及致不良反应的危险因素,为临床应用该药物提供参考。方法回顾性分析4255例患者的临床资料,总结发生不良反应的患者表现及产生不良反应的因素。结果 4255例患者中共发生36例不良反应。骨瓜提取物发生不良反应与年龄、药物本身因素、给药剂量、疗程、给药频次、溶媒选择、剂型等因素有关。与给药性别,给药时间无关。结论骨瓜提取物的不良反应发生因素较多,临床在应用骨瓜提取物时要提高警惕,加强监测,合理使用该药,保证用药安全. Objective To investigate the adverse reactions and the risk factors of adverse reactions caused by Bupleurum extract in clinical application and provide a reference for the clinical application of the drug. Methods The clinical data of 4255 patients were retrospectively analyzed. The patients with adverse reactions and the factors causing adverse reactions were summarized. Results A total of 3655 adverse reactions occurred in 4255 patients. Bupleurum extract adverse reactions and age, the drug itself factors, dosage, treatment, frequency of administration, solvent selection, dosage forms and other factors. And administered sex, administration time has nothing to do. Conclusion There are many factors of adverse reaction of Clove extract. Clinical application of Clove extract should be vigilant, strengthen the monitoring and rational use of the drug to ensure drug safety.