Objective: To provide objective evidence to compare the frequency and intensity of adverse drug reaction (ADR) between traditional Chinese medicine (TCM) and western medicine. Method: Retrieve ADR case reports in CNKI 2006-2011 and build ADR database. Establish the 7-grade rating system of ADR intensity. Drugs are classified by pharmacology, administration, formulation, and compared by the sort ratio of ADR frequency (RF), intensity (RI) and harmfulness (RD) individually. Results: A total of 4925 cases were induced by 723 TCMs and 4374 western medicines according to 3842 reports. The literatures are mostly from Chinese Journal of Misdiagnostics and Shandong Province. ADR occurred mostly in the middle-aged and it is not obvious relationship with gender. The highest incidence of ADR occurred in injection and anti-infective products. ADR decreased with time, most of them occurred within 1 hour and recoverd after treating. Comparison results of ADR: Pharmacology classificationⅠ: RF = 2.10，RI = 1.36，RD = 2.07. Pharmacology classificationⅡ: RF =1.31，RI = 1.34，RD =1.36. Pharmacology classification Ⅲ: RF =1.69，RI = 1.40，RD =1.71. Administration classification: RF = 1.34，RI = 1.86，RD = 1.51. Formulation classification: RF = 1.20，RI = 1.14，RD = 1.27. Conclusion: ADR of TCMs is less severe than western medicines, with less number, lower intensity and less harmful. TCMs are safer than western medicine.

【目的】系统评价我国药品不良反应的发生特点及规律，比较中药与西药不良反 应的频度和强度，为中、西药不良反应严重程度的比较提供全面和客观的证据。 【方法】检索 CNKI 2006-2011 年符合纳入标准的不良反应案例报告文献，提取 文献来源信息、患者信息、药品信息及不良反应相关信息，分析不良反应的总体 情况。制定“不良反应强度七级评分标准”，以频度（F）、强度（I）、危害程度 （D）作为不良反应严重程度的评价指标，以中西药不良反应频度排序比（RF）、 强度排序比（RI）、危害程度排序比（RD）作为结局指标。分别按用药药理、给药 途径、制剂名称分类有进行比较。 【结果】共纳入 3842 篇文献，涉及 4925 个病例和 5097 个药品。《中国误诊学杂 志》以及山东省是最主要文献来源；不良反应与性别关系不明显，多发生于中年 人；注射液和抗感染药品的发生率最大；不良反应随时间递减，多发生于用药 1 小时内，多数可治疗恢复。中、西药不良反应比较结果为：F 西药=4374，F 中药=723； I 西药=3.2850，I 中药=3.0845；D 西药=2.8197，D 中药=0.4370。按用药药理Ⅰ分类，RF = 2.10，RI = 1.36，RD = 2.07；按用药药理Ⅱ分类，RF =1.31，RI = 1.34，RD =1.36； 按用药药理Ⅲ分类，RF =1.69，RI = 1.40，RD =1.71；按给药途径分类，RF = 1.34， RI = 1.86，RD = 1.51；按制剂名称分类，RF = 1.20，RI = 1.14，RD = 1.27。 【结论】西药的不良反应频度和强度比中药大，对患者造成的危害也更大，说明 西药的不良反应更严重。与西药相比，中药较为安全。 关键词：不良反应；严重程度；中西药比较；系统评价