目的: 比较集采中选仿制药和原研药在主要疾病治疗领域中对主要临床结局指标的影响差异,促进集采中选药品临床合理使用。方法: 主要关注第二、三批国家组织集中采购中选药品在临床真实诊疗环境中的疗效和安全性。联合全国16个省及直辖市共计29家特色明显的医疗机构,覆盖心血管、抗肿瘤、神经精神疾病、抗感染、代谢及内分泌和消化系统6大类。从病历数据中提取研究药物治疗及临床结局相关的基线资料及研究指标,用于有效、安全及经济性评价。采用组间基线校正和结局指标分析方法进行统计分析。结果: 国家集采中选仿制药疗效和安全性与原研药无统计学差异,为临床合理用药提供了循证依据。结论: 本研究为临床医生用药决策提供了重要的参考,为促进集采中选药品的临床合理使用、为国家组织集中采购政策的实施提供了循证支持,也为国家组织集采政策落地实施和效果评价的模式和方法提供了可借鉴的范本。

Objective: The report compares the differences in the impact of VBP generic drugs and original drugs on the main clinical outcome indicators in the treatment of major diseases, and promotes the rational use of VBP drugs in the clinical practice. Methods: The main focus is on the effectiveness and safety of the second and third batches of VBP drugs in clinical diagnosis and treatment. The paper investigates a total of 29 representative medical institutions in 16 provinces and municipalities in China, covering six major categories of cardiovascular, anti-tumor, neuropsychiatric, anti-infection, metabolic and endocrinic, and digestive systems. We extract baseline information and research indicators related to drug treatment and clinical outcomes from medical record data for efficacy, safety, and economic evaluation. Statistical analysis is conducted with inter-group baseline correction and analysis method of outcome indicators. Result: There is no statistically significant difference in the effectiveness and safety between the selected generic drugs in the national centralized procurement and the original drugs, providing evidence-based basis for rational clinical medication. Conclusion: This study provides an important reference for clinical doctors in decision-making of drug use, promotes the clinical rational use of selected drugs in centralized procurement, provides evidence-based data for the implementation of national centralized procurement policies, and also provides a model and method for the implementation and effectiveness evaluation of national centralized procurement policies.