目的 基于《中国医疗机构药品评价与遴选快速指南》（第三版）（《指南》）的量化评价体系，对英夫利西单抗（IFX）与维得利珠单抗（VDZ）治疗难治性溃疡性结肠炎（RUC）进行多维度临床综合评价，为医疗机构药品遴选和临床合理用药提供依据。方法 检索2种生物制剂治疗RUC的随机对照试验、真实世界研究及相关药学、经济学研究文献数据，严格参照《指南》量化评分标准从有效性、安全性、药学特性、经济性及其他属性5个维度，对2种生物制剂进行逐项评分，汇总计算总分并对比分析，结合临床实际需求优化评价结论。结果 IFX与VDZ在治疗RUC中均展现出明确临床价值，综合评分分别为74.12分与75.85分。其中，IFX在有效性、其他属性维度表现更优； VDZ在安全性、药学特性和经济性3个维度优势更显著，不良事件发生率更低，耐受性良好，且给药更便捷。结论 2种生物制剂均符合《指南》临床价值导向，可结合患者病情严重程度、合并症、用药依从性及医保支付情况个体化选择：病情偏重、需快速实现黏膜愈合者优先考虑IFX；存在基础疾病、对药物安全性要求较高、经济负担较重者可优先选择VDZ，医疗机构可根据临床需求、患者特征及药物可及性进行个体化选择。

Objective To conduct a multi-dimensional comprehensive clinical evaluation of infliximab (IFX) and vedolizumab (VDZ) in the treatment of refractory ulcerative colitis (RUC) based on the quantitative evaluation system of the Rapid Guidelines for Drug Evaluation and Selection in Chinese Medical Institutions (Third Edition) (hereinafter referred to as the Guidelines), providing evidence for drug selection in medical institutions and clinical rational drug use. Methods Literature data from randomized controlled trials, real-world studies, and relevant pharmaceutical and pharmacoeconomic studies on the two biologics for RUC were retrieved. Strictly following the quantitative scoring criteria of the Guidelines, the two biologics were scored item by item across five dimensions: efficacy, safety, pharmaceutical properties, economy, and other attributes. Total scores were calculated, summarized, and comparatively analyzed. The evaluation conclusions were optimized in conjunction with actual clinical needs. Results Both IFX and VDZ demonstrated clear clinical value in the treatment of RUC, with comprehensive scores of 74.12 and 75.85, respectively. IFX performed better in the dimensions of efficacy and other attributes. VDZ showed more significant advantages in the three dimensions of safety, pharmaceutical properties, and economy, with a lower incidence of adverse events, good tolerability, and more convenient administration. Conclusion Both biologics align with the clinical value orientation of the Guidelines. Individualized selection can be made based on the patient's disease severity, comorbidities, medication adherence, and medical insurance payment status: IFX may be preferred for patients with severe disease requiring rapid mucosal healing; VDZ may be prioritized for patients with underlying diseases, higher requirements for drug safety, or heavier economic burden. Medical institutions can make individualized selections based on clinical needs, patient characteristics, and drug accessibility.

R975

2025年吴阶平医学基金会专项课题（320.6750.2025-06-259）；黄淮学院青年骨干教师项目院文（2025.220）