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目的 从不同维度对3种单克隆抗体治疗炎症性肠病开展综合评价，以期为临床合理用药提供依据。方法 根据《药品临床综合评价管理指南(2021年版试行)》，主要运用循证医学研究和数据定性分析法对维得利珠单抗、英夫利西单抗和阿达木单抗的安全性、有效性、经济性、创新性、适宜性和可及性6个维度进行综合评价。结果 在安全性方面，阿达木单抗的上市前研究显示其安全性更优，维得利珠单抗的上市后研究显示其不良反应更为轻微；在有效性方面，英夫利西单抗更适用于克罗恩病和溃疡性结肠炎诱导期，维得利珠单抗更适用于溃疡性结肠炎维持期的治疗以及溃疡性结肠炎使用英夫利西单抗失效后的治疗，阿达木单抗更适用于克罗恩病使用英夫利西单抗失效后的治疗；在经济性方面，不同国家差异性较大；在创新性方面，维得利珠单抗更具优势；在适宜性方面，阿达木单抗更具优势；在可及性方面，我国3种药品的价格水平均低于国际水平，英夫利西单抗的可获得性更具优势，阿达木单抗和维得利珠单抗的城镇居民可负担性更好。结论 3种单克隆抗体在治疗炎症性肠病时各具优势，有待开展基于我国人群的有效性和经济性对比评价，为临床合理用药和医保部门相关决策的制定提供依据。
Abstract：AIM To carry out the comprehensive evaluation of 3 monoclonal antibodies in the treatment of inflammatory bowel disease from different dimensions, providing a basis for clinical rational drug use. METHODS According to the Guidelines for the management of comprehensive clinical evaluation of pharmaceuticals(2021 trial edition), evidence-based medicine research and quantitative data analysis were mainly used to comprehensively evaluate 6 dimensions: safety, effectiveness, economics, accessibility, innovation, suitability, and accessibility of vedolizumab, infliximab and adalimumab. RESULTS In terms of safety, the pre-market studies of adalimumab showed better performance, and the post-market studies of vedolizumab showed milder adverse reactions. In terms of effectiveness, infliximab was more suitable for the induction period of Crohn's disease and ulcerative colitis. Vedolizumab was more suitable for the treatment of stable ulcerative colitis and for ulcerative colitis after the failure of infliximab treatment. Adalimumab was more suitable for the treatment of Crohn's disease after the failure of infliximab treatment. In terms of cost-effectiveness, there was a significant difference in the results from different countries. Vedolizumab had a better performance in terms of innovation. In terms of suitability, adalimumab had more advantages. In terms of accessibility, the price levels of all three drugs in our country were below international standards. The availability of infliximab was more advantageous, while the affordability of adalimumab and vedolizumab was better for urban residents. CONCLUSION Each of the 3 monoclonal antibodies has its advantages in treating inflammatory bowel disease. A comparative evaluation of their effectiveness and cost-effectiveness in the Chinese population is necessary to inform clinical practice and assist medical insurance departments in making relevant decisions regarding rational drug use.
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基本信息:
DOI：10.19577/j.1007-4406.2026.02.004
中图分类号:R975
引用信息:
[1]王晓丽,郑盈盈,刘洋,等.3种单克隆抗体治疗炎症性肠病的临床综合评价[J].中国临床药学杂志,2026,35(02):121-127.DOI:10.19577/j.1007-4406.2026.02.004.
基金信息:
河北省药学会“晴冀药学”医院药学专项科研项目（编号2022-Hbsyxhqjyxms21）