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治疗重症肌无力的抗体类药物临床应用与药学管理循证专家共识
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| 篇名： | 治疗重症肌无力的抗体类药物临床应用与药学管理循证专家共识 |
| TITLE： | Evidence-based expert consensus on the clinical application and pharmaceutical management of antibody-based drugs for the treatment of myasthenia gravis |
| 摘要： | 目的 为临床合理应用抗体类药物治疗重症肌无力提供规范化指导，完善该领域指南共识的循证证据体系。方法共识专家团队由来自28个省/自治区/直辖市的71名多学科专家构成，通过多种数据库、药品说明书，以及国际和各国卫生行政主管部门、药监部门、医疗保障部门或相关行业协会的官方网站等多途径，系统检索截至2025年4月30日的证据，按照2014版JBI干预性研究证据预分级体系进行证据分级。在充分考虑当前最佳循证证据、多学科专家经验的基础上，通过改良德尔菲法形成专家共识推荐意见。结果《治疗重症肌无力的抗体类药物临床应用与药学管理循证专家共识》针对中国大陆地区已获批上市的4种治疗重症肌无力的抗体类药物（艾加莫德α、艾加莫德α/透明质酸酶、依库珠单抗、罗泽利昔珠单抗），规范其全流程药学管理要点，形成了37条专家共识推荐意见，涵盖药物的适用性选择、特殊人群用药、用药方式、药品储存、治疗药物监测与药物基因检测、免疫接种管理、药物相互作用、药学监护、超说明书用药9个药学管理环节。结论该共识依托当前最佳循证证据以及多学科专家经验，构建了治疗重症肌无力的抗体类药物从临床应用到药学管理的全流程管理规范，为临床合理精准使用此类药品提供了科学依据，有效促进了药学管理效能的提升，有助于提高患者药物治疗的综合获益。 |
| ABSTRACT： | OBJECTIVE To provide standardized guidance for the rational clinical use of antibody-based drugs for the treatment of myasthenia gravis， and to enhance the evidence-based system of guidelines and consensus in this field. METHODS The consensus expert team consisted of 71 multidisciplinary experts from 28 provinces/autonomous regions/municipalities directly under the Central Government. Evidence was systematically retrieved through multiple databases， drug package inserts， and official websites of international and national health administrative authorities， drug regulatory agencies， healthcare security departments， and related industry associations， up to April 30， 2025. Evidence was graded according to the 2014 version of JBI pre-grading system for evidence from intervention studies. Based on full consideration of the current best evidence and multidisciplinary expert experience， the expert consensus recommendations were formulated using a modified Delphi method. RESULTS The Evidence-based expert consensus on the clinical application and pharmaceutical management of antibody-based drugs for the treatment of myasthenia gravis standardized the key points of whole-process pharmaceutical management for four antibody-based drugs approved for marketing in the mainland of China for the treatment of myasthenia gravis （efgartigimod alfa， efgartigimod alfa/hyaluronidase， eculizumab， and rozanolixizumab）. It formulated 37 expert consensus recommendations covering nine pharmaceutical management aspects： drug suitability selection， medication in special populations， administration methods， drug storage， therapeutic drug monitoring and pharmacogenetic testing， immunization management， drug interactions， pharmaceutical care， and off-label drug use. CONCLUSIONS Based on the current best evidence and multidisciplinary expert experience， this consensus establishes a whole-process management framework for antibody-based drugs for the treatment of myasthenia gravis， from clinical application to pharmaceutical management. It provides a scientific basis for the rational and precise use of these drugs in clinical practice， effectively promotes the enhancement of pharmaceutical management efficiency， and helps improve the overall therapeutic benefits for patients. |
| 期刊： | 2026年第37卷第09期 |
| 作者： | 段蓉；李正翔；左笑丛；赵荣生；侯锐钢；杨春生；乞国艳 |
| AUTHORS： | DUAN Rong，LI Zhengxiang，ZUO Xiaocong，ZHAO Rongsheng，HOU Ruigang，YANG Chunsheng，QI Guoyan |
| 关键字： | 重症肌无力；抗体类药物；专家共识；循证评价；临床应用 |
| KEYWORDS： | myasthenia gravis； antibody-based drugs； expert consensus； evidence-based evaluation； clinical application |
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