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罗莫索珠单抗临床应用中国医药专家共识
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| 篇名： | 罗莫索珠单抗临床应用中国医药专家共识 |
| TITLE： | Chinese medical and pharmaceutical expert consensus on the clinical application of romosozumab |
| 摘要： | 目的 规范罗莫索珠单抗在我国临床的合理使用，明确适用人群，优化全程治疗策略并加强用药风险防控。方法本共识由广东省医院协会医院药事管理专业委员会发起，已完成国际实践指南注册。编写组组织国内药学、骨科领域的25名专家，通过2轮问卷调查与研讨会确定7个核心临床问题；系统检索中英文数据库，采用推荐分级的评估、制订与评价方法评价证据质量与推荐强度并形成共识建议，结合专家组意见修订完善。结果本共识最终形成7条推荐意见，涵盖罗莫索珠单抗的适用人群、序贯与转换药物治疗、用药期间骨折与心血管风险管理等内容，同时，归纳了罗莫索珠单抗的药学特征，以及疗效监测、漏用处理、禁忌证、主要不良反应及用药依从性等其他临床应用注意事项。结论本共识为罗莫索珠单抗在中国人群中的安全、有效、规范使用提供了科学依据与实践参考，有助于促进骨折高风险骨质疏松症患者的个体化治疗，降低骨折风险。 |
| ABSTRACT： | OBJECTIVE To standardize the rational clinical use of romosozumab in China， define suitable patient populations， optimize full-course treatment strategies， and strengthen medication risk management.METHODS This consensus was initiated by the Pharmacy Administration Committee of Guangdong Province Hospital Association and registered on the International Practice Guidelines Registry Platform. Twenty-five experts in pharmacy and orthopedics were organized to identify 7 core clinical questions through 2 rounds of questionnaires and seminars. Chinese and English databases were systematically retrieved， and the Grading of Recommendations Assessment， Development and Evaluation approach was used to assess evidence quality and recommendation strength and to formulate consensus recommendations， which were refined based on expert review.RESULTS Seven recommendations were developed， covering the applicable populations of romosozumab， sequential and switching therapy， and management of fractures and cardiovascular risk during treatment. The pharmaceutical characteristics of romosozumab， as well as other key points for clinical application， including efficacy monitoring， management of missed doses， contraindications， major adverse reactions， and medication adherence， were also summarized.CONCLUSIONS This consensus provides evidence-based guidance and practical reference for the safe， effective， and standardized use of romosozumab in Chinese patients， which may facilitate individualized treatment of patients with osteoporosis at high fracture risk and reduce fracture risk. |
| 期刊： | 2026年第37卷第20期 |
| 作者： | 莫立乾；陈泽夫；吴慧仪；郑萍；张忠民；李亦蕾 |
| AUTHORS： | MO Liqian，CHEN Zefu，WU Huiyi，ZHENG Ping，ZHANG Zhongmin，LI Yilei |
| 关键字： | 罗莫索珠单抗;骨质疏松症;骨折;临床应用;专家共识 |
| KEYWORDS： | romosozumab;Osteoporosis;Fracture;Clinical application;Expert Consensus |
| 阅读数： | 1 次 |
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