体外冲击波治疗股骨头坏死的临床实践指南(2024年版)

Clinical practice guidelines for extracorporeal shock wave therapy for osteonecrosis of the femoral head(2024 edition)

股骨头坏死(osteonecrosis of the femoral head,ONFH)是骨科常见难治性、致残性疾病,是引起髋关节疼痛及功能障碍的常见原因之一,给患者个人、家庭和社会造成了沉重的负担。体外冲击波疗法(extracorporeal shock wave ther-apy,ESWT)具有非侵入、安全、有效的特点,已被广泛应用于包括股骨头坏死在内的骨肌疾病临床治疗领域。然而,现阶段ONFH的ESWT方案在适应证选择、治疗参数、评价方法等层面缺乏统一共识,限制了疗法的推广及应用。因此,如何规范、科学、有效地为早、中期ONFH患者提供ESWT干预是临床医生关注的问题。本指南由中国人民解放军总医院第三医学中心、中日友好医院牵头,组织中国研究型医院学会冲击波医学专业委员会,以及国内ONFH、ESWT领域专家,参考国内外最新文献、结合国内临床经验及实际情况,采用改良2011年版牛津大学循证医学中心(Oxford Center for Evidence-Based Medicine,OCEBM)证据级别及推荐等级标准,遵循2014年版《世界卫生组织指南制订手册》及中华医学会发布的《中国制订/修订临床诊疗指南的指导原则(2022版)》。同时参考了指南研究与评价工具Ⅱ(Appraisal of Guide-lines for Research and EvaluationⅡ,AGREEⅡ)、卫生保健实践指南的报告条目(Reporting Items for Practice Guidelines in Healthcare,RIGHT)以及中国临床实践指南评价体系(Appraisal of Guidelines for Research and Evaluation in China,A-GREE-China)等方法,遴选出医生最为关注的9个临床问题,并最终形成9条循证医学推荐意见。本指南旨在为ONFH ESWT治疗技术的推广应用提供建设性意见及依据,提高ESWT的科学性和规范性。

Osteonecrosis of the femoral head(ONFH)is a common and refractory orthopedic disease that leads to disability and is one of the common causes of hip joint pain and dysfunction,imposing a heavy burden on patients,their families,and society.Extracorporeal shock wave therapy(ESWT)is a non-invasive,safe,and effective treatment that has been widely used in the clinical management of musculoskeletal diseases,including ONFH.However,the current application of ESWT for ONFH lacks a unified consensus regarding treatment protocols and evaluation methods,limiting its widespread adoption.Consequently,developing standardized,scientific,and effective ESWT interventions for patients with early-and mid-stage ONFH remains a critical concern for clinicians.This guideline has been developed under the organization of the Third Medical Center of the Chinese PLA General Hospital and the China-Japan Friendship Hospital,with contributions from the Shock Wave medical Professional Committee of Chinese Research Hospital Association and experts in ONFH and ESWT.It references the latest domestic and international literature,integrates domestic clinical experience and actual conditions,and employs the modified 2011 Oxford Centre for Evidence-Based Medicine(OCEBM)levels of evidence and grades of recommendation.It also follows the 2014 World Health Organization Handbook for Guideline Development and the Guiding Principles for the Development/Revision of Clinical Practice Guidelines in China(2022 Edition)issued by the Chinese Medical Association.Additionally,it considers methodologies from the Appraisal of Guidelines for Research and EvaluationⅡ(AGREEⅡ),Reporting Items for Practice Guidelines in Healthcare(RIGHT),and the Chinese Clinical Practice Guidelines Evaluation System(AGREE-China).Nine clinical questions of utmost concern to physicians were and nine evidence-based medical recommendations were finalized.The guideline aims to provide constructive recommendations and a basis for the promotion and application of ESWT in the treatment of ONFH,thereby improving the scientific rigor and standardization of ESWT.