使用生物制剂的国际专家共识声明：最佳实践与不确定性领域
简介
一项国际德尔菲专家共识（24人专家组，3轮调查，100%参与率）围绕骨科生物制剂（orthobiologics）在肌肉骨骼疾病中的应用达成62条最终共识。共识覆盖了PRP用于膝、髋关节骨关节炎、跟腱病、网球肘及半月板修复增强等适应症，但PRP用于肩袖修复增强及自体细胞疗法未达成共识。尽管多数条目获得高度一致，专家指出剂量、制备方法与质量控制仍是临床不确定领域…
英文摘要
BACKGROUND: The use of orthobiologics has received increasing interest given the potential positive treatment effects on symptoms and tissue regeneration. However, there remains substantial variability surrounding the uses of orthobiologics in clinical practice. The purpose of this study was to create an international Delphi expert consensus statement on the use of orthobiologics in musculoskeletal medicine. METHODS: A working group consisting of 6 members developed 77 initial statements for review by a 24-member panel of international experts. Surveys were conducted in 3 rounds and administered electronically to participants. Participants were asked to respond to each statement using a Likert scale of "strongly disagree," "disagree," "neither disagree nor agree," "agree," and "strongly agree." The final consensus statement included those statements that achieved ≥70% agreement and <20% disagreement. Statements that did not initially achieve consensus were iteratively revised between rounds, which included the incorporation of qualifying language to reflect areas of clinical uncertainty. RESULTS: Sixty-two final statements were utilized in round 3. Each round had 100% participation. Consensus increased sequentially from 48.1% (37 of 77 statements) in round 1 to 96.8% (60 of 62 statements) in round 3. Complete consensus (≥70% agreement and <20% disagreement) was achieved in the following categories: general orthobiologics and PRP (platelet-rich plasma) topics; PRP for knee, hip, and glenohumeral osteoarthritis; PRP for Achilles tendinopathy; PRP for lateral epicondylitis and rotator cuff tendinitis; PRP for meniscus repair augmentation; bone marrow aspirate concentrate; autologous conditioned serum; amniotic derivatives; gene therapy; exosomes; and biologic delivery methods. Some of the topics concerning PRP for rotator cuff repair augmentation and autologous cell-based therapies did not achieve consensus. CONCLUSIONS: A high degree of consensus was achieved across statements concerning appropriate use cases for various orthobiologic therapies. However, many of the adopted statements retained qualifying language, reflecting persistent areas of uncertainty in orthobiologic preparation, dosing, and indication-specific efficacy. Despite high levels of agreement across most categories, experts contended that dosing, preparation methods, and quality control remain areas of uncertainty and inconsistency that require standardization in order to allow for reproducible and meaningful treatment effects.