生物治疗增强前交叉韧带重建与临床或影像学结果改善无关：随机对照试验的系统综述与Meta分析
简介
该系统综述/Meta分析纳入9项RCT、543例，评估PRP、BMAC和间充质干细胞增强ACL重建的疗效。与单纯ACL重建相比，生物增强未改善Lysholm/KOOS评分，未减少骨道扩大，移植物成熟影像学多无显著改善，且无相关并发症。提示其临床和影像学获益有限，不宜常规辅助。
英文摘要
PURPOSE: To review current randomized controlled trials (RCTs) investigating the efficacy of orthobiologic augmentation for anterior cruciate ligament reconstruction (ACLR) for clinical or radiographic outcomes. METHODS: PubMed, EMBASE, and the Web of Science databases were queried in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines to identify RCTs investigating the efficacy of orthobiologics for ACLR. Studies were included if they compared patient-reported outcome measures or radiographic evaluation of graft maturation of ACLR with and without orthobiologics. Included forms of orthobiologics were platelet-rich plasma, bone marrow aspirate concentrate, and mesenchymal stem cell. Studies were excluded if they applied the orthobiologic to the harvest or donor site, rather than the ACL graft itself, or if they did not report patient-reported outcome measures or radiographic evaluation of graft maturation. For outcome measures with 3 or more studies that used the same orthobiologic, meta-analyses were conducted using DerSimonian-Laird random-effects models, reported in standardized mean difference (SMD). RESULTS: There were 9 RCTs with 543 total patients investigating platelet-rich plasma (5 studies), bone marrow aspirate concentrate (3 studies), and mesenchymal stem cell (1 study) augmentation in ACLR. Meta-analysis revealed no significant difference in Lysholm scores (SMD = 0.99 [0.72-1.36], I2 = 0.58%, P = .95) with versus without platelet-rich plasma augmentation for ACLR. Similar knee injury and osteoarthritis outcome scores were found for ACLR augmented by bone marrow aspirate concentrate versus ACLR alone (SMD = 0.78 [0.41-1.49], I2 = 76.97%, P = .45). Orthobiologic augmentation was not found to decrease bone tunnel enlargement (SMD = 1.56 [0.61-3.96], I2 = 87.46%, P = .35). All studies reported a radiographic evaluation of graft maturation, 6 of which reported no significant change with orthobiologic augmentation. No complications related to orthobiologics were reported. CONCLUSIONS: Orthobiologic augmentation for ACLR shows similar patient-reported outcome measures and bone tunnel healing as compared with ACLR alone, although these results are limited by heterogeneity. This review suggests limited efficacy regarding orthobiologic augmentation for ACLR. LEVEL OF EVIDENCE: Level II, systematic review and meta-analysis of Level I and II randomized controlled trials.