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比较关节内单次交联透明质酸(HYAJOINT Plus)和富血小板血浆(PRP)与单独 PRP 治疗膝骨关节炎的疗效。

Comparing efficacy of intraarticular single crosslinked Hyaluronan (HYAJOINT Plus) and platelet-rich plasma (PRP) versus PRP alone for treating knee osteoarthritis.

机构信息

Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, No 386, Ta-Chung 1st Road, Kaohsiung, 813, Taiwan.

National Yang-Ming University School of Medicine, Taipei City, Taiwan.

出版信息

Sci Rep. 2021 Jan 8;11(1):140. doi: 10.1038/s41598-020-80333-x.

Abstract

Intraarticular hyaluronan or platelet-rich plasma (PRP) is widely used in the treatment of knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP remained inconclusive. This study aimed to investigate the efficacy of combined a single crosslinked hyaluronan (HYAJOINT Plus) and a single PRP versus a single PRP in patients with knee OA. In a prospective randomized-controlled trial, 85 patients with knee OA (Kellgren-Lawrence 2) were randomized to receive a single intraarticular injection of HYAJOINT Plus (3 ml, 20 mg/ml) followed by 3 ml PRP (the combined-injection group, N = 43) or a single injection of 3 ml PRP (the one-injection group, N = 42). The primary outcome was the change from baseline in the visual analog scale (VAS) pain (0-00 mm) at 6 months. Secondary outcomes included The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale), Lequesne index, single leg stance test (SLS), use of rescue analgesics and patient satisfaction at 1, 3 and 6 months. Seventy-eight patients were available for the intention-to-treat analysis at 6 months. Both groups improved significantly in VAS pain, WOMAC, Lequesne index and SLS at each follow-up visit (p < 0.001). Patients receiving a single PRP experienced significantly greater improvements in VAS pain than patients receiving combined injections at 1-month follow-up (adjusted mean difference: - 5.6; p = 0.017). There were no significant between-group differences in several of the second outcomes at each follow-up visit, except the WOMAC-pain and WOMAC-stiffness scores favoring the one-injection group at 1 month (p = 0.025 and p = 0.011). However, at 6-month follow-up, the combined-injection group achieved significantly better VAS pain reduction (p = 0.020). No serious adverse events occurred following injections. In conclusion, either combined injections of HYAJOINT Plus and PRP or a single PRP alone was safe and effective for 6 months in patients with Kellgren-Lawrence 2 knee OA. Combined injections of HYAJOINT Plus and PRP achieved better VAS pain reduction than a single PRP at 6 months. The results indicating a long term benefit effect of a combination of HYAJOINT Plus and PRP in a particular subset of patients with moderate knee OA need to be replicated in larger trials.ClinicalTrials.gov number NCT04315103.

摘要

关节内透明质酸或富含血小板的血浆 (PRP) 广泛用于治疗膝骨关节炎 (OA)。联合透明质酸和 PRP 的疗效仍不确定。本研究旨在探讨单次交联透明质酸 (HYAJOINT Plus) 联合单次 PRP 与单次 PRP 治疗膝骨关节炎患者的疗效。在一项前瞻性随机对照试验中,85 例膝骨关节炎患者(Kellgren-Lawrence 2 级)被随机分为接受单次关节内注射 HYAJOINT Plus(3 ml,20 mg/ml)后再注射 3 ml PRP(联合注射组,N=43)或单次注射 3 ml PRP(单次注射组,N=42)。主要结局是 6 个月时视觉模拟量表(VAS)疼痛(0-00 毫米)从基线的变化。次要结局包括西安大略和麦克马斯特大学骨关节炎指数(WOMAC,Likert 量表)、Lequesne 指数、单腿站立试验(SLS)、使用解救性镇痛药和 1、3 和 6 个月时的患者满意度。78 例患者在 6 个月时进行意向治疗分析。两组在每次随访时 VAS 疼痛、WOMAC、Lequesne 指数和 SLS 均显著改善(p<0.001)。在 1 个月随访时,接受单次 PRP 治疗的患者 VAS 疼痛改善明显优于接受联合注射的患者(调整平均差异:-5.6;p=0.017)。除 1 个月时 WOMAC 疼痛和 WOMAC 僵硬评分倾向于单次注射组(p=0.025 和 p=0.011)外,两组在各次随访的其他次要结局指标之间均无显著差异。然而,在 6 个月随访时,联合注射组的 VAS 疼痛缓解程度显著更好(p=0.020)。注射后无严重不良事件发生。总之,对于 Kellgren-Lawrence 2 级膝骨关节炎患者,HYAJOINT Plus 和 PRP 联合注射或单次 PRP 单独注射均安全有效,可维持 6 个月。与单次 PRP 相比,HYAJOINT Plus 和 PRP 联合注射在 6 个月时可更好地减轻 VAS 疼痛。这些结果表明,在特定的中度膝骨关节炎患者亚组中,HYAJOINT Plus 和 PRP 的联合具有长期获益效应,需要在更大的试验中进行复制。ClinicalTrials.gov 编号:NCT04315103。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c93e/7794411/0ea83197be20/41598_2020_80333_Fig1_HTML.jpg

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