双关节内注射皮质类固醇和透明质酸与单关节内注射皮质类固醇治疗踝关节骨关节炎的随机对照试验
Dual intra-articular injections of corticosteroid and hyaluronic acid versus single corticosteroid injection for ankle osteoarthritis: a randomized comparative trial.
作者信息
Woo Inha, Park Jeong-Jin, Park Chul Hyun
机构信息
The Armed Forces Daejeon Hospital, Daejeon, Republic of Korea.
Korea Armed Forces Athletic Corps, Mungyeong, Gyeongsangbuk-do Province, Republic of Korea.
出版信息
BMC Musculoskelet Disord. 2025 Mar 11;26(1):239. doi: 10.1186/s12891-025-08488-0.
BACKGROUND
Intra-articular corticosteroid injection is commonly used for pain relief in ankle osteoarthritis (OA). The effects of corticosteroids (CS) are short-lived, whereas hyaluronic acid (HA) have longer-lasting effects. The objective was to compare the efficacy of dual injections of CS and HA to CS alone. We hypothesized that intra-articular injections of dual agents would be more effective than CS alone.
METHODS
A single-blind, randomized, controlled trial was designed to investigate this hypothesis. 135 patients with ankle OA were enrolled into an intra-articular CS injection group (CS group, n = 61) or dual HA plus CS injection group (CS + HA group, n = 74). The CS group received 1 mL of corticosteroid and 1 mL of 0.5% bupivacaine and 1 mL of normal saline once, and the CS + HA group received 3 mL of a total of 5 mL mixtures containing 2 mL of HA, or 1 mL of corticosteroid, 0.5% bupivacaine, and normal saline in the first week, followed by 2 mL of HA in the second and third weeks. Clinical evaluations were performed before injection, 6 and 12 weeks after the first injections. The Ankle Osteoarthritis Scale (AOS) was used as the primary outcome measure, and the Visual Analogue Scale (VAS), Short Form Health Survey (SF-36), and complications were used as secondary outcomes.
RESULTS
The mean AOS change from baseline was significantly greater in the CS + HA group than in the CS group at 6 (p ≤ 0.01) and 12 weeks (p ≤ 0.01). The mean VAS change from baseline was significantly greater in the CS group than in the CS + HA group at 6 weeks (p = 0.023), but not at 12 weeks (p = 0.731). The mean SF-36 change from baseline was not significant between the CS and CS + HA groups at 6 (p = 0.416) and 12 weeks (p = 0.215).
CONCLUSIONS
The combination of corticosteroid and HA injection is more effective than corticosteroid alone in relieving pain in ankle OA.
TRIAL REGISTRATION
Clinical Research Information Service in South Korea, KCT0008690 // Registration Date (First Posted): July 21th, 2023 ( http://cris.nih.go.kr ).
背景
关节内注射皮质类固醇常用于缓解踝关节骨关节炎（OA）的疼痛。皮质类固醇（CS）的效果是短暂的，而透明质酸（HA）的效果持续时间更长。目的是比较CS和HA联合注射与单独注射CS的疗效。我们假设关节内注射两种药物比单独注射CS更有效。
方法
设计了一项单盲、随机、对照试验来研究这一假设。135例踝关节OA患者被纳入关节内CS注射组（CS组，n = 61）或HA加CS联合注射组（CS + HA组，n = 74）。CS组接受1 mL皮质类固醇、1 mL 0.5%布比卡因和1 mL生理盐水注射一次，CS + HA组在第一周接受总共5 mL混合物中的3 mL，其中含有2 mL HA，或1 mL皮质类固醇、0.5%布比卡因和生理盐水，在第二周和第三周接受2 mL HA。在注射前、首次注射后6周和12周进行临床评估。踝关节骨关节炎量表（AOS）用作主要结局指标，视觉模拟量表（VAS）、简短健康调查问卷（SF - 36）和并发症用作次要结局。
结果
在6周（p≤0.01）和12周（p≤0.01）时，CS + HA组从基线开始的平均AOS变化显著大于CS组。在6周时，CS组从基线开始的平均VAS变化显著大于CS + HA组（p = 0.023），但在12周时无显著差异（p = 0.731）。在6周（p = 0.416）和12周（p = 0.215）时，CS组和CS + HA组从基线开始的平均SF - 36变化无显著差异。
结论
皮质类固醇和HA联合注射在缓解踝关节OA疼痛方面比单独使用皮质类固醇更有效。
试验注册
韩国临床研究信息服务中心，KCT0008690 // 注册日期（首次发布）：2023年7月21日（http://cris.nih.go.kr）
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