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膝关节骨关节炎中关节内单次注射透明质酸凝胶Hylan G-F 20与皮质类固醇的比较:一项双盲随机对照试验

Intra-Articular, Single-Shot Hylan G-F 20 Hyaluronic Acid Injection Compared with Corticosteroid in Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial.

作者信息

Tammachote Nattapol, Kanitnate Supakit, Yakumpor Thanasak, Panichkul Phonthakorn

机构信息

Department of Orthopaedics, Faculty of Medicine, Thammasat University, Khlong Nueng, Khlong Luang, Pathumthani, Thailand Orthopaedic Outpatient Unit, Thammasat University Hospital, Khlong Nueng, Khlong Luang, Pathumthani, Thailand

Department of Orthopaedics, Faculty of Medicine, Thammasat University, Khlong Nueng, Khlong Luang, Pathumthani, Thailand Orthopaedic Outpatient Unit, Thammasat University Hospital, Khlong Nueng, Khlong Luang, Pathumthani, Thailand.

出版信息

J Bone Joint Surg Am. 2016 Jun 1;98(11):885-92. doi: 10.2106/JBJS.15.00544.

Abstract

BACKGROUND

The treatment of knee osteoarthritis with hyaluronic acid or corticosteroid injection has been widely used. The purpose of this study was to compare the efficacy of hyaluronic acid (hylan G-F 20) with triamcinolone acetonide as a single intra-articular injection for knee osteoarthritis.

METHODS

This study was a prospective, randomized, double-blind clinical trial. Participants with symptomatic knee osteoarthritis were recruited. They were randomized to receive a single-shot, intra-articular injection of either 6 mL of hylan G-F 20 or 6 mL of a solution comprising 1 mL of 40-mg triamcinolone acetonide and 5 mL of 1% lidocaine with epinephrine. The primary outcomes were knee pain severity, knee function, and range of motion at 6 months. Ninety-nine patients were assessed before injection and underwent a 6-month follow-up. Patients and evaluators were blinded. Multilevel regression models were used to estimate differences between the groups.

RESULTS

At the 6-month follow-up, compared with patients who took hylan G-F 20, patients who took triamcinolone acetonide had similar improvement in knee pain, knee function, and range of motion. The difference in mean outcome scores between groups was, with regard to knee pain, a visual analog scale (VAS) score of 3 points (95% confidence interval [95% CI], -6 to 11 points); with regard to knee function, a modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score of 0 points (95% CI, -8 to 6 points); and, with regard to range of motion, flexion of -1° (95% CI, -5° to 2°) and extension of 0° (95% CI, -0.5° to 0.5°). However, patients who took triamcinolone acetonide had better pain improvement from 24 hours until 1 week after injection; the mean difference between groups with regard to the VAS score was 12 points (95% CI, 5 to 20 points; p = 0.002) at 24 hours and 9 points (95% CI, 1 to 15 points; p = 0.018) at 1 week. At 2 weeks after injection, patients who took triamcinolone acetonide also had better knee functional improvement; the mean difference between groups for the modified WOMAC score was 6 points (95% CI, 0.7 to 12 points; p = 0.03). Both groups had improvement in pain, knee function, and range of motion during the 6-month follow-up (p < 0.0001).

CONCLUSIONS

Triamcinolone acetonide provided similar improvement in knee pain, function, and range of motion compared with hylan G-F 20 at the 6-month follow-up, with better pain control in the first week and better knee functional improvement in the second week.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

摘要

背景

透明质酸或皮质类固醇注射治疗膝骨关节炎已被广泛应用。本研究的目的是比较透明质酸(hylan G-F 20)与曲安奈德单次关节腔内注射治疗膝骨关节炎的疗效。

方法

本研究是一项前瞻性、随机、双盲临床试验。招募有症状的膝骨关节炎患者。他们被随机分为接受单次关节腔内注射6 mL hylan G-F 20或6 mL由1 mL 40 mg曲安奈德和5 mL含肾上腺素的1%利多卡因组成的溶液。主要结局指标为6个月时的膝关节疼痛严重程度、膝关节功能和活动范围。99例患者在注射前进行评估并接受6个月的随访。患者和评估者均为盲法。采用多水平回归模型估计组间差异。

结果

在6个月随访时,与接受hylan G-F 20治疗的患者相比,接受曲安奈德治疗的患者在膝关节疼痛、膝关节功能和活动范围方面有相似的改善。组间平均结局评分差异为:膝关节疼痛方面,视觉模拟量表(VAS)评分为3分(95%置信区间[95%CI],-6至11分);膝关节功能方面,改良的西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分为0分(95%CI,-8至6分);活动范围方面,屈曲为-1°(95%CI,-5°至2°),伸展为0°(95%CI,-0.5°至0.5°)。然而,接受曲安奈德治疗的患者在注射后24小时至1周疼痛改善更好;组间VAS评分在24小时时平均差异为12分(95%CI,5至20分;p = 0.002);在1周时为9分(95%CI,1至15分;p = 0.018)。在注射后2周,接受曲安奈德治疗的患者膝关节功能改善也更好;改良WOMAC评分组间平均差异为6分(95%CI,0.7至12分;p = 0.03)。两组在6个月随访期间疼痛、膝关节功能和活动范围均有改善(p < 0.0001)。

结论

在6个月随访时,曲安奈德与hylan G-F 20相比,在膝关节疼痛、功能和活动范围方面改善相似,在第一周疼痛控制更好,在第二周膝关节功能改善更好。

证据水平

治疗性I级。有关证据水平的完整描述,请参阅作者指南。

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