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透明质酸钠关节腔注射治疗早期肩袖疾病的多中心随机单盲开放临床对比研究

Does hyaluronate injection work in shoulder disease in early stage? A multicenter, randomized, single blind and open comparative clinical study.

机构信息

Department of Orthopaedic Surgery, Catholic University School of Medicine, Seoul, South Korea.

出版信息

J Shoulder Elbow Surg. 2012 Jun;21(6):722-7. doi: 10.1016/j.jse.2011.11.009. Epub 2012 Feb 25.

Abstract

BACKGROUND

This study assessed the hypothesis that injection of high-molecular weight hyaluronate in the treatment of subacromial impingement syndrome is effective and safe, compared with corticosteroid injection in the shoulder joint.

METHODS

One hundred five patients were allocated randomly into 2 groups: 1 group was injected once a week for 3 weeks with hyaluronate and the other group was injected once with corticosteroid. All injections were guided to the subacromial space by an ultrasonogram. Eighty patients were followed up for 12 weeks after the injection: 38 patients in the hyaluronate group and 42 patients in the corticosteroid group. The functional outcome was measured using the American Shoulder and Elbow Surgeons standardized shoulder assessment form (ASES).

RESULTS

The Visual Analogue Scale (VAS) score at 12 weeks was decreased significantly from 58.6 ± 19.3 to 24.6 ± 23.1 in the hyaluronate group (P < .0001) and from 57.2 ± 19.9 to 36.9 ± 26.5 (P < .0001) in the corticosteroid group. There was a significant difference in the VAS score between the hyaluronic acid group and corticoid group (P = .0180) at 12 weeks. The functional ASES scores in the hyaluronate and corticosteroid groups were increased from 17.6 ± 4.8 to 22.4 ± 6.5 and from 17.3 ± 4.9 to 21.7 ± 5.8, respectively, at 12 weeks (P = .4825). There was no difference in the number of patients requiring rescue medication between the hyaluronate group and corticosteroid group at 12 weeks (P = .9254).

CONCLUSION

A subacromial hyaluronate injection to treat impingement syndrome produces similar pain and functional improvement to corticosteroid at a short-term follow-up.

摘要

背景

本研究评估了这样一种假设,即与肩关节内注射皮质类固醇相比,在肩峰下撞击综合征中注射高分子量透明质酸是有效且安全的。

方法

105 名患者被随机分为 2 组:一组每周注射 1 次,共 3 周,另一组注射 1 次皮质类固醇。所有注射均在超声引导下进行。注射后 12 周,80 例患者接受随访:透明质酸组 38 例,皮质类固醇组 42 例。使用美国肩肘外科医生协会(ASES)的标准肩部评估表(ASES)评估功能结果。

结果

透明质酸组治疗 12 周后,视觉模拟量表(VAS)评分从 58.6 ± 19.3 显著下降至 24.6 ± 23.1(P <.0001),皮质类固醇组从 57.2 ± 19.9 显著下降至 36.9 ± 26.5(P <.0001)。12 周时,透明质酸组和皮质类固醇组的 VAS 评分差异有统计学意义(P =.0180)。透明质酸组和皮质类固醇组的 ASES 功能评分分别从 17.6 ± 4.8 增加到 22.4 ± 6.5 和从 17.3 ± 4.9 增加到 21.7 ± 5.8(P =.4825)。12 周时,透明质酸组和皮质类固醇组需要救援药物的患者数量无差异(P =.9254)。

结论

在短期随访中,肩峰下透明质酸注射治疗撞击综合征可产生与皮质类固醇相似的疼痛和功能改善。

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