Department of Orthopaedic Surgery, Chang Gung Memorial Hospital-Kaohsiung Medical Center and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
J Shoulder Elbow Surg. 2010 Jun;19(4):557-63. doi: 10.1016/j.jse.2009.08.006. Epub 2009 Dec 5.
A randomized, double-blind, placebo-controlled study of sodium hyaluronate (ARTZ Dispo) treatment was performed in 51 patients with rotator cuff lesions without complete tears. We hypothesized that ARTZ Dispo would render better results than the placebo.
Twenty-five patients (ARTZ Dispo group) had injections of 25 mg/wk of sodium hyaluronate into the subacromial bursa for 5 consecutive weeks. Twenty-six patients (placebo group) were given 2.5 mL of normal saline solution with the same injection protocol as the ARTZ Dispo group. No significant difference in age, height, weight, gender, vocation, involved shoulder, duration of symptoms, baseline Constant score, or visual analog scale (VAS) score existed between the 2 groups.
The 2 groups did not significantly differ with regard to Constant scores, VAS scores, or global improvement assessments 1 week after injections. The ARTZ Dispo group had a better Constant score (P = .0095) and VAS score (P = .0018) than the placebo group 6 weeks after treatment. Patients in the placebo group were given 5 sodium hyaluronate injections, rather than placebo, after disclosure of the blind list, if they wished. Forty-one patients who underwent hyaluronate injection exhibited a significantly improved Constant score, from 64.0 +/- 11.7 at baseline to 88.9 +/- 10.4 (P < .0001), and a significantly improved VAS score, from 6.4 +/- 1.3 to 1.5 +/- 1.6 (P < .0001), at a mean follow-up of 33.1 months. No significant adverse effect was noted.
Subacromial injections of sodium hyaluronate are effective in treating rotator cuff lesions without complete tears.
对 51 例无完全撕裂的肩袖病变患者进行了随机、双盲、安慰剂对照的透明质酸钠（ARTZ Dispo）治疗研究。我们假设 ARTZ Dispo 会比安慰剂产生更好的效果。
25 例患者（ARTZ Dispo 组）每周接受 25mg/wk 的透明质酸钠关节内注射，连续 5 周。26 例患者（安慰剂组）给予 2.5ml 生理盐水，注射方案与 ARTZ Dispo 组相同。两组在年龄、身高、体重、性别、职业、受累肩、症状持续时间、基线 Constant 评分或视觉模拟评分（VAS）评分方面无显著差异。
两组在注射后 1 周的 Constant 评分、VAS 评分或总体改善评估方面无显著差异。ARTZ Dispo 组在治疗 6 周后 Constant 评分（P=.0095）和 VAS 评分（P=.0018）均优于安慰剂组。如果愿意，安慰剂组的患者在揭盲后可接受 5 次透明质酸钠注射，而非安慰剂。41 例接受透明质酸钠注射的患者的 Constant 评分显著改善，从基线时的 64.0±11.7 提高到 88.9±10.4（P<.0001），VAS 评分从 6.4±1.3 提高到 1.5±1.6（P<.0001），平均随访 33.1 个月。未观察到明显的不良反应。
肩峰下注射透明质酸钠治疗无完全撕裂的肩袖病变有效。
