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【drug-news 透明质酸钠治疗持续性肩痛:一项随机对
A Multicenter Study
Background: Presently, there are no approved nonoperative therapies for the ongoing treatment of persistent shoulder pain. Preliminary data suggest that intra-articular sodium hyaluronate injections may be beneficial for the treatment of persistent shoulder pain resulting from various etiologies. The present study evaluated the efficacy and safety of sodium hyaluronate (Hyalgan; molecular weight, 500 to 730 kDa) for these patients
Methods: Six hundred and sixty patients with persistent shoulder pain and limitation resulting from glenohumeral joint osteoarthritis, rotator cuff tear, and/or adhesive capsulitis who had had a failure of conventional therapy were enrolled in this double-blind, randomized, phosphate-buffered saline solution-controlled study, and 456 patients completed twenty-six weeks of follow-up. Patients were randomized to receive either five weekly intra-articular injections of sodium hyaluronate, three weekly intra-articular injections of sodium hyaluronate followed by two weekly intra-articular injections of saline solution, or five weekly intra-articular injections of saline solution. The main outcomes were improvement in terms of shoulder pain on movement at thirteen weeks after the initiation of treatment (as assessed with use of a 100-mm visual analog scale) and the treatment effect throughout twenty-six weeks.
Results: For the overall intent-to-treat population, patients who were managed with sodium hyaluronate had greater pain relief than controls did; significant differences were noted at Week 7 (for the five-injection hyaluronate group), Week 17 (for the three and five-injection hyaluronate groups), and Week 26 (for the three-injection hyaluronate group). Analysis of the stratified populations clearly established that this effect was due to benefits experienced by the patients with osteoarthritis. The treatment effect through twenty-six weeks was significant in patients with osteoarthritis in the three-injection (p = 0.003) and five-injection (p = 0.002) groups, with no significant difference for either regimen in patients without osteoarthritis. The safety profile was very favorable, with no product-related serious adverse effects and no between-group differences for any reported adverse event.
Conclusions: Although the primary end point of this study (that is, improvement in terms of shoulder pain at thirteen weeks) was not achieved, the overall findings, including secondary end points, indicate that sodium hyaluronate (500 to 730 kDa) is effective and well tolerated for the treatment of osteoarthritis and persistent shoulder pain that is refractory to other standard nonoperative interventions.
Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.
本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Treatment of Persistent Shoulder Pain with Sodium Hyaluronate: A Randomized, Controlled Trial
透明质酸钠治疗持续性肩痛:一项随机对照试验
A Multicenter Study 多中心研究
Background: Presently, there are no approved nonoperative therapies for the ongoing treatment of persistent shoulder pain. Preliminary data suggest that intra-articular sodium hyaluronate injections may be beneficial for the treatment of persistent shoulder pain resulting from various etiologies. The present study evaluated the efficacy and safety of sodium hyaluronate (Hyalgan; molecular weight, 500 to 730 kDa) for these patients.
背景:目前还没有已认可的非手术疗法来治疗持续性肩痛的发展.初步的资料显示关节内注射透明质酸钠也许对多种原因引起的持续性肩痛有效.本研究是评估玻璃酸钠(Hyalgan;分子量500到730kDa)治疗这些病人的效果及安全性.
Methods: Six hundred and sixty patients with persistent shoulder pain and limitation resulting from glenohumeral joint osteoarthritis, rotator cuff tear, and/or adhesive capsulitis who had had a failure of conventional therapy were enrolled in this double-blind, randomized, phosphate-buffered saline solution-controlled study, and 456 patients completed twenty-six weeks of follow-up. Patients were randomized to receive either five weekly intra-articular injections of sodium hyaluronate, three weekly intra-articular injections of sodium hyaluronate followed by two weekly intra-articular injections of saline solution, or five weekly intra-articular injections of saline solution. The main outcomes were improvement in terms of shoulder pain on movement at thirteen weeks after the initiation of treatment (as assessed with use of a 100-mm visual analog scale) and the treatment effect throughout twenty-six weeks.
方法:因盂肱关节炎、肩袖撕裂和\或肩关节周围炎的持续性肩痛及受限用常规方法治疗失败660个病人，被纳入这个双盲、随机、磷酸盐缓冲液对照研究中，456位病人完成了26周的随访。病人随机区组接受5周玻璃酸钠关节内注射、3周玻璃酸钠关节内注射后注射2周生理盐水或注射生理盐水5周。结局评估根据初期治疗后13周肩活动疼痛（根据100mm的目视疼痛评分表来评估）以及26周后的疗效。
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作者:admin@医学,生命科学 2010-11-04 05:11
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