多中心、随机、双盲临床试验评估硫酸氨基葡萄糖和硫酸软骨素胶囊联合治疗膝骨关节炎的疗效和安全性。

Multicenter, randomized, double-blind clinical trial to evaluate efficacy and safety of combined glucosamine sulfate and chondroitin sulfate capsules for treating knee osteoarthritis.

机构信息

Centro Paulista de Investigação Clínica (CEPIC), Rua Moreira e Costa, 342 - Ipiranga, São Paulo, SP, 04266-010, Brazil.

Instituto de Pesquisa Clínica e Assistência Médica de Campinas (IPECC), Campinas, SP, Brazil.

出版信息

Adv Rheumatol. 2018 Dec 5;58(1):41. doi: 10.1186/s42358-018-0041-9.

DOI:10.1186/s42358-018-0041-9

PMID:30657100

Abstract

OBJECTIVES

To compare the efficacy and safety of a new fixed dose combination of glucosamine sulfate and chondroitin sulfate capsules (GS/CS) versus the fixed dose combination of glucosamine hydrochloride and chondroitin sulfate (Cosamin DS®) in capsules in patients with osteoarthritis (OA) of the knee.

METHODS

Multicenter, randomized, double-blind study. Participants with knee OA Kellgren-Lawrence grades 1 to 3 and VAS of symptoms ≥4 cm were randomized to receive GS/CS or Cosamin DS® over 12 weeks. The primary efficacy endpoint was the evaluation of the analgesic efficacy by the investigator. Secondary efficacy endpoints included: joint pain and swelling, investigator efficacy of the medication, and the use of rescue medication. Adverse events and drug tolerability were analyzed.

RESULTS

One hundred patients were randomized, and 50 patients were allocated to each group. The analgesic efficacy evaluated by the investigator in the GS/CS group was 88.9, 95%CI: 75.2, 95.8% and in the Cosamin DS® group was 85.4%; 95%CI: 70.1, 93.4%. The mean reduction in the pain intensity was significant in both groups (p < 0.001), with no difference between them. The primary efficacy analysis demonstrated the non-inferiority of the GS/CS group compared with the Cosamin DS® group; the lower limit of the 90% confidence interval (CI) between the two groups (- 8.39%) was higher than the established margin of non-inferiority of - 10.00%. Improvement in other efficacy outcomes was observed, again without differences between groups. Adverse events were similar between groups and both presented good tolerability.

CONCLUSIONS

The new fixed-dose formulation of GS/CS is effective in treating knee OA, presenting a good safety and tolerability profile.

TRIAL REGISTRATION

( https://clinicaltrials.gov/ct2/show/NCT00955552?term=NCT00955552&rank=1 ; ClinicalTrials.gov ; register number NCT00955552; First randomized patient: 08/17/2010).

摘要

目的

比较硫酸氨基葡萄糖和硫酸软骨素（GS/CS）固定剂量组合胶囊与盐酸氨基葡萄糖和硫酸软骨素（Cosamin DS®）固定剂量组合胶囊治疗膝骨关节炎（OA）患者的疗效和安全性。

方法

多中心、随机、双盲研究。纳入膝关节 OA 患者，Kellgren-Lawrence 分级 1 至 3 级，症状 VAS≥4cm，随机接受 GS/CS 或 Cosamin DS®治疗 12 周。主要疗效终点为研究者评估的镇痛疗效。次要疗效终点包括：关节疼痛和肿胀、研究者对药物的疗效评估以及使用解救药物。分析不良事件和药物耐受性。

结果

共纳入 100 例患者，随机分为每组 50 例。研究者评估的 GS/CS 组镇痛疗效为 88.9%，95%CI：75.2，95.8%；Cosamin DS®组为 85.4%，95%CI：70.1，93.4%。两组的疼痛强度均显著降低（均 P<0.001），两组间无差异。主要疗效分析表明，GS/CS 组与 Cosamin DS®组相比非劣效性；两组间 90%置信区间（CI）的下限（-8.39%）高于设定的非劣效性边界-10.00%。观察到其他疗效结果的改善，两组间无差异。两组的不良反应相似，均具有良好的耐受性。