硫酸氨基葡萄糖与牛软骨素固定剂量复方新制剂治疗膝骨关节炎的多中心、随机、单盲、非劣效性临床试验。

Treatment of knee osteoarthritis with a new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin: a multicenter, randomized, single-blind, non-inferiority clinical trial.

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 Medicina Avançada (IMA Brasil), São Paulo, Brazil.

出版信息

Adv Rheumatol. 2021 Jan 19;61(1):7. doi: 10.1186/s42358-021-00165-9.

DOI:10.1186/s42358-021-00165-9

PMID:33468249

Abstract

OBJECTIVES

To compare the efficacy and safety of a new formulation of a fixed dose combination of glucosamine sulfate (GS; 1500 mg) and bovine chondroitin sulfate (CS; 1200 mg) versus the reference product (RP) in patients with knee osteoarthritis (OA).

METHODS

In this multicenter, randomized, single-blind trial, 627 patients with knee osteoarthritis (OA)-Kellgren-Lawrence grades 2 or 3 and mean score ≥ 40 mm in the WOMAC pain subscale-were randomized to receive GS/CS or the RP for 24 weeks. The primary efficacy endpoint was the absolute change in WOMAC pain subscale score. The secondary endpoints included the following: WOMAC total and subscale scores, overall assessment of the disease by the patient and the investigator, SF-12 score, OMERACT-OARSI response rate to the treatment, and rescue medication use.

RESULTS

Mean reductions of WOMAC pain score were - 35.1 (sd = 23.2) mm in the GS/CS group and - 36.5 (sd = 24.9) mm in the RP group. The difference between the adjusted means of both treatments confirmed the non-inferiority of GS/CS versus the RP. Improvement was observed in pain, stiffness, physical function and total WOMAC score, as well as in overall OA assessment by the patient and the investigator for both groups. No improvement was observed in SF-12. The rate of OMERACT-OARSI responders was 89.4% in GS/CS group and 87.9% in the RP group. Headache and changes in glucose tolerance were the most frequent treatment-related adverse events.

CONCLUSIONS

The new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin sulfate was non-inferior to the RP in symptomatic treatment of knee OA, with a high responder rate and good tolerability profile.

TRIAL REGISTRATION

ClinicalTrials.gov; Registration number NCT02830919 ; Date of registration: July 13, 2016; First randomization date: December 05, 2016).

摘要

目的

比较新型固定剂量组合氨基葡萄糖硫酸盐（GS；1500mg）和牛软骨素硫酸盐（CS；1200mg）与参比制剂（RP）治疗膝骨关节炎（OA）患者的疗效和安全性。

方法

这是一项多中心、随机、单盲试验，627 例膝骨关节炎（OA）-Kellgren-Lawrence 分级 2 或 3 级且 WOMAC 疼痛子量表评分≥40mm 且平均评分≥40mm 的患者被随机分为 GS/CS 或 RP 治疗组，治疗 24 周。主要疗效终点为 WOMAC 疼痛子量表评分的绝对变化。次要终点包括：WOMAC 总评分和子量表评分、患者和研究者对疾病的总体评估、SF-12 评分、OMERACT-OARSI 对治疗的反应率以及解救药物的使用。

结果

GS/CS 组 WOMAC 疼痛评分平均下降 35.1（标准差 [sd]=23.2）mm，RP 组下降 36.5（sd=24.9）mm。两种治疗方法调整后均值的差异证实了 GS/CS 与 RP 的非劣效性。两组患者疼痛、僵硬、身体功能和 WOMAC 总评分以及患者和研究者对 OA 的总体评估均有改善。SF-12 未见改善。GS/CS 组和 RP 组的 OMERACT-OARSI 应答率分别为 89.4%和 87.9%。最常见的治疗相关不良事件是头痛和葡萄糖耐量变化。