硫酸软骨素和氨基葡萄糖联合治疗膝关节和髋关节骨关节炎:俄罗斯的一项长期观察研究。

IF 2 Q2 ORTHOPEDICS World Journal of Orthopedics Pub Date : 2023-06-18 DOI:10.5312/wjo.v14.i6.443
Alexander M Lila, Lyudmila I Alekseeva, Andrey A Baranov, Elena A Taskina, Natalya G Kashevarova, Natalia A Lapkina, Evgeny A Trofimov
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引用次数: 0

摘要

背景:据报道,在临床试验中,口服葡萄糖胺(GA)联合硫酸软骨素(CS)对中度至重度膝关节疼痛的骨关节炎患者的疼痛缓解和功能改善有效。虽然GA和CS在临床和放射学表现上的有效性已得到证实,但只有少数高质量的试验存在。因此,关于它们在现实世界临床实践中的有效性的争议仍然存在。目的:探讨GA + CS在常规临床实践中对膝、髋骨关节炎患者临床预后的影响。方法:2017年11月20日至2020年3月20日,一项多中心前瞻性观察队列研究纳入了俄罗斯联邦51个临床中心的1102名男女膝关节或髋关节骨关节炎患者(Kellgren & Lawrence分级I-III级),这些患者根据批准的患者信息手册开始服用盐酸氨基葡萄糖500 mg和CS 400 mg口服胶囊,每天服用3粒,持续3周。随后在纳入研究前每天减少2粒胶囊的剂量(最小推荐治疗时间为3-6个月)。在观察期间(长达54-64周,共4次访问),膝关节损伤和骨关节炎结局评分(oos)/髋关节残疾和骨关节炎结局评分(HOOS)问卷的亚量表评分[疼痛、症状、功能和生活质量(QOL)]的变化。对患者的治疗满意度、盐酸氨基葡萄糖与CS联合口服、非甾体抗炎药(NSAIDs)联合使用以及不良事件(ae)进行了评价。结果:共纳入1102例膝、髋骨关节炎患者。患者平均年龄60.4岁,女性居多(87.8%),平均体重指数29.49 kg/m2。kos和HOOS的所有子量表评分(疼痛、症状、功能和生活质量)均表现出临床和统计学上的显著改善。在膝关节骨关节炎患者中,从基线到第64周末,疼痛、症状、身体功能(KOOS-PS)和生活质量亚量表的平均评分分别为22.87、20.78、16.60和24.87(均P < 0.001)。在髋关节骨关节炎患者中,疼痛、症状、身体功能(HOOS-PS)和生活质量亚量表的平均评分分别增加22.81、19.93、18.77和22.71分(均P < 0.001)。在观察期结束时,使用任何非甾体抗炎药的患者人数从43.1%下降到13.5% (P < 0.001)。治疗相关不良事件发生率为2.8%,主要包括胃肠道疾病[24例(2.2%)患者中有25例不良事件]。大多数患者(78.1%)对治疗满意。结论:在常规临床实践中,长期口服GA + CS可减轻膝关节和髋关节骨关节炎患者的疼痛,减少伴随的非甾体抗炎药治疗,改善关节功能和生活质量。
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Chondroitin sulfate and glucosamine combination in patients with knee and hip osteoarthritis: A long-term observational study in Russia.

Background: Oral treatment of glucosamine (GA) combined with chondroitin sulfate (CS) was reportedly effective for pain relief and function improvement in osteoarthritis patients with moderate to severe knee pain in clinical trials. While the effectiveness of GA and CS on both clinical and radiological findings has been demonstrated, only a few high-quality trials exist. Therefore, controversy regarding their effectiveness in real-world clinical practice remains.

Aim: To investigate the impact of GA + CS on clinical outcomes of patients with knee and hip osteoarthritis in routine clinical practice.

Methods: A multicenter prospective observational cohort study included 1102 patients of both genders with knee or hip osteoarthritis (Kellgren & Lawrence grades I-III) in 51 clinical centers in the Russian Federation from November 20, 2017, to March 20, 2020, who had started to receive oral capsules of glucosamine hydrochloride 500 mg and CS 400 mg according to the approved patient information leaflet starting from 3 capsules daily for 3 wk, followed by a reduced dosage of 2 capsules daily before study inclusion (minimal recommended treatment duration is 3-6 mo). Changes in subscale scores [Pain, Symptoms, Function, and Quality of Life (QOL)] of the Knee Injury and Osteoarthritis Outcome Score (KOOS)/Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaires during the observational period (up to 54-64 wk with a total of 4 visits). Patients' treatment satisfaction, data on the combined oral use of glucosamine hydrochloride and CS, concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs), and adverse events (AEs) were also evaluated.

Results: A total of 1102 patients with knee and hip osteoarthritis were included in the study. The mean patient age was 60.4 years, most patients were women (87.8%), and their average body mass index was 29.49 kg/m2. All subscale scores (Pain, Symptoms, Function, and QOL) of the KOOS and HOOS demonstrated clinically and statistically significant improvements. In patients with knee osteoarthritis, the mean score increases from baseline to the end of Week 64 were 22.87, 20.78, 16.60, and 24.87 on Pain, Symptoms, Physical Function (KOOS-PS), and QOL subscales (P < 0.001 for all), respectively. In patients with hip osteoarthritis, the mean score increases were 22.81, 19.93, 18.77, and 22.71 on Pain, Symptoms, Physical Function (HOOS-PS), and QOL subscales (P < 0.001 for all), respectively. The number of patients using any NSAIDs decreased from 43.1% to 13.5% (P < 0.001) at the end of the observation period. Treatment-related AEs occurred in 2.8% of the patients and mainly included gastrointestinal disorders [25 AEs in 24 (2.2%) patients]. Most patients (78.1%) were satisfied with the treatment.

Conclusion: Long-term oral GA + CS was associated with decreased pain, reduced concomitant NSAID therapy, improved joint function and QOL in patients with knee and hip osteoarthritis in routine clinical practice.

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