背景:据报道,在临床试验中,葡萄糖胺(GA)联合硫酸软骨素(CS)口服治疗可有效缓解疼痛和改善中重度膝关节疼痛的骨关节炎患者的功能。虽然已经证明了GA和CS对临床和放射学结果的有效性,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:探讨常规临床实践中GA+CS对膝髋骨关节炎患者临床结局的影响。
方法:一项多中心前瞻性观察性队列研究包括从2017年11月20日至2020年3月20日在俄罗斯联邦51个临床中心的1102名男女膝或髋骨关节炎患者(Kellgren&LawrenceI-III级),根据批准的患者信息说明书,他们开始接受盐酸氨基葡萄糖500mg和CS400mg口服胶囊,持续3周,然后在纳入研究前每天减少2粒胶囊的剂量(推荐的最小治疗时间为3-6个月)。子量表得分的变化[疼痛,症状,Function,和生活质量(QOL)]的膝关节损伤和骨关节炎结果评分(KOOS)/髋关节残疾和骨关节炎结果评分(HOOS)问卷在观察期间(长达54-64周,共4次访问)。患者治疗满意度,关于联合口服使用盐酸氨基葡萄糖和CS的数据,伴随使用非甾体抗炎药(NSAIDs),和不良事件(AE)也进行了评估。
结果:本研究共纳入1102例膝髋骨关节炎患者。患者平均年龄为60.4岁,大多数患者是女性(87.8%),平均体重指数为29.49kg/m2。所有子量表得分(疼痛,症状,Function,KOOS和HOOS的QOL)显示出临床和统计学上的显着改善。在膝骨关节炎患者中,从基线到第64周结束时,疼痛的平均得分分别为22.87、20.78、16.60和24.87,症状,物理功能(KOOS-PS),和生活质量分量表(全部P<0.001),分别。在髋关节骨关节炎患者中,疼痛的平均得分分别为22.81、19.93、18.77和22.71,症状,物理功能(HOOS-PS),和生活质量分量表(全部P<0.001),分别。在观察期结束时,使用任何NSAIDs的患者人数从43.1%降至13.5%(P<0.001)。2.8%的患者发生与治疗相关的不良事件,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:长期口服GA+CS与疼痛减轻有关,减少伴随NSAID治疗,膝关节和髋关节骨性关节炎患者的关节功能和生活质量的改善。
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.
OBJECTIVE: 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.
CONCLUSIONS: 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.