Alekseeva L I, Chichasova N V, Benevolenskaia L I, Nasonov E L, Mendel' O I
Ter Arkh. 2005;77(11):69-75.
To study clinical effectiveness, safety and duration of the effect of combined medication ARTRA (500 mg glucosamine hydrochloride+500 mg chondroitine sulphate) in osteoarthrosis.
Ninety women aged 40-75 suffering from knee OA and satisfying diagnostic criteria for OA of American Rheumatological Committee having x-ray II-III stages according to Kellgren-Lawrence; with distinct pain syndrome (pain intensity at walking 40 mm and more by the analogue visual scale); taking NSAIDS regularly during 30 days within 3 months before the study were enrolled in the study. The patients were randomly divided into 2 groups: 45 patients of the study group taking 1 tablet ARTRA 2 times a day within the first month, than 1 tablet a day within the following 5 months and diclofenac sodium 50 mg 2 times a day with gradual decrease of the dosage as the pain was decreasing; 45 patients of the control group taking only diclofenac sodium 50 mg twice a day during 6 months. Clinical examination of the patients was done before the treatment, 30, 120 and 180 days after the study. Long-term effects of ARTRA was evaluated 3 months after the study. The treatment efficacy was assessed by WOMAC index, daily need in NSAIDS intake, evaluation of the efficacy by the patient and the doctor.
The true WOMAC index decreased in 4 and 6 months of therapy in the study group (p < 0.03). 3 months after the treatment the study group patients experienced continuous reduction of the functional index and pain intensity unlike of the control patients experiencing a pain increase and worsening of joints functional ability. When analysing pain syndrome according to VAS, after 4 months of the treatment pain was relieved more in the study group (p = 0.008). The differences were stable for 6 months. On aftertreatment month 3 pain syndrome tended to attenuation in the study group but to intensification in the controls. While taking ARTRA, the patients decreased their need in NSAIDS intake (diclofenac). After 1 month of therapy 4.5% patients gave up taking diclofenac; after 4--20%, after 6--40%. Objective and subjective effects did not differ much (94 and 90%, respectively). ARTRA tolerability was very good. None of the patients of the study group discontinued therapy because of side effects, in the control group 14 patients gave up diclofenac because of the adverse effects.
Combined ARTRA medication decreases pain, improves joint function. Regular intake of ARTRA helps decrease NSAIDS dosage or discontinue intake in many cases. ARTRA is very well tolerated and is safe. ARTRA has an evident long lasting effect.
研究联合用药ARTRA（500毫克盐酸氨基葡萄糖+500毫克硫酸软骨素）治疗骨关节炎的临床疗效、安全性及疗效持续时间。
选取90名年龄在40 - 75岁之间、患有膝关节骨关节炎且符合美国风湿病学会骨关节炎诊断标准、根据凯尔格伦-劳伦斯分级为X线II - III期、有明显疼痛综合征（视觉模拟评分法中行走时疼痛强度达40毫米及以上）、在研究前3个月内30天规律服用非甾体抗炎药的女性纳入研究。患者被随机分为2组：研究组45例患者，在第一个月每天服用2次ARTRA片剂，每次1片，接下来的5个月每天服用1片，同时每天2次服用双氯芬酸钠50毫克，并随着疼痛减轻逐渐减少剂量；对照组45例患者，在6个月内仅每天2次服用双氯芬酸钠50毫克。在治疗前、研究开始后30、120和180天对患者进行临床检查。在研究结束后3个月评估ARTRA的长期疗效。通过WOMAC指数、非甾体抗炎药每日摄入量需求、患者及医生对疗效的评估来评估治疗效果。
研究组在治疗4个月和6个月时真实WOMAC指数下降（p < 0.03）。治疗3个月后，研究组患者的功能指数和疼痛强度持续降低，而对照组患者疼痛增加且关节功能能力恶化。根据视觉模拟评分法分析疼痛综合征时，治疗4个月后研究组疼痛缓解更明显（p = 0.008）。差异在6个月内稳定。在治疗后第3个月，研究组疼痛综合征趋于减轻，而对照组趋于加重。服用ARTRA时，患者对非甾体抗炎药（双氯芬酸钠）的摄入量需求减少。治疗1个月后，4.5%的患者停止服用双氯芬酸钠；4个月后为20%，6个月后为40%。客观和主观效果差异不大（分别为94%和90%）。ARTRA的耐受性非常好。研究组中没有患者因副作用而停止治疗，对照组中有14名患者因不良反应而停止服用双氯芬酸钠。
联合使用ARTRA药物可减轻疼痛，改善关节功能。规律服用ARTRA有助于在许多情况下减少非甾体抗炎药的剂量或停止服用。ARTRA耐受性良好且安全。ARTRA有明显持久的效果。
