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Combined medication ARTRA in the treatment of osteoarthrosis

机译：联合用药ARTRA治疗骨关节炎

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AIM: To study clinical effectiveness, safety and duration of the effect of combined medication ARTRA (500 mg glucosamine hydrochloride+500 mg chondroitine sulphate) in osteoarthrosis. MATERIAL AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
机译：目的：研究联合用药ARTRA（500 mg氨基葡萄糖盐酸盐+500 mg硫酸软骨素）在骨关节炎中的临床疗效，安全性和持续时间。材料与方法：90名年龄在40-75岁的女性患有膝盖OA，并符合美国风湿病学委员会对OA的诊断标准，根据凯格伦-劳伦斯（Kellgren-Lawrence）的研究结果，该患者具有X射线II-III期。具有明显的疼痛综合症（按类似的视觉标度，行走40毫米或以上时的疼痛强度）;在研究被纳入研究前三个月内的30天内定期服用NSAIDS。将患者随机分为两组：研究组的45名患者在第一个月内每天2片服用1片ARTRA，在接下来的5个月内每天服用1片，双氯芬酸钠50 mg每天2次，并逐渐减少随着疼痛减轻剂量的增加;对照组的45位患者在6个月内每天仅服用两次双氯芬酸钠50 mg。在治疗前，研究后30、120和180天对患者进行临床检查。研究后3个月评估了ARTRA的长期效果。通过WOMAC指数，NSAIDS每日摄入量，患者和医生对疗效的评估来评估治疗效果。结果：研究组在治疗的4个月和6个月中，真实的WOMAC指数降低了（p <0.03）。在治疗后3个月，研究组患者经历了功能指数和疼痛强度的持续降低，这不同于对照组患者经历了疼痛增加和关节功能能力恶化。根据VAS分析疼痛综合征时，研究组在治疗4个月后疼痛得到了进一步缓解（p = 0.008）。差异稳定了6个月。在治疗后第3个月，疼痛综合征在研究组中趋于减轻，但在对照中趋于加剧。服用ARTRA时，患者减少了对NSAIDS的摄入量（双氯芬酸）。治疗1个月后，有4.5％的患者放弃服用双氯芬酸。在4--20％之后，在6--40％之后。客观效果和主观效果相差不大（分别为94％和90％）。 ARTRA的耐受性非常好。研究组的患者均未因副作用而中断治疗，对照组中有14位患者因不良反应而放弃了双氯芬酸。结论：ARTRA联合用药可减轻疼痛，改善关节功能。在许多情况下，定期摄入ARTRA有助于减少NSAIDS剂量或中断摄入。 ARTRA的耐受性非常好，很安全。 ARTRA具有明显的持久作用。

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