Alekseeva L I, Sharapova E P, Kashevarova N G, Taskina E A, Anikin S G, Korotkova T A, Pyanykh S E
V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia.
Representative Office, Unipharm Inc., Moscow, Russia.
Ter Arkh. 2015;87(12):49-54. doi: 10.17116/terarkh2015871249-54.
To study the clinical efficacy and safety of the combined medication ARTRA MSM FORTE (400 mg chondroitin sulfate, 500 mg glucosamine hydrochloride, 300 mg methylsulfonylmethane (MSM), and 10 mg sodium hyaluronate calculated with reference to hyaluronic acid) in patients with knee osteoarthritis (OA).
The study enrolled 100 patients with Kellgren-Lawrence grades 2-3 knee OA with obvious pain syndrome (pain intensity scores on a visual analog scale (VAS)) equal or greater than 40 mm during walking. The patients were examined monthly; changes in WOMAC index scores, Get-Up and Go test results, the efficiency of therapy in the opinion of a physician and a patient, and quality of life according to the EQ-5D questionnaire were estimated. They were randomized into 2 groups: 1) 50 patients took ARTRA MSM as 2 tablets daily for one month, then 1 tablet daily; 2) 50 received ARTRA in accordance with the same scheme. Clinical examination was performed before and at 30, 60, 90 and 120 days of the study.
All the 100 patients completed treatment. Analysis of the results showed a significant decrease in pain on VAS in both groups. Reduced pain intensity was observed by the end of the first month of therapy and remained throughout the follow-up. Both medications diminished stiffness just after a month of therapy. They alleviated joint function and reduced total WOMAC scores at Visit 2. Analysis of Get-Up and Go test results indicated significantly less spent time in both groups; however, these differences reached the statistical significance in the ARTRA MSM group just at Visit 2 and in the ARTRA group only at Visit 3. The effect ARTRA MSM occurred more rapidly. This was confirmed by the patient and physician evaluations of the efficiency of treatment, which indicated that its positive effect occurred more rapidly in the ARTRA MSM group (p=0.02). Estimation of EQ-5D scores also showed positive results: there was a significant improvement of these indicators in the two compared groups at Visit 3. Both medications were very well tolerated and caused no adverse reactions; therapy was not discontinued.
ARTRA MSM is rapider in its effect: a significant improvement in Get-Up and Go test results and patient and physician evaluations of the efficiency of treatment. Additional interviews of the patients taking ARTRA MSM demonstrated that 36 (72%) of them reported a prompter pain relief than the ARTRA-treated patients. ARTRA MSM may be recommended for the treatment of OA in clinical practice.
研究复方药物ARTRA MSM FORTE（含400毫克硫酸软骨素、500毫克盐酸氨基葡萄糖、300毫克甲基磺酰甲烷（MSM）以及按透明质酸计10毫克透明质酸钠）治疗膝骨关节炎（OA）患者的临床疗效及安全性。
本研究纳入100例Kellgren-Lawrence分级为2-3级且伴有明显疼痛综合征（视觉模拟量表（VAS）疼痛强度评分在行走时等于或大于40毫米）的膝OA患者。患者每月接受检查；评估WOMAC指数评分变化、起立行走试验结果、医生和患者对治疗效果的评价以及根据EQ-5D问卷得出的生活质量。患者被随机分为2组：1）50例患者每日服用2片ARTRA MSM，持续1个月，之后每日服用1片；2）50例患者按照相同方案服用ARTRA。在研究开始前以及第30、60、90和120天进行临床检查。
100例患者均完成治疗。结果分析显示两组患者的VAS疼痛评分均显著降低。在治疗第一个月末观察到疼痛强度减轻，且在整个随访期间持续存在。两种药物在治疗1个月后均减轻了僵硬感。在第二次就诊时，它们改善了关节功能并降低了WOMAC总分。起立行走试验结果分析表明两组患者花费的时间均显著减少；然而，这些差异仅在ARTRA MSM组的第二次就诊时以及ARTRA组的第三次就诊时达到统计学意义。ARTRA MSM的效果出现得更快。患者和医生对治疗效果的评价证实了这一点，表明其积极效果在ARTRA MSM组出现得更快（p = 0.02）。EQ-5D评分的评估也显示出阳性结果：在第三次就诊时，两个比较组的这些指标均有显著改善。两种药物耐受性都很好，未引起不良反应；治疗未中断。
ARTRA MSM起效更快：起立行走试验结果以及患者和医生对治疗效果的评价有显著改善。对服用ARTRA MSM的患者进行的额外访谈表明，其中36例（72%）报告疼痛缓解比接受ARTRA治疗的患者更快。ARTRA MSM在临床实践中可被推荐用于治疗OA。
