On the efficacy of parenteral chondroitin sulfate in patients with osteoarthritis in the presence of grade 1 functional joint failure

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It is necessary to reconsider the use of drugs affecting the pathobiochemical pathways in the development of cartilaginous tissue structural changes in functional joint failure (FJF) in the presence of osteoarthritis (OA). Objective. To evaluate the efficacy of the parenteral formulation of the pharmaceutically active substance chondroitin sulfate (CS; Chondroguard®, CS-Bioactive© Bioiberica S.A.U., Spain, manufactured by the ZAO «FarmFirma “Sotex», Russia) in patients with Stage II knee OA (KOA) and grade 1 FJF. Subjects and methods. A 50-day open-label, prospective, controlled, randomized trial was conducted according to inclusion/exclusion criteria. The trial enrolled 82 patients with Stage II KOA, grade 1 FJF, who were divided into two groups: 1) 42 patients received CS (Chondroguard®, 100 mg/ml) intramuscularly every other day; the first three 1-ml injections; and if well tolerated, the fourth and next 2-ml injections (a 50-day treatment cycle included 25 injections); 2) 40 patients took celecoxib at a dose of 200 mg/day, which can be reduced to 100 mg/day and discontinued. On days 0 and 50, the investigators assessed pain intensity using a visual analogue scale (VAS), Lequesne’s functional indices, WOMAC, and joint ultrasound data and the safety of therapy using the WHO and Naranjo scales. The data were statistically processed applying the Statistica 10.0 software (StatSoft, Inc., USA). Results. Chondroguard® therapy was well tolerated by patients and was accompanied by a significant improvement in pain intensity scores according to VAS (U test=7.79; p<0.0001), a decrease in the severity of OA according to Lequesne’s indices (U test=7.79; p=< 0.0001), and WOMAC (U test=7.12; p=<0.0001). There was a decline in the number of combined signs of synovitis and tendonitis in Group 1 (Chondroguard®) as compared with that in Group 2 (celecoxib). A marked improvement in the Lequesne subscales («Pain and discomfort», «Walking distance», «Daily activity») and WOMAC was also recorded in patients receiving Chondroguard®. Conclusion. The use of Chondroguard® is effective and safe in patients with Stage II KOA and grade 1 FJF, who require outpatient care.

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作者简介

I. Sarvilina

OOO «Novomeditsina» (New Medicine) Medical Center

编辑信件的主要联系方式.
Email: isarvilina@mail.ru

MD

俄罗斯联邦, Rostov-on-Don

参考

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2. Fig. 1. Time course of changes in the indicators of the Lequesne subscale «Pain and discomfort». Note. Here and in Figs 2, 3: the data are presented as the mean value (M); *p<0.05, **p>0.05 is the significance of differences in the mean values of the indicators according to the Mann–Whitney U-test upon inclusion in the investigation and at 50 days after start of treatment in Groups 1 and 2; the significance of differences between Groups 1 and 2 at 50 days after start of treatment; the significance of differences in the mean values of the indicators according to the Mann–Whitney U test is indicated in the following order: first in order is the significance of differences in the mean values of indicators according to the Mann–Whitney U test upon inclusion in the investigation and at 50 days after start of treatment between Groups 1 and 2 upon inclusion in the investigation upon inclusion in the investigation; second in order is the significance of differences in the mean values of indicators according to the Mann–Whitney U test between Groups 1 and 2 at 50 days after start of treatment.

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3. Fig. 2. Time course of changes in the indicators of the Lequesne subscale «Walking distance»

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4. Fig. 3. Time course of changes in the indicators of the Lequesne subscale «Daily activity»

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