EFFECTIVENESS AND SAFETY OF CHONDROGUARD THERAPY IN PATIENTS WITH ENDOCRINE PHENOTYPE OF OSTEOARTHRITIS

Abstract

Objective. To evaluate the efficiency and safety of therapy with parenteral chondroitin sulfate (CS) Chondroguard®, CS-Bioactive© (Bioiberica S.A.U., Spain); ZAO “Sotex” PharmFirm, Russia) in patients with Stage II knee osteoarthritis (KOA), grade 1 knee functional insufficiency (FI), and type 2 diabetes mellitus (T2DM). Subjects and methods. A 50-day comparative pilot study involved 80 patients with Kellgren-Lawrence Stage II KOA, grade 1 FI, and T2DM, who were divided into 2 groups; Group 1 (a study group; n=40) received CS (Chondroguard®, 100 mg/ml, intramuscularly, every other day; the first three injections of 1 ml each; if they were well tolerated; starting from injection 4 of ml each; the treatment cycle was 25 injections for 50 days) and therapy for T2DM and its complications; Group 2 (a comparison group; n=40) took oral symptomatic slow acting drugs for osteoarthritis (SYSADOA) agents containing CS, glucosamine, unsaponifiable compounds of avocado and soybean, and therapy for T2DM and its complications. On study days 0 and 50, the investigators calculated in the patients the scores of the visual analogue scale (VAS), WOMAC index, the Lequesne index, those of the WHO and the Narango Therapy Safety Scales, assessed the parameters of the blood hormonal and metabolic profile, free radical oxidation (FRO), antioxidant system (AOS), and the levels of blood proinflammatory factors. Results. In Group 1, therapy with CS was well tolerated and was accompanied by a reduction in pain intensity on VAS at rest and in motion, in functional restrictions on the WOMAS index and the Lequesne index, as well аs by a decrease in blood proinflammatory markers (С-reactive protein, interleukin 6 and 1β, leptin, lipocalin-2), in the concentration of fasting and postprandial glucose, HbA1c, С-peptide, insulin-like growth factor-1, and in FRO-AOS activity (malondialdehyde, protein oxidative modification, superoxide dismutase) as compared with the indicators in Group 2. Conclusion. Chondroguard® was shown to be effective and safe in the combination therapy in patients with Stage II endocrine KOA phenotype, grade 1 FI, and T2DM.