On the effectiveness and safety of parafarmaceuticals products with chondroprotective effects in patients with II-III stage knee osteoarthritis: results of non-interventional observational program

Background. The current focus of scientific research is to find treatment methods and auxiliary support for patients with OA with an improved safety and tolerability profile, including parafarmaceuticals with chondroprotective effects. Objective. The purpose of the study was to evaluate the efficacy and safety of the parafarmaceutical Chondroguard Quadro in patients with stage II-III (K-L) OA of the knee and grade 1-2 joint functional insufficiency (FI). Materials and methods. The non–interventional follow-up program included 47 patients (14 men and 33 women aged 59-74 years) with stage II-III (K-L) and grade 1-2 FI. The control group (CG) included 15, and the main group (MG) included 32 patients who received standard therapy for OA (NSAIDs) for courses of up to 10 days. The MG patients parafarmaceutical with chondroprotective effects Chondroguard Quadro take 2 tablets 2 times per day with meals in the morning and afternoon for 1 month after taking NSAIDs. The dynamics of pain were assessed using the VAS, the severity of OA using the Leken index, the quality of life (QL) using the SF-36 questionnaire before and after treatment, the global assessment of therapy effectiveness by the doctor and the patient using the 5-point Likert scale. A radiological examination of the knee was performed. The dynamics of CRP, TNF-α, interleukin-6, PIIANP, N-osteocalcin, COMP, 25(OH)D3, vitamin K2, as well as uCTX-1, deoxypyridinoline, uCTX-II in urine by ELISA, CLIA and HPLC/MS. The safety of parafarmaceutical with chondroprotective effects was evaluated using the WHO and Naranjo scales. Results. In MG after taking parafarmaceutical with chondroprotective effects, the difference from the initial indicators of pain severity was more significant compared to CG: the dynamics of pain intensity according to VAS during movement (-85.1% vs. -73.8% in CG) and at rest (-86% vs. -58.1% in CG), according to the Leken index (-83.5% vs. -61.8% in CG). In MG the most pronounced improvement of the QL of patients was noted using the SF-36. On the 40th day of the program, a significant increase in the patient's and doctor's assessment of the overall effectiveness and tolerability of the therapy was observed using the Likert scale compared to the CG. In patients with OA, there was a significant decrease in all biomarkers in the blood, an increase in the levels of 25(OH)D3 and vitamin K2 in the blood, and there were intergroup differences in all laboratory tests by the 40th day of the program. No adverse events were reported during the use of parafarmaceutical with chondroprotective effects. Conclusion. Parafarmaceutical with chondroprotective effects Chondroguard Quadro can be recommended as an adjuvant support for patients with OA of the knee with moderate to mild pain syndrome when markers of cartilage degradation and calcification are detected.