Objective  To evaluate the efficacy and safety of compound Fengshining tablets in the treatment of knee osteoarthritis (KOA), and conduct a pharmacoeconomic assessment.

Methods  A prospective study was conducted. Patients with KOA admitted to Shenzhen University General Hospital from February to November 2024 were selected and randomly divided into an experimental group and a control group. The experimental group received treatment with Fengshining tablets, while the control group received treatment with Zhuifeng Tougu pills. The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores, Visual Analog Scale (VAS) scores, traditional Chinese medicine (TCM) syndrome scores, as well as inflammatory factor levels [tumor necrosis factor-α (TNF-α), interleukin-1β (IL^-1β)] and were compared between the two groups after 4 weeks of treatment. The safety and efficacy of the two groups were evaluate. The cost-effectiveness (C/E) ratio was calculated for both groups.

Results  A total of 128 patients were enrolled, with 64 cases in each of the two groups. After treatment, the WOMAC scores, VAS scores, TCM syndrome scores, serum TNF-α levels, and IL^-1β levels in both groups were significantly reduced compared to pre-treatment levels (P<0.05), and all indicators in the experimental group were lower than those in the control group (P<0.05). The overall effective rate was 92.19% in the experimental group and 87.50% in the control group, with no statistically significant difference between the two groups (P>0.05). General adverse reactions occurred in 1 case (1.56%) in each group, with no statistically significant difference (P>0.05). After treatment, the C/E  ratio was 84.62 in the experimental group and 88.44 in the control group, indicating that the experimental group incurred lower drug costs per 1% increase in clinical efficacy.

Conclusion  Compound Fengshining tablets can improve clinical symptoms and relieve pain in patients with KOA, reduce levels of inflammatory factors, demonstrate good safety, and is more cost-effective compared to similar drugs.

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