Zheng Xixi, W. Zheng, Fengchun Zhang
Nov 15, 2016
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Quality indicators
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Abstract
Objective To evaluate the efficacy and safety of imrecoxib tablets in the treatment of osteoarthritis (OA). Methods In this multi-centered, open-labeled study, 100 mg imrecoxib tablets were given twice a day for 8 weeks in patients with OA. At baseline and 8 week after treatment, the Western Ontario and McMaster Universities ArthritisIndex (WOMAC) VA 3.0 scores were compared to assess efficacy while any complaints and laboratory abnormalities were included to assess for adverse effects. Covariance analysis was used to analyze the collected data. Results Two thousand four hundred and thirteen patients were enrolled. After 8 weeks' treatment, the WOMAC VA 3.0 score decreased to (15±10) from baseline (t=68.29, P<0.01) and the difference was statistically significant. Three hundreds and eighty-four (16.07%) of the patients reported to have adverse effects, in which 217 cases (9.08%) had treatment related. The rate of gastrointestinal bleeding was 0.13%. Forty-five cases (1.88%) were cardiovascular adverse effects. No case of coronary artery infarction, stroke or thromboembolism was reported. Conclusion Imrecoxib is an efficacious drug in the treatment of OA with a low adverse effect profile. Key words: Osteoarthritis, knee; Cyclooxygenase inhibitors; Clinical trial