한국인 골관절염 환자에 대한 Celecoxib와 서방형Diclofenac의 유효성 및 안전성 비교: 다기관 임상연구

Objective: Long-term use of the analgesic acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of osteoarthritis is limited due to the lack of effectiveness and presence of side effects. Celecoxib is a selective inhibitor of cyclo-oxygenase (COX)-2 and expected to help NSAIDs in expressing the effective anti-inflammatory effect by not inhibiting COX-1. Thus, 200 mg of celecoxib and 100 mg of slow releasing diclofenac were compared for their effectiveness and safety in Korean patients with knee osteoarthritis. Methods: We administered 200 mg of celecoxib or 100 mg of slow releasing diclofenac in 223 randomly selected patients with knee osteoarthritis for 4 weeks. The effectiveness of these drugs on osteoarthritis was assessed by evaluating pain in each patient, making overall evaluation on osteoarthritis by the patient and his/her attending physician, and measuring the severity indices on osteoarthritis before treatment, and 2 weeks and 4 weeks after treatment. Moreover, safety and drug resistance were evaluated by assessing the rate of adverse effects, rate of withdrawal, laboratory tests, and vital signs. Results: The clinical symptoms of osteoarthritis were improved significantly by 4 weeks after treatment with celecoxib and diclofenac. According to the results of overall evaluation made by attending physicians 2 weeks after treatment, the rate of improvement was 49.5% in celecoxib group and 35.7% in diclofenac group, showing a statistically significant difference (p=0.023). Other than this difference, no other significant difference was present between the two groups with other variables used for the evaluation of effectiveness. The rate of adverse effects was significantly lower in celecoxib group compared with diclofenac group. According to laboratory findings, no abnormal figure was found in both groups but total bilirubin, SGOT, and SGPT were consistently higher in patients in diclofenac group. Thirteen patients dropped out of the study due to side effects (10 patients) and treatment failure (3 patients). Conclusion: Our findings from the clinical comparison of celecoxib and diclofenac in Korean patients with knee osteoarthritis were similar to those results found in previous studies. Although celecoxib showed similar effectiveness as diclofenac on knee osteoarthritis in the treatment of symptoms, it showed a lower rate of adverse effects; thus, we concluded that celecoxib is safer compared with diclofenac.