特异性COX-2抑制剂对骨性关节炎的软骨保护作用的临床对照研究

The Clinical Study on the Protection of Articular Cartilage for the Osteoarthritis with the Treatment of Celecoxib

目的：探讨特异性COX-2抑制剂对骨性关节炎的关节软骨的保护作用的临床研究。方法：门诊选取膝关节骨关节炎患者80例，随机分为特异性COX-2抑制剂组和维骨力对照组，各40例，单盲给药。应用平均Womac关节炎指数评分和平均OA严重程度指数来评定两组用药前后临床症状改善情况以及使用血清软骨代谢标志物：蛋白聚糖和Ⅱ型胶原和关节MRI进行检测关节软骨结构与功能的改变情况，并作统计学分析。结果：经l2个月治疗观察，特异性COX-2抑制剂组的平均Womac关节炎指数评分和平均OA严重程度指数在前3个月改善明显优于维骨力对照组（P〈0．01），但在治疗12个月后，两组差异不显著（P〉0．05）；治疗12个月后特异性COX-2抑制剂组的软骨代谢指标：蛋白聚糖和Ⅱ型胶原及关节MRI均显示组内变化显著（P〈0．01），而与维骨力组对比结果无显著性差异（P〉0．05）。结论：特异性COX-2抑制剂对骨性关节炎的软骨有保护和促进其修复作用，其兼有抗炎与保护软骨双重疗效；它是一类既能改善关节炎的症状又能改善关节软骨结构的药物，值得在临床上广泛应有。同时本研究为其在临床应用和进一步研究此类药物提供了更好的理论基础和依据。

Objective： To evaluate the clinical efficacy of the protection of articular cartilage for the osteoarthritis with the treatment celecoxib. Methods： 80 Out - Patients with knee osteoarthritis were randomized to 2 groups . Each group had 40 patients. The experiment group was treated with celecoxib and the control group was treated with the glucosamine sulfate （ Viartril - S）. The Womac and osteoarthritis severity index , the proteoglycan and collagen type Ⅱ for the cartilage metabolism and the knee MRI should been used for the evaluation of the protection of the articular cartilage. All patients were treated for one year. Results： Among the first 3 months, the efficacy rate of the experiment group was superior to the control groups in efficacy either womac or osteoarthritis severity index （ P 〈 0.01 ） , but there were not the difference （ P 〉 0.05 ） between the two groups at the last. At the end of the trail, the Proteoglycan , Collagen type Ⅱ and the knee MRIs all showed the significance （ P 〈 0.01 ） in the experiment group. The Proteoglycan and Collagen type Ⅱ have the same results between the two groups （ P 〉 0.05） , and the knee MRIs had showed the non - significant for the restore of the articular cartilage between the both （ P 〉 0.05 ）. Conclusion Celecoxib have the function for the protection of the articular cartilage on the osteoarthritis and that should be the basis for the deep research and complication on the drug . At the same time it should been widely used for the treatment of the osteoarthritis in clinic