氟比洛芬巴布膏治疗膝骨关节炎疼痛的全国多中心随机开放阳性药对照临床研究

Nationwide multicentre clinical research on flurbiprofen cataplasm for treating patients with osteoarth- rifis pain

目的研究氟比洛芬巴布膏治疗中国人群膝骨关节炎疼痛的有效性和安全性。方法将183例膝骨关节炎患者分为氟比洛芬巴布膏、吲哚美辛巴布膏或奇正消痛贴膏组，观察2周并评估各组疼痛、关节僵硬和关节功能障碍评分，同时评价不良反应情况。采用Kruskal—WallisH检验、NeInenyi检验和CMH检验。结果3组患者治疗后各项视觉模拟评分法（VAS）评分均显著降低，氟比洛芬巴布膏组治疗前后VAS评分降低最显著（其中平地走路VAS评分差值为31±21；上下楼梯VAS评分差值为35±20；夜间VAS评分差值为24±19；休息时VAS评分差值为20±18；负重时VAS评分差值为37±20）。3组患者关节僵硬评分及关节功能障碍评分治疗后均比治疗前显著下降。在安全性方面，氟比洛芬巴布膏和吲哚美辛巴布膏均优于奇正消痛贴，而吲哚美辛巴布膏组的束缚感发生率高于氟比洛芬巴布膏。结论氟比洛芬巴布膏具有良好的止痛疗效，减少患者关节僵硬，改善关节功能障碍，安全性高，适于临床应用。

Objective To study the effect and safety of flurbiprofen cataplasm on osteoarthritis pain in Chinese patients. Methods One hundred and eighty-three patients were divided into flurbiprofen cataplasm group, indometacin cataplasm group and Qizheng-xiaotong piaster group randomly. The score of pain, stiffness and physical function were analyzed with WOMAC scale and adverse reactions were also assessed. KruskalWallis H test, Nemenyi test and CMH tese were used. Results After treatment, the VAS value of the three groups decreased significantly and the VAS difference value of the flurbiprofen cataplasm group changed the most significantly （the changes of VAS value in flat walking, up and down stairs, nighttime, rest and weightbearing were 31±21, 35±20, 24±19, 20±18 and 37±20 respectively）. Meanwhile, the value of stiffness and physical function decreased significantly. In terms of safety, flurbiprofen cataplasm group and the indome-taein cataplasm group were better than Qizheng-xiaotong plaster group. But in sense of constriction, the flurbiprofen cataplasm group was better than the indometacin eataplasm group. Conclusion Flurbiprofen Cataplasm, with its favorable analgesic effect, is suitable for general clinical use. It can reduce stiffness, improvephysical function, and has good safety profile.