双蚁祛湿通络胶囊治疗膝骨性关节炎的临床研究

【目的】评价双蚁祛湿通络胶囊治疗膝骨性关节炎(KOA)的有效性及安全性。【方法】采用多中心、随机、平行对照方法,将240例KOA患者随机分为试验组和对照组,每组各120例。试验组给予双蚁祛湿通络胶囊治疗,对照组给予仙灵骨葆胶囊治疗,疗程均为8周。于治疗前及治疗2、4、8周后分别记录2组患者临床症状、中医症候积分、骨关节炎指数WOMAC评分及膝关节功能JOA评分的变化情况,并观察2组临床疗效和不良反应的发生情况。【结果】1治疗8周后,试验组疗效优于对照组,差异有统计学意义(P0.05)。2治疗8周后,试验组关节疼痛的目视模拟测试表(VAS)评分、活动受限VAS评分和晨僵时间等各项临床症状的改善均明显优于对照组(P0.05或P0.01)。3治疗4周和8周后,试验组的中医症候积分、WOMAC评分和JOA评分的改善均明显优于对照组(P0.05或P0.01)。42组患者治疗前后血、尿、大便常规,肝、肾功能,心电图等均无明显改变。【结论】双蚁祛湿通络胶囊治疗KOA疗效确切,且起效时间短,安全性高。

Clinical Study of Shuangyi Qushi Tongluo Capsules in Treating Knee Osteoarthritis

Objective To evaluate the efficacy and safety of Shuangyi Qushi Tongluo Capsules (SQTC) for the treatment of knee osteoarthritis (KOA).Methods A multi-center,randomized,parallel-controlled trial was carried out in 240 cases of KOA patients.The patients were divided into trial group (N =120) and control group (N =120),which was given SQTC,Xianlinggubao capsules respectively for 8 weeks.Before treatment,and 2,4 and 8 weeks after treatment,we recorded the scores of clinical symptoms and traditional Chinese medical syndromes,Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores and knee function scores.After treatment,the clinical efficacy and adverse reaction were observed.Results (1) After treatment for 8 weeks,the clinical efficacy of the trial group was superior to that of the control group (P ＜ 0.05).(2) The trial group had better effect on improving the visual analogue scale (VAS) scores of knee pain,VAS scores of limitation of motion and time for morning stiffness than the control group after treatment for 8 weeks(P ＜ 0.05 or P ＜ 0.01).(3) After treatment for 4 and 8 weeks,the trial group had better effect on improving scores of traditional Chinese medical syndromes,WOMAC scores and Japanese Orthopedic Association(JOA) scores than the control group (P ＜ 0.05 or P ＜ 0.01).(4) Before and after treatment,the results of blood,urine and stool routine examination,liver and kidney function,and electrocardiography showed no significant changes.Conclusion SQTC are effective and safe in treating KOA,and can start an effect shortly.