玄七健骨片治疗膝骨关节炎筋脉瘀滞证Ⅲ期临床研究

Phase Ⅲ Clinical Study on Xuanqi Jiangu Tablets for the Treatment of Knee Osteoarthritis with Tendon and Meridian Stagnation Syndrome

目的验证玄七健骨片治疗膝骨关节炎(KOA)筋脉瘀滞证的有效性及安全性。方法选取2012年12月-2015年2月7家医院476例KOA筋脉瘀滞证患者进行Ⅲ期临床研究,采用随机数字表法分为试验组和对照组。试验组予玄七健骨片,对照组予安慰剂,均4片/次,3次/d,疗程28 d。比较2组中医证候疗效及疼痛消失情况,观察2组治疗前及治疗7、14、28 d西安大略和麦克马斯特大学骨关节炎指数(WOMAC)总分及疼痛、僵硬、日常活动评分,中医症状积分,监测2组安全性指标及试验期间出现的不良反应。结果共剔除10例患者,最终466例纳入分析数据集中的全分析集,2组一般资料比较差异无统计学意义(P>0.05),具有可比性。试验组临床控制率为24.86%(86/346),愈显率为50.00%(173/346),总有效率为89.60%(310/346),对照组临床控制率为0.00%(0/120),愈显率为4.17%(5/120),总有效率为29.17%(35/120),2组比较差异有统计学意义(P=0.000)。试验组治疗后107例患者疼痛消失(30.92%),对照组疼痛消失1例(0.83%),试验组疼痛消失率高于对照组(P<0.05)。与本组治疗前比较,2组治疗7、14、28 d WOMAC总分及疼痛、僵硬、日常活动评分,中医症状积分均显著改善(P<0.05);2组同时点比较,试验组治疗7、14、28 d WOMAC总分及疼痛、僵硬、日常活动评分,中医症状积分均低于对照组(P<0.05)。2组治疗后各相关症状均有所改善,且试验组对疼痛、活动不利、局部肿胀、局部压痛、关节僵硬、日常活动的改善显著优于对照组(P<0.05)。2组不良反应发生率差异无统计学意义(P>0.05)。结论玄七健骨片治疗KOA筋脉瘀滞证安全有效,其特点在于对患者疾病相关症状体征的改善作用。

Objective To verify the effectiveness and safety of Xuanqi Jiangu Tablets for the treatment of knee osteoarthritis(KOA)with tendon and meridian stagnation syndrome.Methods Phase Ⅲ clinical studies on 476 cases of KOA with tendon and meridian stagnation syndrome from 7 hospitals from Dec.2012 to Feb.2015 were included in this study.The 476 cases were divided into experimental group and control group according to random number table method.The experimental group was given Xuanqi Jiangu Tablets,while the control group was given placebo,with 4 tablets each time,3 times per day,with 28 days of medication course.The TCM syndrome efficacy and pain disappearance of the two groups were compared,and the total score of osteoarthritis index of Western Ontario and McMaster University(WOMAC)and the score of pain,stiffness,daily activity dimensions and TCM syndrome score before treatment and on the 7th,14th and 28th days of treatment of the two groups were observed.The safety indicators and adverse reactions of the two groups during the experiment were monitored.Results During the study period,a total of 10 patients were excluded,and 466 patients were included in the full analysis set of the analysis dataset.There was no statistical significance in general information between the two groups(P>0.05),indicating comparability of the data.The clinical control rate of patients in the experimental group was 24.86%(86/346),the healing and significant improvement rate was 50.00%(173/346),and the total effective rate was 89.60%(310/346).The clinical control rate of patients in the control group was 0.00%(0/120),the healing and significant improvement rate was 4.17%(5/120),and the total effective rate was 29.17%(35/120),with statistical significance(P=0.000).After treatment,107 patients in the experimental group experienced pain relief(30.92%),while one patient in the control group experienced pain relief of 0.83%.The pain relief rate in the experimental group was higher than that in the control group(P<0.05).Compared with before treatment,the total WOMAC scores,pain,stiffness,daily activity scores,and TCM syndrome scores of both groups significantly improved on the 7th,14th,and 28th days of treatment(P<0.05);comparing the two groups at the same time points,the total WOMAC score,pain,stiffness,daily activity scores,and TCM syndrome score of the experimental group on the 7th,14th,and 28th days of treatment were lower than those of the control group(P<0.05).After treatment in both groups,all related symptoms of patients improved,and the experimental group showed significantly better improvement than the control group in terms of pain,poor mobility,local swelling,tenderness,stiffness,and daily activities(P<0.05).There was no statistical significance in the incidence of adverse reactions between the two groups(P>0.05).Conclusion Xuanqi Jiangu Tablets is safe and effective in treating KOA with tendon and meridian stagnation syndrome,and its characteristic effect is to improve the symptoms and signs related to the disease in patients.