双乌风湿合剂治疗类风湿关节炎(寒湿痹阻证)的临床研究

The Curative Effects and Safety of Shuangwu Fengshi Decoction on RA of Cold-damp Obstruction Type

目的观察自制双乌风湿合剂治疗中度类风湿关节炎(RA)(寒湿痹阻证)急性发作期的临床疗效及安全性。方法本研究将符合条件的132例患者按随机数字表法分为治疗组与对照组各66例,对照组予口服甲氨蝶呤片10 mg每周1次,来氟米特片(妥抒)10 mg每日1次;治疗组在对照组的基础上加服自制制剂双乌风湿合剂20 m L,每日3次。两组疗程12周。观察两组患者在治疗前后的症状、实验室指标[血沉(ESR)、C反应蛋白(CRP)]、中医证候积分及DAS28(ESR)评分等疗效指标。结果两组在治疗8周前后,关节肿胀数、压痛数明显减轻,生活质量HAQ评分量表、DAS28评分显著改善,差异有统计学意义(P<0.05或P<0.01);治疗组在第12周,关节压痛数显著优于对照组(P<0.05);治疗组患者晨僵持续时间、受试者整体状况VAS评分在第8周、12周优于对照组,差异有统计学意义(P<0.05或P<0.01);而治疗组中医证候积分在第4周就显著优于对照组(P<0.01);两组ESR、CRP在第4周治疗前后显著改善(P<0.01),但两组之间没有统计学差异(P>0.05),但治疗组ESR在第12周,优于对照组(P<0.05)。两组治疗前后中医临床疗效比较,治疗组总有效率82.46%,优于对照组总有效率65.52%,两组之间总有效率有明显差异(P<0.05)。结论自制制剂双乌风湿合剂联合西药治疗中度RA(寒湿痹阻证)的疗效明显优于单用西药,能改善RA关节肿痛及寒湿痹阻证,并降低疾病活动度,且具有良好的安全性。

Objective：To observe the clinical effects and safety of Shuangwu Fengshi Decoction on RA of colddamp obstruction type.Methods：The following test methods were used in this study：non-blind test,positive drug test,randomized trial,parallel control test.132 RA patients of cold-damp obstruction type were randomly divided into the treatment group and the control group,66 cases in each.The control group took MTX 10 mg qw and LEF 10 mg qd.The treatment group,on this basis,were added Shuangwu Fengshi Decoction 20 m L tid.The treatment course of both groups was 12 weeks.The symptoms,laboratory indexes（ESR,CRP）,TCM syndrome scores,DAS28 score（ESR）and other curative effect indexes of the two groups were observed before and after treatment.Results：In the two groups,after treatment for 8 weeks,the number of joint swelling and pressure pain was significantly reduced and HAQ scale for the quality of life and DAS28 score improved significantly;the difference was statistically significant（P〈0.05 or P〈0.01）.But the curative effects of the two groups were similar;the difference was not statistically significant（P〈0.05）.In 12～（th） week,joint tenderness of the treatment group was significantly better than that of the control group（P〈0.05）;in 8～（th）and 12～（th） week,the duration of morning stiffness and subjects′overall status VAS score in the treatment group were superior to those of the control group;the difference was statistically significant（P〈0.05 or P〈0.01）.The TCM syndrome score in the treatment group was significantly better than that of the control group in the fourth week（P〈0.01）.Around 4 weeks′treatment,ESR and CRP of both groups were improved（P〈0.01）;the difference was not statistically significant（P〈0.05）.In 12～（th） week,ESR of the treatment group was better than that of the control group（P〈0.05）.The total effective rate of the treatment group was 82.42%,and compared with the control group 65.52%,the total effective rate between the two groups was statistically different（P〈0.05）.Conclusion：Shuangwu Fengshi Decoction combined with Western medicine has a more obvious effect on RA of cold-damp obstruction type than only Western medicine,and it can relieve joint swelling and pain and cold-damp obstruction syndrome of RA,and reduce disease activity,with a good safety.