痹祺胶囊治疗类风湿关节炎的多中心随机对照临床试验  

Biqi Capsule for rheumatoid arthritis:A clinical multi-center andomized controlled trial

作　　者：白人骁[1] 

机构地区：[1]天津医院,天津300211

出　　处：《中华中医药杂志》2016年第9期3821-3825,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家科技部基础性工作专项资金课题(No.2001DEA20010)~~

摘　　要：目的:观察痹祺胶囊治疗类风湿关节炎(RA)的临床疗效及安全性,为临床决策提供依据。方法:采用多中心、随机、对照临床研究方案,纳入符合1987年美国风湿病协会RA分类标准及中医气血亏虚证、寒湿痹阻证、肾气虚寒证、瘀血痹阻证等证型的患者236例,随机分为2组。其中,Ⅰ组178例,Ⅱ组58例(脱落2例),两组患者性别、年龄、病程、双手X线分期等基本资料在统计学上无显著性差异,具有可比性。研究期间Ⅰ组口服痹祺胶囊,1.2g/次,3次/d;Ⅱ组口服正清风痛宁片80mg/次,3次/d。2组均以4周为1个疗程,连续观察4个疗程。观察治疗前及治疗后中医症候积分,主要相关症状、体征及实验室指标,并记录不良反应。结果:所有患者中医辨证为气血亏虚证Ⅰ组19例,Ⅱ组8例;寒湿痹阻证Ⅰ组87例,Ⅱ组33例;肾气虚寒证Ⅰ组27例,Ⅱ组8例;瘀血痹阻证Ⅰ组45例,Ⅱ组9例,组间比较差异无统计学意义。治疗后疾病疗效判定,Ⅰ组缓解63例,显效58例,有效43例,无效14例,Ⅱ组缓解9例,显效7例,有效26例,无效16例,Ⅰ组对疾病的总体改善程度优于Ⅱ组。治疗后中医证候疗效判定,Ⅰ组临床治愈35例,显效71例,有效58例,无效14例,Ⅱ组临床治愈6例,显效8例,有效18例,无效24例,Ⅰ组对中医证候的总体改善程度优于Ⅱ组。治疗16周后两组的症状、体征指标均较治疗前有差异统计学意义(P<0.05)。两组间比较在休息痛、晨僵时间方面有统计学差异(P<0.05)。治疗后,Ⅰ组ESR、RF、CRP、Ig A、Ig G较治疗前差异有统计学意义(P<0.05,P<0.01)。治疗后,Ⅱ组的ESR较治疗前差异有统计学(P<0.01)。两组均未发生不良反应。结论:痹祺胶囊治疗RA临床疗效确切,且具有良好的安全性。Objective：To observe the clinical effects and safety of Biqi Capsule for rheumatoid arthritis（RA） and to provide evidence for clinical decision.Methods：A clinical multi-center randomized controlled trial was conducted.Two hundred and thirty-six participants with RA in syndrome of qi and blood dei ciency,cold-dampness syndrome,kidney qi dei ciency cold syndrome and Bi-syndrome due to external injury by blood stasis,diagnosed according to the criteria of the American College of Rheumatology revised in 1987,were included and randomly assigned into GroupⅠ（178 cases） and Group Ⅱ（58 cases,2 cases drop out）.There was no significant difference in the baseline level of sex,age,course of RA,X-ray stage of articulations at the i rst day after stenting between the two groups.During the research period,participants in GroupⅠ were treated with Biqi Capsule,1.2g tid.orally,while the participants in Group Ⅱ were treated with Zhengqing Fengtongning Pills 80 mg tid.orally.Four courses were needed with 4 weeks as one course.The scores of Chinese medicine symptoms,main symptoms and signs,and the laboratory indexes were assessed before and after the interventions.The adverse effects were recorded as well.Results：There were 19 participants with the syndrome of qi and blood dei ciency in GroupⅠ,and 8 in GroupⅡ;87 participants with colddampness syndrome in GroupⅠ,and 33 in Group Ⅱ;27 participants with kidney qi dei ciency cold syndrome in GroupⅠ,and 8 in Group Ⅱ;45 participants with Bi-syndrome due to external injury by blood stasis in GroupⅡ,and 9 in Group Ⅰ.There was no significant difference in the distribution of TCM syndromes between the two groups.After the administrations,there were 63 cases with clinical remission,58 cases with marked effect,43 cases with effective results,and 14 cases with no effect in Group Ⅰ.There were 9 cases with clinical remission,7 cases with marked effect,26 cases with effective results,and 16 cases with no effect in Group Ⅱ.The improvement degree of Group �

关 键 词：类风湿关节炎 痹祺胶囊 多中心随机对照临床试验 痹证 

分 类 号：R259[医药卫生—中西医结合]