益肾清络活血方治疗痰瘀互结型类风湿关节炎临床观察
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国家中医药管理局重点学科中医痹病学建设项目(国中医药人教发[2012]32号);安徽省科技攻关计划项目(11010402173)


Clinical Efficacy of Yishen Qingluo Huoxue Prescription in Treatment of Rheumatoid Arthritis with Syndrome of Intermingled Phlegm and Blood Stasis
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    目的 观察益肾清络活血方治疗痰瘀互结型类风湿关节炎(rheumatoid arthritis, RA)临床疗效及其安全性。方法 〖JP2〗将60例痰瘀互结型RA患者随机分为试验组和对照组,每组30例(试验组失访1例)。试验组患者内服益肾清络活血方,对照组患者口服来氟米特,两组均连续治疗90 d。治疗前后,分别观察两组患者类风湿因子(rheumatoid factors,RF)、血沉(erythrocyte sedimentation rate,ESR)、C- 反应蛋白(C- reactive protein, CRP)、抗环瓜氨酸肽(cyclic citrullinated peptide,CCP)抗体、双手握力、关节压痛指数、关节肿胀指数,采用视觉模拟评分法(visual analogue scale, VAS)评价疼痛程度,采用健康评价问卷(health assessment questionnaire,HAQ)评价生活质量,并监测血常规、尿常规、粪常规、肝功能、肾功能、心电图的变化。结果 两组治疗后RF、CRP、ESR、抗CCP抗体、关节压痛指数、关节肿胀指数、VAS评分和HAQ评分均较治疗前显著改善(P<0.05);试验组治疗后双手握力较治疗前显著增加(P<0.05),而对照组治疗后双手握力较治疗前无明显变化(P>0.05);试验组在CRP、ESR和VAS评分降低程度方面均不及对照组(P<0.05);两组的中医证候疗效比较,差异无统计学意义(P>0.05)。两组均未出现明显不良反应。结论 益肾清络活血方对痰瘀互结型RA具有显著的近期疗效,其效果与来氟米特相当。

    Abstract:

    Objective To observe the clinical efficacy and safety of Yishen Qingluo Huoxue Prescription (for kidney- nourishing, collateral- dredging, and blood- activating purposes) in the treatment of rheumatoid arthritis (RA) with syndrome of intermingled phlegm and blood stasis. Methods Sixty patients with RA and syndrome of intermingled phlegm and blood stasis were randomly and equally divided into experimental group and control group(One patient in experimental group was lost to follow- up). Patients in the experimental group and the control group received oral administration of Yishen Qingluo Huoxue Prescription and leflunomide, respectively, for 90 continuous days. Rheumatoid factors (RF), erythrocyte sedimentation rate (ESR), C- reactive protein (CRP), anti- cyclic citrullinated peptide (CCP) antibody, dual grip strength, joint tenderness index, and joint swelling index were evaluated in both groups before and after treatment. Pain was scored using the visual analogue scale (VAS). The quality of life was assessed using the health assessment questionnaire (HAQ). The changes in routine blood indices, routine urine indices, routine feces indices, liver function, renal function, and electrocardiogram were monitored. Results In both groups, RF, CRP, ESR, anti- CCP antibody, joint tenderness index, joint swelling index, VAS score, and HAQ score were significantly improved after treatment (P<0.05). Dual grip strength was significantly increased after treatment in the experimental group (P<0.05) rather than the control group (P>0.05). The reduction in CRP, ESR, and VAS score in the control group was significantly superior to that in the experimental group (P<0.05). There were no significant differences in traditional Chinese medicine syndrome outcomes between the two groups (P>0.05). There were no adverse reactions in both groups. Conclusions Yishen Qingluo Huoxue Prescription achieves substantial short- term efficacy in the treatment of RA with syndrome of intermingled phlegm and blood stasis, which is quite similar to that of leflunomide.

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李 艳, 范为民,谷绍飞,刘文惠.益肾清络活血方治疗痰瘀互结型类风湿关节炎临床观察[J].安徽中医药大学学报,2015,34(4):17-20

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  • 在线发布日期: 2015-08-06