中医辨证治疗强直性脊柱炎的临床研究

Clinical study on syndrome differentiation of ankylosing spondylitis

目的:评价应用补肾温督通络法和补肾清化通络法创制中药处方五劳七损方Ⅰ号和五劳七损方Ⅱ号治疗强直性脊柱炎(AS)的疗效及安全性。方法:采用阳性药、分层区组随机、平行对照及优效性,将163例活动期肾虚督寒瘀阻证和肾虚湿热瘀阻证AS患者随机分入中药组和西药组,中药组采取辨证论治,分别予五劳七损方Ⅰ号和五劳七损方Ⅱ号治疗,西药组予柳氮磺吡啶肠溶片口服,疗程24周,采用国际强直性脊柱炎评价(ASAS)工作组制定的ASAS20标准、中医证候疗效评价标准,以及Bath强直性脊柱炎病情活动指数(BASDAI)、Bath强直性脊柱炎功能指数(BASFI)、Bath强直性脊柱炎测量学指数(BASMI)、脊柱痛评分、夜间痛评分、患者总体评价(PGA)、实验室指标C反应蛋白(CRP)及血沉(ESR)综合评价中医辨证治疗AS的临床疗效。结果:五劳七损方Ⅰ号和五劳七损方Ⅱ号治疗AS患者24周后,中医证候疗效总有效率为90.83%,能够显著降低患者的中医证候积分、BASDAI、BASFI、BASMI、脊柱痛评分、夜间痛评分和PGA,与西药组比较差异均有统计学意义(P<0.01,P<0.05)。结论:以补肾温督通络法和补肾清化通络法创制中药五劳七损方Ⅰ号和五劳七损方Ⅱ号治疗AS有一定效果。

Objective: To evaluate the curative effect and safety of Wulao Qisun I Decoction(WQ1D) and Wulao Qisun I Decoction(WQ2D) which created by invigorating kidney, warming governor and dredging channels method and invigorating kidney,clearing and dredging channels method in treating ankylosing spondylitis(AS). Methods: A total of 163 AS patients with kidney deficiency with governor cold and static blood blocking syndrome and kidney deficiency with dampness-heat and static blood blocking syndrome were randomly divided into treatment group and control group using a positive drug parallel controlled clinical trail. The patients in treatment group were treated with WQ1 D or WQ2 D according to syndrome typing, while those in the control group were treated with sulfasalazine enteric coated tablet(SECT), 24 weeks as one therapeutic course. After treatment, the clinical efficacy was evaluated by using ASAS20 standard which was set by Asessment in Ankylosing Spondylitis working group, Chinese medical efficacy evaluation standards, bath ankylosing spondylitis disease activity index(BASDAI), bath ankylosing spondylitis functional index(BASFI), bath ankylosing spondylitis measurement index(BASMI), spinal pain index, night pain index, patients general assessment(PGA), C reactive protein(CRP) and erythrocyte sedimentation rate(ESR). Results: After 24 weeks of treatment by WQ1 D or WQ2 D, while the total effective rate of Chinese medical syndrome was 90.83% in the treatment group, and the patients integrals of Chinese medical syndrome, BASDAI, BASFI, BASMI, night pain index, spinal pain index and PGA significant decreased compared to those in control group(P<0.01, P<0.05). Conclusion: WQ1 D and WQ2 D created by invigorating kidney, warming governor and dredging channels method and invigorating kidney,clearing and dredging channels method got confirmable clinical effects in treating AS.