补肾强督法治疗强直性脊柱炎184例多中心双盲随机对照临床研究

A Multicentered,Double-Blind,Randomize-Controlled Trial of Tonifying Kidney and Fortifying Du Meridian in Treating Ankylosing Spondylitis

目的观察补肾强督法治疗强直性脊柱炎的临床疗效。方法采用多中心、随机、双盲双模拟对照的方法。纳入184例患者,其中肾虚督寒证94例,肾虚湿热证90例,两个证型患者再随机分为治疗组和对照组。肾虚督寒证和肾虚湿热证治疗组分别给予补肾强督祛寒汤和补肾强督清化汤+柳氮磺胺吡啶片模拟剂;两个证型对照组给予柳氮磺胺吡啶片+中药模拟剂。各组疗程均为12周。比较两组治疗前后临床观察指标(整体评分、脊柱疼痛评分、功能指数、脊柱炎症指数、中医证候评分)、体征(枕墙距、颌柄距、指地距、胸廓扩张度、脊柱活动度、Schober's试验)、血沉(ESR)、C反应蛋白(CRP),并判定中医临床疗效及疗效达标情况。结果共162例患者完成实验,肾虚督寒证治疗组40例,对照组37例;肾虚湿热证治疗组42例,对照组43例。两个证型患者治疗组中医临床疗效优于对照组(P<0.01)。肾虚督寒证治疗组治疗后临床观察指标及指地距、胸廓活动度、脊柱活动度、Schober's实验、CRP均优于对照组;肾虚湿热证组治疗组治疗后临床观察指标及体征均较对照组改善明显(P<0.05或P<0.01),但ESR、CRP差异无统计学意义(P>0.05);两个证型的治疗组疗效达标情况亦优于本证型对照组(P<0.01)。结论补肾强督法治疗强直性脊柱炎可明显改善患者临床症状及体征,疗效肯定且安全性好。

Objective To observe the clinical efficacy of tonifying kidney and fortifying Du meridian in treatingankylosing spondylitis. Methods Multi-center,randomized,double-blind,double dummy controlled method was adopted. One hundred and eighty four patients were enrolled,including 94 cases of kidney deficiency and Du meridian cold syndrome,and 90 cases of kidney deficiency and damp-heat syndrome. The patients with each syndrome were randomly divided into the treatment group and the control group. In the treatment groups,in addition to sulfasalazine simulation tablets,patients with kidney deficiency and Du meridian cold syndrome were given Bushen Qiangdu Quhan decoction（ 补肾强督祛寒汤）,and patients with kidney deficiency and damp-heat syndrome were given Bushen Qiangdu Qinghua decoction（ 补肾强督清化汤）. In the control groups,all the patients were treated with the sulfasalazine tablets and simulation Chinese medicine preparation. The treatment course was 12 weeks in each group. The clinical observation index（ overall score,spinal pain score,function index,spinal inflammation index,Chinese medicine syndrome score）,signs（ occiput to wall distance,mandible to sternum distance,finger to floor distance,thoracic expansion degree,spinal mobility,Schober’ s test）,erythrocyte sedimentation rate（ ESR）,and C-reactive protein（ CRP） in the two groups before and after treatment were compared. Chinese medicine clinical efficacy and the percentage of reaching the efficacy standard were determined. Results Totally 162 patients completed the trial. Among the patients with kidney deficiency and Du meridian cold syndrome,40 cases were in the treatment group,and 37 cases the control group. Among the patients with kidney deficiency and damp heat syndrome,42 cases were in the treatment group,and 43 cases in the control group. Patients with either syndrome in the treatment groups had superior Chinese clinical efficacy than those in the control group. After treatment,the clinical observation indexes and finger to floor distance,thoracic expansion degree,spinal mobility,Schober’s test and CRP in kidney deficiency and Du meridian cold syndrome treatment group were all better than those in the control group; the clinical observation indexes and the signs in kidney deficiency and damp heat syndrome treatment group improved significantly than those in the control group（ P 〈 0. 05 or P 〈 0. 01）,but there were no statistical difference in ESR and CRP between the groups（ P 〉 0. 05）. The percentages of reaching the efficacy standard in the treatment groups of each syndrome were also better than those in the same syndrome of the control groups（ P 〈 0. 01）. Conclusion Tonifying kidney and fortifying Du meridian could significantly improve the symptoms and signs of ankylosing spondylitis,with clear curative effect and good safety.