二活附子方治疗强直性脊柱炎的临床疗效及安全性评价

Evaluation of Efficacy and Safety of Erhuofuzi Decoction in Treatment of Patients with Ankylosing Spondylitis

目的评价中药二活附子方治疗强直性脊柱炎(ankylosing spondylitis,AS)的临床疗效及安全性。方法采用前瞻性随机对照临床试验,将78例AS患者随机分入观察组和对照组,观察组给予二活附子方,对照组给予柳氮磺胺吡啶片口服,疗程12周,疗效评价采用ASAS20、ASAS40及BASDAI50标准及中医证候疗效评价标准。观察治疗前后患者Bath强直性脊柱炎疾病活动指数(BASDAI)、Bath强直性脊柱炎功能指数(BASFI)、Bath强直性脊柱炎测量指数(BASMI)、脊柱痛评分、夜间痛评分、患者总体评价(PGA)、红细胞沉降率(ESR)及C反应蛋白(CRP)等指标。结果治疗4周后,观察组达到ASAS20标准的患者例数多于对照组(P<0.05)。治疗12周后,观察组达到ASAS20、ASAS40、BASDAI50标准的患者例数多于对照组(P<0.05);中医证候疗效观察组高于对照组(P<0.05);两组治疗后中医证候积分、BASDAI、BASFI、脊柱痛评分、夜间痛评分、PGA均优于治疗前(P<0.05,P<0.01),且观察组上述指标改善情况均优于对照组(P<0.05);两组治疗后ESR、CRP较治疗前降低(P<0.05);两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论应用二活附子方治疗AS疗效确切且安全性较高。

Objective To evaluate the efficacy and safety of Erhuofuzi Decoction in treatment of patients with ankylosing spondylitis（ AS）. Methods A prospective randomized controlled clinical trial was carried out in 78 AS patients,and the patients were randomly divided into experiment group（ n = 39） and control group（ n = 39）. The experiment group took Erhuofuzi Decoction,while the control group took Sulfasalazine tablets orally. One course of treatment was 12 weeks. Therapeutic effect was evaluated using standards of AS assessment in ankylosing spondylitis international society（ ASAS） 20,ASAS40 and Bath AS disease activity index（ BASDAI） 50 and Zheng Hou efficacy evaluation of traditional Chinese medicine（ TCM）. Indexes such as BASDAI,Bath AS function index（ BASFI）,Bath AS metrology index（ BASMI）,rachialgia score,night pain score,patient general assessment（ PGA）,erythrocyte sedimentation rate（ ESR） and C reactive protein（ CRP） before and after the treatment were observed. Results After 4 weeks of treatment,the number of patients reached ASAS20 standard in the experiment group,which was significantly larger than that in the control group（ P〈0. 05）. After 12 weeks of treatment,the number of patients reached standards of ASAS20,ASAS40 and BASDAI50 in the experiment group,which were significantly larger than that in the control group（ P〉0. 05）,and the value of Zheng Hou efficacy of TCM in the experiment group was significantly higher than that in the control group（ P〈0. 05）; the Zheng Hou score of TCM,BASDAI,BASFI,rachialgia score,night pain score and PGA after the treatment were superior to those before the treatment in the two groups（ P〈0. 05,P〈0. 01）,and the above indexes in experiment group were superior to those in the control group（ P〈0. 05）; the ESR and CRP values were decreased after the treatment compared with those before the treatment in the two groups（ P〉0. 05）; the difference in the incidence rate of adverse reaction was not statistically significant in the two groups（ P〉0. 05）. Conclusion Erhuofuzi Decoction is effective and safe in treatment of AS patients.