解放军医药杂志2016，Vol.28Issue(3)：96-100,5.DOI:10.3969/j.issn.2095-140X.2016.03.023
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
摘要
Abstract
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 pa-tients, and the patients were randomly divided into experiment group (n=39) and control group (n=39). The experi-ment 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 tra-ditional Chinese medicine ( TCM) . Indexes such as BASDAI, Bath AS function index ( BASFI) , Bath AS metrology in-dex (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 treat-ment, 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 con-trol 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 af-ter 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.关键词
强直性脊柱炎/疗效评价/安全性Key words
Ankylosing spondylitis/Efficacy evaluation/Safety分类
中医学引用本文复制引用
辛昊洋,王澎澎,马玉琛..二活附子方治疗强直性脊柱炎的临床疗效及安全性评价[J].解放军医药杂志,2016,28(3):96-100,5.基金项目
“十一五”军队中医药重大临床攻关课题(2006011003) （2006011003）
