八味肾气丸治疗肾阳亏虚型强直性脊柱炎随机、双盲、安慰剂对照临床研究  

Clinical study on Bawei Shenqi Pill in treating ankylosing spondylitis with deficiency of kidney yang:a randomized,double-blind,and placebo-controlled trial

作　　者：王晓赟 陈晓旭[1] 金舒纯 茅建春[1] WANG Xiaoyun;CHEN Xiaoxu;JIN Shuchun;MAO Jianchun(Department of Rheumatism,Longhua Hospital Affliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Immunology Laboratory,Shanghai Research Instiute of Acupuncture and Meridian,Shanghai 200030,China)

机构地区：[1]上海中医药大学附属龙华医院风湿科,上海200032 [2]上海市针灸经络研究所免疫实验室,上海200030

出　　处：《上海中医药杂志》2022年第4期56-61,共6页Shanghai Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金青年科学基金项目(81904227);上海市科委科研计划项目(17401971500)。

摘　　要：目的 观察八味肾气丸治疗肾阳亏虚型强直性脊柱炎的临床疗效。方法 采用随机、双盲、安慰剂对照临床试验,将80例肾阳亏虚型强直性脊柱炎患者分为治疗组和对照组,每组40例,治疗组服用八味肾气丸联合美洛昔康片,对照组服用八味肾气丸安慰剂联合美洛昔康片,疗程均为12周。观察两组中医疗效及中医证候积分、脊柱疼痛评分、脊柱活动度(枕墙距、扩胸距、指地距、Schober试验)、强直性脊柱炎疾病活动性指数(BASDAI)评分、强直性脊柱炎功能指数(BASFI)评分、炎症指标(C反应蛋白、血细胞沉降率)及生活质量评估量表评分等变化情况。结果 (1)最终完成本试验者74例,其中治疗组38例,对照组36例。(2)治疗组中医证候总有效率为92.10%,对照组中医证候总有效率为36.10%;两组中医证候疗效比较差异有统计学意义(P<0.05)。(3)治疗后两组中医证候积分与治疗前比较均有改善(P<0.05);组间治疗后比较,治疗组腰背疼痛、腰背僵硬活动受限、神疲乏力、面色少华及腰膝酸软症状治疗前后评分差值优于对照组(P<0.05)。(4)治疗后两组脊柱疼痛评分与治疗前比较均有改善(P<0.05);组间治疗后比较,治疗组治疗前后评分差值优于对照组(P<0.05)。(5)治疗后两组枕墙距、扩胸距、指地距、Schober试验评分与治疗前比较均有改善(P<0.05);组间治疗后比较,治疗组扩胸距及Schober试验评分的治疗前后差值均优于对照组(P<0.05)。(6)治疗后两组BASDAI评分、BASFI评分与治疗前比较均有改善(P<0.05);组间治疗后比较,治疗组BASDAI评分、BASFI评分治疗前后差值优于对照组(P<0.05)。(7)治疗后治疗组C反应蛋白与治疗前比较有改善(P<0.05),对照组与治疗前比较无明显变化(P>0.05),组间治疗后比较,两组C反应蛋白差异无统计学意义(P>0.05);治疗后,两组红细胞沉降率组内、组间比较差异均无统计学意义(P>0.05)。(8)治疗后两Objective To explore the clinical efficacy of Bawei Shenqi Pill in the treatment of ankylosing spondylitis with deficiency of kidney yang.Methods Using a randomized,double-blind,placebo-controlled clinical trial,80 patients of ankylosing spondylitis with deficiency of kidney yang were randomly divided into the treatment and the control group,40 in each group. The treatment group was administered with the Bawei Shenqi Pill and meloxicam,while the control group was given the Bawei Shenqi Pill placebo and meloxicam,with a course of 12 weeks. TCM curative effect and TCM syndrome score,spinal pain score,spinal mobility index(occiput to wall distance,chest expansion,finger to floor distance and Schober test),bath ankylosing spondylitis disease activity index(BASDAI),bath ankylosing spondylitis function index(BASFI),C reactive protein(CRP),erythrocyte sedimentation rate(ESR) and scores of quality of life assessment scale were observed after the treatment. Results (1) There were 74 cases of this experiment completed,including 38 cases in the treatment group and 36 cases in the control group.(2) The total effective rate of TCM in the treatment group and the controlgroup were 92.1% and 36.1% respectively,and the two groups were statistically significant in clinical efficacy(P<0.05).(3) After treatment,the TCM syndrome scores of the two groups were improved(P<0.05);the difference scores of low back pain,low back stiffness,limited activity,mental fatigue,pale complexion and low back and knee soreness in the treatment group were better than those in the control group(P<0.05).(4) After treatment,the spinal pain score was improved in both groups(P<0.05);the difference of the spinal pain score in the treatment group was significantly better than that in the control group(P<0.05).(5) After treatment,The spinal mobility index was improved in both groups(P<0.05);the difference scores of chest expansion and Schober test in the treatment group were better than those in the control group(P<0.05).(6) After treatment,BASDAI score and BA

关 键 词：强直性脊柱炎 肾阳亏虚证 八味肾气丸 临床试验 

分 类 号：R259[医药卫生—中西医结合]