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)
王晓赟,女,硕士,研究实习员,主要从事风湿病的中西医结合临床研究工作
茅建春,主任医师,硕士研究生导师; E-mail:mjczyczx@163.com
扫 描 看 全 文
王晓赟,陈晓旭,金舒纯等.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[J].上海中医药杂志,2022,56(04):56-61.
WANG Xiaoyun,CHEN Xiaoxu,JIN Shuchun,et al.Clinical study on Bawei Shenqi Pill in treating ankylosing spondylitis with deficiency of kidney yang:a randomized, double⁃blind, and placebo⁃controlled trial[J].Shanghai Journal of Traditional Chinese Medicine,2022,56(04):56-61.
王晓赟,陈晓旭,金舒纯等.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[J].上海中医药杂志,2022,56(04):56-61. DOI: 10.16305/j.1007-1334.2022.2110021.
WANG Xiaoyun,CHEN Xiaoxu,JIN Shuchun,et al.Clinical study on Bawei Shenqi Pill in treating ankylosing spondylitis with deficiency of kidney yang:a randomized, double⁃blind, and placebo⁃controlled trial[J].Shanghai Journal of Traditional Chinese Medicine,2022,56(04):56-61. DOI: 10.16305/j.1007-1334.2022.2110021.
目的,2,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,2,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,2,①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治疗后两组生理机能(PF)、生理职能(RP)、躯体疼痛(BP)、一般健康状况(GH)、精力(VT)、社会功能(SF)评分及治疗组精神健康(MH)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GH、VT及MH评分治疗前后差值优于对照组(,P,<,0.05)。,结论,2,八味肾气丸能明显提高肾阳亏虚型强直性脊柱炎患者中医证候疗效及一定程度改善关节炎症和关节功能,提高患者生活质量。
Objective,2,To explore the clinical efficacy of Bawei Shenqi Pill in the treatment of ankylosing spondylitis with deficiency of kidney yang.,Methods,2,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,2,①There 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 control group 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 BASFI score in both groups improved (,P,<,0.05); the difference of BASDAI score and BASFI score in the treatment group were better than those in the control group (,P,<,0.05).⑦ After treatment, CRP in the treatment group was improved (,P,<,0.05), but there was no significant change in the control group (,P,>,0.05); there was no significant difference between the two groups (,P,>,0.05). After treatment, there was no significant difference in ESR between the two groups (,P,>,0.05). ⑧After treatment, the physiological function(PF), role-physical (RP), physical pain(BP), general health(GH), energy(VT), social function(SF) in both groups and mental health(MH) in the treatment group were improved (,P,<,0.05); The difference scores of GH, VT and MH in the treatment group was significantly better than those in the control group (,P,<,0.05).,Conclusion,2,Bawei Shenqi Pill can significantly improve the clinical efficacy of TCM in patients with ankylosing spondylitis of kidney yang deficiency type, improve joint inflammation and joint function to a certain extent, and improve the quality of life.
强直性脊柱炎肾阳亏虚证八味肾气丸临床试验
ankylosing spondylitisdeficiency of kidney yangBawei Shenqi Pillclinical trial
中华医学会风湿病学分会. 强直性脊柱炎诊断及治疗指南[J]. 中华风湿病学杂志,2010, 14(8): 557-559.
RUNSHENG W, WARD M M. Epidemiology of axial spondyloarthritis: an update[J]. Curr Opin Rheumatol, 2018, 30(2): 137-143.
HAROON N N, PATERSON J M, LI P, et al. Patients with ankylosing spondylitis have increased cardiovascular and cerebrovascular mortality: A population-based study[J]. Ann Intern Med, 2015, 163(6): 409-416.
焦树德. 大偻(强直性脊柱炎)病因病机及辨证论治探讨(下)[J]. 江苏中医药,2003, 24(2): 1.
VAN DER L S, VALKENBURG H A, CATS A. Evaluation of diagnostic criteria for ankylosing spondylitis: A proposal for modification of the New York criteria[J]. Arthritis Rheum, 1984, 27(4): 361-368.
国家中医药管理局. 中医病证诊断疗效标准[M]. 南京:南京大学出版社,1994: 29-31.
国家药品监督管理局. 中药新药临床研究指导原则(试行)[M]. 北京:中国医药科技出版社,2002: 119-123.
MACHADO P M. Disease activity measurements and monitoring in psoriatic arthritis and axial spondyloarthritis[J].Best Pract Res Clin Rheumatol, 2014 , 28(5): 711-728.
张征,许鸣华,常显,等. 温肾强脊方联合美洛昔康治疗强直性脊柱炎的临床观察及对瘦素、IL-6、IL-17、IL-23的影响[J]. 中药药理与临床,2018, 34(1): 164-167.
李满意,娄玉钤. 肾痹的源流及相关历史文献复习[J]. 风湿病与关节炎,2015, 4(5): 56-64.
李满意,娄玉钤. 骨痹的源流及相关历史文献复习[J]. 风湿病与关节炎,2014, 3(12): 59-68.
焦树德. “大偻”刍议[J]. 中国中医药信息杂志,2000, 7(6): 1-3.
焦树德. 焦树德从大偻论治强直性脊柱炎三方[J]. 山东中医杂志,2003, 22(4): 235.
周丹庆,叶海. 叶海从督脉论治强直性脊柱炎经验介绍[J]. 新中医,2020, 52(12): 223-225.
0
浏览量
338
下载量
0
CSCD
4
CNKI被引量
关联资源
相关文章
相关作者
相关机构