新风胶囊治疗强直性脊柱炎随机对照研究  

Xinfeng Capsule in Treating Patients with Ankylosing Spondylitis:A Randomized Controlled Trial

作　　者：万磊[1] 刘健[1] 黄传兵[1] 李舒 谌曦[1] 范海霞[1] 刘天阳[1] 葛瑶[1] 刘磊[1] 李明[1] 赵磊 朱子衡 马熙檬 郑力 WAN Lei;LIU Jian;HUANG Chuan-bing;LI Shu;CHEN Xi;FAN Hai-xia;LIU Tian-yang;GE Yao;LIU Lei;LI Ming;ZHAO Lei;ZHU Zi-heng;MA Xi-meng;ZHENG Li(Department of Rheumatology,The First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei,230031;Department of Cancer Biology,Cityof Hope National Medical Center and Beckman Research Institute,California,91010,USA)

机构地区：[1]安徽中医药大学第一附属医院风湿病科,合肥230031 [2]Department of Cancer Biology,City of Hope National Medical Center and Beckman Research Institute,California,91010,USA

出　　处：《中国中西医结合杂志》2022年第10期1161-1168,共8页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：国家自然科学基金面上项目(No.81973655);安徽省高校自然科学研究项目(No.KJ2020A0397);科技部国家重点研发计划中医药现代化研究重点专项(No.2018YFC1705204);全国中医药创新骨干人才培训项目(No.国中医药人教函[2019]128号);安徽中医药大学校基金项目(No.2018xrxd17);安徽中医药大学第一附属医院院内基金项目(No.2020yfyzc25,No.2020yfyzc55)。

摘　　要：目的观察新风胶囊对强直性脊柱炎(AS)患者临床疗效、炎症极化及骨代谢的影响。方法40例AS患者按照随机对照表法分为观察组和对照组,每组各20例。对照组采用沙利度胺治疗。观察组采用沙利度胺加新风胶囊治疗。两组均治疗4周为1个疗程,共观察3个疗程。采用国际强直性脊柱炎工作小组(ASAS)拟定的ASAS 20、ASAS 50判断临床疗效。观察治疗前后症状体征变化,包括疼痛视角模拟评分(VAS)、巴氏AS疾病活动性指数(BASDAI)、巴氏AS功能指数(BASFI)、巴氏AS计量指数(BASMI)、巴氏AS健康综合指数(BAS-G)及中医症状量化评分。免疫比浊法检测炎性活动性指标血沉(ESR)、C反应蛋白(CRP),酶联免疫吸附法检测Ⅰ型原胶原N端前肽(PINP)、Ⅰ型胶原羟基端肽β降解产物(β-CTX)、骨钙素(BGP)、抗酒石酸酸性磷酸酶5b(TRACP-5b)、碱性磷酸酶(ALP)。流式细胞术检测M1型巨噬细胞CD86和M2型巨噬细胞CD16表达。结果(1)观察组ASAS20改善有效率高于对照组(P<0.05);(2)与本组治疗前比较,观察组治疗后BASFI、BASMI、BAS-G显著降低(P<0.05,P<0.01)。骶髂脊背疼痛、晨僵、少气懒言、胸闷、气短、乏力明显降低(P<0.05,P<0.01),CRP、ALP、β-CTX、TRACP-5b降低(P<0.05,P<0.01),BGP表达升高(P<0.01)。M1标志物CD86降低,M2标志物CD16升高(P<0.01,P<0.05)。与对照组治疗后比较,观察组治疗后BASFI、BAS-G降低(P<0.05),少气懒言、气短、乏力均明显改善(P<0.05);(3)相关性分析显示,CD86与PINP、TRACP-5b呈正相关(r=0.035,P<0.05;r=0.457,P<0.01),CD16与BGP呈正相关(r=0.480,P<0.01)。结论新风胶囊可能通过上调CD16表达,下调CD86表达,调节炎症极化向M2转化,降低AS炎症反应,改善骨代谢。Objective To observe the effect of Xinfeng Capsule(XFC)on the clinical efficacy,inflammation polarization,and bone metabolism of patients with ankylosing spondylitis(AS).Methods Totally 40 AS patients,selected as the research objectives,were randomly assigned to observation group and control group by random digit table,20 in each group.Patients in the control group took Thalidomide.Those in the observation group took Thalidomide plus XFC.The treatment course for all was 4 weeks as a course of treatment,and a total of 3 courses were included.The ASAS20 and ASAS50 proposed by the International Ankylosing Spondylitis Working Group(ASAS)were used to assess the clinical efficacy.Changes in symptoms and signs,including visual analogue scale(VAS),Bath AS disease activity index(BASDAI),Bath AS function index(BASFI),Bath AS measurement index(BASMI),Bath AS global assessment index(BAS-G),and quantitative score of TCM symptoms were observed before and after treatment.Immunoturbidimetric method was used to detect inflammatory activity indicators,erythrocyte sedimentation rate(ESR),C-reactive protein(CRP).And enzymelinked immunosorbent method was used to detect contents of typeⅠprocollagen N-terminal propeptide(PINP)and C-termianl telopeptide of typeⅠcollagen(β-CTX),osteocalcin(BGP),anti-tartrate acid phosphatase 5b(TRACP-5b),and alkaline phosphatase(ALP).Flow cytometry was used to detect the expressions of CD86 on M1 macrophages and CD16 on M2 macrophages.Results(1)The effective rate of improvement of ASAS 20 in the observation group was higher than that in the control group(P<0.05).(2)Compared with before treatment in the same group,BASFI,BASMI,BAS-G of the observation group were significantly reduced after treatment,sacroiliac spine pain,morning stiffness,lack of breath,chest tightness,shortness of breath,and fatigue were significantly lowered(P<0.05,P<0.01),CRP,ALP,β-CTX,TRACP-5b decreased(P<0.05,P<0.01),BGP expression increased(P<0.01).M1 marker CD86 decreased,M2 marker CD16 increased(P<0.01,P<0.05).Compared with t

关 键 词：新风胶囊 强直性脊柱炎 炎症极化 骨代谢 临床疗效 

分 类 号：R593.23[医药卫生—内科学]