中药内服外治法联合甲氨蝶呤治疗活动期类风湿关节炎的随机对照多中心研究  

Treating Active Rheumatoid Arthritis with Traditional Chinese Medicine Combined with Methotrexate: A Randomized Controlled Multicenter Study

作　　者：沈佳莹 张凯[1] 周倩 陈岚 周碧霞 何奕坤 郑玥琪[1] 吴辉辉[1] 杨光辉[1] SHEN Jiaying;ZHANG Kai;ZHOU Qing;CHEN Lan;ZHOU Bixia;HE Yikun;ZHENG Yueqi;WU Huihui;YANG Guanghui(Department of Rheumatism,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200021,China;Shanghai South Terminal Community Health Service Center,Shanghai 200125,China;Shanghai Sanlin Kangde Community Health Service Center,Shanghai 200120,China;Shanghai College Community Health Service Center,Shanghai 201304,China)

机构地区：[1]上海中医药大学附属曙光医院风湿免疫科,上海200021 [2]上海南码头社区卫生服务中心,上海200125 [3]上海三林康德社区卫生服务中心,上海200120 [4]上海书院社区卫生服务中心,上海201304

出　　处：《辽宁中医杂志》2020年第12期106-110,共5页Liaoning Journal of Traditional Chinese Medicine

基　　金：上海市浦东新区卫生和计划生育委员会卫生科技项目(PW2015D-7);上海市卫生和计划生育委员会科研课题(20164Y0048);上海市科学技术委员会科研计划项目(17401971600);上海中医药大学附属曙光医院四明青年基金(SGKJ-201920)。

摘　　要：目的观察中药内服外治法联合甲氨蝶呤治疗活动期类风湿关节炎(RA)的临床疗效。方法将115例活动期RA患者按照随机、对照、多中心的原则分为治疗组56例和对照组59例。治疗组56例予中药内服外治法联合甲氨蝶呤治疗,对照组59例单纯予甲氨蝶呤治疗,两组均治疗24周。观察并比较两组患者视觉模拟评分(VAS)评分、28个关节疾病活动度(DAS28)、ACR反应标准、中医症状积分、生活质量量表(SF-36量表)、健康评估问卷残疾指数(HAQDI),同时检测患者的红细胞沉降率(ESR)、C-反应蛋白(CRP)的水平。结果治疗后,两组患者的VAS、DAS28评分均显著降低(P <0.05),且治疗组VAS、DAS28评分低于对照组(P <0.05)。治疗后,两组患者的关节压痛数、肿胀数均减少(P <0.001),且治疗组关节压痛数、肿胀数的均值低于对照组(P <0.05)。治疗后,两组患者对疼痛的评价、患者对疾病活动的总体评价、医生对疾病活动的总体评价均降低(P <0.05),且治疗组对疼痛的评价、患者对疾病活动的总体评价、医生对疾病活动的总体评价均值低于对照组(P <0.05)。治疗后,两组HAQ-DI均减少(P <0.05),且治疗组HAQ-DI评分低于对照组(P <0.05)。治疗后,两组患者在SF-36量表中生理机能(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)、情感职能(RE)均有所改善,且治疗组PF、RP、BP、SF方面治疗优于对照组。治疗后,治疗组和对照组的ACR20达标率分别为43.86%(25/56)和32.2%(19/59),两组比较具有统计学意义(P <0.05)。治疗后,对照组的ACR50达标率分别为35.09%(20/56)和28.81%(28/59),两组比较无统计学意义(P> 0.05)。治疗后,治疗组和对照组的ACR7达标率分别为21.05%(12/56)和8.47%(5/59),两组比较具有统计学意义(P <0.05)。治疗后,治疗组和对照组的中医证候疗效的有效率分别为85.96%(49/56)和45.51%(41/59),两组疗效比较差异具有统计学意义(Objective To observe the clinical effect of Chinese herbal medicine combined with methotrexate on active rheumatoid arthritis( RA).Methods A total of 115 patients with active RA were divided into treatment group( 56 cases) and control group( 59 cases) according to the multicenter randomized parallel-controlled principles.The treatment group( 56 cases) was treated with internal and external traditional Chinese medicine therapy combined with methotrexate,while the control group( 59 cases) was treated with methotrexate alone.Both groups were treated for 24 weeks.VAS score,DAS28,ACR reaction standard,TCM symptom score,SF-36 scale and HAQ-DI were observed and compared between the two groups,and erythrocyte sedimentation rate and C-reactive protein( CRP) level were simultaneously detected.Results After treatment,VAS and DAS28 were significantly lower in both groups( P < 0.05),and VAS and DAS28 in treatment group were lower than those in the control group( P <0.05).After treatment,the number of joint tenderness and swelling decreased in both groups( P < 0.001),and the mean number of joint tenderness and swelling in the treatment group was lower than that in the control group( P < 0.05).After treatment,the pain evaluation,the disease activity evaluation and the doctor’ s overall evaluation of the two groups were all decreased( P <0.05),and the pain evaluation,the disease activity evaluation and the doctor’s overall evaluation of the treatment group were lower than those of the control group( P < 0.05).After treatment,HAQ-DI decreased in both groups( P < 0.05),and HAQ-DI in the treatment group was lower than that in the control group( P < 0.05).After treatment,the physiological function( PF),role-physical( RP),body pain( BP),general health status( GH),vitality( VT),social function( SF) and role-emotion( RE) in the SF-36 scale of the two groups were improved,and PF,RP,BP and SF in treatment group were better than those of the control group.After treatment,the ACR20 compliance rates of the treatment group and the contro

关 键 词：中药内服 中药外治 类风湿关节炎 临床疗效 

分 类 号：R593.22[医药卫生—内科学]