益气养阴通络方治疗气阴两虚型类风湿关节炎多中心、双盲、随机对照临床试验  

A Multicenter,Double-Blind,Randomized Controlled Clinical Trial of Yiqi Yangyin Tongluo Formula(益气养阴通络方)in Treatment of Rheumatoid Arthritis with Deficiency of Qi and Yin Syndrome

作　　者：赵夜雨[1] 于静[1] 姜泉[2] 高明利[1] 张博纶 岳月[1] 孙蓬远[1] 王丽敏[1] 刘东武[1] 齐庆[1] 刘岩岩[1] 姚家树[1] 王霖[1] 李略 任冬萌[1] 郑建南 王晓梅 王恩隆 李佳凌 冯博 宋林萱 关凤媛 李东书[6] ZHAO Yeyu;YU Jing;JIANG Quan;GAO Mingli;ZHANG Bolun;YUE Yue;SUN Pengyuan;WANG Limin;LIU Dongwu;QI Qing;LIU Yanyan;YAO Jiashu;WANG Lin;LI Lue;REN Dongmeng;ZHENG Jiannan;WANG Xiaomei;WANG Enlong;LI Jialing;FENG Bo;SONG Linxuan;GUAN Fengyuan;LI Dongshu(Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,Liaoning,China;Guang'anmen Hospital,Chinese Academy of traditional Chinese medicine,Beijing 100000,China;Liaoning University of Traditional Chinese Medicine,Shenyang 110847,Liaoning,China;Second Affiliated Hospital of Dalian Medical University,Dalian 116000,Liaoning,China;Yingkou Hospital of Traditional Chinese Medicine,Yingkou 115000,Liaoning,China;Shenyang Hospital of Traditional Chinese Medicine,Shenyang 110000,Liaoning,China)

机构地区：[1]辽宁中医药大学附属医院,辽宁沈阳110032 [2]中国中医科学院广安门医院,北京100000 [3]辽宁中医药大学,辽宁沈阳110847 [4]大连医科大学附属二院,辽宁大连116000 [5]营口市中医院,辽宁营口115000 [6]沈阳市中医院,辽宁沈阳110000

出　　处：《中华中医药学刊》2022年第12期57-63,共7页Chinese Archives of Traditional Chinese Medicine

基　　金：国家重点研发计划中医药现代化研究重点专项(2018YFC1705200);辽宁省中医药临床学(专)科能力建设项目(2017032);辽宁省教育厅科学研究经费项目(L202041);辽宁省自然科学基金(2021-BS-180)。

摘　　要：目的观察益气养阴通络方联合甲氨蝶呤治疗类风湿关节炎(气阴两虚证)的有效性与安全性。方法将2017年7月—2020年10月纳入的200例气阴两虚型类风湿关节炎(rheumatoid arthritis,RA)患者随机分为试验组或对照组,每组100例。试验组接受益气养阴通络中药联合甲氨蝶呤,对照组接受益气养阴通络中药模拟剂联合甲氨蝶呤,治疗周期12周。结果ACR20/50/70反应标准、中医证候疗效及中医证候单项评分、RA相关症状体征、红细胞沉降率(ESR)、C反应蛋白(CRP),28个关节活动度(DAS 28)评分、医师及病人视觉模拟(VAS)评分、健康评估问卷残疾指数(HAQ)评价、安全性评价。结果试验组与对照组满足ACR20/50/70改善标准者分别为32、10、3例与22、2、0例(P<0.05)。两组DAS28、VAS、HAQ评分均随着治疗时间的推进逐渐减少,且试验组评分低于对照组(P<0.05)。两组关节功能等级数均有所下降,且试验组12周关节功能分级低于对照组(P<0.001)。两组12周晨僵时间、关节压痛数、肿胀数均低于治疗前,且试验组各项水平均低于对照组(P<0.05)。两组ESR、CRP滴度均随着治疗时间的推进有所下降,试验组ESR水平明显低于对照组(P<0.05);试验组第8、12周CRP滴度低于对照组(P<0.001)。试验组12周中医证候总有效率为96.63%(86/89),对照组总有效率52.22%(47/90),试验组总有效率明显高于对照组(P<0.05)。两组中医证候积分、中医证候单项积分均有所下降,且试验组12周中医证候积分、单项积分低于对照组(P<0.05)。试验组与对照组发生不良反应例次分别为56、65例次,试验组低于对照组(P>0.05)。结论益气养阴通络方联合甲氨蝶呤可明显提高气阴两虚型RA患者临床治疗达标率,控制疾病活动度,改善RA症状和生活质量,同时具有良好的安全性。Objective To observe the efficacy and safety of Yiqi Yangyin Tongluo Formula(益气养阴通络方)combined with methotrexate in the treatment of rheumatoid arthritis(RA)(deficiency of Qi and Yin syndrome).Methods A total of 200 RA patients with deficiency of Qi and Yin from July 2017 to October 2020 were randomly divided into exPerimental group or control group,with 100 cases in each group.The experimental group received Yiqi Yangyin Tongluo Formula combined with methotrexate,and the control group received Yiqi Yangyin Tongluo Formula simulant combined with methotrexate for 12 weeks.ACR20/50/70 response standard,TCM syndrome efficacy and single score of TCM syndrome,RA related symPtoms and signs,erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),28 joint activity(DAS 28)scores,physician and patient visual analog(VAS)scores,health assessment questionnaire,disability index(HAQ)evaluation and safety evaluation were compared.Results 32,10 and 3 cases in the experimental group and 22,2 and 0 cases in the control group met the ACR20/50/70 improvement standard respectively(P<0.05).The scores of DAS28,VAS and HAQ in the two groups decreased gradually with the progress of treatment time,and the scores in the experimental group were lower than those in the control group(P<0.05).The number of joint function grades in the two groups decreased,and the joint function grade in the experimental group was lower than that in the control group at 12 weeks(P<0.001).The morning stiffness time,joint tenderness and swelling of the two groups at 12 weeks were lower than those before treatment,and the levels of the experimental group were lower than those of the control group(P<0.05).The levels of ESR and CRP of the two groups decreased with the advance of treatment time,and the ESR level in the experimental group was significantly lower than that in the control group(P<0.05).The CRP level in the experimental group was lower than that in the control group at 8 and 12 weeks(P<0.001).The total effective rate of TCM syndrome in th

关 键 词：益气养阴通络方 类风湿关节炎 气阴两虚证 多中心临床随机对照试验 

分 类 号：R259.932.2[医药卫生—中西医结合]