基于《黄帝内经》不荣则痛探讨益气养阴通络方治疗类风湿关节炎(气阴两虚证)研究  

Based on theory of“No Glory Leads to Pain”in Inner Canon of Huangdi,A Trial of Yiqi Yangyin Tongluo Decoctiom(益气养阴通络方)in the Treatment of Rheumatoid Arthritis(Qi-Yin Deficiency Syndrome)

作　　者：张博纶 高洪语 荆晴晴 鞠宝兆[1] 高明利[3] 姜泉[4] 于静[3] 赵夜雨[3] 齐庆[3] 宋林萱 关凤媛 李东书[7] ZHANG Bolun;GAO Hongyu;JING Qingqing;JU Baozhao;GAO Mingli;JIANG Quan;YU Jing;ZHAO Yeyu;QI Qing;SONG Linxuan;GUAN Fengyuan;LI Dongshu(Liaoning University of Traditional Chinese Medicine,Shenyang 110847,Liaoning,China;Qingdao Sixth People's Hospital,Qingdao 266000,Shandong,China;Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,Liaoning,China;Guang'anmen Hospital,Chinese Academy of Traditional Chinese Medicine,Beijing 100032,China;The 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 110001,Liaoning,China)

机构地区：[1]辽宁中医药大学,辽宁沈阳110847 [2]青岛市第六人民医院,山东青岛266000 [3]辽宁中医药大学附属医院,辽宁沈阳110032 [4]中国中医科学院广安门医院,北京100032 [5]大连医科大学附属第二医院,辽宁大连116000 [6]营口市中医院,辽宁营口115000 [7]沈阳市中医院,辽宁沈阳110001

出　　处：《辽宁中医药大学学报》2023年第11期177-182,共6页Journal of Liaoning University of Traditional Chinese Medicine

基　　金：国家重点研发计划项目(2018YFC1705202);辽宁省中医药临床学(专)科能力建设项目(2017-32);中医药古籍文献和特色技术传承专项(GZY-KJS-2020-045);2020-2021年度《中华医藏》提要编纂项目(二、三编)(KJS-ZHYC-2020-010);辽宁省中央引导地方科技发展专项(2020JH610500004)。

摘　　要：目的基于《黄帝内经》“不荣则痛”理论探讨类风湿关节炎(rheumatoid arthritis,RA)气阴两虚证的基本病机,并通过临床观察明确益气养阴通络方干预的有效性与安全性。方法120例类风湿关节炎气阴两虚证患者随机分配至试验组或对照组,每组60例。对照组接受益气养阴通络方模拟剂联合甲氨蝶呤,试验组接受益气养阴通络方联合甲氨蝶呤,干预12周。观察指标:美国风湿病学会类风湿关节炎20%、50%、70%改善率标准(ACR20/50/70),症状体征评价,28个关节疾病活动度(DAS28)评分,目测模拟标尺法(VAS)评分,健康状况评估(HAQ)评分,血沉(ESR),C反应蛋白(CRP),中医总有效率评价,中医证候总分,中医证候单项评分及安全性评价。根据试验结果,以“不荣则痛”立论,探讨益气养阴通络方干预RA的意义。结果临床疗效评价:试验组达到ACR20/50/70改善标准的比例高于对照组(P<0.05),与对照组相比,试验组治疗12周的关节压痛数、肿胀数、晨僵时间改善明显(P<0.05),DAS28评分、VAS评分有所下降(P<0.05),HAQ评分明显降低(P<0.01),ESR、CRP水平均明显下降(P<0.01)。中医证候疗效评价:试验组治疗12周的中医证候总有效率明显高于对照组(P<0.01),与对照组相比,试验组治疗12周证候总分明显下降(P<0.01),单项评分(关节肿大、肌肉酸痛、气短乏力、自汗、口干、眼干、盗汗、手足心热)有所下降(P<0.05)。安全性评价:试验组不良反应发生率和例次未显著低于对照组(P>0.05)。结论基于“不荣则痛”理论探讨痹证气阴两虚证的关键病机,通过试验,明确了本方可明显提高RA气阴两虚证患者临床治疗达标率,中医证候疗效,控制疾病活动度,改善疾病症状体征和生存质量,且安全性良好。Objective To explore the basic pathogenesis of Qi-Yin deficiency syndrome in rheumatoid arthritis(RA)based on the theory of“no glory leads to pain”in Inner Canon of Huangdi,and to clarify the effectiveness and safety of Yiqi Yangyin Tongluo Decoction(益气养阴通络方)through clinical observation.Methods 120 rheumatoid arthritis patients with Qi-Yin deficiency syndrome were randomly assigned to the experimental group or the control group,with 60 cases in each group.The control group received Yiqi Yangyin Tongluo formula simulant combined with methotrexate,and the experimental group received Yiqi Yangyin Tongluo Decoction combined with methotrexate for 12 weeks.Outcome measures:20%,50%,and 70%improvement rate standards(ACR20/50/70)of the American Society of Rheumatology for rheumatoid arthritis,symptom and physical sign evaluation,28 joint disease activity(DAS28)scores,visual analog scale(VAS)scores,health status assessment(HAQ)scores,erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),total effective rate evaluation of traditional Chinese medicine,total score and single score of traditional Chinese medicine syndromes,and safety evaluation.Results Clinical efficacy evaluation:The proportion of patients in the experimental group who achieved the ACR20/50/70 improvement standard was higher than that in the control group(P<0.05).Compared with the control group,the experimental group showed significant improvement in joint tenderness,swelling,and morning stiffness time after 12 weeks of treatment(P<0.05),with a decrease in DAS28 score and VAS score(P<0.05),a significant decrease in HAQ score(P<0.01),and a significant decrease in ESR and CRP levels(P<0.01).Evaluation of TCM syndrome efficacy:The total effective rate of TCM syndrome in the experimental group after 12 weeks of treatment was significantly higher than that in the control group(P<0.01).Compared with the control group,the total score of symptoms in the experimental group decreased significantly after 12 weeks of treatment(P<0.01),and the indi

关 键 词：《黄帝内经》 益气养阴通络方 四神煎 类风湿关节炎 气阴两虚证 临床试验 

分 类 号：R221[医药卫生—中医基础理论] R289.5[医药卫生—中医学] R593.22