益气养阴通络方治疗老年类风湿关节炎(气阴两虚证)临床研究  

Clinical Study on the Treatment of Senile Rheumatoid Arthritis(Qi-Yin Deficiency Syndrome)with Yiqi Yangyin Tongluo Decoction(益气养阴通络方)

作　　者：张博纶 鞠宝兆[1] 高明利[2] 姜泉[3] 于静[2] 赵夜雨[2] 齐庆[2] 邓国伟 ZHANG Bolun;JU Baozhao;GAO Mingli;JIANG Quan;YU Jing;ZHAO Yeyu;QI Qing;DENG Guowei(Liaoning University of Traditional Chinese Medicine,Shenyang 110847,Liaoning,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;General Hospital of the Northern Theater Command,Shenyang 110015,Liaoning,China)

机构地区：[1]辽宁中医药大学,辽宁沈阳110847 [2]辽宁中医药大学附属医院,辽宁沈阳110032 [3]中国中医科学院广安门医院,北京100032 [4]北部战区总医院,辽宁沈阳110015

出　　处：《辽宁中医药大学学报》2023年第12期49-54,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);《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：目的通过临床观察明确益气养阴通络方干预老年类风湿关节炎(气阴两虚证)的有效性与安全性。方法66例老年类风湿关节炎(rheumatoid arthritis,RA)气阴两虚证患者随机分配至试验组或对照组,每组33例。对照组接受益气养阴通络方模拟剂联合甲氨蝶呤治疗,试验组接受益气养阴通络方联合甲氨蝶呤治疗,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)、中医证候疗效及中医证候单项评分、RA相关症状体征、血沉(erythrocyte sedimentation rate,ESR)、C反应蛋白(c-reactive protein,CRP)、28个关节疾病活动度(disease activity score-28,DAS28)评分、目测模拟标尺法(visual analogue scale,VAS)评分、健康状况评估(health assessment questionnaire,HAQ)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老年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);试验组12周的DAS28、VAS、HAQ评分较对照组低(P<0.05);试验组12周的关节压痛数、肿胀数、晨僵时间、ESR水平较对照组明显降低(P<0.05)。中医证候疗效评价:试验组12周的中医证候总有效率明显高于对照组(P<0.05);与对照组相比,试验组12周证候总积分和单项积分(关节肿大、肌肉酸痛、气短乏力、自汗、口干、眼干、盗汗、手足心热)明显降低(P<0.05)。安全性评价:试验组不良反应发生率未显著低于对照组(P>0.05)。结论益气养阴通络方能明显提高老年RA气阴两虚证患者临床治疗达标率及中医证候疗效,并能控制疾病活动度,改善疾病症状体征和生存质量,且安全性良好。Objective Through clinical observation,it is clear that the effectiveness and safety of Yiqi Yangyin Tongluo Decoction(益气养阴通络方)in the intervention of elderly rheumatoid arthritis(RA)with Qi-Yin deficiency syndrome.Methods 66 elderly RA patients with Qi-Yin deficiency syndrome were randomly assigned to the experimental group or the control group,with 33 cases in each group.The control group received Yiqi Yangyin Tongluo Decoction 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,TCM syndrome efficacy,single score of TCM syndrome,RA related symptoms,ESR,DAS28 score,VAS score,HAQ score and safety evaluation.We explored the intervention significance of Yiqi Yangyin Tongluo Decoction in the treatment of elderly RA.Results The clinical efficacy evaluation:the compliance rate of ACR20/50/70 in the experimental group was higher than that in the control group(P<0.05);the DAS28 efficacy and VAS score at 12 weeks in the test group were lower than those in the control group(P<0.05);the level of the number of joint tenderness and swelling,morning stiffness time,ESR and CRP in the experimental group at 12 weeks were significantly lower than those in the control group(P<0.05).Evaluation of curative effect of TCM syndrome:the total effective rate of TCM syndrome in the experimental group at 12 weeks was significantly higher than that in the control group(P<0.05);compared with the control group,the total score and single score(joint swelling,shortness of breath and fatigue,dry eyes,dry mouth,spontaneous sweating,night sweating)of the experimental group were significantly lower at 12 weeks(P<0.05).Safety evaluation:the incidence of adverse reactions in the experimental group was lower than that in the control group(P>0.05).Conclusion Yiqi Yangyin Tongluo Decoction can significantly improve th

关 键 词：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：R289.5[医药卫生—方剂学] R593.22[医药卫生—中药学]