现代中西医结合杂志2025，Vol.34Issue(6)：757-763,7.DOI:10.3969/j.issn.1008-8849.2025.06.005
羌活地黄颗粒联合穴位敷贴治疗肝肾阴虚、寒湿痹阻型类风湿关节炎疗效观察
Efficacy of Qianghuo Dihuang granules combined with acupoint application on rheumatoid arthritis with syndrome of liver-kidney Yin deficiency and cold-dampness impediment obstruction
摘要
Abstract
Objective It is to evaluate the efficacy and safety of Qianghuo Dihuang granules combined with acupoint ap-plication in the treatment of rheumatoid arthritis(RA)with syndrome of liver-kidney Yin deficiency and cold-dampness im-pediment obstruction.Methods Ninety RA patients with syndrome of liver-kidney Yin deficiency and cold-dampness imped-iment obstruction treated in Shanghai Municipal Hospital of Traditional Chinese Medicine from October 2021 to October 2023 were randomly divided into a treatment group and a control group according to a software-generated random sequence,the experimental and control drugs were also blinded using this random sequence.The treatment group(n=45)was trea-ted with Qianghuo Dihuang granules,acupoint application and methotrexate,the control group(n=45)was treated with placebo of Chinese medicine granules,placebo of acupoint application and methotrexate.Both groups were continuously treated for 12 weeks.The number of swollen and painful joints,pain scores,Disease Activity Score in 28 joints(DAS28)scores,traditional Chinese medical(TCM)syndrome scores,levels of laboratory indicators[ESR,C-reactive protein(CRP),rheumatoid factor(RF),25-hydroxyvitamin D],patient-reported clinical outcome(PRO)scores,health assess-ment questionnaire(HAQ)scores of the two groups were observed and compared,the ACR response rates and efficacy of TCM syndrome of the two groups were calculated or assessed after 12 weeks of treatment,and the withdrawal of hormones and occurrence of adverse events during the treatment period were recoded in the two groups.Results Forty-four patients in the treatment group and 42 ones in the control group completed the study.Compared with before treatment,the numbers of swollen and painful joints of patients in the treatment group were significantly reduced(all P<0.05),and the doctor VAS scores,patient VAS scores,DAS28 scores,scores of joint cold pain,swelling or heaviness,scores of unfavorable joint flexion and extension,scores of morning stiffness,scores of waist and knee weakness,PRO scores,HAQ scores,and the levels of ESR,CRP and RF were all significantly reduced(all P<0.05),and serum level of 25(OH)D was significantly increased(P<0.05);the numbers of swollen and painful joints of patients in the control group were significantly reduced(P<0.05),and the DAS28 scores,scores of joint cold pain,swelling or heaviness,scores of unfavorable joint flexion and extension,scores of morning stiffness,scores of hot flash and night sweat,and the levels of ESR and CRP were significantly reduced(all P<0.05).The numbers of swollen and painful joints of patients in the treatment group were significantly less,while the DAS28 scores,scores of joint cold pain,swelling or heaviness,scores of unfavorable joint flexion and exten-sion,scores of morning stiffness and HAQ scores were significantly lower than those in the control group(all P<0.05).At the end of treatment,the ACR20 response rates in the treatment group and control group respectively were50.0%(22/44)and 28.6%(12/42),the hormone withdrawal rates respectively were 46.7%(7/15)and 28.6%(4/14),the total effective rates of TCM syndrome respectively were 86.4%(38/44)and 66.7%(28/42),and the incidence rates of ad-verse reactions respectively were 9.1%(4/44)and 21.4%(9/42),the ACR20 response rate and the total effective rate of the treatment group were significantly higher than those of the control group(both P<0.05),there was no siginificant difference in the hormone withdrawal rate and incidence rate of adverse reactions between the two groups(all P>0.05).Conclusion Qiangwu Dihuang granules combined with acupoint application is helpful to alleviate joint swelling,joint pain and TCM syndrome,reduce disease activity and increase ACR20 response rate in RA patients with syndrome of liver-kidney Yin deficiency and cold-dampness impediment obstruction,its efficacy is definite with good safety.关键词
类风湿关节炎/羌活地黄颗粒/穴位敷贴/肝肾阴虚/寒湿痹阻Key words
rheumatoid arthritis/Qiangwu Dihuang granules/acupoint application/Yin deficiency of liver and kid-ney/cold-dampness impediment obstruction分类
医药卫生引用本文复制引用
刘智超,陈薇薇..羌活地黄颗粒联合穴位敷贴治疗肝肾阴虚、寒湿痹阻型类风湿关节炎疗效观察[J].现代中西医结合杂志,2025,34(6):757-763,7.基金项目
上海市科学技术委员会科研计划项目(18401901000) （18401901000）
上海市中医医院未来计划中医药传承人才培育院级青年名医项目(WLJH2021ZY-MZY037) （WLJH2021ZY-MZY037）
上海中医药大学产业发展中心医养结合科创项目(YYKC-2021-01-139) （YYKC-2021-01-139）
上海市医院中药制剂产业转化协同创新中心项目(K211009N) （K211009N）
