摘要
目的评估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(RA)的有效性和安全性。方法选择2021年10月—2023年10月就诊于上海市中医医院的90例肝肾阴虚、寒湿痹阻型RA患者,根据软件生成的随机序列将患者分为2组,且对实验药物和对照药物进行编盲处理。治疗组45例给予羌活地黄颗粒+穴位敷贴+甲氨蝶呤治疗,对照组45例给予安慰剂中药颗粒+穴位敷贴方安慰剂+甲氨蝶呤治疗,2组均连续治疗12周。观察比较2组治疗前后肿胀和疼痛关节数、疼痛评分、28个关节疾病活动度评分(DAS28)、中医证候积分、实验室指标[血沉(ESR)、C反应蛋白(CRP)、类风湿因子(RF)、25-羟维生素D[25(OH)D]水平]、患者报告的临床结局(PRO)量表评分、健康评定问卷(HAQ)评分,统计2组治疗12周后的ACR应答率、中医证候疗效,记录2组患者治疗期间激素撤减情况和不良反应发生情况。结果治疗组44例、对照组42例完成研究。与治疗前比较,治疗后治疗组患者肿胀、疼痛关节数均明显减少(P均<0.05),医生VAS评分、患者VAS评分、DAS28评分、关节冷痛肿胀或重着评分、关节屈伸不利评分、晨僵评分、腰膝酸软评分、PRO评分、HAQ评分及ESR、CRP、RF水平均明显降低(P均<0.05),血清25(OH)D水平明显升高(P<0.05);对照组患者肿胀、疼痛关节数均明显减少(P均<0.05),DAS28评分、关节冷痛肿胀或重着评分、关节屈伸不利评分、晨僵评分、潮热盗汗评分和ESR、CRP水平均明显降低(P均<0.05)。治疗后组间比较,治疗组肿胀、疼痛关节数均明显少于对照组(P均<0.05),DAS28评分、关节冷痛肿胀或重着评分、关节屈伸不利评分、晨僵评分、HAQ评分均明显低于对照组(P均<0.05)。治疗结束时治疗组和对照组ACR20应答率分别为50.0%(22/44)和28.6%(12/42),激素撤减率分别为46.7%(7/15)和28.6%(4/14),中医证候治疗总有效率分别为86.4%(38/44)和66.7%(28/42),不良反应发生率分别为9.1%(4/44)和21.4%(9/42),治疗组ACR20应答率和中医证候治疗总有效率均明显高于对照组(P均<0.05),2组激素撤减率和不良反应发生率比较差异均无统计学意义(P均>0.05)。结论羌活地黄颗粒联合穴位敷贴治疗肝肾阴虚、寒湿痹阻型RA患者有助于减轻关节肿胀、疼痛和中医证候,降低疾病活动度,提高ACR20应答率,疗效确切且安全。
Objective It is to evaluate the efficacy and safety of Qianghuo Dihuang granules combined with acupoint application in the treatment of rheumatoid arthritis(RA)with syndrome of liver-kidney Yin deficiency and cold-dampness impediment obstruction.Methods Ninety RA patients with syndrome of liver-kidney Yin deficiency and cold-dampness impediment 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 treated 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 assessment 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 extension,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 were 50.0%(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 adverse 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.
作者
刘智超
陈薇薇
LIU Zhichao;CHEN Weiwei(Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China)
出处
《现代中西医结合杂志》
2025年第6期757-763,共7页
Modern Journal of Integrated Traditional Chinese and Western Medicine
基金
上海市科学技术委员会科研计划项目(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)
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)
上海市医院中药制剂产业转化协同创新中心项目(K211009N)。
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
rheumatoid arthritis
Qiangwu Dihuang granules
acupoint application
Yin deficiency of liver and kidney
cold-dampness impediment obstruction
