摘要
目的:探讨正清风痛宁片对类风湿关节炎(RA)活动期患者的临床疗效及正清风痛宁片联合甲氨蝶呤是否能够成为一种联合方案有效应用至临床中。方法:本研究在7家医院风湿免疫科招募159例RA患者,并将其随机安排分为3组(每组53例),正清风痛宁片组(SIN组)予以正清风痛宁片(3粒/次,3次/d);甲氨蝶呤组(MTX组)予以MTX(4粒/次,1次/周);正清风痛宁片联合甲氨蝶呤组(SIN+MTX组)予以正清风痛宁片(3粒/次,3次/d)+MTX(4粒/次,1次/周)。在基线及干预治疗12周后进行评估,主要疗效指标为12周时达到美国风湿病学会20%缓解(ACR20)应答的患者比例,并记录晨僵、关节压痛、肿胀数等临床症状的改善程度,监测免疫炎症指标[血沉(ESR)、C反应蛋白(CRP)、类风湿因子(RF)],进行疾病活动度量化评价[视觉模拟评分(VAS)评分、基于28关节疾病活动度(DAS28)评分]及中医症状积分,评估患者生活质量。结果:94.3%(150/159)患者完成12周随访,MTX组ACR20应答率为60.78%,SIN组的ACR20应答率为61.22%,SIN+MTX组ACR20应答率为70%,优于单用药物组,但差异无统计学意义。与本组治疗前比较,3组均能降低ESR、CRP、DAS28、VAS等疾病活动度及免疫炎症指标(P<0.05,P<0.01),与SIN组和MTX组比较,SIN+MTX组VAS评分降低更明显(P<0.05)。与本组治疗前比较,3组患者中医证候及分均明显降低(P<0.05),与MTX组和SIN+MTX组比较,SIN组降低中医症状积分更为明显(P<0.05)。与本组治疗前比较,治疗后SIN组患者红细胞计数和血红蛋白明显升高(P<0.05)。随访期间,MTX组不良反应发生率为6.0%,SIN组为2.04%,SIN+MTX组为3.92%,MTX组的发生率稍高,但差异无统计学意义,SIN+MTX两药联用可能不会增加不良反应发生的风险。结论:正清风痛宁片能够有效降低RA患者免疫炎症指标及中医症状积分,减缓疾病进展,改善RA患者生活质量,提示正清风痛宁片能有效抑制RA患者的免疫炎症反应,且其疗效
Objective:To investigate the clinical efficacy of Zhengqing Fengtongning tablets(Sinomenine,SIN)in treating active rheumatoid arthritis(RA)in the patients with the syndrome of wind-cold-dampness impediment and whether the regimen of Zhengqing Fengtongning tablets combined with methotrexate can be used in clinical practice.Method:A total of 159 RA patients were recruited from the rheumatology and immunology departments of 7 hospitals and randomized into three groups(n=53):SIN(3 tablets/time,3 times/d),methotrexate tablets(MTX,4 tablets/time,1 time/week),SIN+MTX(3 tablets/time,3 times/d+4 tablets/time,1 time/week).The clinical efficacy was evaluated at baseline and after 12 weeks of intervention,with the primary efficacy index being the proportion of patients achieving an American College of Rheumatology(ACR)20 response after 12 weeks.The mitigation of clinical symptoms such as morning stiffness,joint tenderness,and swollen joint count was recorded,and immune inflammation indexes[erythrocyte sedimentation rate(ESR),C reactive protein(CRP),and rheumatoid factor(RF)]were monitored.The disease activity was assessed based on the visual analogue scale(VAS)score and disease activity based on 28 joints(DAS28)score.The traditional Chinese medicine(TCM)symptom scores were recorded to assess the patients'quality of life.Result:Among the 159 patients,150(94.3%)completed the 12-week treatment.The ACR20 response rates in the MTX and SIN group were 60.78% and 61.22%,respectively,which were lower than that(70%)in the SIN+MTX group.The treatment regimens in all the three groups reduced ESR,CRP,DAS28,and VAS,and the SIN+MTX group had lower VAS score than the SIN and MTX groups(P<0.05).Notably,the reductions in TCM symptom scores were more significant in the SIN group than in the MTX and SIN+MTX groups(P<0.05).The erythrocyte count and haemoglobin in the SIN group increased after treatment(P<0.05).During the treatment period,the incidence of adverse reactions was 6.0% in the MTX group,2.04%in the SIN group,and 3.92% in the SIN+MTX g
作者
陈君洁
孙玥
李明
黄传兵
程丽丽
汤忠富
CHEN Junjie;SUN Yue;LI Ming;HUANG Chuanbing;CHENG Lili;TANG Zhongfu(The First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230031,China;Center for Xin'an Medicine and Modernization of Traditional Chinese Medicine of IHM,Hefei 230031,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2024年第16期132-139,共8页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家自然科学基金项目(81473672)
大健康研究院新安医学与中医药现代化研究所专项(2023CXMMTCM004)
北京医学奖励基金会项目(hxjf20200012)
安徽省教育厅研究生创新创业实践项目(ahzyydx-tb83)
安徽省高校协同创新项目(GXXT-2021-085)。
关键词
类风湿关节炎
正清风痛宁片
疾病活动
疗效评估
多中心
rheumatoid arthritis
Zhengqing Fengtongning tablets
disease activity
efficacy assessment
multicenter
