补肾抗痹汤联合甲氨蝶呤治疗类风湿性关节炎的疗效与安全性

发布时间：2019-02-13 17:08

【摘要】：研究目的:观察补肾抗痹汤联合甲氨蝶呤治疗类风湿性关节炎的疗效与安全性。研究方法:临床选取符合美国风湿病学会(ACR)和欧洲抗风湿联盟(RULAR)2010年联合推出RA分类诊断标准且病情处于中度以上活动期(DAS28评分3.2)的患者78例,随机分为两组(治疗组和对照组),每组各39例,治疗组采用补肾抗痹汤联合甲氨蝶呤治疗,对照组采用甲氨蝶呤联合来氟米特治疗,观察并记录两组患者治疗前及治疗后16周(8周为一疗程,共两个疗程)后关节压痛计数、关节肿胀计数、疼痛视觉模拟评分(VAS)、患者对病情的总体评估(Pt GA)、医生对病情的总体评估(Ph GA)、健康评估问卷(HAQ)及实验室指标:血常规、尿常规、肝肾功能、类风湿因子(RF)、抗CCP抗体、血沉(ESR)、C反应蛋白(CRP),并比较两组治疗后ACR20、ACR50、ACR70缓解率及治疗前后DAS28平均值的变化。研究结果:78例类风湿性关节炎患者均完成了为期16周的研究,补肾抗痹汤联合甲氨蝶呤组以下称治疗组及甲氨喋吟联合来氟米特组以下称对照组各39例。在疾病疗效方面,两组在疗程8周、16周时无显著性差异,在实验室指标方面如:ESR、CRP、RF方面两组对比无统计学差异,抗CCP两组在治疗8周后无显著性差异,但在治疗16周后治疗组抗CCP平均值较对照组低,并且差异有统计学意义。在毒副作用方面,治疗组与对照组在治疗后的肝肾功能异常发生情况比较无显著差异。两组中出现消化道不适症状不良反应方面,治疗组与对照组比较无显著性差异,在白细胞下降发生方面,治疗组远远低于对照组,差异有统计学意义,且对照组出现显著脱发6例,治疗组无脱发不良反应出现,差异有统计学意义。结论:补肾抗痹汤联合甲氨蝶呤治疗类风湿性关节炎疗效确切,安全性高。
[Abstract]:Objective: to observe the efficacy and safety of Bushen Kangbi decoction combined with methotrexate in the treatment of rheumatoid arthritis. Methods: a total of 78 patients who met the requirements of the American Rheumatology Society (ACR) and the European Union against Rheumatism (RULAR) in 2010 were enrolled in the study. 78 patients with moderate or more active phase (DAS28 score 3.2) were enrolled in the study. They were randomly divided into two groups (treatment group and control group) with 39 cases in each group. The treatment group was treated with Bushen Kangbi decoction combined with methotrexate, while the control group was treated with methotrexate combined with leflunomide. To observe and record the joint tenderness count, joint swelling count, pain visual analogue score (VAS),) in both groups before and 16 weeks after treatment (8 weeks as a course of treatment, two courses of treatment). (Pt GA), Doctor's overall assessment of the condition (Ph GA), health assessment questionnaire (HAQ) and laboratory indicators: routine blood routine urine routine liver and kidney function rheumatoid factor (RF), anti CCP antibody ESR (ESR), C reactive protein (CRP), The remission rate of ACR20,ACR50,ACR70 and the changes of DAS28 before and after treatment were compared between the two groups. Results: 78 cases of rheumatoid arthritis were studied for 16 weeks, 39 cases in each group were treated with Bushen Kangbi decoction combined with methotrexate group and 39 cases in methotrexate combined with leflunomide group. There was no significant difference between the two groups in the course of treatment for 8 weeks and 16 weeks, but there was no significant difference between the two groups in laboratory indexes such as ESR,CRP,RF, and no significant difference between the two groups after 8 weeks of treatment. But after 16 weeks of treatment, the average value of anti-CCP in the treatment group was lower than that in the control group, and the difference was statistically significant. There was no significant difference in the incidence of liver and kidney dysfunction between the treatment group and the control group. There was no significant difference between the treatment group and the control group in the occurrence of leukopenia in the treatment group, which was significantly lower than that in the control group. There were 6 cases of alopecia in the control group and 6 cases in the treatment group without alopecia, the difference was statistically significant. Conclusion: Bushen Kangbi decoction combined with methotrexate is effective and safe in the treatment of rheumatoid arthritis.
【学位授予单位】：南昌大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R593.22

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