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机构地区:[1]大同市第五人民医院风湿免疫科,山西大同037006
出 处:《山西大同大学学报(自然科学版)》2012年第1期52-55,共4页Journal of Shanxi Datong University(Natural Science Edition)
摘 要:目的评价甲氨喋呤(MTX)联合来氟米特(LEF)及单用MTX治疗类风湿关节炎(RA)的疗效和安全性。方法90例患者随机分为两组:甲氨蝶呤联合来氟米特组(45例),甲氨蝶呤每周定量口服7.5 mg~10 mg 1次,来氟米特20 mg每日1次;单用甲氨蝶呤组(45例),甲氨蝶呤每周10 mg~15 mg 1次,疗程分别为12周及24周。以ACR20为主要评价指标,ACR50、关节疼痛指数、关节肿胀数目、晨僵时间、患者对疼痛的评价(VAS)、患者对疾病活动性的总体评价(VAS)、医生对疾病活动的总体评价(VAS)、健康评估问卷(HAQ)、血沉(ESR)、C反应蛋白(CRP)具体观察指标为次要评价指标。结果联合用药组ACR20及各具体观察指标与单药组比较差异有显著性(P<0.05);ACR50联合用药组高于单药组,但无统计学差异(P>0.05)。两组之间不良反应发生率差异无统计学意义。结论MTX联合LEF治疗能显著改善RA症状、体征和实验室炎性指标,疗效优于单用MTX;两者联合治疗安全性耐受性好,与单用MTX相比并不增加不良反应的发生率。Objective: To evaluate the efficacy and safety of methotrexate (MTX) combined with fluorine milt (LEF) and MTX alone in the treatment o'f rheumatoid arthritis (RA). Methods: 90 patients were randomly divided to two groups, and 45cases in the methotrexate (MTX) combined with fluorine milt (LEF) were treated by methotrexate (MTX) 7.5-10 mg once a day and fluorine milt (LEF) 20rag once a day. 45 cases in the methotrexate (MTX) alone group were treated by methotrexate (MTX) 10-15 mg once a week, and the treatment procedures were 12 weeks and 24 weeks. We regarded ACR20 as assessing items, ACR50, the index of joint pain, the number of joint swelling, the time of morning stiffness, the evaluation of pain patients (VAS), the total evaluation of patients on the disease activity (VAS), the overall evaluation of doctor on the disease activity (VAS), the questionnaire of health assessment (HAQ), Erythrocyte Sedimentation Rate (ESR) and the specific indicators of C reactive protein (CRP) as the unimportant evaluation index. Results: The comparative differences between combination group ACR20 with the specific indicators and the single drug group have statistical significance (P〈0.05); ACR50 was higher in combination group than in single drug group. But there was no statistical significance between them (P〉0.05). The incidence rate of adverse effect between the two groups has no statistical significance. Conclusions: MTX associated with LEF could improve RA signs, symptoms and the index of laboratory inflammatory and its effects is superior to MTX alone. The combination therapy has superior tolerability and well safety. As compared with using MTX alone, the incidence rate of adverse reaction would not increase.
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