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目的探讨双醋瑞因(Diacerein)联合甲氨喋呤(MTX)及单用甲氨蝶呤治疗类风湿关节炎的疗效、细胞因子变化及安全性。方法符合纳入及排除标准的类风湿关节炎120例随机数字表法分为单用甲氨喋呤(10mg/周)组、双醋瑞因联合甲氨喋呤治疗组(Diacerein50mg/次,每日2次+MTX10mg/周),n=60。总疗程52周,在2、6、26、52周进行疗效、细胞因子变化及安全性评价,以ACR20作为主要疗效指标,ACR50作为次要疗效指标。结果治疗2、6、26、52周2组达ACR20%的患者比例,治疗组:20.3%(12/59)、40.7%(24/59)、81.4%(48/59)、91.5%(54/59),对照组:1.7%(1/59)、22.0%(13/59)、59.3%(35/59)、71.2%(42/59),治疗组明显高于对照组,差异有统计学意义(P<0.05);达ACR50%的患者比例,治疗组:0%(0/59)、13.6%(8/59)、50.8%(30/59)、83.1%(49/59),对照组:0%(0/59)、0%(0/59)、39.0%(23/59)、59.3%(35/59),治疗组明显高于对照组,自第6周起差异有统计学意义(P<0.01,P<0.05)。52周时双醋瑞因联合甲氨喋呤组疼痛、患者对自身健康状况的总体评估(PGA)、健康评价(HAQ)、血沉(ESR)、C反应蛋白(CRP)、IL-1、IL-6、TNF-α的改善和变化高于单用甲氨喋呤组(P<0.01,P<0.05)。结论双醋瑞因联合甲氨喋呤治疗类风湿关节炎能显著改善其症状及实验室指标,疗效明显优于单用甲氨蝶呤组,并且起效快、安全性好,不增加不良反应的发生率。
Objective To investigate the efficacy, cytokine changes and safety of Diacerein in combination with methotrexate (MTX) and methotrexate alone in the treatment of rheumatoid arthritis. Methods One hundred and twenty patients with rheumatoid arthritis who met the inclusion and exclusion criteria were randomly divided into methotrexate (10mg / week) group, Diacerein combined with methotrexate (Diacerein 50mg / time, daily 2 times + MTX 10 mg / week), n = 60. The total course of treatment was 52 weeks, and the curative effect, cytokine changes and safety evaluation were performed at 2,6,26,52 weeks. ACR20 was taken as the main efficacy index and ACR50 as the secondary efficacy index. Results The proportion of patients with ACR 20% in group 2 at 2, 6, 26 and 52 weeks after treatment was 20.3% (12/59), 40.7% (24/59), 81.4% (48/59) and 91.5% / 59), control group: 1.7% (1/59), 22.0% (13/59), 59.3% (35/59) and 71.2% (42/59) respectively. The treatment group was significantly higher than the control group (P <0.05); The proportion of patients with ACR of 50%, the treatment group: 0% (0/59), 13.6% (8/59), 50.8% (30/59), 83.1% Control group: 0% (0/59), 0% (0/59), 39.0% (23/59) and 59.3% (35/59) respectively. The treatment group was significantly higher than that of the control group Statistical significance (P <0.01, P <0.05). After 52 weeks, the patients were treated with the combination of methotrexate and diacerein, the patients’ overall assessment of health status (PGA), health assessment (HAQ), ESR, CRP, IL-1 and IL-6 The improvement and change of TNF-α were higher than that of methotrexate alone (P <0.01, P <0.05). Conclusion Diacerein combined with methotrexate in the treatment of rheumatoid arthritis can significantly improve its symptoms and laboratory parameters, the effect was significantly better than methotrexate alone group, and rapid onset, good safety, without increasing adverse reactions The incidence of.