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目的研究白芍总苷联合甲氨蝶呤与来氟米特治疗类风湿关节炎的临床疗效及安全性。方法将70例诊断明确的RA患者随机分为治疗组和对照组,完成本次实验的仅有64例。治疗组33例给予甲氨喋呤(MTX)+来氟米特(LEF)+白芍总苷(TGP);对照组31例给予甲氨喋呤(MTX)+来氟米特(LEF)。分别于治疗0、4、8、12周观察患者关节症状改善程度及药物副作用。结果治疗第12周后疗效比较:2组ACR20、50、70分别为90%Vs 74%、70%Vs 52%、45%Vs 35%,差异均有显著意义(P<0.05)。治疗12周后,治疗组在关节肿胀、关节压痛、晨僵时间、血沉、DAS28评分等临床和实验室指标的改善均优于对照组,差异具有统计学意义(P<0.05);MTX+LEF+TGP组的肝损害低于MTX+LEF组。结论联合应用TGP治疗活动期RA,能很好的缓解患者的关节症状;且不良反应发生率低,患者依从性高。
Objective To study the clinical efficacy and safety of total glucosides of paeony plus methotrexate and leflunomide in the treatment of rheumatoid arthritis. Methods Seventy patients with diagnosed RA were randomly divided into treatment group and control group. Only 64 cases completed this experiment. Thirty-three patients in the treatment group were given methotrexate (MTX) + leflunomide (LEF) + total glycosides of paeony glycosides (TGP); control group, 31 patients were given methotrexate (MTX) + leflunomide (LEF). At 0, 4, 8, and 12 weeks after treatment, the degree of improvement of joint symptoms and side effects of drugs were observed. Results After 12 weeks of treatment, the difference was significant (P <0.05). The ACR20, 50 and 70 were 90% Vs 74%, 70% Vs 52% and 45% Vs 35% respectively. After 12 weeks of treatment, the clinical and laboratory indexes in the treatment group were better than those in the control group in swelling, joint tenderness, morning stiffness, erythrocyte sedimentation rate, DAS28 score, and the difference was statistically significant (P <0.05); MTX + LEF + TGP group of liver damage than MTX + LEF group. Conclusions The combination of TGP and active phase RA can relieve the patients ’joint symptoms well, and the incidence of adverse reactions is low and patients’ compliance is high.