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目的 评价霉酚酸酯 (MMF)治疗重症系统性红斑狼疮 (SLE)的有效性和安全性 ,探讨MMF治疗重症SLE的价值。方法 采用随机对照方法 ,并选用环磷酰胺 (CTX)作为对照。两组共治疗重症SLE 10 6例 ,其中MMF组 5 3例 ,采用激素联合MMF (1 0～ 1 5g/d)治疗 ,CTX组 5 3例 ,采用激素联合CTX冲击治疗。观察指标包括SLE疾病活动性指数、血红蛋白、血小板、2 4h尿蛋白总量、血清白蛋白、补体C3、血肌酐、抗心磷脂抗体 (aCL)、ANA、抗 dsDNA等。结果 治疗 3个月时MMF组临床观察指标均明显改善 ,CTX组只有部分指标明显改善 ,MMF组提高血红蛋白和血小板、降低尿蛋白和抗 dsDNA的作用强于CTX组。治疗 6个月时两组临床观察指标均明显改善 (P <0 0 1) ,MMF组改善程度略高于CTX组 (P >0 0 5 )。不良反应 :MMF组胃肠道症状、脱发、感染、白细胞减少、肝功能损害及停经的发生率明显低于CTX组 (P <0 0 1)。结论 MMF与CTX治疗重症SLE疗效相同 ,并略优于CTX ,MMF起效快于CTX ,MMF不良反应显著低于CTX ,MMF的风险 /效果比率较CTX低 ,是治疗重症SLE的一个值得应用的免疫干预药物
Objective To evaluate the efficacy and safety of mycophenolate mofetil (MMF) in the treatment of severe systemic lupus erythematosus (SLE) and explore the value of MMF in the treatment of severe SLE. Methods A randomized controlled trial was conducted. Cyclophosphamide (CTX) was used as a control. Totally 106 patients with severe SLE were enrolled in the two groups. Among them, 53 patients in MMF group were treated with hormones combined with MMF (10 ~ 15g / d) and CTX group with 53 patients treated with hormones combined with CTX. Observations included SLE disease activity index, hemoglobin, platelets, 24 h urine protein, serum albumin, complement C3, serum creatinine, anti-cardiolipin antibodies (aCL), ANA, anti-dsDNA and so on. Results At 3 months of treatment, the clinical observation indexes in MMF group were significantly improved. Only part of the indexes in CTX group were significantly improved. In MMF group, hemoglobin and platelet were increased, but proteinuria and anti-dsDNA were lower than CTX group. At 6 months of treatment, the clinical observation indexes of both groups were significantly improved (P <0.01), and the improvement degree of MMF group was slightly higher than that of CTX group (P> 0.05). Adverse reactions: The incidence of gastrointestinal symptoms, hair loss, infection, leukopenia, impaired liver function and menopause in MMF group were significantly lower than those in CTX group (P <0.01). Conclusion MMF and CTX have the same curative effect on severe SLE and slightly better than CTX. MMF has a faster onset of action than CTX. The adverse reactions of MMF are significantly lower than that of CTX. The risk / benefit ratio of MMF is lower than that of CTX, which is worthy of application in the treatment of severe SLE Immune intervention drugs