摘要
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 。
Objective To evaluate the therapeutic effects and side effects of MMF on severe SLE patients compared with CTX.Method All 106 severe SLE patients were randomly allocated to 2 groups:MMF treatment group (53 patients):1 5 g/d for 3 months,1 0 g/d for following 3 months,and then 0 5~0 75 g/d;IVCTX treatment group:0 75 g/m 2 per month for 6~12 months.Prednisone was used in all patients.Clinical and laboratory parameters including SLE DAI,Hb,platelet,urine protein,albumin,SCr,aCL,ANA and anti dsDNA were observed.Results After 3 month treatment,all clinical and laboratory parameters were significantly improved in MMF group,while only partial parameters were improved in CTX group.Hb and platelet increased and urine protein and anti dsDNA decreased faster in MMF group than in CTX group.At month 6 the clinical and laboratory parameters improved significantly in both groups ( P <0 01).Side effect incidence such as digestive tract reaction,infection,leukopenia,hairloss,liver dysfunction,menopause,was less in MMF group than in CTX group ( P <0 01).Conclusion Like CTX,MMF is effective for severe SLE, but its action appears more quickly and its side effects occur less than those of CTX,suggesting that MMF can be used as an alternative immuno suppressive drug in severe SLE.
出处
《中华风湿病学杂志》
CAS
CSCD
2001年第5期313-316,共4页
Chinese Journal of Rheumatology