吗替麦考酚酯治疗系统性红斑狼疮的多中心前瞻性研究

A multicentric and prospective study on mycophenolate mofetil in the treatment of systemic lupus erythematosus

目的 观察吗替麦考酚酯 (骁悉 )治疗系统性红斑狼疮的疗效及安全性。方法 通过观察治疗前后狼疮病情活动指数 (SLEDAI)、2 4h尿蛋白定量等指标的变化 ,对比分析骁悉与环磷酰胺的疗效和安全性。结果 6 8例SLE患者完成为期 6个月的研究 ,骁悉组 36例 ,环磷酰胺 (CTX)组 32例。骁悉组SLEDAI由治疗前的 2 0± 8减少至治疗后 4± 3(P <0 0 1) ,CTX组由 2 1± 6减少至 7± 8(P <0 0 1) ,治疗后两组对比实验组改善较对照组明显 (P <0 0 1)。尿蛋白的变化 :骁悉组由 (3 2±2 8)g降至 (1 1± 1 1)g (P <0 0 1) ,环磷酰胺组由 (2 6± 2 4 )g降至 (1 3± 1 4 )g (P <0 0 1) ,治疗后两组对比差异无显著性 (P >0 0 5 )。总有效率骁悉组为 97 2 % (35 / 36 ) ,环磷酰胺组为 93 8% (30 / 32 )(P >0 0 5 )。骁悉组的副作用发生率为 2 2 2 % (8/ 36 ) ,环磷酰胺组为 6 9 7% (2 3/ 33) (P <0 0 5 )。结论 骁悉作为一种免疫抑制剂治疗SLE和环磷酰胺一样有效 ,并且安全性更高 ,对于CTX无效的患者亦有效。

Objective To observe the effect and safety of mycophenolate mofetil(cellcept)in the treatment of systemic lupus erythematosus (SLE) patients. Methods SLE disease activated index (SLEDAI) and proteinuria of SLE patients were analyzed after 6 months of treatment with cellcept and CTX.The side effect was recorded.Results Sixty eight patients were enrolled with 36 in cellcept group and 32 in CTX group.After 6 months of treatment,SLEDAI was decreased from 20±8 to 4±3 in cellcept group ( P <0 01),and form 21±6 to 7±8 in CTX group ( P <0 01).Proteinuria was reduced from (3 2±2 8) g to (1 1±1 1) g in cellcept group ( P <0 01),and from(2 6±2 4) g to (1 3±1 4) g in CTX group ( P <0 01).The effective rate was 97 2% in cellcept group and 93 8% in CTX group ( P >0 05).Side effects were recorded in 22 2%(8/36) of patients with cellcept,and in 69 7%(23/33) patients with CTX ( P <0 05).Conclusion Cellcept was as effective as CTX in treatment of SLE with better safety profile.Furthermore,cellcept could be used in the SLE patients who have no response to CTX.