单用泼尼松及联用吗替麦考酚酯、硫唑嘌呤治疗天疱疮近期临床观察

Prospective study of three treatment regimens for pemphigus

目的:观察泼尼松(P)联合吗替麦考酚酯(MMF)、泼尼松联合硫唑嘌呤(AZA)及单纯使用泼尼松治疗天疱疮的近期疗效及安全性。方法:采用随机对照方法进行观察。选择首次就诊经皮肤活检行组织病理及直接免疫荧光确诊的天疱疮患者42例,随机分为泼尼松联合MMF治疗组(P+MMF组,n=14),单纯使用泼尼松治疗组(P组,n=14)和泼尼松联合AZA治疗组(P+AZA组,n=14),均接受基础(对症支持预防等)治疗。观察治疗前及治疗6个月后皮损变化情况[病情严重程度评分、ABSIS(autoimmune bnullous skin disorder intensity score)评分]、药物使用情况(泼尼松使用剂量及减量情况)、起效时间(第一次泼尼松减量时间、皮损全部消退时间)、有效率、复发率以及不良反应等,对比分析3组的疗效及安全性。结果:3组完成随访观察病例数分别为14(P+MMF组)、13(P组)、14(P+AZA组)例;3组及3组间泼尼松初始量、减少量差异无统计学意义(P>0.05);3组泼尼松控制量差异无统计学意义(P>0.05),但P+MMF组和P组、P+MMF组和P+AZA组间差异有统计学意义(P<0.05);3组观察结束时泼尼松剂量、泼尼松累积总剂量差异有统计学意义(P<0.05),但P组和P+AZA组间差异无统计学意义(P<0.05)。3组及3组间皮损全部消退时间差异无统计学意义(P>0.05)。3组首次泼尼松减量时间、泼尼松减至2/3最大控制量的时间经方差分析显示差异无统计学意义(P>0.05),但P+MMF组和P组间首次泼尼松减量时间、泼尼松减至2/3最大控制量的时间差异有统计学意义(P<0.05)。3组及3组间有效率、复发率、不良反应差异无统计学意义(P>0.05)。结论:3种疗法治疗天疱疮近期疗效和安全性相似,但泼尼松联合MMF组比单纯使用泼尼松组和泼尼松联合AZA组需要更小的泼尼松控制量,还可加快泼尼松减量,减少泼尼松累积使用量。

Objectives： To observe the efficacy and safety of prednisone combined with mycophenolate mofetil （MMF） （P＋MMF group）, prednisone alone （P group） and prednisone combined with azathioprine （AZA） （P＋AZA group） in the treatment of pemphigus. Methods： Total 42 patients with pemphigus confirmed by histopathology were randomly divided into three groups, i.~ P＋MM, P, P＋ AZA and P, 14 patient per group. The severity index, autoimmune bullous skin disorder intensity score （ABSIS）, response time, drug doses, efficacy and side effects were analyzed ＇after 6 months of treatment with three treatment regimens. Results： Except one patient in P groups, all others completed the full 6-month study. There were no significant differences in initial steroid dose~ steroid tapering doses, disease-controlled maximal steroid doses and lesion clearance times among the three groups （P〉O.05）. The differences in disease--controlled maximal steroid doses between P＋MMF and P or between P＋MMF and P＋AZA were significant （P〈O.05）. The end doses and total doses of steroid were significantly different among the three groups （P〈0.05）, but not different between P and P＋ AZA group. Times of initial steroid dose reduction and reduced to 2/3 of disease--controlled maximal doses were no differences among the three groups except between P＋MMF and P, which differences were significant. The total effective rates, side effects and recurrence rates were not significantly different among the 3 groups （P〉O.05）. Conclusions： The efficacy and safety of 3 treatment regimens are similar. Prednisone combined with MMF requires a lower maintenance dose of steroid with earlier dose reduction and lower total steroid dosage than prednisone or prednisone combined with AZA.