医学论文-他克莫司治疗狼疮性肾炎的前瞻性研究.docVIP

医学论文-他克莫司治疗狼疮性肾炎的前瞻性研究 ????????????????? 作者：徐安平， 吕军， 梁艳仪， 王珍， 李劲高， 宛霞， 赖德源， 黄湖辉 【摘要】? 【目的】 前瞻性比较观察他克莫司（FK506）与传统疗法环磷酰胺（CTX）静脉冲击联合激素诱导治疗狼疮性肾炎（LN）的临床疗效。 【方法】 40例经肾活检诊断为Ⅲ、Ⅳ、Ⅴ型肾功能正常的活动性LN患者，尿蛋白定量≥1.5 g/24 h，随机分为他克莫司组20例[他克莫司起始剂量为0.1 mg/（kg·d）]和传统疗法组20例（CTX 1 g/月×6月），同时口服泼尼松1 mg /（kg·d），比较两组治疗3、6个月的临床疗效。疗效评价分为完全缓解（CR），部分缓解（PR）及无效（NR）。【结果】 治疗3个月内他克莫司组有3例退出，传统疗法组有4例退出。诱导治疗3个月他克莫司组的总有效率(76%，CR 5/17,PR 8/17)显著高于传统疗法组(37.5%，CR 2/16,PR 4/16，P＜ 0.05)。治疗6个月他克莫司组和传统疗法组的总有效率分别为88.2%( CR 11/17, PR 4/17)和62.5%(CR 5/16, PR 5/16)。治疗3个月及6个月，他克莫司组在水肿消退、尿蛋白水平下降、血清白蛋白升高、SLEDAI减少等方面与传统疗法比较，均有显著差异（P＜ 0.05)，而且出现副反应较传统疗法组为少。【结论】 与传统疗法相比，他克莫司联合激素是一种快速有效地诱导LN缓解的治疗方法。 【关键词】? 狼疮肾炎； 他克莫司； 环磷酰胺； 诱导治疗 ??? Abstract：【Objective】 To evaluate the efficacy of tacrolimus as the induction therapy in the patients with lupus nephritis (LN). 【Methods】 A prospective study was conducted in 40 patients with urinary protein excretion ≥1.5 g/d, normal renal function and class Ⅲ,Ⅳ,Ⅴ of LN proven by renal biopsy. They are randomly assigned to either tacrolimus 0.1 mg (/kg·d) for 6 months or intravenous cyclophosphamide (CTX) 1 g monthly for 6 month in addition to corticosteroids. The baseline characteristics between the two groups were no significant differences and the efficacy were compared. Clinical efficacy was defined as comlplete remission (CR), partial remission (PR), and no-response (NR). 【Results】 There were 3 patients in tacrolimus group and 4 patients in CTX group that withdraw from the study for 3 month treatment. The remission rate after 3 months in tacrolimus group (76%，CR 5/17,PR 8/17) was significantly higher than that of CTX group(37.5%，CR 2/16,PR 4/16). The remission occurred in 15 out of 17 patients (88.2%，CR 11/17,PR 4/17) in the tacrolimus group and 10 out of 16 patients (62.5%，CR 5/16, PR 5/16) in the CTX group at 6 months. Tacrolimus as induction therapy was found to be more effective in improvement of the edema, proteinuria, serum albumin and SLEDAI, and better tolerated with less adverse eff