Efficacy and safety of tacrolimus for lupus nephritis: a placebo-controlled double-blind multicenter study
Efficacy and safety of tacrolimus for lupus nephritis: a placebo-controlled double-blind multicenter study
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DOI：
10.1007/s10165-009-0218-5
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发表时间：
2009-12-01
影响因子：
2.2
通讯作者：
Hashimoto, Hiroshi
中科院分区：
文献类型：
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作者：
Miyasaka, Nobuyuki;Kawai, Shinichi;Hashimoto, Hiroshi
我们评价了他克莫司在接受糖皮质激素治疗的狼疮性肾炎患者中的疗效和安全性。持续性肾炎患者随机接受他克莫司（3 mg/天）或安慰剂双盲治疗28周。主要终点是狼疮性肾炎疾病活动指数（LNDAI）的变化，根据每日尿蛋白排泄、尿红细胞、血清肌酐、抗双链DNA抗体和血清补体的评分计算。使用全分析集进行统计分析。最终评估时，他克莫司组（n = 28）的LNDAI降低32.9 +/- A 31.0%（平均值+/- A SD），安慰剂组（n = 35）增加2.3 +/- A 38.2%。他克莫司组有显著改善。他克莫司组每日尿蛋白排泄量显著减少（p < 0.001）。他克莫司组的补体（C3）水平显著升高（p = 0.001）。他克莫司组治疗相关不良事件发生率为92.9%，安慰剂组为80.0%，但差异无显著性。在接受糖皮质激素治疗的狼疮性肾炎患者中，与安慰剂相比，在基础治疗基础上加用他克莫司可获得显著改善。因此，他克莫司可能是一种有用的替代治疗狼疮性肾炎。
We evaluated the efficacy and safety of tacrolimus in patients receiving glucocorticoid therapy for lupus nephritis. Patients with persistent nephritis were randomized to receive 28 weeks of double-blind treatment with tacrolimus (3 mg/day) or placebo. The primary endpoint was the change in the lupus nephritis disease activity index (LNDAI) calculated from scores for daily urinary protein excretion, urinary red cells, serum creatinine, anti-double-stranded DNA antibody, and serum complement. Statistical analysis was performed using the full analysis set. The LNDAI was decreased by 32.9 +/- A 31.0% (mean +/- A SD) in the tacrolimus group (n = 28) and was increased by 2.3 +/- A 38.2% in the placebo group (n = 35) at final evaluation. There was significant improvement in the tacrolimus group. Daily urinary protein excretion showed a significant decrease in the tacrolimus group (p < 0.001). The complement (C3) level showed a significant increase in the tacrolimus group (p = 0.001). Treatment-related adverse events occurred in 92.9% of the tacrolimus group and 80.0% of the placebo group, but the difference was not significant. In patients on glucocorticoid therapy for lupus nephritis, addition of tacrolimus to basal therapy achieved significant improvement compared with placebo. Tacrolimus may therefore be a useful alternative treatment for lupus nephritis.