Clinical trial of focal segmental glomerulosclerosis in children and young adults.
Clinical trial of focal segmental glomerulosclerosis in children and young adults.
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DOI：
10.1038/ki.2011.195
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发表时间：
2011-10
影响因子：
19.6
通讯作者：
中科院分区：
文献类型：
--
作者：
这项由NIH资助的局灶节段性肾小球硬化（FSGS）治疗的多中心随机研究比较了12个月疗程的环孢素与口服脉冲地塞米松和吗替麦考酚酯联合治疗激素耐药的儿童和成人原发性FSGS的疗效。在入组的192例患者中，138例被随机分配至环孢霉素组（72例）或霉酚酸酯/地塞米松组（66例）。主要分析比较了第一年期间测量缓解的有序变量的水平。与环孢霉素相比，霉酚酸酯/地塞米松达到至少部分缓解的比值比（0.59）不显著。在12个月时，22例霉酚酸酯/地塞米松和33例环孢素治疗的患者获得部分或完全缓解。主要的次要结局，即停止治疗后缓解持续26周，在这两种治疗之间没有显著差异。在整个78周的研究期间，8例接受环孢素治疗的患者和7例接受霉酚酸酯/地塞米松治疗的患者死亡或发生肾衰竭。因此，我们的研究没有发现在类固醇耐药FSGS患者中，环孢素与霉酚酸酯/地塞米松治疗12个月后蛋白尿缓解率的差异。然而，样本量小可能会妨碍检测到中度治疗效应。
This NIH-funded multicenter randomized study of focal segmental glomerulosclerosis (FSGS) treatment compared the efficacy of a 12-month course of cyclosporine to a combination of oral pulse dexamethasone and mycophenolate mofetil in children and adults with steroid-resistant primary FSGS. Of the 192 patients enrolled, 138 were randomized to cyclosporine (72) or to mycophenolate/dexamethasone (66). The primary analysis compared the levels of an ordinal variable measuring remission during the first year. The odds ratio (0.59) for achieving at least a partial remission with mycophenolate/dexamethasone compared to cyclosporine was not significant. Partial or complete remission was achieved in 22 mycophenolate/dexamethasone- and 33 cyclosporine-treated patients at 12 months. The main secondary outcome, preservation of remission for 26 weeks following cessation of treatment, was not significantly different between these two therapies. During the entire 78 weeks of study, 8 patients treated with cyclosporine and 7 with mycophenolate/dexamethasone died or developed kidney failure. Thus, our study did not find a difference in rates of proteinuria remission following 12 months of cyclosporine compared to mycophenolate/dexamethasone in patients with steroid-resistant FSGS. However, the small sample size might have prevented detection of a moderate treatment effect.
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影响因子：
13.3
作者：
Moranne, O.;Watier, L.;Stengel, B.
通讯作者：
Stengel, B.
影响因子：
6.1
作者：
Nayagam, Lakshmanan Senthil;Ganguli, Anirban;Jha, Vivekanand
通讯作者：
Jha, Vivekanand
影响因子：
19.6
作者：
通讯作者：
--
影响因子：
13.2
作者：
RYDEL, JJ;KORBET, SM;SCHWARTZ, MM
通讯作者：
SCHWARTZ, MM
影响因子：
6.1
作者：
Alexopoulos, E;Stangou, M;Papadimitriou, M
通讯作者：
Papadimitriou, M