Effective and safe treatment with cyclosporine in nephrotic children: A prospective, randomized multicenter trial
Effective and safe treatment with cyclosporine in nephrotic children: A prospective, randomized multicenter trial
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DOI：
10.1038/ki.2008.24
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发表时间：
2008-05-01
影响因子：
19.6
通讯作者：
Honda, M.
中科院分区：
文献类型：
--
作者：
Ishikura, K.;Ikeda, M.;Honda, M.
我们进行了一项前瞻性、开放性、多中心临床试验，以评价环孢素治疗儿童频繁复发性肾病综合征的疗效和安全性。患者被随机分为两组，两组最初均接受环孢素治疗6个月，以维持全血谷浓度在80至100 ng/ml之间。在接下来的18个月内，调整剂量以维持A组中略低（60- 80 ng/ml）的谷水平，而B组接受2.5 mg/kg/天的固定剂量。主要终点是基于意向治疗原则分析的持续缓解率。2年后，A组的持续缓解率显著高于B组，而复发风险比显著低于B组。轻度肾小动脉玻璃样变性在A组比B组更常见，但没有患者被诊断为条纹状间质纤维化或肾小管萎缩。我们的结论是，给予环孢素维持目标谷水平是一种有效的和相对安全的治疗儿童频繁复发性肾病综合征。
We conducted a prospective, open-label multicenter trial to evaluate the efficacy and safety of treating children with frequently relapsing nephrotic syndrome with cyclosporine. Patients were randomly divided into two groups with both initially receiving cyclosporine for 6 months to maintain a whole-blood trough level between 80 and 100 ng/ml. Over the next 18 months, the dose was adjusted to maintain a slightly lower (60-80ng/ml) trough level in Group A, while Group B received a fixed dose of 2.5mg/kg/day. The primary end point was the rate of sustained remission with analysis based on the intention-to-treat principle. After 2 years, the rate of sustained remission was significantly higher while the hazard ratio for relapse was significantly lower in Group A as compared with Group B. Mild arteriolar hyalinosis of the kidney was more frequently seen in Group A than in Group B, but no patient was diagnosed with striped interstitial fibrosis or tubular atrophy. We conclude that cyclosporine given to maintain targeted trough levels is an effective and relatively safe treatment for children with frequently relapsing nephrotic syndrome.