BACKGROUND While patients with frequently relapsing nephrotic syndrome (FRNS) are initially treated with long-term alternate-day prednisolone, relapses and adverse effects are common. In an open-label randomized controlled trial, we compared the efficacy of therapy with low-dose daily to standard alternate-day prednisolone in reducing relapse rates over 12-month follow-up. METHODS Consecutive patients, aged 2-18 years, with FRNS were included. Following therapy of relapse, prednisolone was tapered to 0.75 mg/kg on alternate days. Stratifying for steroid dependence, patients were randomly assigned to prednisolone at 0.2-0.3 mg/kg daily or 0.5-0.7 mg/kg alternate day for 12 months. Relapses were treated with daily prednisolone, followed by return to intervention. Primary outcome was the incidence of relapses. Proportion with therapy failure (≥ 2 relapses in any 6 months or significant steroid toxicity) and sustained remission, cumulative prednisolone intake and adverse events were evaluated. RESULTS Patients receiving daily prednisolone (n = 30) showed significantly fewer relapses than those on alternate-day therapy (n = 31) (0.55 relapses/person-year versus 1.94 relapses/person-year; incidence rate ratio 0.28; 95% CI 0.15, 0.52). Daily therapy was associated with higher rates of sustained remission at 6 months (73.3 versus 48.4%) and 1 year (60 versus 31.6%; log rank p = 0.013), lower rates of treatment failure at 6 months (3.3 versus 32.8%) and 1 year (6.7 versus 57.4%; p < 0.0001), and lower prednisolone use (0.27 ± 0.07 versus 0.39 ± 0.19 mg/kg/day; p = 0.003). Three and two patients need to receive the study intervention to enable sustained remission and prevent treatment failure, respectively. CONCLUSIONS In patients with FRNS, daily administration of low-dose prednisolone is more effective than standard-dose alternate day therapy in lowering relapse rates, sustaining remission, and enabling steroid sparing.

中文翻译：

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低剂量的每日泼尼松龙与隔日强的松龙在频繁复发的肾病综合征中的疗效：一项开放标签的随机对照试验。

背景技术虽然经常使用长期交替的泼尼松龙对患有频繁复发性肾病综合征（FRNS）的患者进行治疗，但复发和不良反应很常见。在一项开放标签的随机对照试验中，我们比较了每日低剂量泼尼松龙与标准隔天泼尼松龙治疗在降低12个月随访中的复发率方面的功效。方法纳入2〜18岁连续性FRNS患者。复发治疗后，泼尼松龙在隔日逐渐减少至0.75 mg / kg。为使类固醇依赖，对患者随机分配泼尼松龙，剂量为每天0.2-0.3 mg / kg或隔天0.5-0.7 mg / kg，持续12个月。每天用泼尼松龙治疗复发，然后恢复干预。主要结局是复发的发生率。评估治疗失败的比例（在任何6个月内≥2次复发或明显的类固醇毒性）和持续缓解，累计泼尼松龙摄入量和不良事件的比例。结果每日接受泼​​尼松龙（n = 30）的患者复发率显着低于隔日疗法（n = 31）（0.55复发/人年对1.94复发/人年；发生率0.28; 95％CI 0.15 ，0.52）。每日治疗与6个月（73.3 vs 48.4％）和1年（60 vs 31.6％; log rank p = 0.013）的持续缓解率更高，6个月治疗失败率较低（3.3 vs 32.8％）和1年（6.7比57.4％； p <0.0001），泼尼松龙的使用量更低（0.27±0.07比0.39±0.19 mg / kg /天； p = 0.003）。三名和两名患者需要接受研究干预，以分别实现持续缓解和预防治疗失败。结论在FRNS患者中，低剂量泼尼松龙的每日给药比标准剂量的隔日治疗在降低复发率，维持缓解和减少类固醇方面更有效。