Lancet. 1991 Jun 29;337(8757):1555-7.
In children with corticosteroid-responsive nephrotic syndrome who are dependent on high-dose prednisolone, alkylating therapy often fails to maintain a remission, and long-term immunosuppression may be hazardous. An alternative approach to treatment is to use an immunostimulant such as levamisole. 61 children with frequently relapsing corticosteroid sensitive and dependent nephrotic syndrome were randomly allocated to receive levamisole, 2.5 mg/kg on alternate days (31 patients) or placebo (30 patients) for a maximum of 112 days. After entry to the trial, prednisolone was progressively reduced and was stopped by 56 days. The two groups were well matched for age and sex distribution, indices of corticosteroid toxicity, and previous alkylating therapy. 14 patients in the levamisole group and 4 in the placebo group remained in remission at 112 days (log rank analysis p less than 0.01). No significant adverse events were recorded. Levamisole is effective in maintaining a steroid-free remission in this condition and has few side-effects.
对于依赖大剂量泼尼松龙的皮质类固醇反应性肾病综合征患儿,烷化剂治疗往往无法维持缓解状态,且长期免疫抑制可能存在风险。另一种治疗方法是使用免疫刺激剂,如左旋咪唑。61例频繁复发的皮质类固醇敏感型和依赖型肾病综合征患儿被随机分配,分别隔日接受2.5mg/kg左旋咪唑治疗(31例患者)或安慰剂治疗(30例患者),最长治疗112天。进入试验后,泼尼松龙逐渐减量,至56天时停用。两组在年龄、性别分布、皮质类固醇毒性指标以及既往烷化剂治疗方面匹配良好。112天时,左旋咪唑组有14例患者、安慰剂组有4例患者仍处于缓解状态(对数秩检验p值小于0.01)。未记录到显著不良事件。左旋咪唑在这种情况下能有效维持无类固醇缓解状态,且副作用较少。