Abstract：
BACKGROUND: Levamisole is less expensive and has a better toxicity profile compared to other steroid sparing agents used in nephrotic syndrome. It has a plasma half-life of 2.0 to 5.6 hours, but is conventionally administered on alternate days. We aimed to assess whether daily levamisole is safe and more effective than standard alternate-day therapy in maintaining remission in children with frequently relapsing or steroid-dependent nephrotic syndrome (FR/SDNS).
METHODS: An open-label randomized controlled trial was conducted in children with FR/SDNS. Group A received daily while Group B received alternate-day levamisole (2-3 mg/kg/dose) for 12 months. Prednisolone was tapered off by 3 months. Patients were monitored for relapses, further steroid requirement, and adverse effects.
RESULTS: A total of 190 children with FR/SDNS (94 in Group A and 96 in Group B) were analyzed. Sustained remission for 12 months was observed in 36% of Group A and 27% of Group B patients (p = 0.18). Numbers completing 12 months in the study were 67% in Group A and 56% in Group B (p = 0.13). Time to first relapse, persistent FR/SDNS, and withdrawal due to poor compliance were statistically similar in both groups, while relapse rate and cumulative steroid dosage were significantly lower in Group A compared to Group B (p = 0.03 and p = 0.02, respectively). The incidence of adverse effects was comparable in both groups, with reversible leucopenia and hepatic transaminitis being the commonest.
CONCLUSIONS: Daily levamisole therapy was not superior to alternate-day therapy in maintaining sustained remission over 12 months. Nevertheless, relapse rate and cumulative steroid dosage were significantly lower without increased adverse effects.
METHODS: An open-label randomized controlled trial was conducted in children with FR/SDNS. Group A received daily while Group B received alternate-day levamisole (2-3 mg/kg/dose) for 12 months. Prednisolone was tapered off by 3 months. Patients were monitored for relapses, further steroid requirement, and adverse effects.
RESULTS: A total of 190 children with FR/SDNS (94 in Group A and 96 in Group B) were analyzed. Sustained remission for 12 months was observed in 36% of Group A and 27% of Group B patients (p = 0.18). Numbers completing 12 months in the study were 67% in Group A and 56% in Group B (p = 0.13). Time to first relapse, persistent FR/SDNS, and withdrawal due to poor compliance were statistically similar in both groups, while relapse rate and cumulative steroid dosage were significantly lower in Group A compared to Group B (p = 0.03 and p = 0.02, respectively). The incidence of adverse effects was comparable in both groups, with reversible leucopenia and hepatic transaminitis being the commonest.
CONCLUSIONS: Daily levamisole therapy was not superior to alternate-day therapy in maintaining sustained remission over 12 months. Nevertheless, relapse rate and cumulative steroid dosage were significantly lower without increased adverse effects.
摘要：
背景：与用于肾病综合征的其他类固醇保护剂相比，左旋咪唑更便宜，并且具有更好的毒性特征。它的血浆半衰期为2.0至5.6小时，但通常隔日给药。我们的目的是评估左旋咪唑在维持经常复发或类固醇依赖性肾病综合征（FR/SDNS）患儿缓解方面是否比标准隔日治疗更安全和有效。
方法：在FR/SDNS患儿中进行了一项开放标签的随机对照试验。A组每天服用左旋咪唑（2-3mg/kg/剂），为期12个月。泼尼松龙逐渐减少到3个月。监测患者复发情况，进一步的类固醇需求，和不利影响。
结果：对190例FR/SDNS患儿（A组94例，B组96例）进行分析。在36％的A组和27％的B组患者中观察到12个月的持续缓解（p=0.18）。在研究中完成12个月的人数在A组中为67％，在B组中为56％（p=0.13）。是第一次复发的时候了，持久性FR/SDNS，和因依从性差而退出的两组在统计学上相似，与B组相比，A组的复发率和累积类固醇剂量显着降低（分别为p=0.03和p=0.02）。两组的不良反应发生率相当，可逆性白细胞减少症和肝转氨酶炎是最常见的。
结论：在维持12个月的持续缓解方面，每日左旋咪唑治疗并不优于隔日治疗。然而，复发率和累积类固醇剂量显著降低,且不良反应无增加.
方法：在FR/SDNS患儿中进行了一项开放标签的随机对照试验。A组每天服用左旋咪唑（2-3mg/kg/剂），为期12个月。泼尼松龙逐渐减少到3个月。监测患者复发情况，进一步的类固醇需求，和不利影响。
结果：对190例FR/SDNS患儿（A组94例，B组96例）进行分析。在36％的A组和27％的B组患者中观察到12个月的持续缓解（p=0.18）。在研究中完成12个月的人数在A组中为67％，在B组中为56％（p=0.13）。是第一次复发的时候了，持久性FR/SDNS，和因依从性差而退出的两组在统计学上相似，与B组相比，A组的复发率和累积类固醇剂量显着降低（分别为p=0.03和p=0.02）。两组的不良反应发生率相当，可逆性白细胞减少症和肝转氨酶炎是最常见的。
结论：在维持12个月的持续缓解方面，每日左旋咪唑治疗并不优于隔日治疗。然而，复发率和累积类固醇剂量显著降低,且不良反应无增加.
