Study protocol: high-dose mizoribine with prednisolone therapy in short-term relapsing steroid-sensitive nephrotic syndrome to prevent frequent relapse (JSKDC05 trial).
Study protocol: high-dose mizoribine with prednisolone therapy in short-term relapsing steroid-sensitive nephrotic syndrome to prevent frequent relapse (JSKDC05 trial).
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DOI：
10.1186/s12882-018-1033-z
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发表时间：
2018-09-10
期刊：
影响因子：
2.3
通讯作者：
Japanese Study Group of Kidney Disease in Children (JSKDC)
中科院分区：
文献类型：
--
作者：
Hama T;Nakanishi K;Ishikura K;Ito S;Nakamura H;Sako M;Saito-Oba M;Nozu K;Shima Y;Iijima K;Yoshikawa N;Japanese Study Group of Kidney Disease in Children (JSKDC)
80%患有类固醇敏感性肾病综合征（SSNS）的儿童在2年内复发，40-50%的患者表现为频繁复发肾病综合征（FRNS）。初次缓解后6个月内复发的患者是FRNS的高危人群。由于频繁使用强的松龙治疗FRNS会引起严重的强的松龙副作用，因此需要开发一种防止患者转向FRNS的治疗方法。米佐利滨是一种免疫抑制药物，副作用比强的松龙少。最近的研究报道了高剂量米佐利滨对FRNS患儿的疗效。我们进行了一项多中心、开放、随机对照试验，以研究标准强的松龙加大剂量米佐利滨治疗在最初缓解后6个月内复发的SSNS儿童的有效性和安全性。患者被分配到标准强的松龙单独治疗组或标准强的松龙加高剂量米佐利滨组。对于前一组，米佐利滨给药剂量为10mg /kg/天，每天一次，持续2年。主要终点是到频繁复发的持续时间。研究结果为使用大剂量米佐利滨预防SSNS患者向FRNS转移提供了重要数据。由于米佐利滨的血药浓度尚未被详细研究，因此有可能米佐利滨被低估，而被其他免疫抑制药物所取代。未来，高剂量米佐利滨治疗可能会预防FRNS高风险儿童的复发，并减少泼尼松龙的总剂量。UMIN000005103,（预期于2011年3月1日注册）。
Eighty percent of children with steroid-sensitive nephrotic syndrome (SSNS) relapse within 2 years and 40–50% patients show frequently-relapsing nephrotic syndrome (FRNS). Patients showing a relapse within 6 months after initial remission are at high risk of FRNS. Since frequent prednisolone treatment for FRNS induces severe prednisolone side effects, development of a treatment to prevent patients from shifting to FRNS is desirable. Mizoribine is an immunosuppressive drug with fewer side effects than prednisolone. Recent studies reported the efficacy of high-dose mizoribine in children with FRNS. We conduct a multicenter, open, randomized controlled trial to investigate the efficacy and safety of standard prednisolone plus high-dose mizoribine therapy in children with SSNS showing a relapse within 6 months after an initial remission. Patients are allocated to either standard prednisolone alone treatment group, or standard prednisolone plus high-dose mizoribine group. For the former group, mizoribine is administered at a dose of 10 mg/kg/day once daily and continued for 2 years. The primary endpoint is the duration to frequent relapse. The results provide important data on use of high-dose mizoribine to prevent SSNS patients from shifting to FRNS. Since blood concentrations of mizoribine have not been investigated in detail until now, there is a possibility that mizoribine is underestimated in favor of other immunosuppressive drugs. In future, high-dose mizoribine therapy may lead to prevention of relapse in children at high risk of FRNS, and to decreased total dose of prednisolone. UMIN000005103, (Prospectively registered 1st March 2011).
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影响因子：
2.3
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通讯作者：
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