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タナカ リョウジロウ
Ryojiro Tanaka
田中 亮二郎 所属 川崎医科大学 医学部 臨床医学 小児科学 職種 特任教授 |
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| 論文種別 | 原著 |
| 言語種別 | 英語 |
| 査読の有無 | 査読あり |
| 表題 | Rituximab for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind, randomised, placebo-controlled trial. |
| 掲載誌名 | 正式名：Lancet (London, England) 略 称：Lancet ISSNコード：1474547X/01406736 |
| 掲載区分 | 国外 |
| 巻・号・頁 | 384(9950),pp.1273-81 |
| 著者・共著者 | Kazumoto Iijima, Mayumi Sako, Kandai Nozu, Rintaro Mori, Nao Tuchida, Koichi Kamei, Kenichiro Miura, Kunihiko Aya, Koichi Nakanishi, Yoshiyuki Ohtomo, Shori Takahashi, Ryojiro Tanaka, Hiroshi Kaito, Hidefumi Nakamura, Kenji Ishikura, Shuichi Ito, Yasuo Ohashi, |
| 発行年月 | 2014/10 |
| 概要 | BACKGROUND:Rituximab could be an effective treatment for childhood-onset, complicated, frequently relapsing nephrotic syndrome (FRNS) and steroid-dependent nephrotic syndrome (SDNS). We investigated the efficacy and safety of rituximab in patients with high disease activity.METHODS:We did a multicentre, double-blind, randomised, placebo-controlled trial at nine centres in Japan. We screened patients aged 2 years or older experiencing a relapse of FRNS or SDNS, which had originally been diagnosed as nephrotic syndrome when aged 1-18 years. Patients with complicated FRNS or SDNS who met all other criteria were eligible for inclusion after remission of the relapse at screening. We used a computer-generated sequence to randomly assign patients (1:1) to receive rituximab (375 mg/m(2)) or placebo once weekly for 4 weeks, with age, institution, treatment history, and the intervals between the previous three relapses as adjustment factors. Patients, guardians, caregivers, physicians, and individuals assessing outcomes were masked to assignments. All patients received standard steroid treatment for the relapse at screening and stopped taking immunosuppressive agents by 169 days after randomisation. Patients were followed up for 1 year. The primary endpoint was the relapse-free period. Safety endpoints were frequency and severity of adverse events. Patients who received their assigned intervention were included in analyses. This trial is registered with the University Hospital Medical Information Network clinical trials registry, number UMIN000001405.FINDINGS:Patients were centrally registered between Nov 13, 2008, and May 19, 2010. Of 52 patients who underwent randomisation, 48 received the assigned intervention (24 were given rituximab and 24 placebo). The median relapse-free period was significantly longer in the rituximab group (267 days, 95% CI 223-374) than in the placebo group (101 days, 70-155; hazard ratio: 0·27, 0·14-0·53; p<0·0001). Ten patients (42%) in the rituxi |
| DOI | 10.1016/S0140-6736(14)60541-9 |
| PMID | 24965823 |