Akizawa Tadao, Saito Akira, Gejyo Fumitake, Suzuki Masashi, Nishizawa Yoshiki, Tomino Yasuhiko, Tsubakihara Yoshiharu, Akiba Takashi, Hirakata Hideki, Watanabe Yuzo, Kawanishi Hideki, Bessho Masami, Udagawa Yukio, Aoki Kotonari, Uemura Yukari, Ohashi Yasuo
Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
Ther Apher Dial. 2014 Oct;18(5):404-13. doi: 10.1111/1744-9987.12155. Epub 2014 Feb 25.
Although erythropoiesis-stimulating agents (ESAs) are effective at treating anemia, the association between hemoglobin (Hb) levels and survival is still unclear, especially for the incident Japanese hemodialysis (HD) population. The Japan Erythropoietin Treatment (JET) Study is an open multi-center, prospective, observational study designed to evaluate the relationship between the maintenance of Hb levels and new HD patient prognosis after the first administration of epoetin beta. Landmark analyses were performed to examine the relationship between Hb levels at 6 months and survival. Among a total of 10,310 patients, 6631 completed the initial 6 months of epoetin beta treatment (induction phase) and were followed up for a further 2.5 years (maintenance phase). Three-year survival rate of patients with <9 g/dL Hb levels after 6 months was 74.1%, which was significantly lower than 89.3% for patients with Hb levels 10 to 11 g/dL; the adjusted hazard ratio (HR) was 2.08 (95% CI, 1.57-2.77; P < 0.0001). Moreover, the 3-year survival rate for poor responders defined by Hb levels <10 g/dL and weekly epoetin beta doses ≥ 9000 IU during the induction phase was 71.6%, which was significantly lower than 89.4% for the group, which had Hb levels 10 to 11 g/dL excluding poor responders and those with excursion; the HR was 1.71 (95% CI, 1.13-2.60; P = 0.0118). Adverse events related to the treatment were reported in 71 of 10,310 patients (0.69%). These findings suggest that the achieved low Hb levels and poor response to ESA therapy are significantly associated with high mortality.
尽管促红细胞生成素(ESAs)在治疗贫血方面有效,但血红蛋白(Hb)水平与生存率之间的关联仍不明确,尤其是对于初诊的日本血液透析(HD)人群。日本促红细胞生成素治疗(JET)研究是一项开放的多中心、前瞻性观察性研究,旨在评估首次使用促红细胞生成素β后维持Hb水平与新的HD患者预后之间的关系。进行了里程碑分析以检验6个月时Hb水平与生存率之间的关系。在总共10310例患者中,6631例完成了促红细胞生成素β治疗的初始6个月(诱导期),并进一步随访2.5年(维持期)。6个月后Hb水平<9 g/dL的患者3年生存率为74.1%,显著低于Hb水平为10至11 g/dL患者的89.3%;校正风险比(HR)为2.08(95%CI,1.57 - 2.77;P < 0.0001)。此外,诱导期Hb水平<10 g/dL且每周促红细胞生成素β剂量≥9000 IU定义的低反应者3年生存率为71.6%,显著低于Hb水平为10至11 g/dL(不包括低反应者和波动者)组的89.4%;HR为= 1.71(95%CI,1.13 - 2.60;P = 0.0118)。10310例患者中有71例(0.69%)报告了与治疗相关的不良事件。这些发现表明,所达到的低Hb水平和对ESA治疗的低反应与高死亡率显著相关。