Muso Eri, Mune Masatoshi, Hirano Tsutomu, Hattori Motoshi, Kimura Kenjiro, Watanabe Tsuyoshi, Yokoyama Hitoshi, Sato Hiroshi, Uchida Shunya, Wada Takashi, Shoji Tetsuo, Yuzawa Yukio, Takemura Tsukasa, Sugiyama Satoshi, Nishizawa Yoshiki, Ogahara Satoru, Yorioka Noriaki, Sakai Soichi, Ogura Yosuke, Yukawa Susumu, Iino Yasuhiko, Imai Enyu, Matsuo Seiichi, Saito Takao
Division of Nephrology and Dialysis, Kitano Hospital, Tazuke Kofukai Medical Institute, 2-4-20 Ohgimachi, Kita-ku, Osaka, 530-8480, Japan.
Ryoshukai Takaishi Fujii Hospital, Takaishi, Japan.
Clin Exp Nephrol. 2015 Jun;19(3):379-86. doi: 10.1007/s10157-014-0996-8. Epub 2014 Jun 17.
Hyperlipidemia is not merely a complication but a major exacerbating factor in longstanding nephrotic syndrome (NS). Low-density lipoprotein apheresis (LDL-A) has been reported to ameliorate dyslipidemia and induce rapid remission of NS. Several clinical studies have suggested the therapeutic efficacy of LDL-A, but the level of clinical evidence is insufficient. Therefore, a multicenter prospective study, POLARIS (Prospective Observational Survey on the Long-Term Effects of LDL Apheresis on Drug-Resistant Nephrotic Syndrome), was initiated in Japan.
Patients with drug-resistant NS were prospectively recruited into the study and treated with LDL-A in facilities that were registered in advance. In the POLARIS study design, the clinical data are to be followed up for 2 years. In the current study, we aimed at evaluating the short-term efficacy based on the treatment outcome of LDL-A immediately after completion of treatment.
Along with rapid improvement of hyperlipidemia, LDL-A significantly improved proteinuria and hypoproteinemia after treatment. More than half of the patients showed remission of NS based on the urinary protein level at the completion of LDL-A. The duration of NS before the start of treatment was significantly shorter in patients who responded to LDL-A.
An analysis of patients registered in the POLARIS study indicated that LDL-A has short-term efficacy for drug-resistant NS. Rapid relief of dyslipidemia by LDL-A may provide early remission in about half of the NS patients who are resistant to conventional medication. Completion of the POLARIS study may reveal additional long-term effects of LDL-A in these patients.
高脂血症不仅是长期肾病综合征(NS)的一种并发症,而且是一个主要的加重因素。据报道,低密度脂蛋白单采术(LDL-A)可改善血脂异常并促使NS快速缓解。多项临床研究提示了LDL-A的治疗效果,但临床证据水平不足。因此,在日本启动了一项多中心前瞻性研究——北极星研究(LDL单采术对耐药肾病综合征长期影响的前瞻性观察调查)。
前瞻性招募耐药NS患者进入本研究,并在预先登记的机构接受LDL-A治疗。在北极星研究设计中,临床数据将随访2年。在本研究中,我们旨在根据治疗结束后立即进行的LDL-A治疗结果评估短期疗效。
随着高脂血症的快速改善,LDL-A治疗后显著改善了蛋白尿和低蛋白血症。超过半数的患者在LDL-A治疗结束时根据尿蛋白水平显示NS缓解。对LDL-A有反应的患者治疗开始前NS的病程显著较短。
对北极星研究中登记患者的分析表明,LDL-A对耐药NS有短期疗效。LDL-A快速缓解血脂异常可能使约半数对传统药物耐药的NS患者早期缓解。北极星研究的完成可能会揭示LDL-A对这些患者的其他长期影响。