LANCET:靶向性释放布地奈德治疗免疫球蛋白肾炎

2017-05-26 MedSci MedSci原创

IgA肾病被认为与粘膜免疫系统功能障碍相关,其表现为肾脏IgA沉积,导致20-40%的患者在10-20年内出现损伤和终末期肾脏疾病。在这项试验(NEFIGAN)中,研究人员旨在评估一种新靶向释放制剂(TRF-布地奈德)的安全性和功效,设计将药物递送至IgA肾病患者的远端回肠。

原发性IgA肾病是全世界最常见的慢性肾小球疾病,患者通常为年轻人。近日,国际杂志LANCET上在线发表一项关于靶向性释放budesonide和安慰剂治疗免疫球蛋白肾炎的双盲,随机,安慰剂对照的临床二期试验。

IgA肾病被认为与粘膜免疫系统功能障碍相关,其表现为肾脏IgA沉积,导致20-40%的患者在10-20年内出现损伤和终末期肾脏疾病。在这项试验(NEFIGAN)中,研究人员旨在评估一种新靶向释放制剂(TRF-布地奈德)的安全性和功效,设计将药物递送至IgA肾病患者的远端回肠。

研究人员开展了一项随机,双盲,安慰剂对照的2b期试验,包括在欧洲10个国家的62个肾脏诊所进行的6个月的准备,9个月的治疗和3个月的随访。研究人员募了18岁以上的活检确诊为原发性IgA肾病和持续性蛋白尿的患者。采用计算机程序随机分配患者,以基线尿蛋白肌酐比(UPCR)分层,使用固定大小为3,比例为1:1比例,16 mg /TRF-布地奈德,8 mg /TRF-布地奈德或安慰剂。患者每天一次,在治疗阶段早餐前1小时自行服药。所有患者在整个试验期间继续进行优化RAS阻断治疗。该试验已在ClinicalTrials.gov注册,编号NCT01738035

20121211日至2015625日期间,对150名随机对照患者进行治疗(安全性)研究,149名患者符合全套分析标准。总体而言,在9个月时,与平均UPCR基线相比,TRF-布地奈德(16mg /天加8mg /天)减少了24.4%(SEM7.7%),而安慰剂为0.74。(95CI 0.59-0.94; p = 0.0066)。在9个月时,接受16 mg / day0.71; 0.53-0.94p = 0.0092)的48例患者UPCR下降了27.3%,接受8毫克/天的48例患者UPCR下降了21.5%(0.76; 0.58-1.01; p = 0.0290),而接受安慰剂的50例患者平均UPCR增加了2.7%。在随访期间效果一直持续。不良事件的发生率在所有组中相似,TRF-布地奈德16mg /天组49例中43例(88%),TRF-布地奈德51mg/d中的51例(94%)中48例,对照组 50例中42例(84%)。13个严重不良事件中的两个可能与TRF-布地奈德-深静脉血栓形成(16 mg/天)和随访中肾功能不明原因恶化有关(患者在2周内从16 mg/d降至8 mg/d并在4周后进行随访评估)。

研究表明,将TRF布地奈德16 mg /天加入优化RAS阻断治疗,IgA肾病患者蛋白尿会减少。这种效应表明发展为晚期期肾病的风险有所降低。TRF-布地奈德可能成为以肠粘膜免疫上游为靶标的IgA肾病第一个特异性治疗方法。

原始出处:

Bengt C Fellström, Jonathan Barratt, et.al. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial.

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    2018-01-02 howi
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    2017-05-28 villahu
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    2017-05-26 圣艮山

    学习了不少事情!

    0

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    2017-05-26 139****5926

    好文章学习了

    0

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