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坏死性小肠结肠炎(NEC)的治疗:人胎盘提取物Protego-PD™获得FDA孤儿药称号

2020-06-20 Allan MedSci原创

人胎盘提取物Protego-PD已被FDA授予孤儿药称号。

Plakous制药公司近日宣布,其人胎盘提取物Protego-PD™可预防早产儿坏死性小肠结肠炎(NEC),已被FDA授予孤儿药称号。Protego-PD™是一款从人胎盘提取而来的口服型无细胞生物治疗药物。

Plakous Therapeutics首席执行官Robert Boyce表示:“由于目前尚无批准的NEC治疗方法,因此Protego-PD™是阻止这种破坏性疾病的重要一步”。

坏死性小肠结肠炎(NEC)是一种多发于早产婴儿的疾病,可能会导致小肠坏死,严重时会危及生命。NEC案例中超过90%发生在极低体重婴儿(VLBWB)中,出生越早的婴儿,越容易得NEC。NEC初期症状包括喂养不耐受,增加胃残留物,腹胀,便血。症状可能迅速恶化至小肠穿孔,腹膜炎和低血压以及腹部变色。NEC是一种罕见的儿科疾病,在美国每年影响约6,000例极低体重婴儿(VLBWB),死亡率为30%,目前尚无批准的NEC治疗方法。

 

原始出处:

https://www.firstwordpharma.com/node/1734108

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    2020-06-22 millore
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    2020-06-22 sunylz

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关于红细胞(RBC)输血和贫血而引起坏死性小肠结肠炎(NEC)的数据是相互矛盾的。这些关联还没有前瞻性评估,计算那些反复,随时间变化的风险。原始出处:Ravi M. Patel,Andrea Knezevic,Neeta Shenvi,et al.Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocol

2016新生儿坏死性小肠结肠炎小肠造瘘术后临床治疗专家共识发布

小肠造瘘术是新生儿坏死性小肠结肠炎(necrotizing enterocolitis,NEC)常见的手术方式之一,改善了危重NEC患儿的预后。但由于解剖生理的改变,术后易出现肠液大量丢失、营养物质消化吸收障碍,导致营养不良,水、电解质紊乱等临床问题,在治疗上极具挑战性。规范化的治疗可减少并发症的发生,改善预后,因此,就NEC小肠造瘘术后营养治疗、药物治疗、关瘘时机等问题经讨论形成如下专家共识。全

拓展阅读

JOP:预测晚发败血症和坏死性小肠结肠炎的机器学习模型的开发

人工智能技术可以帮助临床医生在新生儿重症监护中早期检测LOS和NEC,这可能会带来临床和社会经济效益。

Shwachman-Diamond综合征二例

Shwachman-Diamond综合征:是一种少见的常染色体隐性遗传病,目前国内对这种疾病的认识尚不足,仅有1例有基因诊断的文献报道。

J Transl Med:红细胞生成素预防极早产儿坏死性小肠结肠炎

坏死性小肠结肠炎(NEC)是极早产婴儿最严重的并发症之一,但目前还没有公认的方法来预防NEC。研究表明,红细胞生成素(EPO)有可能预防NEC或改善早产NEC的结果。近日,一项前瞻性的随机临床试验旨在

早产儿坏死性小肠结肠炎:IBT和FDA就III期研究的设计达成一致

IBT已经与美国食品和药品监督管理局(FDA)就如何设计IBP-9414的III期研究进行了长时间的磋商。目前,FDA现以书面形式通知IBT,对IBT的试验设计表示满意

2016新生儿坏死性小肠结肠炎小肠造瘘术后临床治疗专家共识发布

小肠造瘘术是新生儿坏死性小肠结肠炎(necrotizing enterocolitis,NEC)常见的手术方式之一,改善了危重NEC患儿的预后。但由于解剖生理的改变,术后易出现肠液大量丢失、营养物质消化吸收障碍,导致营养不良,水、电解质紊乱等临床问题,在治疗上极具挑战性。规范化的治疗可减少并发症的发生,改善预后,因此,就NEC小肠造瘘术后营养治疗、药物治疗、关瘘时机等问题经讨论形成如下专家共识。全

Lancet:婴儿的肠道菌群可预测坏死性小肠结肠炎的发生

肠道细菌可能会诱发或防止早产儿发生坏死性小肠结肠炎,一种严重的疾病导致早产。

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