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近期新药获批情况,第二部分:正在儿童中进行积极临床研究的药物。

Recent new drug approvals, part 2: drugs undergoing active clinical studies in children.

作者信息

Chhim Rebecca F, Shelton Chasity M, Christensen Michael L

机构信息

Departments of Clinical Pharmacy ; Le Bonheur Children's Hospital, Memphis, Tennessee.

出版信息

J Pediatr Pharmacol Ther. 2013 Jan;18(1):14-38. doi: 10.5863/1551-6776-18.1.14.

DOI:10.5863/1551-6776-18.1.14
PMID:23616733
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3626063/
Abstract

The objective of this 2-part review is to provide information about drugs that have been recently approved by the US Food and Drug Administration. Part 1 reviewed recently approved drugs with pediatric indications. Part 2 reviews drugs recently approved only in adults and have published or ongoing studies in children.

摘要

这篇分两部分的综述旨在提供有关美国食品药品监督管理局最近批准的药物的信息。第一部分回顾了最近批准的有儿科适应症的药物。第二部分回顾了最近仅在成人中批准且已发表或正在进行儿童研究的药物。

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本文引用的文献

1
Safety and efficacy of ezogabine (retigabine) in adults with refractory partial-onset seizures: Interim results from two ongoing open-label studies.依佐加滨(瑞替加滨)治疗成人难治性部分发作性癫痫的安全性和有效性:两项正在进行的开放性研究的中期结果。
Epilepsy Res. 2012 Nov;102(1-2):117-21. doi: 10.1016/j.eplepsyres.2012.05.007. Epub 2012 Jul 5.
2
Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study.本妥昔单抗维迪昔(SGN-35)治疗复发或难治性系统性间变大细胞淋巴瘤患者的Ⅱ期研究结果。
J Clin Oncol. 2012 Jun 20;30(18):2190-6. doi: 10.1200/JCO.2011.38.0402. Epub 2012 May 21.
3
Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma.一项评估 Brentuximab vedotin 治疗复发或难治性霍奇金淋巴瘤患者的关键性 II 期研究结果。
J Clin Oncol. 2012 Jun 20;30(18):2183-9. doi: 10.1200/JCO.2011.38.0410. Epub 2012 Mar 26.
4
Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib.维莫非尼治疗 BRAF V600 突变型晚期黑色素瘤的生存情况。
N Engl J Med. 2012 Feb 23;366(8):707-14. doi: 10.1056/NEJMoa1112302.
5
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Arch Pathol Lab Med. 2012 Nov;136(11):1385-91. doi: 10.5858/arpa.2011-0505-OA. Epub 2012 Feb 14.
6
Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. fidaxomicin 与万古霉素治疗欧洲、加拿大和美国艰难梭菌感染:一项双盲、非劣效、随机对照试验。
Lancet Infect Dis. 2012 Apr;12(4):281-9. doi: 10.1016/S1473-3099(11)70374-7. Epub 2012 Feb 8.
7
The mechanism of action of retigabine (ezogabine), a first-in-class K+ channel opener for the treatment of epilepsy.瑞替加滨(依佐加滨)作用机制,一种用于癫痫治疗的首个钾通道开放剂。
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8
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Drug Des Devel Ther. 2011;5:471-85. doi: 10.2147/DDDT.S19045. Epub 2011 Nov 23.
9
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Clin Pharmacol Ther. 2012 Jan;91(1):71-80. doi: 10.1038/clpt.2011.272. Epub 2011 Dec 7.
10
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Ann Allergy Asthma Immunol. 2011 Dec;107(6):529-37. doi: 10.1016/j.anai.2011.08.015. Epub 2011 Oct 5.