Implications of the US Food and Drug Administration draft guidance for mitigating septic reactions from platelet transfusions.
作者信息
Sachais Bruce S, Paradiso Sarai, Strauss Donna, Shaz Beth H
机构信息
New York Blood Center, New York, NY.
出版信息
Blood Adv. 2017 Jun 23;1(15):1142-1147. doi: 10.1182/bloodadvances.2017008334. eCollection 2017 Jun 27.
Abstract
摘要
相似文献
1
Implications of the US Food and Drug Administration draft guidance for mitigating septic reactions from platelet transfusions.美国食品药品监督管理局减轻血小板输注所致败血症反应的指导草案的影响
Blood Adv. 2017 Jun 23;1(15):1142-1147. doi: 10.1182/bloodadvances.2017008334. eCollection 2017 Jun 27.
2
Septic reactions to platelet transfusions. A persistent problem.血小板输注的败血症反应。一个长期存在的问题。
JAMA. 1991;266(4):555-8.
3
Regulatory Forum Opinion Piece: Review of FDA Draft Guidance Testicular Toxicity-Evaluation during Drug Development Guidance for Industry.监管论坛观点文章：美国食品药品监督管理局（FDA）《药物研发期间睾丸毒性评估行业指南》草案综述
Toxicol Pathol. 2016 Oct;44(7):927-30. doi: 10.1177/0192623316656416. Epub 2016 Jun 29.
4
5
6
US Food and Drug Administration regulatory oversight of laboratory-developed tests: Commentary on the draft guidance.美国食品药品监督管理局对实验室自行开发检测的监管：对指南草案的评论
Cancer Cytopathol. 2015 Oct;123(10):573-5. doi: 10.1002/cncy.21566. Epub 2015 Jun 4.
7
8
Therapeutic protein-drug interactions and implications for drug development.治疗性蛋白-药物相互作用及其对药物开发的影响。
Clin Pharmacol Ther. 2010 Apr;87(4):497-503. doi: 10.1038/clpt.2009.308. Epub 2010 Mar 3.
9
Detecting bacterial contamination in platelet products.检测血小板制品中的细菌污染
Clin Lab. 2006;52(9-10):443-56.
10
Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report.关于支持电子和纸质患者报告结局（PRO）测量等效性所需证据的建议：国际药物经济学与结果研究协会（ISPOR）电子PRO良好研究实践工作组报告
Value Health. 2009 Jun;12(4):419-29. doi: 10.1111/j.1524-4733.2008.00470.x. Epub 2008 Nov 11.
引用本文的文献
1
How do you… decide which platelet bacterial risk mitigation strategy to select for your hospital-based transfusion service?你……如何决定为你们医院的输血服务选择哪种血小板细菌风险缓解策略？
Transfusion. 2020 Apr;60(4):675-681. doi: 10.1111/trf.15693. Epub 2020 Feb 6.
2
The argument(s) for lowering the US minimum required content of apheresis platelet components.降低美国单采血小板成分最低要求含量的理由。
Transfusion. 2019 Feb;59(2):779-788. doi: 10.1111/trf.15036. Epub 2018 Nov 21.
3
Pathogen Inactivation of Cellular Blood Products-An Additional Safety Layer in Transfusion Medicine.细胞血液制品的病原体灭活——输血医学中的又一安全保障
Front Med (Lausanne). 2017 Dec 4;4:219. doi: 10.3389/fmed.2017.00219. eCollection 2017.
本文引用的文献
1
Bacterial screening of platelet components by National Health Service Blood and Transplant, an effective risk reduction measure.英国国民医疗服务体系血液与移植部门对血小板成分进行细菌筛查，这是一项有效的风险降低措施。
Transfusion. 2017 May;57(5):1122-1131. doi: 10.1111/trf.14085.
2
Clinical effectiveness of platelets in additive solution treated with two commercial pathogen-reduction technologies.两种商业性病原体灭活技术处理的添加溶液中血小板的临床有效性。
Transfusion. 2017 May;57(5):1171-1183. doi: 10.1111/trf.14042. Epub 2017 Feb 24.
3
Patient outcomes and amotosalen/UVA-treated platelet utilization in massively transfused patients.大量输血患者的治疗效果及氨甲环酸/紫外线A处理血小板的应用情况
Vox Sang. 2017 Apr;112(3):249-256. doi: 10.1111/vox.12489. Epub 2017 Feb 15.
4
Safety and efficacy of cryopreserved autologous platelet concentrates in HLA-alloimmunized patients with hematologic malignancies.冷冻保存的自体血小板浓缩物在 HLA 同种免疫的血液系统恶性肿瘤患者中的安全性和有效性。
Transfusion. 2016 Oct;56(10):2426-2437. doi: 10.1111/trf.13690. Epub 2016 Jun 24.
5
Trends in United States blood collection and transfusion: results from the 2013 AABB Blood Collection, Utilization, and Patient Blood Management Survey.美国血液采集与输血趋势：2013年美国血库协会血液采集、利用及患者血液管理调查结果
Transfusion. 2016 Sep;56(9):2173-83. doi: 10.1111/trf.13676. Epub 2016 Jun 15.
6
How do we implement Day 6 and Day 7 platelets at a hospital-based transfusion service?在医院输血服务中，我们如何实施第6天和第7天的血小板？
Transfusion. 2016 Jun;56(6):1262-6. doi: 10.1111/trf.13577. Epub 2016 Mar 28.
7
Storage of platelets at 4°C in platelet additive solutions prevents aggregate formation and preserves platelet functional responses.血小板在血小板添加剂溶液中于4°C储存可防止聚集体形成并保留血小板功能反应。
Transfusion. 2016 Jun;56(6):1320-8. doi: 10.1111/trf.13511. Epub 2016 Feb 8.
8
A study protocol for a randomised controlled trial evaluating clinical effects of platelet transfusion products: the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial.一项评估血小板输注产品临床效果的随机对照试验研究方案：病原体灭活评估与预测分析评分（PREPAReS）试验
BMJ Open. 2016 Jan 27;6(1):e010156. doi: 10.1136/bmjopen-2015-010156.
9
Detection of septic transfusion reactions to platelet transfusions by active and passive surveillance.主动和被动监测对血小板输注后脓毒性输血反应的检测。
Blood. 2016 Jan 28;127(4):496-502. doi: 10.1182/blood-2015-07-655944. Epub 2015 Nov 23.
10
Bench Test for the Detection of Bacterial Contamination in Platelet Concentrates Using Rapid and Cultural Detection Methods with a Standardized Proficiency Panel.使用标准化能力验证样本通过快速检测方法和培养检测方法对血小板浓缩物中细菌污染进行的实验室检测
Transfus Med Hemother. 2015 Jul;42(4):220-5. doi: 10.1159/000437396. Epub 2015 Jul 16.
Zotero 插件