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Fungal Prophylaxis with a Gastro-Resistant Posaconazole Tablet for Patients with Hematological Malignancies in the POSANANTES Study.在 POSANANTES 研究中,对于血液恶性肿瘤患者,使用一种耐胃酸的泊沙康唑片剂进行真菌预防。
Antimicrob Agents Chemother. 2018 Jan 25;62(2). doi: 10.1128/AAC.01746-17. Print 2018 Feb.
2
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Antifungal prophylaxis with posaconazole tablet and oral suspension in patients with haematologic malignancy: Therapeutic drug monitoring, efficacy and risk factors for the suboptimal level.血液病恶性肿瘤患者应用泊沙康唑片剂和口服混悬液进行抗真菌预防:治疗药物监测、疗效和治疗浓度不理想的相关因素。
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Intravenous and tablet formulation of posaconazole in antifungal therapy and prophylaxis: A retrospective, non-interventional, multicenter analysis of hematological patients treated in tertiary-care hospitals.泊沙康唑静脉制剂和口服制剂在抗真菌治疗和预防中的应用:一项回顾性、非干预性、多中心分析,纳入了在三级医院接受治疗的血液科患者。
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Risk factors for subtherapeutic levels of posaconazole tablet.泊沙康唑片治疗浓度不足的危险因素。
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Co-administration of proton pump inhibitors and/or of steroids may be a risk factor for low trough concentrations of posaconazole delayed-released tablets in adult patients with haematological malignancies.质子泵抑制剂和/或类固醇的联合使用可能是血液恶性肿瘤成年患者中泊沙康唑延迟释放片谷浓度较低的一个危险因素。
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Retrospective analysis of goal drug level attainment of posaconazole for invasive fungal infection prophylaxis in patients with acute myeloid leukemia pre- and post-switch to tablet formulation.对急性髓系白血病患者在转换为泊沙康唑片剂制剂前后预防侵袭性真菌感染时达到目标药物水平情况的回顾性分析。
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Efficacy, safety and feasibility of antifungal prophylaxis with posaconazole tablet in paediatric patients after haematopoietic stem cell transplantation.泊沙康唑片用于造血干细胞移植术后儿科患者抗真菌预防的疗效、安全性及可行性
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Treatment by Posaconazole Tablets, Compared to Posaconazole Suspension, Does Not Reduce Variability of Posaconazole Trough Concentrations.与泊沙康唑混悬剂相比,泊沙康唑片治疗并未降低泊沙康唑谷浓度的变异性。
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Impact of patient education on plasma concentrations and effectiveness of posaconazole oral suspension under clinical conditions.临床条件下患者教育对泊沙康唑口服混悬液血药浓度和疗效的影响。
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Posaconazole versus fluconazole as primary antifungal prophylaxis for patients at high risk of invasive fungal infections receiving allogeneic hematopoietic stem cell transplantation.泊沙康唑与氟康唑作为接受异基因造血干细胞移植的侵袭性真菌感染高危患者的一线抗真菌预防用药比较
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Antifungal Prophylaxis with Posaconazole Delayed-Release Tablet and Oral Suspension in a Real-Life Setting: Plasma Levels, Efficacy, and Tolerability.泊沙康唑延迟释放片和口服混悬液在真实环境中的抗真菌预防作用:血药浓度、疗效和耐受性。
Antimicrob Agents Chemother. 2018 May 25;62(6). doi: 10.1128/AAC.02655-17. Print 2018 Jun.

本文引用的文献

1
Phase 3 pharmacokinetics and safety study of a posaconazole tablet formulation in patients at risk for invasive fungal disease.泊沙康唑片剂在侵袭性真菌病高危患者中的3期药代动力学和安全性研究。
J Antimicrob Chemother. 2016 Mar;71(3):718-26. doi: 10.1093/jac/dkv380. Epub 2015 Nov 26.
2
Chemotherapy-driven dysbiosis in the intestinal microbiome.化疗引起的肠道微生物组失调。
Aliment Pharmacol Ther. 2015 Sep;42(5):515-28. doi: 10.1111/apt.13302. Epub 2015 Jul 6.
3
National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: V. The 2014 Ancillary Therapy and Supportive Care Working Group Report.美国国立卫生研究院慢性移植物抗宿主病临床试验标准共识发展项目:五、2014年辅助治疗与支持性护理工作组报告
Biol Blood Marrow Transplant. 2015 Jul;21(7):1167-87. doi: 10.1016/j.bbmt.2015.03.024. Epub 2015 Mar 31.
4
Phase 1b study of new posaconazole tablet for prevention of invasive fungal infections in high-risk patients with neutropenia.新型泊沙康唑片用于预防中性粒细胞减少高危患者侵袭性真菌感染的1b期研究。
Antimicrob Agents Chemother. 2014 Oct;58(10):5758-65. doi: 10.1128/AAC.03050-14. Epub 2014 Jul 21.
5
Fourth European Conference on Infections in Leukaemia (ECIL-4): guidelines for diagnosis, prevention, and treatment of invasive fungal diseases in paediatric patients with cancer or allogeneic haemopoietic stem-cell transplantation.第四届欧洲白血病感染会议(ECIL-4):儿童癌症或异基因造血干细胞移植患者侵袭性真菌感染的诊断、预防和治疗指南。
Lancet Oncol. 2014 Jul;15(8):e327-40. doi: 10.1016/S1470-2045(14)70017-8.
6
Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British Society for Medical Mycology.抗真菌药物的治疗药物监测(TDM):英国医学真菌学会指南
J Antimicrob Chemother. 2014 May;69(5):1162-76. doi: 10.1093/jac/dkt508. Epub 2013 Dec 29.
7
Effect of varying amounts of a liquid nutritional supplement on the pharmacokinetics of posaconazole in healthy volunteers.不同剂量液体营养补充剂对健康志愿者泊沙康唑药代动力学的影响。
Antimicrob Agents Chemother. 2009 Nov;53(11):4749-52. doi: 10.1128/AAC.00889-09. Epub 2009 Sep 8.
8
A routine method for the quantification of the novel antimycotic drug posaconazole in plasma using liquid chromatography-tandem mass spectrometry.一种使用液相色谱-串联质谱法对血浆中新型抗真菌药物泊沙康唑进行定量分析的常规方法。
Clin Chem Lab Med. 2009;47(5):579-84. doi: 10.1515/CCLM.2009.129.
9
Epidemiology and outcome of invasive fungal infection in adult hematopoietic stem cell transplant recipients: analysis of Multicenter Prospective Antifungal Therapy (PATH) Alliance registry.成年造血干细胞移植受者侵袭性真菌感染的流行病学及转归:多中心前瞻性抗真菌治疗(PATH)联盟登记研究分析
Clin Infect Dis. 2009 Feb 1;48(3):265-73. doi: 10.1086/595846.
10
Pharmacokinetics and absorption of posaconazole oral suspension under various gastric conditions in healthy volunteers.健康志愿者在不同胃部条件下泊沙康唑口服混悬液的药代动力学及吸收情况。
Antimicrob Agents Chemother. 2009 Mar;53(3):958-66. doi: 10.1128/AAC.01034-08. Epub 2008 Dec 15.

在 POSANANTES 研究中,对于血液恶性肿瘤患者,使用一种耐胃酸的泊沙康唑片剂进行真菌预防。

Fungal Prophylaxis with a Gastro-Resistant Posaconazole Tablet for Patients with Hematological Malignancies in the POSANANTES Study.

机构信息

Service d'Hématologie Clinique, Centre d'Investigation Clinique en Cancérologie (CI2C), Centre Hospitalier et Universitaire (CHU) de Nantes, CHU Hotel-Dieu, Nante, France

Unité de pharmacie clinique oncologique, Centre Hospitalier Universitaire de Nantes, CHU Hotel-Dieu, Nantes, France.

出版信息

Antimicrob Agents Chemother. 2018 Jan 25;62(2). doi: 10.1128/AAC.01746-17. Print 2018 Feb.

DOI:10.1128/AAC.01746-17
PMID:29133564
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5786819/
Abstract

Posaconazole is an antifungal drug used in both prophylaxis and treatment of invasive fungal infections. Its oral formulation requires therapeutic drug monitoring. To overcome gastric acidity, a gastro-resistant posaconazole tablet has recently been developed. POSANANTES was a prospective noninterventional study that aimed to monitor plasma concentration trough level () of posaconazole tablets used prophylactically in patients with hematological malignancies. Fifty patients were included. Group A ( = 31) included patients receiving induction chemotherapy for myeloid malignancies, and group B ( = 19) included patients treated for graft-versus-host disease after allogeneic hematopoietic stem cells transplantation. In multivariate analysis, female sex, group B assignment, and evaluation of at day 8 (versus any other day planned by the analysis) were associated with a higher , while diarrhea was associated with a lower ( < 0.05). Thirty-four percent ( = 17) of all included patients had to prematurely stop treatment, mainly in group A. In conclusion, this real-life prospective study showed good absorption of posaconazole tablets used for prophylaxis in patients with hematological malignancies, even though this strategy was somewhat limited due to the high number of patients in group A who had to stop their treatment in an untimely fashion.

摘要

泊沙康唑是一种抗真菌药物,用于预防和治疗侵袭性真菌感染。其口服制剂需要治疗药物监测。为了克服胃酸,最近开发了一种胃耐受力的泊沙康唑片剂。POSANANTES 是一项前瞻性非干预性研究,旨在监测用于血液恶性肿瘤患者预防的泊沙康唑片剂的血药浓度谷值()。共纳入 50 例患者。A 组(n=31)包括接受髓系恶性肿瘤诱导化疗的患者,B 组(n=19)包括接受异基因造血干细胞移植后移植物抗宿主病治疗的患者。多变量分析显示,女性、B 组分配和第 8 天(与分析计划的任何其他日期相比)评估与较高的 相关,而腹泻与较低的 相关(<0.05)。所有纳入患者中有 34%(n=17)不得不提前停止治疗,主要发生在 A 组。总之,这项真实世界的前瞻性研究表明,泊沙康唑片剂用于预防血液恶性肿瘤患者的吸收良好,尽管由于 A 组中许多患者不得不提前不恰当地停止治疗,这种策略受到一定限制。