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本文引用的文献

1
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。
J Oncol Pharm Pract. 2018 Dec;24(8):599-603. doi: 10.1177/1078155217722405. Epub 2017 Aug 2.
2
Evaluation of Serum Posaconazole Concentrations in Patients with Hematological Malignancies Receiving Posaconazole Suspension Compared to the Delayed-Release Tablet Formulation.接受泊沙康唑混悬液与缓释片剂的血液系统恶性肿瘤患者血清泊沙康唑浓度的评估。
Leuk Res Treatment. 2017;2017:3460892. doi: 10.1155/2017/3460892. Epub 2017 Jun 11.
3
Real-Life Assessment of the Safety and Effectiveness of the New Tablet and Intravenous Formulations of Posaconazole in the Prophylaxis of Invasive Fungal Infections via Analysis of 343 Courses.通过对343个疗程的分析,对泊沙康唑新片剂和静脉制剂预防侵袭性真菌感染的安全性和有效性进行实际评估
Antimicrob Agents Chemother. 2017 Jul 25;61(8). doi: 10.1128/AAC.00188-17. Print 2017 Aug.
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Multicentre study of posaconazole delayed-release tablet serum level and association with hepatotoxicity and QTc prolongation.泊沙康唑缓释片血清水平及其与肝毒性和QTc延长相关性的多中心研究。
J Antimicrob Chemother. 2017 Aug 1;72(8):2355-2358. doi: 10.1093/jac/dkx122.
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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
J Cancer Res Clin Oncol. 2017 Jul;143(7):1281-1292. doi: 10.1007/s00432-017-2369-7. Epub 2017 Mar 3.
6
Comparison of serum concentrations between different dosing strategies of posaconazole delayed-release tablet at a large academic medical centre.泊沙康唑缓释片不同给药策略在某大型学术医疗中心的血清浓度比较
Mycoses. 2017 Apr;60(4):241-243. doi: 10.1111/myc.12587. Epub 2016 Dec 1.
7
Posaconazole Tablet Formulation at 400 Milligrams Daily Achieves Desired Minimum Serum Concentrations in Adult Patients with a Hematologic Malignancy or Stem Cell Transplant.每日400毫克的泊沙康唑片剂制剂在患有血液系统恶性肿瘤或接受干细胞移植的成年患者中达到了所需的最低血清浓度。
Antimicrob Agents Chemother. 2016 Oct 21;60(11):6945-6947. doi: 10.1128/AAC.01489-16. Print 2016 Nov.
8
Therapeutic Drug Monitoring of Posaconazole: an Update.泊沙康唑的治疗药物监测:最新进展
Curr Fungal Infect Rep. 2016;10:51-61. doi: 10.1007/s12281-016-0255-4. Epub 2016 May 7.
9
Pharmacokinetics of Posaconazole Oral Suspension in Children Dosed According to Body Surface Area.按体表面积给药的儿童泊沙康唑口服混悬液的药代动力学
Pediatr Infect Dis J. 2016 Feb;35(2):183-8. doi: 10.1097/INF.0000000000000963.
10
Prevention of invasive fungal infections in immunocompromised patients: the role of delayed-release posaconazole.免疫功能低下患者侵袭性真菌感染的预防:迟释泊沙康唑的作用。
Infect Drug Resist. 2015 Sep 9;8:321-31. doi: 10.2147/IDR.S65592. eCollection 2015.

泊沙康唑缓释片与混悬液在儿童血液学/肿瘤学患者中的疗效比较

Comparison of the Efficacy of Posaconazole Delayed Release Tablets and Suspension in Pediatric Hematology/Oncology Patients.

作者信息

Wass Erika N, Hernandez Elvin A, Sierra Caroline M

出版信息

J Pediatr Pharmacol Ther. 2020 Jan-Feb;25(1):47-52. doi: 10.5863/1551-6776-25.1.47.

DOI:10.5863/1551-6776-25.1.47
PMID:31897075
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6938289/
Abstract

OBJECTIVES

Posaconazole is effective in preventing invasive fungal infections in neutropenic pediatric patients. The oral suspension has challenges in administration and absorption that are theorized to be minimized with delayed release tablets. However, this has not been validated in the pediatric population. This study was conducted to compare the efficacy and safety of posaconazole suspension and delayed release tablets in pediatric hematology/oncology patients.

METHODS

A retrospective chart review in pediatric hematology/oncology patients was conducted from February 2013 to February 2017. Data collected include patient demographic data; posaconazole formulation, dose, and serum concentrations; and adverse events.

RESULTS

Sixty-five patients with 353 serum posaconazole concentrations were included; 51.6% of concentrations drawn while patients were receiving posaconazole suspension were therapeutic, whereas 62.5% of concentrations drawn while patients were receiving posaconazole delayed release tablets were therapeutic (p = 0.035). Serum concentrations drawn while taking acid suppression (histamine receptor antagonists or proton pump inhibitors) and posaconazole suspension were less likely to be therapeutic (p < 0.0001) compared with those taken while receiving delayed release tablets. Adverse event profiles were similar between both formulations.

CONCLUSIONS

Delayed release tablets proved more effective in achieving therapeutic serum posaconazole concentrations than posaconazole suspension, with minimal difference in adverse events, in pediatric hematology/oncology patients.

摘要

目的

泊沙康唑在预防中性粒细胞减少的儿科患者侵袭性真菌感染方面有效。口服混悬液在给药和吸收方面存在挑战,理论上缓释片可将这些挑战降至最低。然而,这一点尚未在儿科人群中得到验证。本研究旨在比较泊沙康唑混悬液和缓释片在儿科血液学/肿瘤学患者中的疗效和安全性。

方法

对2013年2月至2017年2月期间儿科血液学/肿瘤学患者进行回顾性病历审查。收集的数据包括患者人口统计学数据;泊沙康唑制剂、剂量和血清浓度;以及不良事件。

结果

纳入65例患者,共353次泊沙康唑血清浓度检测结果;患者接受泊沙康唑混悬液时,51.6%的浓度检测结果为治疗有效,而患者接受泊沙康唑缓释片时,62.5%的浓度检测结果为治疗有效(p = 0.035)。与接受缓释片时相比,服用抑酸剂(组胺受体拮抗剂或质子泵抑制剂)和泊沙康唑混悬液时的血清浓度检测结果更不易达到治疗有效水平(p < 0.0001)。两种制剂的不良事件情况相似。

结论

在儿科血液学/肿瘤学患者中,缓释片在达到泊沙康唑治疗有效血清浓度方面比泊沙康唑混悬液更有效,不良事件差异极小。