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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.

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。

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