13岁以下儿童使用泊沙康唑口服混悬液的真实世界安全性研究

doi:10.5246/jcps.2024.04.027

中国药学(英文版) ›› 2024, Vol. 33 ›› Issue (4): 352-357.DOI: 10.5246/jcps.2024.04.027

13岁以下儿童使用泊沙康唑口服混悬液的真实世界安全性研究

涂颖秋, 赖敏芳, 钟楠, 曹洪晓, 黄正刚^*()

南昌大学第一附属医院, 江西南昌 330006

收稿日期:2023-09-27 修回日期:2023-10-05 接受日期:2023-11-13 出版日期:2024-04-30 发布日期:2024-04-30
通讯作者: 黄正刚

Real-world safety study of posaconazole oral suspension in children under 13 years of age

Yingqiu Tu, Minfang Lai, Nan Zhong, Hongxiao Cao, Zhenggang Huang^*()

The First Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi, China

Received:2023-09-27 Revised:2023-10-05 Accepted:2023-11-13 Online:2024-04-30 Published:2024-04-30
Contact: Zhenggang Huang

摘要/Abstract

摘要：

本文探讨了13岁以下儿童使用泊沙康唑口服混悬液的安全性。通过回顾性分析6例急性淋巴细胞白血病患儿预防或序贯使用泊沙康唑口服混悬液的安全性。结果发现, 6例患者中, 男性4例, 女性2例, 平均年龄(8.67 ± 1.86)岁, 其中有1例患儿使用泊沙康唑口服混悬液7天后出现双下肢水肿, 有2例患儿使用泊沙康唑口服混悬液过程中出现肝酶升高。结果发现, 泊沙康唑常见的不良反应为肝脏损害及胃肠道不良反应, 导致患者双下肢水肿的报道很少见。需要更多样本量研究泊沙康唑口服混悬液在13岁以下儿童人群的安全性。

关键词: 泊沙康唑口服混悬液, 儿童, 双下肢水肿, 肝酶升高, 不良反应

Abstract:

In the present study, we aimed to investigate the safety of posaconazole oral suspension in children under 13 years of age. A retrospective analysis was conducted on six cases of pediatric patients with acute lymphocytic leukemia who received prophylactic or sequential treatment with posaconazole oral suspension. Among the six patients (four boys and two girls) with an average age of (8.67 ± 1.86) years, one child developed bilateral lower limb edema after 7 d of posaconazole oral suspension, and two children experienced elevated levels of liver enzymes during the course of treatment. In conclusion, common adverse reactions of posaconazole included liver damage and gastrointestinal symptoms. However, reports of lower limb edema in patients are rare. Further studies with larger sample sizes are needed to evaluate the safety of posaconazole oral suspension in children under 13 years of age.

Key words: Posaconazole oral suspension, Children, Lower limb edema, Elevated liver enzymes, Adverse reactions

Supporting:

涂颖秋, 赖敏芳, 钟楠, 曹洪晓, 黄正刚. 13岁以下儿童使用泊沙康唑口服混悬液的真实世界安全性研究[J]. 中国药学(英文版), 2024, 33(4): 352-357.

Yingqiu Tu, Minfang Lai, Nan Zhong, Hongxiao Cao, Zhenggang Huang. Real-world safety study of posaconazole oral suspension in children under 13 years of age[J]. Journal of Chinese Pharmaceutical Sciences, 2024, 33(4): 352-357.

图/表 6

Table 1. Basic information of pediatric patients.

Table 2. Specific details of pediatric patients receiving posaconazole oral suspension.

Table 3. Summary of liver enzyme levels and other adverse reactions in pediatric patients using posaconazole oral suspension.

Table 4. Naranjo’s probability scale for adverse drug reaction (ADR) assessment.

Table 5. Naranjo’s assessment results for posaconazole oral suspension-induced lower limb edema.

Table 6. Naranjo’s assessment results for posaconazole oral suspension-induced hepatotoxicity.

参考文献 10

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13岁以下儿童使用泊沙康唑口服混悬液的真实世界安全性研究

Real-world safety study of posaconazole oral suspension in children under 13 years of age

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