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

作　　者：涂颖秋[1] 赖敏芳 钟楠 曹洪晓[1] 黄正刚[1] Yingqiu Tu;Minfang Lai;Nan Zhong;Hongxiao Cao;Zhenggang Huang(The First Affiliated Hospital of Nanchang University,Nanchang 330006,Jiangxi,China)

机构地区：[1]南昌大学第一附属医院,江西南昌330006

出　　处：《Journal of Chinese Pharmaceutical Sciences》2024年第4期352-357,共6页中国药学（英文版）

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。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.

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 

分 类 号：R973[医药卫生—药品]