Rafiei Tabatabaei Sedigheh, Moradi Omid, Karimi Abdollah, Armin Shahnaz, Fahimzad Alireza, Mansour Ghanaie Roxana, Jamee Mahnaz, Mousavizadeh Azam, Amini Hossein, Mirrahimi Bahador
Pediatric Infections Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Iran J Pharm Res. 2022 May 17;21(1):e127034. doi: 10.5812/ijpr-127034. eCollection 2022 Dec.
Coronavirus disease 2019 (COVID-19) affects the pediatric population.
Due to limited data, this study aimed to evaluate the safety and efficacy of favipiravir in the hospitalized pediatric population diagnosed with COVID-19.
The present retrospective cohort study was conducted on pediatric patients aged 1 - 18 years with a diagnosis of COVID-19 admitted to Mofid Children's Hospital, Tehran, Iran. Favipiravir was administrated at a dose of 60 mg/kg/day (max: 3200 mg/day) on the first day and then 23 mg/kg/day (max: 1200 mg/day) for 7 to 14 days. The patients were evaluated regarding the need for invasive mechanical ventilation, intensive care unit admission, duration of hospital stay, and mortality. Safety was measured by the occurrence of related adverse drug reactions (ADRs).
A total of 95 patients were included in the study. Favipiravir was administered to 25 patients. The need for invasive mechanical ventilation was reported in 4 (16.00%) and 11 (15.71%) patients in the favipiravir and control groups, respectively (P = 1.000). The median duration of hospital stays was significantly higher in patients who received favipiravir than in the controls (P = 0.002). No difference was observed in the mortality rate (P = 0.695). The ADRs, including decreased appetite, hypotension, and chest pain, were more prevalent in patients who received favipiravir than in the controls (P < 0.05).
The administration of favipiravir in the pediatric population is associated with higher ADR occurrence with no positive effect on the need for invasive mechanical ventilation, hospital stay, and mortality. Further randomized controlled trials are necessary for better judgment.
2019冠状病毒病（COVID-19）会影响儿童群体。
由于数据有限，本研究旨在评估法匹拉韦对确诊为COVID-19的住院儿童患者的安全性和有效性。
本回顾性队列研究针对伊朗德黑兰莫菲德儿童医院收治的1至18岁确诊为COVID-19的儿科患者开展。法匹拉韦首日剂量为60毫克/千克/天（最大剂量：3200毫克/天），之后7至14天为23毫克/千克/天（最大剂量：1200毫克/天）。对患者进行了有创机械通气需求、重症监护病房收治情况、住院时长和死亡率方面的评估。通过相关药物不良反应（ADR）的发生情况来衡量安全性。
本研究共纳入95例患者。25例患者接受了法匹拉韦治疗。法匹拉韦组和对照组分别有4例（16.00%）和11例（15.71%）患者需要有创机械通气（P = 1.000）。接受法匹拉韦治疗的患者住院中位时长显著高于对照组（P = 0.002）。死亡率方面未观察到差异（P = 0.695）。包括食欲减退、低血压和胸痛在内的ADR在接受法匹拉韦治疗的患者中比对照组更常见（P < 0.05）。
在儿童群体中使用法匹拉韦会导致更高的ADR发生率，对有创机械通气需求、住院时长和死亡率没有积极影响。需要进一步开展随机对照试验以做出更好的判断。
