Yan Gangfeng, Zhou Jianguo, Zhu Haitao, Chen Yiwei, Lu Yanming, Zhang Ting, Yu Hui, Wang Libo, Xu Hong, Wang Zheng, Zhou Wenhao
Pediatric Intensive Care Unit, Children's Hospital of Fudan University, Shanghai, China.
Department of Neonatology, Children's Hospital of Fudan University, Shanghai, China.
Ann Transl Med. 2022 Jun;10(11):619. doi: 10.21037/atm-22-2791.
Paxlovid is recognized as an effective medication in preventing the progression of coronavirus disease of 2019 (COVID-19) to severe form in adults; however, its efficacy has remained unknown in pediatric cases. This study aimed to analyze the feasibility, safety, and efficacy of Paxlovid treatment in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected children aged 6-14 years.
We conducted a cohort study based on prospectively collected clinical data. We recruited 5 pediatric cases with underlying diseases treated with Paxlovid from 7 April 2022 to 26 May 2022 and 30 age-matched patients with underlying diseases who were not treated with Paxlovid as controls. The safety and efficacy of Paxlovid were primarily assessed by inter-group comparisons.
Of the 5 Paxlovid-treated cases, including 1 male and 4 females, 3 and 2 cases were mildly and moderately ill, respectively. The underlying diseases included congenital heart defects, cerebral palsy, Down syndrome, and leukemia. Only 1 patient had received 1 dose of an inactivated SARS-CoV-2 vaccine. Paxlovid was initiated within 5 days after the onset of symptoms in all cases. Comedications were used in 2 cases. In the safety analyses, after Paxlovid initiation, 1 patient had transient diarrhea, and 1 patient had transiently elevated liver enzymes [alanine transaminase (ALT), 125 U/L; aspartate transaminase (AST), 83 U/L; normal range, <40 U/L]. In the efficacy analyses, all 5 Paxlovid-treated cases recovered, with the respective viral shedding times of 11, 4, 10, 9, and 9 days. Compared with age-matched controls, the viral shedding times were not significantly different between groups.
Based on the current small sample size study, Paxlovid is a feasible option for treating SARS-CoV-2-infected children aged 6-14 years with underlying diseases. However, the safety and efficacy of Paxlovid warrant further large-scale studies.
帕罗韦德被认为是一种有效药物，可预防成人2019冠状病毒病（COVID-19）进展为重症；然而，其在儿科病例中的疗效尚不清楚。本研究旨在分析帕罗韦德治疗6至14岁严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染儿童的可行性、安全性和疗效。
我们基于前瞻性收集的临床数据进行了一项队列研究。我们招募了2022年4月7日至2022年5月26日期间接受帕罗韦德治疗的5例患有基础疾病的儿科病例，并招募了30例年龄匹配的患有基础疾病但未接受帕罗韦德治疗的患者作为对照。帕罗韦德的安全性和疗效主要通过组间比较进行评估。
在5例接受帕罗韦德治疗的病例中，包括1例男性和4例女性，轻度和中度患病的分别有3例和2例。基础疾病包括先天性心脏病、脑瘫、唐氏综合征和白血病。只有1例患者接种过1剂灭活SARS-CoV-2疫苗。所有病例均在症状出现后5天内开始使用帕罗韦德。2例使用了合并用药。在安全性分析中，开始使用帕罗韦德后，1例患者出现短暂腹泻，1例患者肝酶[丙氨酸转氨酶（ALT），125 U/L；天冬氨酸转氨酶（AST），83 U/L；正常范围，<40 U/L]短暂升高。在疗效分析中，所有5例接受帕罗韦德治疗的病例均康复，病毒清除时间分别为11天、4天、10天、9天和9天。与年龄匹配的对照组相比，两组间病毒清除时间无显著差异。
基于目前的小样本研究，帕罗韦德是治疗6至14岁患有基础疾病的SARS-CoV-2感染儿童的一种可行选择。然而，帕罗韦德的安全性和疗效有待进一步大规模研究。
