Wang Yi, Wang Min, Zhang Hua, Wang Ying, Du Yanqiang, Guo Zhangyan, Ma Le, Zhou Yong, Zhang Huiping, Liu Li
Department of Neonatology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Pediatric Intensive Care Unit, The Affiliated Children's Hospital of Xi'an Jiaotong University, Xi'an, China.
Transl Pediatr. 2022 Oct;11(10):1671-1681. doi: 10.21037/tp-22-441.
Sivelestat, a neutrophil elastase inhibitor, is a selective and targeted therapy for acute respiratory distress syndrome (ARDS) in adults; and it is also reported to apply to children with ARDS. However, there is little evidence of its efficacy in children.
This study recruited 212 patients ranging in age from 28 days to 18 years old, and who met the diagnostic criteria for pediatric ARDS (PARDS) while hospitalized in the Intensive Care Department of the Affiliated Children's Hospital of Xi'an Jiaotong University. A total of 125 patients (case group) received sivelestat treatment, and 87 were assigned to the control group. There were no significant differences in gender (P=0.445) or age (P=0.521). Control group data were collected from the Electronic Case Information System for pediatric patients diagnosed with ARDS between March 2017 to January 2020. Data for the case group were collected from the Electronic Case Information System between February 2020 to February 2022. Demographic data, clinically relevant indicators, respiratory parameters were recorded. The 28-day mortality was the primary endpoint; the Kaplan-Meier and log-rank tests were used to evaluate cumulative survival rate.
For general demographic and clinical characteristics, no significant differences were observed between the two groups. Compared to the control group, the case group displayed significant improvements in PaO/FiO at 48 h (141±45 115±21, P<0.001) and 72 h (169±61 139±40, P<0.001) post-admission, and plateau pressure was lower than that in the control group at 24 h (24±3 . 28±7, P<0.001), 48 h (21±4 . 26±7, P<0.001), and 72 h (20±2 . 25±6, P<0.001) post-admission. Interleukin-8 levels were lower in the case group at 48 and 72 h post-admission. Overall, 28-day mortality was 25.47% (54/212). Twenty-five children died in the sivelestat group, 29 children died in the control group. Survival analysis revealed that cumulative survival in the case group was higher than that in the control group (P=0.028).
ARDS is expected to have high morbidity and mortality in critical care medicine, and precise targeted drugs are lacking. Our study showed that sivelestat improved prognosis and reduces mortality in children with ARDS.
西维来司他是一种中性粒细胞弹性蛋白酶抑制剂，是治疗成人急性呼吸窘迫综合征（ARDS）的一种选择性靶向疗法；也有报道称其适用于儿童ARDS。然而，几乎没有证据表明其对儿童有效。
本研究招募了212例年龄在28天至18岁之间、在西安交通大学附属儿童医院重症监护科住院期间符合儿童ARDS（PARDS）诊断标准的患者。共有125例患者（病例组）接受西维来司他治疗，87例被分配到对照组。两组在性别（P = 0.445）或年龄（P = 0.521）方面无显著差异。对照组数据收集自2017年3月至2020年1月期间诊断为ARDS的儿科患者电子病例信息系统。病例组数据收集自2020年2月至2022年2月期间的电子病例信息系统。记录人口统计学数据、临床相关指标、呼吸参数。28天死亡率是主要终点；采用Kaplan-Meier法和对数秩检验评估累积生存率。
在一般人口统计学和临床特征方面，两组之间未观察到显著差异。与对照组相比，病例组入院后48小时（141±45对115±21，P<0.001）和72小时（169±61对139±40，P<0.001）时的PaO/FiO有显著改善，入院后24小时（24±3对28±7，P<0.001）、48小时（21±4对26±7，P<0.001）和72小时（20±2对25±6，P<0.001）时的平台压低于对照组。病例组入院后48小时和72小时的白细胞介素-8水平较低。总体而言，28天死亡率为25.47%（54/212）。西维来司他组25名儿童死亡，对照组29名儿童死亡。生存分析显示，病例组的累积生存率高于对照组（P = 0.028）。
在重症医学中，ARDS预计具有高发病率和死亡率，且缺乏精准的靶向药物。我们的研究表明，西维来司他可改善儿童ARDS的预后并降低死亡率。
