Zhang Weilong, Huang Jihan, Liu Hongxia, Wen Xin, Zheng Qingshan, Li Lujin
Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Clinical Research Center, Zhujiang Hospital of Southern Medical University, Guangzhou, China.
J Clin Pharmacol. 2022 Feb;62(2):245-253. doi: 10.1002/jcph.1969. Epub 2021 Oct 12.
Immunostimulants are gradually being used in the prevention and treatment of recurrent respiratory tract infections in susceptible children, but their drug effects have not been quantified. The purpose of this study was to confirm the efficacy of immunostimulants in the prevention and treatment of recurrent respiratory tract infections in susceptible children. A model-based meta-analysis was used to describe the time course of placebo and immunostimulants in the prevention of respiratory tract infections in children. The cumulative number of respiratory tract infections was used as an indicator of efficacy. A meta-analysis was used to analyze the incidence of drug-related adverse events. Fourteen articles with 2400 pediatric subjects were finally included in the analysis. The results showed that the cumulative number of respiratory tract infections increased linearly with time, with the incidence of respiratory tract infections in the placebo group being 0.65 (95% confidence interval [CI], 0.55-0.75) per month. OM-85 BV and pidotimod reduced the incidence of respiratory tract infections by 0.21 (95%CI, 0.16-0.26) and 0.19 (95%CI, 0.17-0.21) compared to placebo per month, respectively. Pidotimod and OM-85 BV can effectively reduce the incidence of respiratory tract infections in susceptible children, with no significant increase in the incidence of drug-related adverse events when compared with placebo (risk ratio values were 1.07 [95%CI, 0.66-1.71] and 1.31 [95%CI, 0.54-3.19], respectively). This study provides quantitative support for the application of immunostimulants for the prevention of recurrent respiratory tract infections in children.
免疫刺激剂正逐渐用于易感儿童反复呼吸道感染的预防和治疗，但其药物效果尚未量化。本研究的目的是证实免疫刺激剂在易感儿童反复呼吸道感染预防和治疗中的疗效。采用基于模型的荟萃分析来描述安慰剂和免疫刺激剂在预防儿童呼吸道感染中的时间进程。呼吸道感染的累计次数用作疗效指标。采用荟萃分析来分析药物相关不良事件的发生率。最终纳入分析的有14篇文章，涉及2400名儿科受试者。结果显示，呼吸道感染的累计次数随时间呈线性增加，安慰剂组呼吸道感染的发生率为每月0.65（95%置信区间[CI]，0.55 - 0.75）。与安慰剂相比，OM - 85 BV和匹多莫德分别使每月呼吸道感染的发生率降低了0.21（95%CI，0.16 - 0.26）和0.19（95%CI，0.17 - 0.21）。匹多莫德和OM - 85 BV可有效降低易感儿童呼吸道感染的发生率，与安慰剂相比，药物相关不良事件的发生率无显著增加（风险比值分别为1.07 [95%CI，0.66 - 1.71]和1.31 [95%CI，0.54 - 3.19]）。本研究为免疫刺激剂用于预防儿童反复呼吸道感染的应用提供了定量支持。
