热毒宁注射液治疗儿童社区获得性肺炎临床疗效和安全性回顾性分析

目的 通过回顾性分析方法评价热毒宁注射液治疗非重症儿童社区获得性肺炎(CAP)的疗效和安全性。方法 使用中国药物警戒系统(CHPS)收集新乡市中心医院2019年1月1日—2022年12月31日期间住院的701例儿童CAP(3~14岁)患者的信息。按其治疗方案中是否含有热毒宁注射液将患者分成热毒宁组和对照组。使用倾向性评分匹配(PSM)方法按1∶1的比例对两组患者进行匹配,以减少两组之间的混杂偏倚。比较匹配后的两组之间疗效和安全性结局的差异。结果 PSM后,两组各有202例患者被纳入分析。两组患者基线特征、合并症和合并用药情况相当。结果表明,热毒宁组的总有效率显著高于对照组(92.08% vs 80.20%,P＜0.05)。热毒宁组的住院时间短于对照组[(8.66±1.56)d vs (9.36±1.39)d,P＜0.05]。与对照组相比,热毒宁组中儿童CAP典型症状或体征的缓解时间更短(P＜0.05)。两组的重症监护室(ICU)转入人数、病死率和药物不良反应(ADR)发生率无显著差异(P＞0.05)。结论 对现有数据的分析显示,热毒宁注射液能够有效提高儿童CAP的治愈率、缩短症状或体征缓解时间并缩短患儿住院时间,同时不增加ADR的发生。

Retrospective analysis of clinical efficacy and safety of Reduning Injection in children with community-acquired pneumonia

Objective To evaluate the efficacy and safety of Reduning Injection in children with nonsevere community-acquired pneumonia(CAP) through a retrospective study.Methods Data of 701 pediatric patients(3—14 years old) with CAP admitted to Xinxiang Central Hospital from January 1, 2019 to December 31, 2022 was collected by using China Hospital Pharmacovigilance system(CHPS). These patients were divided into Reduning group and control group, depending on whether or not their treatment regimens contained Reduning Injection. Patients were propensity score-matched(PSM) at a 1∶1 ratio to minimize the confounding bias between the two groups. A comparison of efficacy and safety outcomes between the two groups was performed after PSM.Results After PSM, 202 patients in each group were included in the analysis. The two groups were comparable for baseline patient characteristics, comorbidities and concomitant medications. The overall efficacy rate in the Reduning group was significantly higher than that in the control group(92.08% vs 80.20%, P＜0.05). Length of stay in the Reduning group was shorter than that in the control group [(8.66 ±1.56) d vs (9.36 ±1.39) d, P＜0.05]. Compared with the control group, the Reduning group showed shorter time to resolution of typical symptoms or signs of pediatric CAP(P＜0.05). Number of intensive care unit(ICU) transfer, mortality as well as incidence of adverse drug reactions(ADRs) were not significantly different between the two groups(P＞0.05).Conclusion Analysis of available data shows that Reduning Injection is effective in increasing clinical cure rate, reducing time to resolution of symptoms or signs, shortening the length of stay for pediatric CAP without increasing the incidence of ADRs in children with CAP.