目的 通過回顧性分析方法評價熱毒寧注射液治療非重癥兒童社區(qū)獲得性肺炎(CAP)的療效和安全性。方法 使用中國藥物警戒系統(tǒng)(CHPS)收集新鄉(xiāng)市中心醫(yī)院2019年1月1日—2022年12月31日期間住院的701例兒童CAP(3~14歲)患者的信息。按其治療方案中是否含有熱毒寧注射液將患者分成熱毒寧組和對照組。使用傾向性評分匹配(PSM)方法按1∶1的比例對兩組患者進行匹配,以減少兩組之間的混雜偏倚。比較匹配后的兩組之間療效和安全性結(jié)局的差異。結(jié)果 PSM后,兩組各有202例患者被納入分析。兩組患者基線特征、合并癥和合并用藥情況相當。結(jié)果表明,熱毒寧組的總有效率顯著高于對照組(92.08% vs 80.20%,P＜0.05)。熱毒寧組的住院時間短于對照組[(8.66±1.56)d vs (9.36±1.39)d,P＜0.05]。與對照組相比,熱毒寧組中兒童CAP典型癥狀或體征的緩解時間更短(P＜0.05)。兩組的重癥監(jiān)護室(ICU)轉(zhuǎn)入人數(shù)、病死率和藥物不良反應(yīng)(ADR)發(fā)生率無顯著差異(P＞0.05)。結(jié)論 對現(xiàn)有數(shù)據(jù)的分析顯示,熱毒寧注射液能夠有效提高兒童CAP的治愈率、縮短癥狀或體征緩解時間并縮短患兒住院時間,同時不增加ADR的發(fā)生。

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.

R974

河南省醫(yī)學科技攻關(guān)計劃聯(lián)合共建項目(LHGJ20200944); 河南省市場監(jiān)督管理局科技計劃項目(2022sj59)