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头孢洛林治疗儿科患者急性细菌感染的疗效和安全性——随机对照试验的系统评价和荟萃分析

The efficacy and safety of ceftaroline in the treatment of acute bacterial infection in pediatric patients - a systemic review and meta-analysis of randomized controlled trials.

作者信息

Chen Chih-Wei, Chang Shen-Peng, Huang Hui-Ting, Tang Hung-Jen, Lai Chih-Cheng

机构信息

Division of Neurosurgery, Department of Surgery, Chi Mei Medical Center, Tainan, Taiwan.

Department of Occupational Safety and Health/Institute of Industrial Safety and Disaster Prevention, College of Sustainable Environment, Chia Nan University of Pharmacy and Science, Tainan, Taiwan.

出版信息

Infect Drug Resist. 2019 May 15;12:1303-1310. doi: 10.2147/IDR.S199978. eCollection 2019.

Abstract

This meta-analysis aims to assess the clinical efficacy and safety of ceftaroline in treating acute bacterial infections - community-acquired pneumonia (CAP) and skin and skin structure infection (SSSI) in pediatric patients. The Pubmed, Embase, ClinicalTrials.gov. and the Cochrane databases were searched up to December 31, 2018. Only randomized controlled trials (RCTs) evaluating ceftaroline and other comparators in the treatment of acute bacterial infection in pediatric patients were included. The primary outcome was the clinical cure rate and the secondary outcome was the risk of adverse event. Three RCTs were included. Overall, ceftaroline had a clinical cure rate at end of therapy (EOT) and test of cure (TOC) similar to comparators in the treatment of acute bacterial infection (at EOT, OR, 1.93; 95% CI, 0.88-4.25, =0%, and at TOC, OR, 1.36; 95% CI, 0.64-2.91, =14%). In addition, ceftaroline had a clinical failure rate at EOT and TOC similar to comparators in the treatment of acute bacterial infection (at EOT, OR, 0.62; 95% CI, 0.22-1.76, =0%, and at TOC, OR, 0.68; 95% CI, 0.24-1.91, =0%). No significant differences were found for the risk of treatment-emergent adverse events (TEAE) in all and different degrees between ceftaroline and comparators (OR, 0.81; 95% CI, 0.37-1.78, =56%). The risks of TEAE and severe adverse events related to study drug were similar between ceftaroline and comparators (TEAE related to study drug, OR, 0.98; 95% CI, 0.52-1.82, =0%, severe adverse event related to study drug, OR, 1.09; 95% CI, 0.22-5.44, =22%). The clinical efficacy of ceftaroline is as good as comparator therapy in the treatment of acute bacterial infections - CAP and SSSI, and this antibiotic is well tolerated as the comparators.

摘要

本荟萃分析旨在评估头孢洛林治疗儿科患者急性细菌感染——社区获得性肺炎(CAP)和皮肤及皮肤结构感染(SSSI)的临床疗效和安全性。检索了截至2018年12月31日的PubMed、Embase、ClinicalTrials.gov和Cochrane数据库。仅纳入评估头孢洛林和其他对照药物治疗儿科患者急性细菌感染的随机对照试验(RCT)。主要结局为临床治愈率,次要结局为不良事件风险。共纳入3项RCT。总体而言,在治疗急性细菌感染时,头孢洛林在治疗结束时(EOT)和治愈检测时(TOC)的临床治愈率与对照药物相似(在EOT时,OR=1.93;95%CI为0.88 - 4.25,P = 0%;在TOC时,OR=1.36;95%CI为0.64 - 2.91,P = 14%)。此外,在治疗急性细菌感染时,头孢洛林在EOT和TOC时的临床失败率与对照药物相似(在EOT时,OR=0.62;95%CI为0.22 - 1.76,P = 0%;在TOC时,OR=0.68;95%CI为0.24 - 1.91,P = 0%)。在所有治疗出现的不良事件(TEAE)风险及不同程度方面,头孢洛林与对照药物之间未发现显著差异(OR=0.81;95%CI为0.37 - 1.78,P = 56%)。头孢洛林与对照药物在与研究药物相关的TEAE风险和严重不良事件风险方面相似(与研究药物相关的TEAE,OR=0.98;95%CI为0.52 - 1.82,P = 0%;与研究药物相关的严重不良事件,OR=1.09;95%CI为0.22 - 5.44,P = 22%)。在治疗急性细菌感染——CAP和SSSI方面,头孢洛林的临床疗效与对照治疗相当,且这种抗生素与对照药物一样耐受性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dca/6526920/f9d1ce5640a9/IDR-12-1303-g0001.jpg

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