头孢洛林治疗儿童急性细菌感染性疾病的有效性与安全性的Meta分析

The efficacy and safety of ceftaroline in the treatment of acute bacterial infection in pediatric patient:Meta-Analysis

目的:通过Meta分析研究头孢洛林治疗儿童急性细菌感染性疾病的有效性与安全性。方法:计算机检索PubMed,EMBASE,Cochrane Central Register of Controlled Trials,MEDLINE,CBM和CNKI,全面收集头孢洛林治疗儿童急性细菌感染性疾病的临床随机对照试验,用Review manager 5.0软件进行Meta分析。结果:最终纳入3项随机对照临床研究,共计363例患者。Meta分析结果表明:在临床可评估患者中,头孢洛林组的临床治愈率与对照组相当,治疗结束后(EOT)临床治愈率为92.6%[OR=1.93,95%Cl(0.88~4.25),P=0.1,I 2=0%],随访期结束后(TOC)临床治愈率为90.9%[OR=1.36,95%CI(0.64~2.91),P=0.43,I 2=14%];头孢洛林组的临床治疗失败率与对照组相当,EOT临床治疗失败率为4.1%[OR=0.62,95%CI(0.22~1.76),P=0.37,I 2=0%],TOC临床治疗失败率为4.5%[OR=0.68,95%CI(0.24~1.91),P=0.46,I 2=0%];头孢洛林组治疗期间不良事件(TEAE)发生率与对照组相当[OR=0.81,95%CI(0.37~1.78),P=0.60,I 2=0%],且各种程度的TEAE发生率均与对照组相当;头孢洛林组的药物相关性TEAE发生率和药物相关性严重TEAE发生率均与对照组相当[OR=0.98,95%CI(0.53~1.83),P=0.96,I 2=0%和OR=1.16,95%CI(0.34~3.96),P=0.81,I 2=22%]。结论:头孢洛林治疗儿童急性细菌感染性疾病的临床疗效和安全性较好。

Objective:The meta-analysis was conducted to study the efficacy and safety of ceftaroline in the treatment of acute bacterial infection in pediatric patient.Methods:The PubMed,EMBASE,Cochrane Central Register of Controlled Trials,MEDLINE,CBM,CNKI databases were searched for RCTs.All eligible studies were randomized controlled trials assessing the efficacy and safety of ceftaroline in the treatment of acute bacterial infection in pediatric patient.The data were analyzed by Review Manager 5.0 software.Results:Three RCTs reporting data on 363 patients were finally included.Meta-analysis showed,among clinically evaluable patients,the clinical cure rate of the ceftaroline group was equivalent to that of the control group,and the clinical cure rate after the end of treatment(EOT)was 92.6%[OR=1.93,95%CI(0.88~4.25),P=0.1,I 2=0%],the clinical cure rate after the end of the follow-up period(TOC)is 90.9%[OR=1.36,95%CI(0.64~2.91),P=0.43,I 2=14%].The clinical treatment failure rate of the ceftaroline group was equivalent to that of the control group.The EOT clinical treatment failure rate was 4.1%[OR=0.62,95%CI(0.22~1.76),P=0.37,I 2=0%],TOC clinical treatment failure The rate is 4.5%[OR=0.68,95%CI(0.24~1.91),P=0.46,I 2=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),P=0.60,I 2=0%).The risks of TEAE and severe TEAE related to study drug were similar between ceftaroline and comparators(TEAE related to study drug,OR=0.98,95%CI(0.53~1.83),P=0.96,I 2=0,severe TEAE related to study drug,OR=1.16,95%CI(0.34~3.96),P=0.81,I 2=22%).Conclusion:The clinical efficacy of ceftaroline is as good as comparator therapy in the treatment of acute bacterial infections in pediatric patient,and its safey is also as good as the comparators.