基于随机对照试验的儿童利奈唑胺抗感染治疗有效性和安全性的Meta分析

Systematic Review and Meta-Analysis of Linezolid Anti-Infective Therapy in Pediatric Patients Based on Randomized Controlled Trials

目的:评价利奈唑胺在儿科感染患者中应用的有效性和安全性。方法:检索Pumed、EMBase、the Cochrane Library、中国知网(CNKI)、万方数据库和中国生物医学文献数据库(CBM),检索时限均从建库至2017年7月。纳入利奈唑胺治疗儿科感染患者的相关随机对照试验(RCT),应用Rev Man 5.3软件进行Meta分析。结果:共纳入2篇RCT文献,包括815例患儿。对照组为万古霉素等其他抗革兰阳性菌有效的阳性对照药物。有效性研究显示,试验组临床有效性[OR=1.39,95%CI(0.98,1.98),P=0.07]和微生物有效性[OR=1.12,95%CI(0.61,2.03),P=0.72]与对照组比较差异无统计学意义(P>0.05);亚组分析显示,利奈唑胺治疗耐甲氧西林金黄色葡萄球菌(MRSA)[OR=1.20,95%CI(0.18,7.92),P=0.85]和甲氧西林敏感金黄色葡萄球菌(MSSA)[OR=1.05,95%CI(0.48,2.30),P=0.90]疗效与对照组比较差异无统计学意义(P>0.05)。安全性研究显示,试验组与对照组腹泻[RR=0.86,95%CI(0.51,1.45),P=0.58]、恶心[RR=1.31,95%CI(0.54,3.18),P=0.55]、呕吐[RR=0.56,95%CI(0.25,1.22),P=0.14]和中性粒细胞减少[RR=1.34,95%CI(0.73,2.49),P=0.35]发生率比较差异无统计学意义(P>0.05)。结论:基于目前的RCT研究,利奈唑胺治疗儿科患者感染性疾病的有效性较好,但与其他抗菌药物的有效性和安全性比较无显著优势,有待更大规模的临床试验进一步深入研究。

Objective： To systematically evaluate the efficacy and safety of linezolid in the treatment of infection in pediatric patients.Methods： Electronic databases such as Pub Med,Embase,Cochrane Library,CNKI,Wanfang Database and CBM were searched from establishment to Aug. 2017. Randomized controlled trials（ RCT） of linezolid in the treatment of infection in pediatric patients was included,and meta-analysis was performed using Rev Man 5. 3 software. Results： Two RCT studies were included,including 815 children. In control group,other antigram-positive drugs such as vancomycin were used. According to validity study,the clinical effectiveness [OR = 1.39,95% CI（0.98,1.98）,P = 0.07] and microbiological effectiveness [OR = 1.12,95% CI（0.61,2.03）,P =0.72] of experimental group were not statistically significant compared with control group（ P0.05）; subgroup analysis showed that the efficacy of linezolid in the treatment of methicillin-resistant staphylococcus aureus（ MRSA） [OR = 1. 20,95% CI（ 0. 18,7. 92）,P = 0.85] and methicillin-sensitive staphylococcus aureus（ MSSA） [OR = 1.05,95% CI（ 0.48,2.30）,P = 0.90] was not statistically significant compared with control group（ P 0.05）. According to safety study,there was no statistically significant difference between experimental group and control group in incidences of diarrhea [RR = 0.86,95% CI（0.51,1.45）,P = 0.58],nausea [RR = 1. 31,95%CI（ 0.54,3.18）,P = 0.55],vomiting [RR = 0.56,95% CI（ 0.25,1.22）,P = 0.14] and neutropenia [RR = 1.34,95% CI（ 0.73,2.49）,P = 0.35]（ P 0. 05）. Conclusion： Based on the current RCT studies,the efficacy of linezolid in the treatment of infection in pediatric patients is relatively good,but it has no significant advantages compared with the efficacy and safety of other antibacterial drugs; further research is needed for larger clinical trials.