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| 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 |
| 田超1,孟瑶1,赵紫楠2,王晓玲1 |
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| (1. 国家儿童医学中心,首都医科大学附属北京儿童医院,北京 100045;2. 北京医院,北京 100730) |
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| 摘要: |
| 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RevMan 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。 |
| 关键词: 利奈唑胺 儿童 随机对照试验 Meta分析 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2018.10.001 |
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| 基金项目:卫计委购买服务项目“保障儿童用药理论政策及基础数据研究”,药政[2016]61号 |
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| Systematic Review and Meta-Analysis of Linezolid Anti-Infective Therapy in Pediatric Patients Based on Randomized Controlled Trials |
| Tian Chao1 , Meng Yao1 , Zhao Zinan2 , Wang Xiaoling1 |
| (1. National Center for Children's Health, Beijing Children's Hospital Affiliated to the Capital Medical University, Beijing 100045, China; 2. Beijing Hospital, Beijing 100730, China) |
| Abstract: |
| Objective: To systematically evaluate the efficacy and safety of linezolid in the treatment of infection in pediatric patients.
Methods: Electronic databases such as PubMed, 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 RevMan 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 (P>0.05); 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. |
| Key words: linezolid children randomized controlled trials meta-analysis |
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