左西替利嗪治疗儿童变态反应性疾病的系统评价与Meta分析

Levocetirizine for treatment of allergic diseases in children:a systematic review and Meta-analysis

目的系统评价左西替利嗪(levocetirizine,LCTZ)在儿童变态反应性疾病中的有效性、安全性和对生活质量的改善情况,为临床决策提供循证依据。方法系统检索PubMed、Embase、the Cochrane Library、Clinicaltirals.gov、CNKI、WanFang Data和SinoMed数据库,检索时间从建库到2021年8月31日。纳入LCTZ用于治疗儿童变态反应性疾病的随机对照试验(RCTs),对照组为其他组胺H1受体拮抗剂(AHs)、皮质类固醇或安慰剂。由两位研究者进行文献筛选、质量评价(Cochrane风险偏倚评估工具)和数据提取,如遇分歧通过讨论或与第3位研究者协商解决,手工检索相关研究的参考文献列表作为补充。采用GRADE系统对研究结果的可信度进行评估。采用RevMan 5.3软件进行Meta分析,或进行定性分析。结果最终纳入12篇RCTs(2296例患儿),偏倚风险整体中等偏低。Meta分析结果显示,LCTZ主要用于治疗儿童慢性荨麻疹和变应性鼻炎等疾病,相比安慰剂的疗效更好(变应性鼻炎,第4周症状点评分,MD-1.24[-1.97,-0.51];P=0.0008;GRADE:C级),但相比其他AHs的差异无统计学意义;LCTZ相比安慰剂或其他AHs的各类不良事件发生率基本无差异,相比安慰剂(总不良事件发生率,RR 0.99[0.77,1.28],P=0.95;GRADE:C级),程度轻微且可耐受;使用LCTZ的过敏性鼻结膜炎患儿的生活质量,相比安慰剂有所改善,相比其他AHs同样无差异。结论LCTZ治疗儿童变态反应性疾病具有良好的有效性、安全性,可改善生活质量,但相比其他AHs则无差异。仍需开展进一步临床研究探讨LCTZ相比其他AHs的应用价值,以及其应用于儿童的长期安全性。

Objective To evaluate the efficacy,safety,and the quality of lite of levocetirizine(LCTZ)for treatment of allergic diseases in children,providing evidence-based reference for clinical decision.Methods PubMed,Embase,Cochrane Library,Clinicaltirals.gov,CNKI,WanFang Data and Sinomed were systematically searched,literatures of randomized controlled trials(RCTs)on efficacy,safety,and compliance of LCTZ among children with allergic diseases were included from inception to August 31st,2021.Article screening,data extraction,and Cochrane risk of bias evaluation was performed by two independent researchers,while any disagreement was solved by discussing or consulting with a third researcher.The references of included articles were also manually searched as supplement.The quality of literatures was evaluated according to GRADE system.Meta-analysis was performed by using RevMan 5.3 software.Results A total of 12 RCTs(2296 pediatric patients)with moderate to low risk of bias were ultimately included.The results of meta-analyses demonstrated that LCTZ was of significant better efficacy compared to placebo(allergic rhinitis,total system score at 4 weeks,MD-1.24[-1.97,-0.51];P=0.0008;GRADE:C level),especially for treatment of chronic urticaria and allergic rhinitis among children.However,LCTZ showed similar efficacy in comparison to other H1 antihistamines(AHs).Reported adverse events were all mild and well-tolerant.There was no obvious difference between LCZT and control or placebo group(total adverse events,RR 0.99[0.77,1.28],P=0.95;GRADE:C level)in safety.Additionally,the quality of life of patients with allergic rhinitis was improved in LCTZ group,which is significantly better than that of placebo group.However,there was no difference between LCTZ and other AHs groups in compliance.Conclusions LCTZ can be an appropriate choice for treatment of allergic diseases,whereas it has not shown difference from the other AHs.Further studies should be conducted to explore advantage of LCTZ and safety of long-term use.