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作 者:周本刚[1] 程其娇 刘梅[1] 郭鹏[2] 肖政[3] 陈安海[1]
机构地区:[1]遵义医学院附属医院消化内科,贵州遵义563003 [2]湖北医药学院附属人民医院肝胆外科,湖北十堰442000 [3]遵义医学院附属医院遵义医学院循证医学中心循证医学教育部网上合作研究中心遵义医学院分中心,贵州遵义563003
出 处:《中国循证医学杂志》2016年第5期550-556,共7页Chinese Journal of Evidence-based Medicine
基 金:贵州省科技厅社会发展攻关项目[黔科合SY字(2011)3056号]
摘 要:目的系统评价含益生菌的补救方案根除幽门螺杆菌(Hp)感染的有效性和安全性。方法计算机检索Pub Med、EMbase、CENTRAL(2015年12期)、CBM、CNKI、WanFang Data和VIP数据库,同时检索中国临床试验注册中心(www.chictr.org.cn)和Clinical Trials.gov,追溯纳入文献和相关综述的参考文献,搜集关于含益生菌的补救根除方案治疗Hp感染的随机对照试验(RCT),检索时限均为建库至2015年12月。由两位研究员独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果最终纳入11个RCT,共1 888例患者。Meta分析结果显示:与对照组相比,含益生菌的补救方案有利于提高Hp的根除率[ITT分析:RR=1.15,95%CI(1.10,1.22),P<0.000 01;PP分析:RR=1.16,95%CI(1.11,1.22),P<0.000 01]和降低总的不良反应发生率[ITT分析:RR=0.60,95%CI(0.40,0.91),P=0.02];敏感性分析显示结果较为稳健,发表偏倚检测显示无明显发表偏倚。结论含益生菌的补救治疗方案有利于提高Hp的根除率,并能降低抗生素治疗过程中主要胃肠道不良反应的发生。受纳入研究质量和数量的限制,上述结论有待更多高质量的RCT来验证。Objective To systematically review the efficacy and safety of probiotics-containing rescue regimen for the eradication of Helicobacter pylori (Hp) infection. Methods We electronically searched PubMed, EMbase, Cochrane Central Register of Controlled Trials (CENTRAL), CBM, CNKI, WanFang Data and VIP databases, and Chinese Clinical Trial Register (ChiCTR) and ClinicalTrial.gov from inception to December 2015, to collect randomized controlled trials (RCTs) about probiotics-containing rescue regimen for the eradication of Hp infection. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software. Results Eleven RCTs involving 1 888 patients were finally included. The results of meta-analysis showed that: Compared with the control group, probiotics-containing rescue regimen could significantly increase the eradication rate (ITT analysis: 80.3% vs. 69.3%, RR =1.15, 95%CI 1.10 to 1.22, P〈0.000 01; PP analysis: 86.5% vs. 74.3%, RR=1.16, 95%CI 1.11 to 1.22, P〈0.000 01), and decrease the incidence of total adverse reaction (ITT analysis: 19% vs. 29.2%, RR=0.60, 95%CI 0.40 to 0.91, P=0.02). Sensitivity analysis showed that the result was relatively stable. Publication bias test showed no evidence of substantial publication bias. Conclusion Current evidence indicates that probiotics-containing rescue regimen may contribute to improve eradication rate of Hp infection patients, and may reduce the occurrence of major gastrointestinal associated adverse reaction. Due to the limited quality and quantity of included studies, more high-quality RCTs are needed to verify the above conclusion.
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