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[摘要]
目的 系统评价质子泵抑制剂(PPI)治疗功能性消化不良的临床疗效和安全性。方法 计算机检索Pubmed、Embase、Central、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)和万方数据库,收集PPI治疗功能性消化不良的随机对照试验(RCT),检索时限均从建库至2017年9月30日,并同时追溯纳入研究的参考文献。由两名研究者根据纳入和排除标准独立进行文献筛选、资料提取、质量评价并交叉核对后,采用RevMan 5.3和R软件进行Meta-分析。结果 最终纳入15个RCTs,共6 350例患者(试验组4 266例,对照组2 084例)。Meta-分析结果显示:PPI与安慰剂组相比,在综合疗效[RR=1.27,95%CI(1.12,1.44),P=0.000 2]和整体症状完全缓解[RR=1.42,95%CI(1.13,1.80),P=0.003]方面,两组差异有统计学意义,而在不良反应发生率[RR=1.18,95%CI(0.97,1.43),P=0.09]方面,差异无统计学意义。而PPI对亚洲国家功能性消化不良患者未显示出优势[RR=1.26,95%CI(0.80,1.97),P=0.32]。结论 PPI能提高功能性消化不良的综合疗效和整体症状完全缓解率,与安慰剂比较安全性相当。受纳入研究样本量和质量的限制,PPI对亚洲国家功能性消化不良患者的疗效有待大样本、高质量的RCT进一步验证。
[Key word]
[Abstract]
Objective To systematically evaluate the effectiveness and safety of proton pump inhibitors (PPI) in patients with functional dyspepsia.Methods Relevant randomized controlled trials (RCTs) on PPI compared with placebo for functional dyspepsia were searched in Pubmed, Embase, CENTRAL, CBM, CNKI, and WanFang Data from their establishment date to September 30th 2017. Relevant references were searched manually at the same time. Two reviewers independently screened literatures, extracted data, evaluated quality, and cross checked according to strict inclusive and exclusive criteria. Meta-analysis was conducted using RevMan 5.3 and R software.Results A total of 15 RCTs involving 6 350 patients were included (4 266 patients in experimental group, 2 084 patients in control group). The results of meta-analysis showed that the comprehensive effect of PPI was superior to placebo[RR=1.27, 95%CI(1.12, 1.44), P=0.000 2]. Complete relief rate of overall symptoms was superior to placebo[RR=1.42, 95%CI(1.13, 1.80), P=0.003]. The incidence of adverse events of PPI was not superior to placebo, with no significant difference[RR=1.18, 95%CI(0.97, 1.43), P=0.09]. The effect on Asian patients of PPI was similar to placebo[RR=1.26, 95%CI(0.80, 1.97), P=0.32].Conclusion PPI is superior in comprehensive efficacy and overall symptom relief. PPI is similar in side effects to placebo. Because of the limited sample size and quality of literature, the efficacy of PPI in treating FD of Asian remains to be determined.
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