目的 系統(tǒng)評價質(zhì)子泵抑制劑（PPI）治療功能性消化不良的臨床療效和安全性。方法 計算機檢索Pubmed、Embase、Central、中國期刊全文數(shù)據(jù)庫（CNKI）、中國生物醫(yī)學(xué)文獻數(shù)據(jù)庫（CBM）和萬方數(shù)據(jù)庫，收集PPI治療功能性消化不良的隨機對照試驗（RCT），檢索時限均從建庫至2017年9月30日，并同時追溯納入研究的參考文獻。由兩名研究者根據(jù)納入和排除標準獨立進行文獻篩選、資料提取、質(zhì)量評價并交叉核對后，采用RevMan 5.3和R軟件進行Meta-分析。結(jié)果 最終納入15個RCTs，共6 350例患者（試驗組4 266例，對照組2 084例）。Meta-分析結(jié)果顯示：PPI與安慰劑組相比，在綜合療效[RR=1.27，95%CI（1.12，1.44），P=0.000 2]和整體癥狀完全緩解[RR=1.42，95%CI（1.13，1.80），P=0.003]方面，兩組差異有統(tǒng)計學(xué)意義，而在不良反應(yīng)發(fā)生率[RR=1.18，95%CI（0.97，1.43），P=0.09]方面，差異無統(tǒng)計學(xué)意義。而PPI對亞洲國家功能性消化不良患者未顯示出優(yōu)勢[RR=1.26，95%CI（0.80，1.97），P=0.32]。結(jié)論 PPI能提高功能性消化不良的綜合療效和整體癥狀完全緩解率，與安慰劑比較安全性相當(dāng)。受納入研究樣本量和質(zhì)量的限制，PPI對亞洲國家功能性消化不良患者的療效有待大樣本、高質(zhì)量的RCT進一步驗證。

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.