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机构地区:[1]绵阳市第三人民医院消化内科,绵阳621000 [2]四川大学华西医院消化内科,成都610041 [3]成都市第三人民医院消化内科,成都610040 [4]成都市第一人民医院消化内科,成都610040
出 处:《中国循证医学杂志》2012年第7期804-809,共6页Chinese Journal of Evidence-based Medicine
摘 要:目的系统评价伊托必利与莫沙必利比较治疗功能性消化不良的疗效和安全性,为临床实践提供证据。方法计算机检索CENTRAL、PubMed、EMbase、ISI、OVID、CBM、VIP、WanFang Data、CNKI,检索时间从建库至2011年11月,同时手检相关杂志,纳入有关伊托必利与莫沙必利比较治疗功能性消化不良的随机对照试验,由两名研究者按照Cochrane系统评价员手册5.0.2标准独立评价文献质量、提取资料并交叉核对后,使用RevMan5.1软件进行Meta分析。结果共纳入4个随机对照试验,363例患者。Meta分析结果显示:在总体症状缓解率方面,伊托必利与莫沙必利相当,两组差异无统计学意义[OR=1.62,95%CI(0.53,4.93),P=0.4];在单个症状缓解率方面,伊托必利在餐后饱胀、上腹胀、食欲减退、上腹痛、上腹胀等方面与莫沙必利相当,两组差异无统计学意义(P均>0.05);在药物不良反应发生率方面,伊托必利与莫沙必利相当,两组差异无统计学意义[OR=0.63,95%CI(0.31,1.29),P=0.21]。结论现有有限证据表明,伊托必利在改善功能性消化不良患者总体症状、单个症状及不良反应方面均与莫沙必利相似。但纳入研究的质量大多较低,可能会影响结果的真实性,因此上述结论仍需要开展设计更为严格的大样本RCT证实。Objective To systematically evaluate the effectiveness and safety of itopride vs. mosapride in patients with functional dyspepsia, so as to provide references for clinical practice. Methods According to strict inclusive and exclusive criteria, relevant randomized controlled trials (RCTs) on itopride vs. mosapride for functional dyspepsia were searched in CENTRAL, Medline, Embase, ISI, OVID, CBM, VIP, WanFang Data and CNKI from the date of their establishment to November 2011, Two reviewers independently screened literature, extracted data and evaluated methodological quality. Meta-analyses were conducted using Revman 5.1 software. Results A total of 4 trials involving 363 patients were included and data were coped with meta-analysis, a) About the improvement of overall symptoms: itopride was not superior to mosapride, with no significant difference (OR= 1.62, 95%CI 0.53 to 4.93, P=0.4); b) About the improvement of single symptom: itopride was not superior to mosapride in improving single symptom as follows: postprandial fullness, upper abdominal distention, poor appetite, and upper abdominal pain, with no significant difference; and c) About the incidence of adverse events: itopride was similar to mosapride (OR=0.63, 95%CI 0.31 to 1.29, P=0.21). Conclusion Current evidence shows that itopride is similar to mosapride in effectively improving overall symptoms and single symptom, and it has fewer side effects than mosapride does. Due to the low quality of most included studies, more strictly-designed and large-scale RCTs are needed to provide reasonable proofs for clinic.
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