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.
Objective To determine the effectiveness and safety of mosapride in patients with functional dyspepsia. Methods Trials were located through electronic searches of the Cochrane Central Register of Controlled Trails (CENTRAL) ( Issue 2, 2006), MEDLINE (1978 to Jun. 2006), EMbase (1978 to Jun.2006), ISI (2000 to Jun.2006), OVID Database (1978 to Jun.2006), Chinese Biological Medicine Database (1978 to Jun.2006), Chinese VIP Database (1994 to Jun.2006) and WANFANG Database ( 1978 to Jun.2006). We also checked the bibliographies of retrieved articles and handsearched four kinds of important journals. Results Total of 18 trials involving 2 929 patients were included in the meta-analyses. These showed: (1) remission rate of global symptoms: Mosapride was not superior to placebo (RR 2.72, 95%CI 0.87 to 8.46), but was superior to metoclopramide (RR 1.66, 95%CI 0.82 to 3.35) and domperidone (RR 1.23, 95%CI 1.12 to 1.34); (2) remission rate of individual symptoms: 1) upper abdominal flatulence: Mosapride was superior to domperidone (RR 1.35, 95%CI 1.14 to 1.60), but was not superior to cisapride (RR 0.95, 95%CI 0.78 to 1.15); 2) postprandial fullness: Mosapride was superior to domperidone (RR 2.72, 95%CI 2.02 to 3.66), but was not superior to cisapride (RR 0.99, 95%CI 0.82 to 1.18); 3) upper abdominal pain: Mosapride was superior to domperidone (RR 1.27, 95%CI 1.07 to1.49), but was not superior to cisapride (RR 0.94, 95%CI 0.75 to 1.17); 4) early saciety: Mosapride was superior to domperidone (RR 1.42, 95%CI 1.15 to 1.76), but was not superior to cisapride (RR 0.98, 95%CI 0.82 to 1.17); 5) nausea: Mosapride was not superior to cisapride (RR 1.07, 95%CI 0.82 to 1.39) and domperidone (RR 1.12 ,95%CI 0.97 to 1.28); 6) vomitting: Mosapride was not superior to cisapride (P=0.80) and domperidone (RR 1.02, 95%CI 0.87 to 1.18); 7) eructation: Mosapride was superior to domperidone (RR 1.41, 95%CI 1.17 to 1.70), but was not superior to cisapride (RR 0.85, 95%CI 0.68 to 1.05); 8) anorexia: Mosapride was superior to domperidone (RR 1.22, 95%CI 1.20 to 1.44), but was not superior to cisapride (RR0.88, 95%CI 0.64 to 1.19); 9) sour regurgitation: Mosapride was not superior to domperidone (P=0.64) and cisapride (P=0.32); 10) heartburn: Mosapride was not superior to domperidone (RR 0.97, 95%CI 0.96 to 1.10) and cisapride (RR 1.05, 95%CI 0.90 to 1.21); 11) upper abdominal discomfort: Mosapride was not superior to cisapride (P =0.64); (3) adverse event rate: Mosapride had a good safety profile. Conclusions The limited current evidence shows that, mosapride is not superior to placebo in relieving global symptoms, but is superior to domperidone in relieving upper abdominal flatulence, postprandial fullness, upper abdominal pain, early saciety, erutation and anorexia. Mosapride has a good safety profile.
【摘要】 目的 观察莫沙必利联合复方消化酶胶囊治疗功 能性消化不良的临床疗效和安全性。方法 2008年1月—2009年7月对62例功能 性消化不良患者随机分为两组,每组31例,两组均口服莫沙必利片,三餐饭前30 min服用5 mg;试验组加服复方消化酶胶囊,进餐后30 min服用1粒。4周后观察疗 效。结果 试验组治疗总有效率明显优于对照组,分别为87.1%和61.3%(Plt;0 05)。对上腹痛、餐后饱胀、早饱、上腹烧灼感症状改善情况进行比较,试验 组治疗前后的症状总积分及症状改善有效率与对照组比较差异有统计学意义( Plt;005),而且起效时间明显缩短。两组患者均未发现严重不良反应。结论 莫沙必利联合复方消化酶胶囊治疗功能性消化不良安全有效，其疗效明显优于 单用促动力药莫沙必利。