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 assess the clinical efficacy and safety of proton pump inhibitor （PPI） and H2RA for stress ulcer bleeding in stroke patients. Methods Randomized controlled trials （RCT） were identified from MEDLINE （ 1966- Oct. 2005 ） ,EMBASE （ 1984- Oct. 2005 ）, The Cochrane Library （ Issue 4,2005 ）, CBMdisc （ 1980- Oct. 2005 ） and VIP（ 1980- Oct. 2005 ）. We handsearched the related published and unpublished data and their references. The quality of included trials was evaluated. Data were extracted by two reviewers independently with a designed extraction form. RevMan 4. 2.7 software was used for data analysis. Results Twenty RCT were included with 2 624 patients. The results of meta-analysis were listed as follows： （1） stress ulcer bleeding （SUB） ： PPI （ OR 0.14,95% CI 0.08 to 0.24, NNT = 3 ） and H2RA （OR 0.24,95% CI 0.15 to 0.39, NNT =5） significantly reduced the incidence of SUB in comparison with control group. PPI significantly reduced the incidence of SUB compared with H2R.A（P 〈0. 00001 ）. （2） Mortality： PPI （OR 0.22,95% CI 0. 11 to 0.47, NNT =8） and H2RA （OR 0.53,95% CI 0. 34 to 0.81, NNT =16） significantly decreased the mortality compared with non-prophylaxis group. PPI significantly decreased the mortality compared with H2RA （OR 0.28,95% CI 0.09 to 0. 89）. （3） Adverse effect： There were not evident adverse effects in both PPI and H2RA groups. Conclusions PPI and H2RA may reduce the incidence and mortality of SUB in stroke patients, and PPls are better in reducing incidence of SUB than H2RA.
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.
Objectives To assess the effectiveness and safety of additional bedtime H2-receptor antagonists (H2RAs) in suppressing nocturnal gastric acid breakthrough (NAB). Methods We identified eligible trials by searching The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMbase and CINAHL. We handsearched the data from the proceedings of correlated conferences, eight kinds of important Chinese journals and references of all included trials. All randomized controlled trials evaluating H2RAs for the control of NAB were eligible for inclusion. The systematic review was conducted using methods recommended by The Cochrane Collaboration. Results Only two randomized crossover studies including 32 participants met the inclusion criteria. Because the design, dosage and duration of the treatment were different between the studies, it was impossible to conduct Meta-analysis. There was no consistent conclusion between the two included studies in evaluating H2RAs for the control of NAB. Conclusion We can not conclude any implications for practice at this stage. Appropriately designed large-scale randomized controlled trials with long-term follow-up are needed to decide the effects of additional bedtime H2RAs in suppressing NAB.
目的 探讨康复新液联合奥美拉唑三联疗法治疗幽门螺杆菌（Hp）阳性的胃溃疡的临床疗效和内镜下溃疡愈合情况。 方法 将2010年1月－2012年1月对住院及门诊180例内镜诊断并检测证实Hp阳性的胃溃疡患者，按计算机产生的随机数字表随机分为两组，每组各90例。两组均给予口服奥美拉唑20 mg，2次/d，克拉霉素0.5 g，2次/d，甲硝唑0.4 g，2次/d，铝碳酸镁1.0 g，3次/d，治疗7 d。7 d后改为口服奥美拉唑20 mg，1次/d，铝碳酸镁1.0 g，3次/d，疗程4周，治疗组加服康复新液10 mL，3次/d；对照组不使用康复新液。治疗期间以上腹痛作为判断症状改善的主要指标，疗程结束后复查胃镜观察溃疡愈合情况，同时观察药物不良反应。 结果 治疗组在临床症状改善总有效率93.3%，对照组为总有效率82.2%；溃疡病灶愈合方面治疗组总有效率94.4%，对照组为总有效率83.3%，两组比较有统计学意义（P＜0.05），临床应用4周后无任何不良反应，Hp根除率两组间差异无统计学意义。 结论 康复新液联合奥美拉唑三联疗法可有效治疗胃溃疡，治疗期间患者未发生不良反应，为治疗胃溃疡的一种安全有效的药物。
Objective To evaluate the effectiveness and safety of somatostatin and the analogue-octreotide in preventing post-ERCP pancreatitis. Methods We searched Cochrane Clinical Trial Register （Issue 1, April, 2004 ）, MEDLINE （1966- April, 2004）, EMBASE （1985- April, 2004）, CBM disc （1970- April, 2004） and The Clinical Trial Register of Chinese Evidence-Based Medicine Center and handsearched the related journals to identify Randomized Controlled Trials （RCT）of somatostatin and octreotide in post-endoscopic retrograde chnlangiopancreatography pancreatitis（PEP）prevention. Systematic review was conducted using the method recommended by The Cochrane Collaboration. Results Thirty-one trials involving 4 728 patients undergoing ERCP were included. Meta-analysis showed that the incidence of post-ERCP pancreatitis [ OR 0.33, 95% CI 0. 20 to 0. 54; P =0. 000 01 ; NNT =13] was significantly reduced by somatostatin. Octreotide could only reduce the incidence of hyperamylasemia [ OR 0. 54, 95% CI 0. 38 to 0. 77 ; P =0. 000 7 ]. The inci- dence of PEP, severe PEP and post-ERCP abdominal pain could not be reduced by octreotide. Conclusions Somatostatin can prevent post-ERCP pancreatitis. Four trials are of high quality in the 12 included studies and the results are consistent with the sensitive-analysis, so it is credible to some extent. However, existing evidence does not support that octreotide can reduce the incidence of PEP, so it is not recommended for this indication. Sensitive-analysis even showed that octreotide could increase the incidence of PEP. Therefore, whether it is necessary to carry out further clinical trials should be considered with caution.
Objective To assess the effectiveness and safety of ulinastatin in the treatment of patients with acute pancreatitis. Methods A systematic review of randomized controlled trials (RCT) of ulinastatin for acute pancreatitis was performed. Trials were identified by searching The Cochrane Library (issue 3, 2004), MEDLINE, EMBASE (1984-2004) and Chinese Biological Medicine Database (1978-2004), handsearching, and personal contact with pharmaceutical companies. All RCTs comparing ulinastatin with other interventions were included. Two reviewers assessed the quality of each studiy, and extracted data independently. Statisticsal analysis was performed by using RevMan 4.2. Results Seventeen trials involving 1 199 patients were included. Most included trials were of poor quality. Only two trials reported death at the end of follow-up. Meta-analysis of 6 RCTs showed that the clinical effective rate of Ulinastatin plus basic treatment group was 93.12% (176/189), and was 73.33% in basic treatment group. A statistic significant difference was found between the two groups (Peto OR 4.29, 95%CI 2.49 to 7.37, P＜0.000 01). Compared with basic treatment group, Ulinastatin plus basic treatment group significantly reduced the mean hospitalization (WMD -4.93, 95%CI -7.76 to -2.09, P＜0.000 7). Meta-analysis of 2 RCTs showed that the clinical effective rate of Ulinastatin plus basic treatment group was 86.75% (131/151), and was 80.49% (99/123) in other drugs plus basic treatment group. No statistic significant difference was found between the two groups (Peto OR 1.46, 95%CI 1.76 to 2.80, P＜0.26). One trial found that comparing with control group (23.5±7.5 days), Ulinastatin group (34.0±6.4 days) significantly reduced the mean hospitalization (P＜0.05).The reported severe adverse events of ulinastatin appeared to be rare (7/488, 1.43%). Conclusion Ulinastatin appears to be a modality of safe and effective treatment with a favorable trend, but there is no enough evidence to support this conclusion at present as the published trials with poor quality. More trials with enough sample size and scientifically sound methodology are required.