目的 探討康復新液聯合奧美拉唑三聯療法治療幽門螺桿菌（Hp）陽性的胃潰瘍的臨床療效和內鏡下潰瘍愈合情況。 方法 將2010年1月－2012年1月對住院及門診180例內鏡診斷并檢測證實Hp陽性的胃潰瘍患者，按計算機產生的隨機數字表隨機分為兩組，每組各90例。兩組均給予口服奧美拉唑20 mg，2次/d，克拉霉素0.5 g，2次/d，甲硝唑0.4 g，2次/d，鋁碳酸鎂1.0 g，3次/d，治療7 d。7 d后改為口服奧美拉唑20 mg，1次/d，鋁碳酸鎂1.0 g，3次/d，療程4周，治療組加服康復新液10 mL，3次/d；對照組不使用康復新液。治療期間以上腹痛作為判斷癥狀改善的主要指標，療程結束后復查胃鏡觀察潰瘍愈合情況，同時觀察藥物不良反應。 結果 治療組在臨床癥狀改善總有效率93.3%，對照組為總有效率82.2%；潰瘍病灶愈合方面治療組總有效率94.4%，對照組為總有效率83.3%，兩組比較有統計學意義（P＜0.05），臨床應用4周后無任何不良反應，Hp根除率兩組間差異無統計學意義。 結論 康復新液聯合奧美拉唑三聯療法可有效治療胃潰瘍，治療期間患者未發生不良反應，為治療胃潰瘍的一種安全有效的藥物。
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 We handsearched the related published and unpublished data and their references.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.
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.
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.
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 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.
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.