Objective To assess the efficacy and safety of histamine H2 receptor antagonist (H2RA) for the prevention of stress ulcer bleeding (SUB) in critically ill patients. Methods Trials were identified by searching Cochrane Controlled Trials (Issue 4, 2006), MEDLINE (1980 to October 2006),EMbase (1984 to October 2006) and the Chinese Biological Medicine Database (1978 to October), Chinese VIP Database (1989 to October 2006) and Chinese EBM Database. We also handsearched the proceedings of relevant conferences, 5 kinds of important Chinese journals and the references of all included trials. Two reviewers assessed the quality of studies and extracteddata independently. Disagreement was resolved by discussion . The primary outcomes included were incidence of SUB, incidence of nosocomial pneumonia (NP), mortality and adverse events. Secondary outcomes were gastric pH, length of hospital stayand length of ICU stay. RevMan4.2.7 software was used for meta-analyses. Results Sixteen trials involving 2 014 patients were included. Most of the trials were of poor quality. Meta-analyses showed that H2RA significantly less SUB comparedwith patients in the placebo or non-prophylaxis group (RR 0.39, 95%CI 0.28 to 0.56; Plt;0.000 01, NNT=6), but but there was no significant difference in the incidence of clinically important bleeding (RR 0.51 , 95%CI 0.17 to 1.53; P=0.11). No significant difference was observed in the incidence of NP(RR 1.02, 95%CI 0.55 to 1.89,P=0.95). H2RA significantly decreased mortality in comparison with placebo or non-prophylaxis (RR 0.68, 95%CI 0.52 to 0.90; P=0.007, NNT=18). H2RA had a good safety profile. We did not perform meta-analysis for gastric pH due to the methodological limitations. Conclusion H2RA may significantly reduce the incidence of SUB and mortality, but cannot reduce the incidence of clinically important bleeding. Due to the poor quality of included studies, the conclusion should be interpreted cautiously. More randomized controlled trials with sufficient sample size, uniform standards, higher quality and scientifically sound methodology should be performed.
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.
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.
Objective To measure the included angle between tibia anatomical axis and anterior cortex, and to define the relative position of them in order to give direction in placement of tibia extra-medullary alignment bar during total knee arthroplasty. Methods A total of 100 healthy volunteers were included (49 left knees and 51 right knees). There were 52 males and 48 females, aged 20-86 years with an average age of 45.2 years (20-35 years in 29 cases, 35-50 years in 32 cases, and over 50 years in 39 cases). The tibiofibular lateral X-ray films were taken to measure the included angle between tibia anatomical axis and anterior cortex with AutoCAD2004 system. The samples were grouped according to gender, age, and side. Results The included angles between tibia anatomical axis and anterior cortex ranged from 3.007 to 3.021° with an average of 3.001°; the angles were (2.965 ± 0.361)° in male and (3.041 ± 0.311)° in female; the angles were (2.996 ± 0.332)° in the left knee and (3.006 ± 0.347)° in the right knee; and the angles were (2.918 ± 0.346)° in 20-35 years age group, (3.060 ± 0.330)° in 35-50 years age group, and (3.014 ± 0.336)° in over 50 years age group. No significant difference was found in the included angle between tibia anatomical axis and anterior cortex between male and female, among different ages, and between left and right knees (P gt; 0.05). Conclusion The included angle between tibia anatomical axis and anterior cortex is about 3°, so tibia extra-medullary alignment bar should be placed at the angle of 3° with anterior cortex during total knee arthroplasty.