Objective To systematically evaluate the effectiveness and safety of China-made omeprazole in treating acute non-variceal upper gastrointestinal bleeding. Methods Such databases as PubMed, MEDLINE, Springer, The Cochrane Library, CNKI, VIP, CBM and WanFang data were searched to collect the randomized controlled trials (RCTs) about China-made omeprazole in treating acute non-variceal upper gastrointestinal bleeding, and the references of included studies were also retrieved. The retrieval time was from inception to December 2012. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and assessed the quality, and then the meta-analysis was conducted by using RevMan 5.1 software. Results A total of 11 RCTs were included. Among all 1 075 patients, 544 were in the treatment group, while the other 531 were in the control group. The results of meta-analysis showed that, there were no significant differences in the total effective rate (OR=0.68, 95%CI 0.35 to 1.33, P=0.26) and safety (RR=1.33, 95%CI 0.45 to 3.91, P=0.96) between the China-made omeprazole and imported omeprazole. Conclusion China-made omeprazole is effective and safe in treating acute non-variceal upper gastrointestinal bleeding in comparison with the imported omeprazole.
Objective To conduct Meta-analyses on published literatures about the Jianpi Bushen Decoction combined with western medicine for dysfunctional uterine bleeding (DUB), so as to evaluate its efficacy and safety compared with the western medicine treatment. Methods The following databases such as PubMed (1995 to 2011), EMCC (1995 to 2011), CBM (1995 to 2011), CNKI (1995 to 2011), Wanfang (1989 to 2011) and VIP (1989 to 2011) were searched to collect the randomized controlled trials (RCTs) on Jianpi Bushen Decoction combined with western medicine for DUB. The selection of studies, assessment of methodological quality and data extraction were performed independently by two reviewers according to the Cochrane systematic review methods, and Meta-analyses were performed by using RevMan5.0 software. Results A total of 12 RCTs involving 925 cases were included, of which 471 ones were in the experimental group while the other 454 ones were in the control group. Each study was comparable in baseline data, all with reporting of using random methods, but no mention of detailed random methods, blind methods and allocation concealment. The results of Meta-analyses indicated that compared with single therapy of western medicine, Jianpi Bushen Decoction combined with western medicine for DUB was superior in the total effective rate (OR=5.60, 95%CI 3.25 to 9.67, Plt;0.000 01), bleeding recovery rate (OR=3.79, 95%CI 2.70 to 5.32, Plt;0.000 01), and bleeding recurrence rate (OR=0.14, 95%CI 0.05 to 0.42, P=0.000 5), with significant differences. Conclusions The integrated treatment of Jianpi Bushen Decoction and western medicine has certain effects on dysfunctional uterine bleeding, and it may be a promising treatment option. Due to the poor quality and high possibility of bias of the included studies, more well-designed multi-centered RCTs should be performed.
Objective To discuss the common clinical problems and make the individualized treatment for a patient with obscure gastrointestinal bleeding by means of evidence-based medicine, so as to ultimately control the symptoms and reduce the mortality. Methods After the clinical problems were put forward, the systematic reviews and randomized controlled trials (RCTs) were collected in The Cochrane Library (online), MEDLINE, EMBase, SCIE and CNKI databases, from the date of their establishment to 2010. The treatment protocol was made by combining the assessment of evidence with the willingness of both patient and relatives. Results A total of 30 RCTs and 5 systematic reviews were identified. A rational diagnostic and therapeutic plan was made upon a serious evaluation of the data and willingness of patients. The Mickel’s diverticulum was found through capsule endoscopy, which was then locally excised under laparoscopy. After a 6-month follow-up, the plan proved to be optimal. Conclusion The treatment efficacy in diagnosed obscure gastrointestinal bleeding has been improved by adopting an individualized treatment plan according to evidence-based methods.
Objective During primary total knee arthroplasty (TKA), anticoagulant drugs are used for prevention of major venous thrombosis of lower limbs, and this often leads to the increase of perioperative blood loss. To retrospectively analyse the impact of low molecular weight heparin on hidden blood loss and transfusion rate after primary TKA by comparing with the use of aspirin. Methods Between October 2007 and August 2009, the clinical data from 286 patients undergoing primary TKA surgery were retrospectively analyzed. In accordance with different anticoagulation methods, the cases were divided into 2 groups, the trial group (n=166) and the control group (n=120). In the trial group, the patients received low molecular weight heparin (4 000-6 000 U/day) from 8-12 hours after TKA for 14 days; there were 27 males and 139 females with an average age of 66.1 years (range, 22-82 years); the body mass index (BMI) was 26.79 ± 3.87; and the locations were the left knee in 99 cases and the right knee in 67 cases with an average disease duration of 4.1 years (range, 1.8-8.6 years). In the control group, the patients received aspirin (150 mg/day) for 14 days; there were 21 males and 99 females with an average age of 64.9 years (range, 40-84 years); the BMI was 27.87 ± 3.62; and the locations were the left knee in 78 cases and the right knee in 42 cases with an average disease duration of 4.9 years (range, 1.5-8.2 years). There was no significant difference in the general data between 2 groups (P gt; 0.05). Results The incisions healed by first intention in all patients. Postoperative deep venous thrombosis occurred in 37 patients of the trial group and in 28 cases of the control group. All the patients were followed up 12-34 months (mean, 21.6 months). There were significant differences in the United States Hospital for Special Surgery (HSS) score of 2 groups between before surgery and after surgery (P lt; 0.05). The hidden blood loss was (40.55 ± 37.75) g/L in the trial group and (32.52 ± 40.13) g/L in the control group, showing significant difference (t=3.387, P=0.001); the dominant blood loss was (24.08 ± 14.63) g/L and (27.91 ± 18.47) g/L respectively, showing no significant difference (t= —1.899, P=0.059). The blood transfusion rates were 40.4% (67/166) in the trial group and 30.0% (36/120) in the control group, showing no significant difference (χ2=2.771, P=0.081); the transfusion volumes were (1.44 ± 4.03) U and (0.97 ± 3.50) U respectively, showing significant difference (t=2.071, P=0.039). Conclusion The low molecular weight heparin has effect on the hidden blood loss after primary TKA, which may increase postoperative blood loss and blood transfusion rate. The changes in hemoglobin should be monitored during the anticoagulant therapy, and the blood volume should be added promptly.
Objective To evaluate the efficacy and safety of mifepristone for perimenopause dysfunctional uterine bleeding (PDUB). Methods Such databases as VIP, CNKI, Wanfang and CBM were retrieved for collecting randomized controlled trials (RCTs) on mifepristone for PDUB. The quality of included studies was evaluated and Meta-analysis was performed according to the Cochrane methods. Results Forty RCTs involving 3 850 PDUB patients were included. The control group was divided into two sub-groups according to the features of intervention drugs: the sub-group of diagnostic curettage plus progestational hormone, and the sub-group of diagnostic curettage plus antiestrogenic drugs. The Meta-analysis indicated that compared with the sub-group of diagnostic curettage plus progestational hormone, the diagnostic curettage plus mifepristone group was more effective to increase the total effective rate, such as improving symptoms and signs of PDUB (RR=1.11, 95%CI 1.06 to 1.16, Plt;0.000 01), and to reduce recurrence (RR=0.44, 95%CI 0.36 to 0.52, Plt;0.000 01). But no differences were found between the two groups in the change of endometrial thickness, contents of hemoglobin, and serum level of FSH, LH, E2 and P hormone. Both the intervention and control groups appeared mild adverse reactions, such as rashes, tidal fever, nausea, anorexia, vomiting and breast distending, but with no liver and kidney damages. The long-term safety failed to be evaluated due to short follow-up time. Conclusion Based on this review, diagnostic curettage plus mifepristone shows certain advantage in the treatment of PDUB including the total effective rate and reducing recurrence. But there is no difference in regulating sex hormone level, inhibiting endometrial proliferation and improving anemia compared with the group of diagnostic curettage plus progestational hormone. However, this evidence is not b enough due to the low quality of included trials, possible bias risk, and failure of evaluating its long-term safety.
Objective To perform a systematic review on the safety (i.g. cardiovascular, mortality and gastrointestinal bleeding) of clopidogrel versus clopidogrel combined with proton pump inhibitors (PPIs) for the patients with coronary heart disease. Methods Such databases as The Cochrane Library, PubMed, EMbase, SSCI, VIP, CNKI, and CBM were searched from the date of their establishment to September 2010. The bibliographies of the retrieved articles were also checked. The data was extracted and evaluated by two reviewers independently. The RevMan 5.0 software was used for meta-analyses. Results A total of 29 studies were included. The results of meta-analyses showed that the use of clopidogrel combined with PPIs was associated with increasing the risk of cardiovascular events (RR=1.27, 95%CI 1.09 to 1.47), as well as myocardial infarction (RR=1.45, 95% CI 1.20 to 1.76), total mortality (RR=1.23, 95%CI 1.06 to 1.43), and rethrombosis (RR=1.37, 95%CI 1.01 to 1.86). However, there was no enough evidence to reach the conclusion that the combination use could benefit the situation of gastrointestinal bleeding (RR=0.84, 95%CI 0.47 to 1.50). Conclusion?Compared with clopidogrel, the combination use of clopidogrel and PPIs increases cardiovascular events, mortality, and the risks of myocardial infarction and rethrombosis. However, more clinical studies are required to assess the effect of reducing gastrointestinal bleeding.
Objective To evaluate the efficacy and safety of endoscopic variceal ligation (EVL) versus endoscopic variceal sclerotherapy (EVS) for acute esophageal variceal bleeding in patients with liver cirrhosis.Methods We searched CBMdisc (1979 to 2006), CNKI (1994 to 2006) and VIP for randomized controlled trials (RCTs) and quasi-RCTs comparing EVL and EVS for acute esophageal variceal bleeding patients with liver cirrhosis. The methodogical quality of included trials was critically assessed and the data were extracted by two reviewers, working independently. The Cochrane Collaboration’s RevMan 4.2.7 software was used for meta-analysis. Results Nine RCTs involving a total of 1371 patients were included: 688 in EVL group and 683 in EVS. The meta-analyses showed a significant reduction for mortality [RR 0.60, 95%CI (0.36, 0.98)], and non-significant reductions in complications, rebleeding and emergency hemostasis in the EVL group compared to the EVS group. EVS was non-significantly better than EVL for the rate of eradication varices and recurrent varices. Conclusions For acute esophageal variceal bleeding in patients with liver cirrhosis, EVL has better effect and fewer complications than EVS. However, because the quality of included RCTs was poor, the strength of our conclusions was limited. Further high-quality RCTs are required.
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 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 analyze the difference in the incidence of postoperative pancreatic leakage and anasto-motic bleeding complications in various methods of pancreaticojejunostomy after pancreaticoduodenectomy （PD）. Methods The clinical data of 526 patients underwent pancreaticojejunostomy from January 2008 to September 2012 in this hospital were analyzed retrospectively. End-to-side “pancreatic duct to jejunum mucosa-to-mucosa” anastomosis （abbreviation：mucosa-to-mucosa anastomosis） was performed in 359 patients， which contained 149 patients with internal drainage， 130 patients with external drainage， and 80 patients with no drainage. End-to-side invaginated anastomosis was performedin 165 patients without drainage. In addition， side-to-side anastomosis was performed in 2 patients without drainage.Results There were 34 cases （6.46%） of pancreatic leakage， 8 cases （1.52%） of anastomotic bleeding in pancreaticoje-junostomy， and 32 cases of death （6.08%）. ① The pancreatic leakage rate of mucosa-to-mucosa anastomosis was signi-ficantly lower than that of end-to-side invaginated anastomosis 〔4.18% （15/359） versus 11.52% （19/165）， χ2=10.029， P=0.002〕. There was no significant difference of the anastomotic bleeding incidence between mucosa-to-mucosa anasto-mosis and end-to-side invaginated anastomosis 〔1.67% （6/359） versus 1.21% （2/165）， χ2=0.159， P=0.691〕. ② In the mucosa-to-mucosa anastomosis group， the pancreatic leakage rates in the ones with internal drainage and external drainage were lower than those in the ones without drainage， respectively （2.68% （4/149） versus 11.25% （9/80）， χ2=7.132， P=0.008；1.54% （2/130） versus 11.25% （9/80）， χ2=9.410， P=0.002）；which was no significant difference between the ones with internal drainage and external drainage 〔2.68% （4/149） versus 1.54% （2/130）， χ2=0.433， P=0.510〕. But there were no significant differences for both the pancreatic leakage 〔2.68% （4/149） versus 1.54% （2/130）， χ2=0.433， P=0.510〕and anastomotic bleeding incidence 〔2.68% （4/149） versus 1.54% （2/130）， χ2=0.433， P=0.510〕 between the ones with internal drainage and external drainage. Conclusions Mucosa-to-mucosa anastomosis has a lower pancreatic leakage incidence as compared with end-to-side invaginated anastomosis. However， there is no significant difference of the anast-omotic bleeding incidence. Internal or external drainage could reduce the incidence of pancreatic leakage， but have no obvious effect to the anastomotic bleeding incidence.