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 evaluate the adverse events following immunization (AEFI) of meningococcal vaccines, so as to provide references for the appraisal and treatment of AEFI. Methods The Chinese Bio-medicine Database (1978 to April, 2010), China Journal Full-text Database (1994 to April, 2010), VIP Database (1989 to April, 2010) and WangFang database (1988 to April, 2010) were fully searched, and the references listed in original studies were searched manually as well. Then two reviewers independently screened studies and abstracted relevant data.Results A total of 52 articles involving 61 cases were included. Among the AEFI cases, 72.13% were hypersensitive response, including henoch-schonlein purpura (accompanied with or without nephritis), anaphylactic shock, allergic eruption, angioedema, local allergic reaction and so on. Conclusion The results of this study show that meningococcal vaccines may result in AEFI. However, most AEFI are temporary and can be cured after treatment in time. In general, meningococcal vaccine is safe, but monitoring and treatment for AEFI are necessary.
Objective To evaluate the effectiveness and safety of traditional Chinese medicine therapies (TCMT) for prostatitis. Methods We searched Cochrane Controlled Trials Register (CCTR), China EBM/Cochrane center database (CEBM/CCD), PubMed, Chinese Biomedical Literature Database (CBM), Papers on Academic Conference of China (PACC), Chinese Dissertation Database Full-Text (CDDBFT), and Evidence-based Traditional Chinese Medicine Database (EBTCMD). All searches were updated on January 15, 2007. We also performed a manual search of the RCTs of TCMT for prostatitis among periodicals related to TCM, researched the related studies by correlative websites, such as “Baidu” and “Google”, gray literatures, and studies included in the references of eligible studies. At least two reviewers independently screened the studies for eligibility, evaluated the quality, and extracted the data from the eligible literatures, with a cross-check to confirm accuracy. Different views were settled by a third party. We evaluated the quality of eligible studies with the revised Jadad’s scale, and extracted valid data using data tables. Meta-analyses were performed for homogeneous studies using RevMan 4.3 software. If heterogeneity existed among the studies, descriptive analysis was conducted. The potential publication-bias was analyzed by funnel plot analysis. Results A total of 52 randomized clinical trials of TCMT for prostatitis (n=5 209) among 1 282 original studies were identified. The methodological quality ranked high in 9 RCTs (the revised scale were ≥ 4 scores), and 22 RCTS reported the methods of random sequence production. The analysis indicated some TCMT were more effective than the treatments in the controls in relieving the proatatitis patients’ pain or discomfort, paruria, impact of symptoms and NIH-chronic prostatitis symptom index (NIH-CPSI), improving the EPS-WBC and urine flow rate etc. Of the trials, 29 randomized clinical trials of TCMT for prostatitis that studied safety (n=2 502) were identified. The methodological quality ranked high in 8 RCTs (the revised scale were ≥ 4 scores), and 18 RCTs reported the method of random sequence production. Analysis indicated some TCMT may cause lower digestive tract symptoms when compared to the control therapies and some Chinese herbs formulas- may cause sexual disfunction. Conclusion Some TCMT may be more effective than the controls in relieving the patients’ pain or discomfort, paruria, impact of symptoms and NIH-CPSI, improving the prostatic tenderness with DRE, improving the EPS-WBC, lecithin lipophore, and urine flow rate etc. However, some TCMT of the trials included may cause lower digestive tract symptoms when compared to the controls, and some Chinese herbs formulas cause sexual disfunction. Because of the generally low methodological quality and the variations of the herbs used, the overall effects cannot be pooled for analysis. More evidence is needed to support this finding.
Objective To evaluate the efficacy and safety of trimetazidine (TMZ) for chronic congestive heart failure. Methods We searched The Cochrane Library (Issue 3, 2006), MEDLINE (1990-2006), EMBASE (1990-2004), and the Chinese Biomedicine Database (1990- 2006 ) for parallel group randomized controlled trials (RCTs) and cross-over design trials comparing TMZ and placebo or open controls for patients with heart failure.We used The Cochrane Collaboration’s RevMan 4.2 software for data analyses. Results Four RCTs and two cross-over design trials were included. Meta-analyses showed that: compared with the control group, TMZ may improve the NYHA cardiac functional grade (RR 0.85, 95%CI 0.76 to 0.95), increase the total exercise time (WMD 51.40 seconds, 95%CI 15.56 to 87.25), the maximal metabolic equivalents (WMD 0.82, 95%CI 0.28 to 1.37), and the ejection fraction (WMD 7.29%, 95%CI 6.28 to 8.31), but may decrease the left ventricular end-diastolic volume (WMD –12.19 ml, 95%CI –15.29 to –9.09), the left ventricular end-diastolic diameter (WMD –6.05 mm, 95%CI –7.10 to –4.99), the left ventricular end-systolic volume (WMD –16.94 ml, 95%CI –20.34 to –13.55), the left ventricular end-systolic diameter (WMD –5.42 mm, 95%CI –5.98 to –4.86), and the serum brain natriuretic peptide (WMD –239.59 pg/ml, 95%CI –276.53 to –202.65). TMZ may also improve the quality of life (WMD 12.36, 95%CI 5.16 to 19.55). Conclusions TMZ plus standard medical therapy has a beneficial effect on the indices of cardiac function, and may also improve the patient’s quality of life. However, because available RCTs for this systematic review are too small and poor quality, (mainly focusing on the heart failure induced by ischemic heart diseases and merely taking intermediate indices as outcome measures), further high-quality large-scale RCTs with death as the endpoint and which include subgroup analysis of non-ischemic heart failure, are required in order to provide more reliable evidence.
Objective To assess the effectiveness and safety of nine lipid-lowing agents in the national essential drug list (2000) and provide evidence for the adjustment and selection of essential drugs. Methods Based on principles of health technology assessment (HTA) and evidence-based medicine, we searched for all published clinical studies about these drugs from the following databases: MEDLINE (1966-2002.8), The Cochrane Library, EMBASE (1974-2002), CBMdisk (1979-2002.8) and VIP (1989-2002.8), the database of National Center for Adverse Drug Reaction(ADR) Monitoring of China and the database of WHO Uppsala drug monitoring center. Included studies were appraised, analyzed and compared for the reduction of triglyceride (TC) or low density lipoprotein (LDL-C), the prevention for the coronary events and the incidence of ADR. Results The results from comparative trials for lipid-lowing agents showed that the equivalent dose of statins for 25% reduction of LDL-C was atorvastatin 10 mg/d, simvastatin 20 mg/d, pravastatin 40mg/d, lovastatin 40 mg/d, cerivastatin 0.3 mg/d and fluvastatin 80 mg/d. It was difficult to compare fenofibrate with gemfibrozil, acipimox with statins or fibrates based on available data. The study on the primary and secondary prevention of cardiovascular events showed that pravastatin and lovastatin were effective in primary prevention, and long-term use could reduce the incidence of cardiovascular disease.Gemfibrozil could reduce the mortality from coronary heart disease (CHD) but the overall mortality was not changed. Pravastatin, simvastatin, atorvastatin, fluvastatin, gemfibrozil and fenofibrate had a confirmed effect in secondary prevention. Data from large-scale clinical trials and the reports from ADR monitoring center of England, America, Canada and Australia suggested that the statins which had rare ADR were safe and tolerated. Rhabdomyolysis was rare but had a serious adverse reaction associated with statins. The rate of fatal rhabdomyolysis related to cerivastatin was the highest among 6 statins. The safety of simvastatin, lovastatin and atorvastatin was lower than cerivastatin but higher than simvastatin and atorvastatin. The number of ADR reports of fenofibrate was fewer than that of gemfibrozil. Conclusions At present, the best evidence focused on pravastatin, simvastatin and lovastatin are widely used and have a confirmed safety and efficacy. Atorvastatin, fluvastatin and fenofibrate still need more data to confirm their effects on coronary heart disease prevention. The drugs which were shown to be inferior or insufficient evidence are cerivastatin, gemfibrozil and acipimox.
Food and Drug Administration (FDA) has suspended the use of both celecoxib (Celebrex, Pfizer) and naproxen (Aleve, Bayer) in prevention large clinical trials after discovering that celecoxib and naproxen appeared to increase the risk of cardiovascular events with patients on placebo. FDA also advises patients who are currently taking over the counter naproxen products to carefully follow the instructions on the label. Pfizer suggested that alternatives to celecoxib should be considered based on individual patient needs and risk. The cardiovascular community responds differently.
Advancing patient safety is one of the most important strategies developed by WHO. The following paper outlined the main content, aims and goals of WHO the second global patient safety challenges “ Safe surgery saves lives” as well as discussed the importance of communication between surgeons and patients.
Objective To discuss the safety of fast track surgery for patients with obstructive colorectal cancer. Methods Between February 2008 and February 2009, 157 cases of obstructive colorectal cancer were analyzed retrospectively, 59 in fast track (FT) group and 98 in traditional group. Postoperative early rehabilitations and complications were studied and compared. Results The first time of passing flatus, oral intake and postoperative hospital stay in FT group were significantly earlier or less than those in traditional group （Plt;0.05）, while there were no significant differences in time of first ambulation, time with use of nasogastric tubes, urinary catheter, and drains between the 2 groups （Pgt;0.05）. There was also no statistically significant difference in postoperative complications rate between the 2 groups （Pgt;0.05）. Conclusion Fast track surgery for patients with obstructive colorectal cancer is safe and can accelerate recovery with decreasing length of hospital stay and improving life quality of the patients.
Objective To assess the safety of intravenous infusion with self-made perfluorocarbon emulsion (PFE) in rats.Methods 35 Wistar rats were randomly divided into a normal control group and six PFE groups (n=5 in each group).The control group was intravenous injected with normal saline and six PFE groups with PFE.Blood samples were obtained from the PFE groups 5 min after injection via vena orbitalis for perfluorocarbon (PFC) measurement.The control group were sacrificed at 2 hours after injection，and the six PFE groups were respectively killed at 2 h，4 h，6 h，24 h，48 h and 10 d after injection.The blood levels of PFC，PaO2，GPT，GOT，BUN and Cr were measured.Pathological changes of lung，liver and kidney were also observed.Results All rats were in good health state after PFE intravenous injection with no obvious pathological changes in liver and kidney.PFC was wide distributed throughout the pulmonary alveoli and capillaries.The levels of GPT and GOT were higher in the PFC groups at 2，4，6 and 24 h than which in the control group (all Plt;0.05)，but there were no significant difference between the PFE 10 d group and the control group.The levels of BUN and Cr had no remarkably differences in all groups.Blood PFC concentrations were (20±1.8)mg/mL，(1.8±0.7)mg/mL，(1.5±0.6)mg/mL，(1.2±0.4)mg/mL，(0.5±0.2)mg/mL，(0.2±0.03)mg/mL，0 mg/mL in the PFE groups respectively at 5 min，2 h，4 h，6 h，24 h，48 h，10 d after injection.PaO2 of the PFE 2 h group was significant higher than which in the control group [(119.2±8.6)mm Hg vs (99.6±4.7)mm Hg，Plt;0.05].Conclusion Intravenous injection with PFE (10 mL/kg) can enhance PaO2 with good safety and no obvious influence on pathology of lung，liver and kidney，so may be used for the treatment study of acute lung injury.
Objective To evaluate the complication rate of CT-guided percutaneous lung biopsy and determine the risk factors. Methods A retrospective investigation of patients with CT-guided percutaneous lung biopsy in Ruijin Hospital, Shanghai Jiao Tong University School of Medicine between2002 and 2009 was performed. The risk factors for complications were determined by multivariate analysis of variables related to patients’demographics, lung lesions, biopsy procedures, and individual radiological features. Results 281 biopsy procedures were enrolled. The total complication rate was 55. 9% with pneumothorax 32. 4% ( 91/281) , hemoptysis 34. 5% ( 97 /281) , and cutaneous emphysema2. 1% ( 6 /281) , and with no mortality.The pneumothorax rate was correlated with lesion location, lesion depth, and number of pleural passes. The bleeding risk was correlated with lesion size, lesion depth, and age. Prediction models for pneumothorax and bleeding were deduced by logistic regression. The pneumothorax model had a sensitivity of 80. 0% and a specificity of 62. 4% . And the bleeding model had a sensitivity of 67. 4% and a specificity of 88. 8% .Conclusions Lesion location, lesion depth, and number of pleural passes were independent risk factors for pneumothorax. Lesion size, lesion depth, and age were independent risk factors for bleeding. The prediction models for pneumothorax and bleeding will helpfully reduce the complication of CT-guided lung biopsy.