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 assess efficacy of mepivacaine on local anesthesia in dentistry and oral surgery and its safety. Methods Parallel group, stratified randomization, double blinded, muti-center clinical trial was designed. Two percent lidocaine with adrenaline in same cartridge was as control. Healthy patients with deep decay, pulpitis needed operative dentistry, or indication for extraction of the teeth, which located in the maxilla or front part of the mandible were included. Results Except 17 cases, 127 patients fulfilled inclusion criteria: 66 in treatment group and 61 in control group, dental filling for 60 and extraction for 67 cases, male 55 and female 72, average at 38.84 + 12.06 years. Submucous infiltration of 1.5 ml mepivacaine at labial or buccal side of the alveolar process produced onset of anesthesia in the median of 60 seconds which was same as that of lidocaine, anesthesia duration for 146.7 minutes with the median of 125 minutes, permitting painless filling or extractions. In the treatment group 81.82% freed of pain, while 15.15% had slight pain but received no extra local anesthetic for implementation of the treatment procedures, making the successful rate of 96.97%. In the mepivacaine group, 13.64% of the cases had transient elevation of the systolic pressure to the level of 145-162 mmHg, 8.33% diastolic pressure to the level of 91-93 mmHg. Only one case had transient palpitation in half minute after one minute injection of the drug with no medical care needed. All the cardiovascular reactions might result from adrenaline containing in the injections. Conclusion Mepivacaine is an effective, safe and reliable anesthetic agent for dentistry and oral surgery.
Backgroud Chronic hepatitis is the major infectious disease of liver. There is no effective drug for it up to now. Clinical trials have showed that glycyrrhizin have potentional effective for chronic hepatitis. Objective To evaluate the effectiveness, safety and economics of glycyrrhizin for chronic hepatitis B and C. Search strategy The search terms include glycyrrhizin and its products’ name, chronic hepatitis and chronic carrier status. The thais registers of the Cochrane Hepato-Biliary Group, the Cochrane Complementary Medicine Field, and the central database of The Cochrane Library as well as MEDLINE, EMBASE and Chinese Biomedical CD Database were searched from their date of inception onward. And the free Internet search was operated to find ongoing and unpublished researches. Twenty Chinese medical journals and relevant academic conference proceedings have been searched by manual method. The reference lists of identified documents were checked as the complementary search. Inclusion criteria All randomized trials that tested glycryyhizin for chronic hepatitis B virus or hepatitis C virus infection were included in this review. Method of the review According to the principle of Cochrane systematic review, selection of thai for inclusion, assessment of methodological quality, data extraction and data syntheses were conducted by two reviewers.
Background Hepatitis B is one of the major infectious diseases of mankind, and up to now, there is no effective way to handle it. Recent clinical trials have shown the potential advantages of Kurorinone an extract of Chinese herb, in treament of chronic HBV infection. Objectives Systermically review the safety and efficacy of Kurorinone in treatment of chronic HBV infection. Search strategy With the searching terms including Kurorinone, its products’ name, hepatitis B and chronic carrier status, the trials registers of the Cochrane Hepato- Biliary Group, the Cochrane Complementary Medicine Field, and the central database of the Cochrane Library as well as MEDILINE, EMBASE and Chinese Biomedical CD Database were searched from their date of inception onward. 20 Chinese medical journals and relevant academic conference proceedings have been searched by hand. The reference lists of identified documents were checked as the complementary search. Inclusion Criteria All RCTs that tested Kurorinone for chronic HBV infection were included in this review. Method of the review According the demand of Cochrane systematic review, selection of trial for inclusion, assessment of methodological quality, data extraction and data syntheses would be conducted for each included trial.
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.
目的 观察非甾体抗炎药依托芬那酯凝胶联合中枢性肌松药替扎尼定对治疗有潜在胃肠道风险的急性痉挛性颈肩腰痛的疗效和安全性。 方法 2012年3月－5月共诊断急性痉挛性颈肩痛及腰痛患者375例，依据排除标准排除33例，根据分组标准将有潜在胃肠道疾病风险者设为试验组（A组，n=63），明确无胃肠道疾病史者按照年龄、性别和疼痛部位与试验组进行配伍设为阳性对照组（B组，n=63）和安慰剂对照组（C组，n=63），未分组144例不纳入统计。试验组服用替扎尼定2 mg，2次/d，同时外用依托芬那酯凝胶5～10 cm均匀涂抹患处，3次/d；对照组服用替扎尼定2 mg，2次/d，同时口服塞来昔布0.2 g，2次/d；安慰剂对照组服用替扎尼定2 mg，2次/d，同时安慰剂1粒，2次/d。观察药物疗效和不良反应。 结果 A组随访57例，平均起效时间为（2.17 ± 0.99） d，总有效44例（77.2%），胃肠道不良反应2例（3.5%）；B组随访54例，平均起效时间为（1.78 ± 0.96） d，总有效45例（83.3%），胃肠道不良反应发生3例（5.5%）；C组随访55例，平均起效时间（4.10 ± 1.63） d，总有效35例（63.6%），胃肠道不良反应发生2例（3.6%）。 结论 依托芬那酯凝胶和口服非甾体抗炎药疗效和起效时间相当，胃肠道耐受性较好，联合用药效果优于单独使用肌松药。对于有潜在胃肠道风险的痉挛性颈肩腰背痛患者可选择外用非甾体抗炎药联合中枢性肌松药的治疗方案，以获得更好的疗效以及较高耐受性。