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find Keyword "controlled trials" 78 results
  • Complications in Patients after Side-to-side Esophagogastric Anastomosis: A Systematic Review and Meta-analysis

    ObjectiveTo systematically review the impact of side-to-side esophagogastric anastomosis on postoperative anastomostic leak, fibrosis stricture and stroesophageal reflux. MethodsWe searched PubMed, EMbase, The Cochrane Library (Issue 4 2015), Web of Science, CNKI, CBM, Wanfang Database and VIP up to April 2015. Randomized controlled trials involving the complications after side-to-side esophagogastric anastomosis were included. Data were extracted and methodological quality was evaluated by two reviewers independently with a designed extraction form. Then RevMan 5.3 software was used for meta-analysis. ResultsA total of 7 studies involving 684 patients were included. The results of meta-analysis showed that comparing with traditional anastomosis, side-to-side esophagogastric anastomosis could reduce the incidence of fibrosis stricture with RR=0.20 and 95% CI 0.11 to 0.36 (P<0.000 01). There was no statistical difference in incidence of postoperative anasotmostic leaks with RR=0.71 and 95% CI 0.43 to 1.19 (P=0.19) or stroesophageal reflux with RR=0.74 and 95% CI 0.50 to 1.11 (P=0.15) between the two groups. ConclusionComparing with traditional anastomosis, side-to-side esophagogastric anastomosis could reduce the incidences of fibrosis stricture, but there is no statistical difference in anastomostic leak or stroesophageal reflux.

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  • Fibrinogen-depleting agents for acute ischemic stroke: a systematic review of randomized evidence

    Objective To assess the efficacy and safety of fibfinogen-depleting agents (snake venom extracts) in the treatment of acute ischemic stroke. Method A systematic review of all the relevant randomized controlled trails (RCTs) was performed. RCTs were identified from the Cochrane Stroke Group’s Specialized Trials Register, additional electronic and handsearching, and personal contract with pharmaceutical companies. We included all completed and unconfounded truly or quasi-randomized trials in patients with ischemic stroke comparing fibrinogen depleting agents for analysis. Results Ten completed and one ongoing RCTs have been identified so far. Up to 1998, only three trials using ancrod (182 patients) met the inclusion criteria. Ancrod was associated with a significant reduction in early deaths (5.6% vs. 16%; odds ratio [OR], 0.33; 95% confidence interval [CI], 0.13 to 0.85; 2P=0.02) suggesting that treatment of 100 patients would avoid about 10 early deaths. The frequency of asymptomatic intracranial hemorrhage shown by computed tomography was similar between ancrod-treated and control groups (7.6% vs. 9.6%; OR 0.78; 95%CI 0.26 to 2.33; 2P=0.65). No major intracranial or extracranial hemorrhages or recurrent ischemic strokes occurred in the ancord-allocated patients. There were nonsignificant trends in favor of ancrod in death from any cause (OR 0.57; 95%CI 0.27 to 1.23; 2P=0.15) and death or disability (OR 0.52; 95%CI 0.26 to 1.03; 2P=0.06) at the end of trial follow-up. Up to 2000, other two trials published results. This review will be updated with new trial results soon, which will provide more data. Conclusions There were too few patients and outcome events to draw reliable conclusions from the present data. Although ancrod-like agents appeared promising, their routine use cannot be recommended at the moment. Future trials should test simpler fixed-dose regimens to allow better generalizability.

    Release date:2016-08-25 03:16 Export PDF Favorites Scan
  • Thrombolysis (different doses, routes of administration and agents)for acute ischaemic stroke

    Objective To assess the effect of different thrombolytic agents, and different regimens in acute ischaemic stroke. Methods A systematic review of all the relevant randomized controlled trials (RCTs) was performed. RCTs were identified from the Cochrane Stroke Group trials register, Embase (1980 to 1997), handsearching Japanese and Chinese journals, and personal contact with pharmaceutical companies. We included randomised and quasi-randomised trials in patients with confirmed acute ischaemic stroke comparing different doses of a thrombolytic agent, or different thrombolytic agent, or the same agent given by different routes. Results Eight trials involving 1 334 patients were included. Concealment of allocation was generally adequate. All the trials were conducted in Japan. Different doses (of tissue plasminogen activator or urokinase) were compared in six trials. Different agents (tissue plasminogen activator versus urokinase,or tissue-cultured urokinase versus conventional urokinase) were compared in three trials. Few data were available for functional outcomes. A higher dose of thrombolytic therapy was associated with a five-fold increase in fatal intracranial haernorrhages (odds ratio 5.02, 95% confidence interval 1.56 to 16.18). There was a non-significant trend towards more early deaths or clinically significant intracranial haemorrhages in higher dose group. No difference in late deaths or extra-cranial haemorrhages was shown between low and higher doses. However, very few of these events occurred. No difference was shown between the different thrombolytic agents tested. Conclusions There is not enough evidence to conclude whether lower doses of thrombolytic agents might be safer or more effective than higher doses in acute ischaemic stroke. It is not possible to conclude whether one agent might be better than another, or which route of administration might be best.

    Release date:2016-08-25 03:16 Export PDF Favorites Scan
  • Vasodilators for sudden sensorinenral hearing loss:a systematicreview of randomized controlled trials

    Objective To assess the effects and safety of vasodilators for sudden sensorineurial hearing loss (SSHL). Search strategy Electronic databases: MEDLINE from 1966, EMBASE from 1974, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database from 1989. Hand search: Five kinds of Chinese otolaryngology journals were searched. Literature references were checked intensively. Selection criteria Randomized controlled trials comparing vasodilators with placebo or other drugs in patients with SSHL. Data collection and analysis At least two reviewers independently assessed trials quality and extracted data. Main results Thirteen trials with 1 155 patients were eligible and included in the systematic review. Ten of the trials were from developed countries and them were from P. R. China. None of the four trials showed that the effects of vasodilators were better than placebo for SSHL. None of the seven trials showed that the effects of one kind of vasodilators were better than that of the other vasodilators. Two trials showed that other drugs, such as batroxobin and hypaque,were probably better than some vasodilators (dextran, papaverine, 654-2, danshen). Eight trials reported the side effects of vasodilators, such as pruritus, allergy, etc. Reviewers’ conclusions Base on the systematic review of current eligible randomized controlled trials, there is no evidence to prove that vasodilator therapy is better than placebo or other therapies for SSHL, or the effects of one kind of vasodilator are better than that of the other vasodilators. We can’t draw a reliable conclusion about the effects of vasodilators for SSHL at the moment. And we must pay attention to their potential adverse reactions.

    Release date:2016-08-25 03:16 Export PDF Favorites Scan
  • Analysis of randomized controlled trials on information of comumonly-used digestive-related medicines

    Objective To appraise the current situation of randomized controlled trials (RCTs) on information of common-used digestive-related medicines afforded by medicine-salesmen. Methods RCTs on digestive-related medicines were assessed according to clinical epidemiologic standard. Results 60 medicines containing 252 therapeutic articles were searched and 75 RCTs were identified and assessed. Conclusion The qualities and quantities of RCTs of information on digestive-related medicines were of large difference, the RCTs afforded by the joint pharmaceutical enterprises are much better than those of foreign ones and domestic ones.

    Release date:2016-08-25 03:16 Export PDF Favorites Scan
  • Analysis of therapeutic articles on chronic hepatitis B in China

    Objective To investigate the current situation of randomized controlled trials or clinical controlled trial (RCT/CCT) on chronic hepatitis B and whether to offer reliable evidence for clinical practice in China. Methods RCT/CCT identified from six Chinese clinical journals were searched manually and assessed according to international standard of evidence-based medicine. Results 308 issues containing 212 therapeutic articles and 88 RCT/CCT on chronic hepatitis B were identified and analyzed. Conclusion the quantity and quality of RCT/CCT of chronic hepatitis B did not meet the need of clinical practice.

    Release date:2016-08-25 03:17 Export PDF Favorites Scan
  • Analysis of randomized controlled trials/clinical controlled trials on chronic gastritis in China

    Objective To evaluate the current situation of randomized controlled trials/ clinical controlled trials (RCT/CCT) on chronic gastritis and whether it could offer reliable evidence for clinical practice in China. Method RCT/CCT on chronic gastritis from eight Chinese clinical journals were searched manually and assessed according to international standard. Results 823 issues containing 213 therapeutic articles were searched and 81 RCT/CCT were identified and assessed. Conclusions The quantity and quality of RCT/CCT on Chronic gastritis in China could not meet the need of clinical practice. RCT/CCT of western medical therapy are much better than those of traditional Chinese therapy and integrated traditional Chinese and western medical therapy ones.

    Release date:2016-08-25 03:33 Export PDF Favorites Scan
  • How to Establish a Chinese Clinical Controlled Trials Database of Neurology

    Objective To establish a Chinese clinical controlled trials database of neurology. Methods We identified relevant studies by electronic searching of CBMdisc from 1978 to April 2002, and the Library of Evidence-Based Medicine (Chinese). We also searched manually 11 journals and 4 conference proceedings relevant to neurological diseases. The studies included in this database should be controlled studies relevant to treatment on neurological disease, randomized or only controlled without randomization. Results 3 641 studies were included in this database. Conclusions The Chinese neurological trials database was established. This database will provide Chinese evidence on treatments of various neurological diseases. Studies in this database will also be included in the Cochrane Library to facilitate systematic reviewers.

    Release date:2016-08-25 03:33 Export PDF Favorites Scan
  • External Fixation or Intramedullary Nailing For Tibial Shaft Fractures in Adults: A Systematic Review

    Objective To determine the efficacy and safety of external fixation versus intramedulllary nailing in the treatment of adult tibial shaft fracture. Methods We searched the specialized trials register of The Cochrane Collaboration’s Bone, Joint and Muscule Trauma Group, The Cochrane Library (CENTRAL), MEDLINE (1966 to March 2006), EMBASE (1980 to March 2006) and PUBMED (1966 to March 2006). We also handsearched some Chinese orthopedic journals. Randomized controlled trials (RCTs) and quasi-randomized trials (quasi-RCTs) comparing external fixation versus intramedullary nailing for tibial shaft fractures in adults were included. The quality of these trials was critically assessed. We used the Cochrane Collaboration’s RevMan 4.2.8 for data analyses. Result Three RCTs and two quasi-RCTs involving a total of 279 patients were included. The results of meta-analyses showed that external fixation for tibial shaft fractures in adults may increase the infection rate [RR 2.45, 95%CI (1.31,4.61), P=0.005], and the malunion rate [RR 2.85, 95%CI (1.20,6.79), P=0.02] but may reduce the duration of hospitalization [RR –5.50, 95%CI (–6.99,–4.01)]. The nonunion rate, delayed healing rate, and healing time, were comparable between external fixation and intramedulllary nailing. Conclusion The trials available for this systematic review are too few and small for reliable estimates of the relative effects of external fixation and intramedulllary nailing. Further studies are needed to determine these effects , especially for patients who have GustiloШ C fractures.

    Release date:2016-08-25 03:35 Export PDF Favorites Scan
  • Application of CMH Test and Meta-analysis in Multi-center Randomized Controlled Trials

    Objective To seek the statistical solution in the comparison of different effects from multi-center randomized controlled trials (RCTs). Methods The data collected from a multi-center RCT were used as the examples and processed by CMH test and meta-analysis. Results The result of CMH test indicated that the significant difference of the effect values existed among centers (P 〈0. 05 ). While meta-analysis showed no significant difference (P 〉0.05 ) by heterogeneity test. However, when using fixed effect model, inter-group significant difference of merged effect values was observed (P 〈0.05 ). Conclusions In the clinical research based on the method of multi-center RCT, met.a-analysis can be applied if the difference of inclination of the inter-group therapeutic effect is found among different centers. The proper mathematical model should be selected based on the result of heterogeneity test to merge and compare the effect values. The conclusions should be drawn from the results of both meta-analysis and CMH test.

    Release date:2016-08-25 03:34 Export PDF Favorites Scan
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