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The NEW ENGLAND 问题: JOURNAL of MEDICINE TA1SD1N181 JUNE14,2007 0L35686.2+ 1.寝了这幕文献后,你对于罗 Effect of Rosiglitazone on the Risk of Myocardial Infarction 裕列丽璃床使用的安全性有 and Death from Cardiovascular Causes 什么爱法? Steven E.Nissen,M.D.and Kathy Wolski,M.P.H. 2.你认考圆家卫生部门对此应 BACKGROUND 颜做出什么反应2 Rosiglitazone is widely used to treat patients with type 2 diabetes mellitus,but its effect on cardiovascular morbidity and mortality has not been determined. 3。筠物不良反应的研究雯要远 用哪些方法?为什么? METHODS We conducted searches of the published literature,the Web site of the Food and Drug Administration,and a clinical-trials registry maintained by the drug manu- facturer(GlaxoSmithKline).Criteria for inclusion in our meta-analysis included a study duration of more than 24 weeks,the use of a randomized control group not receiving rosiglitazone,and the availability of outcome data for myocardial infarc- tion and death from cardiovascular causes.Of 116 potentially relevant studies.42 trials met the inclusion criteria.We tabulated all occurrences of my tion and death from cardiovascular causes. Study Contr Group o ne.of mventfotal ne. RESULTS Mvocatdial infatction Small trials combined 44/10.2850431 22/61060.36 1450.88-23角 015 Data were combined by means of a fixed-effects model.In the 42 DREAM 15/2.6305刀 926340,30 1650,74-3.6 age of the subjects was approximately 56 years,and the mean b. ADOPT 27/1456(185 41/2*950.42 133080-2211 hemoglobin level was approximately 8.2%.In the rosiglitazone gro Overall 1431.0519期 46 Death from cardiovascufar causes with the control group,the odds ratio for myocardial infarction 25645036 7/1900.1 240117491 confidence interval [CI],1.03 to 1.98;P=0.03),and the odds ratio DREAM 121263划他4间 10/2640.38 120052-27周 ADOPT 21560141 5289到0.17) 0.80017-386 08 cardiovascular causes was 1.64(95%CI,0.98 to 2.74;P=0.06). 164098-27 问题: 1. 读了这篇文献后,你对于罗 格列酮临床使用的安全性有 什么看法? 2. 你认为国家卫生部门对此应 该做出什么反应? 3. 药物不良反应的研究主要运 用哪些方法?为什么?
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