孙忠实可用模板国家药品不良反应监测中心11.58MB.ppt

祝首届学术会议 园满成功! *1 42 * * Results Because the mean follow-up was only 3.75 years, our interim analysis had limited statistical power to detect treatment differences. A total of 217 patients in the rosiglitazone group and 202 patients in the control group had the adjudicated primary end point (hazard ratio, 1.08; 95% confidence interval [CI], 0.89 to 1.31). After the inclusion of end points pending adjudication, the hazard ratio was 1.11 (95% CI, 0.93 to 1.32). There were no statistically significant differences between the rosiglitazone group and the control group regarding myocardial infarction and death from cardiovascular causes or any cause. There were more patients with heart failure in the rosiglitazone group than in the control group (hazard ratio, 2.15; 95% CI, 1.30 to 3.57). Rosiglitazone Evaluated for Cardiovascular Outcomes — An Interim Analysis (RECORD) N Engl J Med 2007;358:8;357;28~38 * 关注含钆造影剂的安全性 * FDA公告-警戒含钆造影剂 2007年5月23日,根据所获不良反应信息,FDA及时发出通知,要求生产用于MRI的含钆造影剂(GBCAs)的企业修改说明书,增加警示语和黑框警告:禁止用于严重肾功能不全患者(GFR30ml/min/1.73m2)和待接受或正在接受肝移植的患者;因可致肾源性系统性纤维化病(NSF)/肾源性纤维化皮肤病(NFD);新生儿,1岁以下小儿,孕妇,哺乳期妇女慎用。 自2006年3月29日报告第1例至今,全球已约有200例报告;在重症肾病患者的发生率约3%~4.3%。 * GBCAs致肾源性纤维化皮肤病 N Engl J Med 2007;357;e2 发病时间2天~75天 * 耶鲁大学的最新报告 2007年6月28日Yale大学医学院报告1例晚期肾衰进行肾透析的患者,在2年内曾使用过6次钆特醇(ProHance),每次32ml,在最后一次给药后的第6个月发生了严重NSF; 不仅再次说明严重肾功不全是发生NSF的关键因素;同时还表明,即使是环状结构的、非离子低渗型的GBCAs─钆特醇亦可诱发NSF,故应“一视同仁”高度警戒! * 慎用EPO * EPO致单纯红细胞再障(PRCA) Pure Red-Cell Aplasia and Epoetin Therapy Background Between 1988 and 1998, antibody-associated pure red-cell aplasia was reported in three patients who had undergone treatment with recombinant human erythropoietin (epoetin). Between 1998 and 2000, 13 such cases were reported from France — 12 in patients who had received the Eprex formulation of epoetin alfa and 1 in a patient who had received Neorecormon (a formulation of epoetin beta); both are products that are marketed outside the United States.