论文部分内容阅读
昔布类药物塞来昔布和罗非昔布最初以其抗炎特点用于治疗类风湿关节炎和骨性关节炎,其疗效与对照的萘普生相当,但已显示出心血管不良事件增高的趋势。1999年以来,昔布类抗炎药物用于结、直肠腺瘤性息肉的防治。其中,罗非昔布25mg/d组的疗程超过18个月后,心脑血管事件发生率达3.5%,明显高于安慰剂组的1.5%。为此,该药于2004年9月30日从全球撤市;同样,塞来昔布也因以400mg/d和800mg/d防治腺瘤性息肉的临床研究中,当疗程平均达33个月时,与安慰剂对比,心血管事件的危险性分别增加2.5倍和3.4倍。为此,美国FDA于2004年12月17日发出紧急通告,停止塞来昔布原订5年的临床试验熏并要求用其他药品替代该产品。
Cocoxib, and rofecoxib, were initially used for the treatment of rheumatoid arthritis and osteoarthritis with their anti-inflammatory properties, which are comparable in efficacy to the control naproxen but have shown cardiovascular adverse events Increasing trend. Since 1999, ciprofibens anti-inflammatory drugs are used in the prevention and treatment of colorectal adenomatous polyps. Among them, rofecoxib 25mg / d group of treatment over 18 months, the incidence of cardiovascular and cerebrovascular events reached 3.5%, significantly higher than the 1.5% of the placebo group. For this reason, the drug was withdrawn from the world on September 30, 2004; similarly, celecoxib also for clinical trials of 400mg / d and 800mg / d prevention and treatment of adenomatous polyps, when the average treatment period of 33 months When compared with placebo, the risk of cardiovascular events increased by 2.5 times and 3.4 times, respectively. To this end, the U.S. FDA issued an urgent circular on December 17, 2004, halting celecoxib’s original five-year clinical trial and requiring the replacement of the product with other drugs.