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在类风湿性关节炎中使用塞莱科西布的抗炎和上部胃肠道作用:一项随机对照试验
L S Simon1, A L Weaver, D Y Graham
1Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass 02215, USA.
JAMA
|December 2, 1999
概括
塞莱科克西布有效地治疗类风湿性关节炎症状,胃肠道的数量比纳普罗森少. 这种COX-2抑制剂提供抗炎功效,而没有显著的COX-1相关的胃损伤.
科学领域:
- 类风湿病学 类风湿病学
- 药理学 药理学是指药理学的学科.
- 胃肠病学 胃肠病学
背景情况:
- 实验室研究表明,与非类固醇抗炎药物 (NSAIDs) 相比,切莱科西布 (COX-2 抑制剂) 可能提供抗炎和止痛效益,降低胃肠道 (GI) 风险.
- 传统上,NSAIDs抑制COX-1和COX-2,导致COX-1抑制导致潜在的上部胃肠道不良影响.
研究的目的:
- 评估塞莱科西布作为类风湿性关节炎患者的抗炎和止痛药的疗效.
- 与传统的NSAID相比,评估赛莱科西布是否会导致消化道粘膜损伤较小.
主要方法:
- 这是一项为期12周的随机,多中心,安慰剂控制,双盲试验,涉及1149名类风湿性关节炎患者.
- 患者接受了塞莱科克西布 (100,200或400毫克两次),纳普罗森 (500毫克两次) 或安慰剂.
- 通过标准关节炎症状评估来测量有效性;通过上部肠道内镜来评估肠道安全性.
主要成果:
- 与安慰剂相比,切莱科西布和纳普罗森显著改善了类风湿性关节炎的症状和体征,效果持续了12周.
- 与纳普洛森 (26%) 相比,在接受赛莱科西布 (4-6%) 或安慰剂 (4%) 治疗的患者中,胃肠的发生率明显较低.
- 整体GI不良事件发生率在赛莱科西布 (25-28%) 和安慰剂 (19%) 之间是可比的,但在纳普罗森 (31%) 之间更高.
结论:
- 切莱科克西布在所有测试剂量中证明了治疗类风湿性关节炎的有效性.
- 该研究证实,与纳普罗森相比,塞莱科西布与内镜的发病率较低有关,这表明在肠道粘膜中保持了COX-1活性.
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