塔利多米德用于由于小肠血管扩张引起的复发性出血
Huimin Chen1, Shan Wu1, Mingyu Tang1
1From the Division of Gastroenterology and Hepatology, Shanghai Jiao-Tong University School of Medicine Renji Hospital, Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health (Shanghai Jiao-Tong University) (Huimin Chen, S.W., M.T., R.Z., Q.Z., Z.D., Y.G., X.L., H.L., H. Xiong, Y.S., Haiying Chen, S.G., H. Xue, Z.G.), the Department of Gastroenterology and Hepatology, Changhai Hospital, Naval Medical University (Z.L., Y.D.), the Department of Gastroenterology, Huashan Hospital (L.Z.), and the Department of Gastroenterology and Hepatology, Zhongshan Hospital (X.S.), Fudan University, the Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao-Tong University School of Medicine (L.L.), the Department of Gastroenterology, Xinhua Hospital, Shanghai Jiao-Tong University School of Medicine (L.X.), and the Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao-Tong University School of Medicine (J.Z.), Shanghai, the Department of Gastroenterology, Xinqiao Hospital, Army Medical University, Chongqing (S.Y.), the Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (A.Y.), and the Department of Gastroenterology, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou (S.L.) - all in China.
沙利多米德显著减少了患者的小肠道复发出血 (SIA). 这项研究证实了thalidomide的存在.
科学领域:
- 胃肠病学 胃肠病学
- 临床药理学 临床药理学
背景情况:
- 复发性小肠道出血 (SIA) 是一个重要的临床挑战,占肠道出血病例的5-10%.
- 之前对SIA的thalidomide的评估缺乏证实性试验数据.
研究的目的:
- 调查thalidomide在治疗由于小肠血管扩张 (SIA) 的复发出血方面的疗效和安全性.
主要方法:
- 一个多中心,双盲,随机,安慰剂对照试验,涉及150名患有复发性SIA的患者.
- 患者接受口服thalidomide (每天100毫克或50毫克) 或安慰剂4个月,然后至少观察1年.
- 主要终点是与治疗前相比,治疗后出血事件减少≥50%.
主要成果:
- 与安慰剂 (16.0%) (P<0.001) 相比,沙利多米德的有效应答率显著更高 (100毫克68.6%,50毫克51.0%).
- 二次终点,包括停止出血和改善血红蛋白水平,也有利于thalidomide治疗.
- 便秘和昏昏欲睡等不良事件在thalidomide组中更为频繁.
结论:
- thalidomide治疗有效地减少了小肠道血管扩张的患者的复发性出血.
- 这项研究提供了强有力的证据,支持thalidomide在管理这种具有挑战性的疾病中的治疗作用.
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