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用于预防重复重度血管综合症患者的心脏起器治疗:第二次血管起器研究 (VPS II):一项随机试验
Stuart J Connolly1, Robert Sheldon, Kevin E Thorpe
1Department of Medicine, McMaster University, Hamilton, Ontario. connostu@hhsc.ca
JAMA
|May 8, 2003
概括
心脏起器治疗并没有显著降低患有血管性的患者中的复发率. 这项研究表明,由于有效性有限和潜在的并发症,它不应该成为一线治疗.
科学领域:
- 心脏病学 心脏病学
- 临床试验 临床试验
- 医疗器械 医疗器械
背景情况:
- 之前的小型试验表明,心脏起器疗法有益于严重的复发性血管同.
- 在非双盲研究中存在关于偏差和安慰剂效应的担忧.
研究的目的:
- 评估心脏起器疗法的有效性,以减少患有血管性的患者中的复发.
- 进行随机,双盲试验,以尽量减少偏见.
主要方法:
- 一个随机的,双盲试验,涉及100名门诊患者的复发性昏迷.
- 患者在心脏起器植入后接受了双室节奏 (DDD) 或仅传感 (ODO).
- 随访时间长达6个月,首要结局是时间到第一次昏迷复发.
主要成果:
- 在6个月后,DDD节拍 (33%) 和ODO (42%) 组之间无显著差异.
- 与DDD节奏相对降低失眠的相对风险在统计学上并不显著.
- 并发症包括脱落,静脉血栓,心周栓塞和感染.
结论:
- 心脏起器疗法没有证明有效性,以减少患有血管性的患者的复发性.
- 鉴于缺乏强有力的证据和并发症风险,不建议作为一线治疗的起器治疗.
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