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患有神经介导性昏迷和记载性心症患者的心脏起器治疗:第三项关于不确定的病因昏迷的国际研究 (ISSUE-3):一种随机试验
Michele Brignole1, Carlo Menozzi, Angel Moya
1Department of Cardiology, Ospedali del Tigullio, Lavagna, Italy. mbrignole@ASL4.liguria.it
Circulation
|May 9, 2012
概括
心脏节奏显著降低了老年人严重的脑性神经介导性昏迷的昏迷复发. 这种干预提供了57%的相对风险降低,证明对这种情况有效.
科学领域:
- 心脏病学 心脏病学
- 临床电生理学 临床电生理学
背景情况:
- 神经介导性 (NMS) 是复发性的常见原因.
- 心脏节奏调节在预防NMS患者同性复发的有效性仍在争论中.
- 严重的脑梗塞性NMS对管理来说是一个特殊的挑战.
研究的目的:
- 评估双室永久节奏在减少同步复发的有效性.
- 评估40岁及以上患有严重心性NMS的患者的节奏疗法.
主要方法:
- 一项双盲,随机,安慰剂对照研究 (ISSUE-3试验) 涉及511名患者.
- 89名患有已记录的心力衰竭和昏迷标准的患者被随机分配到启动或关闭节奏.
- 对77名随机选择的患者进行了治疗意图分析.
主要成果:
- 两年内昏迷复发率为25%的节奏启动与57%的节奏关闭.
- 心脏节奏调节可以将的复发风险降低57% (相对降低风险).
- 过程中的并发症包括脱落 (4名患者) 和下静脉血栓症 (1名患者).
结论:
- 双室永久节奏是有效的预防重复昏迷在患者≥40年与严重心性NMS.
- 观察到的昏迷复发的减少支持节奏作为一种侵入性治疗选择.
- 这项研究提供了证据,证明节奏在治疗严重心性NMS中的有用性.
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