晕厥中的即时动态心电图监测
完整摘要 · 中文译文
背景：在因晕厥到急诊科就诊的患者中，诊断潜在的心律失常仍然困难。 方法：我们在英国45家医院开展了一项开放标签、随机对照试验，旨在评估14天心脏监测对晕厥患者诊断、治疗及结局的影响。在急诊科评估后仍原因不明的晕厥成人患者，按1:1比例分配接受14天动态心电图（ECG）监测（干预组），或接受各参与单位针对不明原因晕厥患者提供的标准治疗（标准治疗组）。主要结局为1年内患者报告的晕厥发作平均次数。 结果：共有2234名患者接受了随机分组：1123人被分配到干预组，1111人被分配到标准治疗组。患者的平均年龄为58.3岁，其中52.1%为男性。在排除了未完成任何随访的患者后，共有1970名患者（干预组1004人，标准治疗组966人）被纳入主要分析。1年时，患者报告的晕厥发作次数的平均值（±SD）在干预组为1.37±5.10，在标准治疗组为1.58±8.56（发生率比，0.89；95%置信区间，0.68至1.18；P = 0.42）。干预组共报告了49起不良事件，标准治疗组报告了8起不良事件，每组各有1起严重不良事件。 结论：对于在急诊科评估后仍原因不明的晕厥患者，与标准治疗相比，使用14天动态心电图监测并未在1年时显著减少患者报告的晕厥发作次数。（由英国心脏基金会和苏格兰国家医疗服务体系研究资助；ASPIRED ISRCTN注册号，ISRCTN10278811。）。
完整摘要 · 英文原文
BACKGROUND: In patients with syncope who present to the emergency department for evaluation, diagnosing an underlying cardiac arrhythmia remains difficult. METHODS: We conducted an open-label, randomized, controlled trial at 45 hospitals in the United Kingdom to assess the effects of 14-day cardiac monitoring on diagnosis, treatment, and outcomes among patients with syncope. Adults with syncope that remained unexplained after an evaluation in the emergency department were assigned in a 1:1 ratio to undergo 14-day ambulatory electrocardiographic (ECG) monitoring (the intervention group) or to receive the standard care provided for patients with unexplained syncope at each participating site (the standard-care group). The primary outcome was the mean number of patient-reported episodes of syncope at 1 year. RESULTS: A total of 2234 patients underwent randomization: 1123 were assigned to the intervention group and 1111 to the standard-care group. The mean age of the patients was 58.3 years, and 52.1% were male. After the exclusion of patients who did not complete any follow-up, a total of 1970 patients (1004 in the intervention group and 966 in the standard-care group) were included in the primary analysis. The mean (±SD) number of patient-reported syncope episodes at 1 year was 1.37±5.10 in the intervention group and 1.58±8.56 in the standard-care group (incidence rate ratio, 0.89; 95% confidence interval, 0.68 to 1.18; P = 0.42). A total of 49 adverse events were reported in the intervention group, and 8 adverse events were reported in the standard-care group, with 1 serious adverse event in each group. CONCLUSIONS: Among patients with syncope that remained unexplained after evaluation in the emergency department, the use of 14-day ambulatory ECG monitoring did not result in significantly fewer patient-reported syncope episodes at 1 year than standard care. (Funded by the British Heart Foundation and National Health Service Research Scotland; ASPIRED ISRCTN Registry number, ISRCTN10278811.).