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临床决策分析建模:心房颤动或心房扑动时心室率的短期控制——地高辛与地尔硫䓬对比

Clinical decision analysis modeling: short-term control of ventricular response rate in atrial fibrillation or atrial flutter-digoxin versus diltiazem.

作者信息

Gonzalez E R, Ornato J P, Lawson C L

机构信息

Department of Pharmacy and Pharmaceutics, Medical College of Virginia, Richmond 23298.

出版信息

Pharmacotherapy. 1994 Jul-Aug;14(4):446-51.

PMID:7937281
Abstract

OBJECTIVE

To develop a clinical decision model to compare the outcome of therapy with digoxin versus diltiazem for short-term control of ventricular response rate (VRR) in patients with atrial fibrillation or atrial flutter.

DESIGN

Review of data from two studies that examined the percentages of response and frequency of adverse reactions in patients treated with intravenous digoxin or diltiazem to control VRR in atrial fibrillation or flutter. We constructed a clinical decision model and performed sensitivity analysis to determine if the model's predictions could be altered.

SETTING

Large teaching, university hospitals.

PARTICIPANTS

Adults age 18 years or older treated with intravenous digoxin or intravenous diltiazem for atrial fibrillation or flutter (VRR > or = 120 beats/min). Patients with severe heart failure New York Heart Association class III or IV, a surgical procedure prior to the exacerbation, or an acute myocardial infarction were excluded.

MEASUREMENTS AND MAIN RESULTS

We measured VRR control after 1 and 24 hours of therapy (VRR < 100 beats/min or decrease of > or = 20%) and assessed the likelihood that a patient would suffer an adverse drug reaction. Initial assumptions were that the probability digoxin would achieve VRR control was 0.10 (95% confidence interval 0.04-0.20) at 1 hour and 0.70 (95% CI 0.56-0.80) at 24 hours; the probability that diltiazem would achieve VRR control was 0.94 (95% CI 0.82-0.99) at 1 hour and 0.83 (95% CI 0.68-0.94) at 24 hours; and the probability of no serious adverse drug reaction would be 0.90 (95% CI 0.80-0.96) for digoxin and 0.96 (95% CI 0.86-0.98) for diltiazem.

RESULTS

Diltiazem was superior to digoxin with respect to the composite end point score at 1 hour (91.20 vs 17.29) and 24 hours (81.65 vs 66.43). Digoxin was superior to diltiazem at 24 hours only if the VRR was assumed to be at the highest 95% CI limit for digoxin and simultaneously at the lowest 95% CI for diltiazem (74.62 vs 68.63).

CONCLUSIONS

Clinical decision analysis suggests that intravenous diltiazem is superior to intravenous digoxin in controlling VRR in patients with atrial fibrillation or flutter.

摘要

目的

建立一个临床决策模型,以比较地高辛与地尔硫䓬治疗心房颤动或心房扑动患者短期心室率(VRR)控制效果。

设计

回顾两项研究数据,这两项研究调查了静脉用地高辛或地尔硫䓬控制心房颤动或扑动患者VRR时的反应百分比及不良反应发生频率。我们构建了一个临床决策模型并进行敏感性分析,以确定该模型的预测是否会改变。

地点

大型教学医院、大学医院。

参与者

年龄18岁及以上、因心房颤动或扑动(VRR≥120次/分钟)接受静脉用地高辛或静脉用地尔硫䓬治疗的成年人。排除纽约心脏协会III或IV级严重心力衰竭患者、病情加重前接受过外科手术的患者或急性心肌梗死患者。

测量指标及主要结果

我们在治疗1小时和24小时后测量VRR控制情况(VRR<100次/分钟或下降≥20%),并评估患者发生药物不良反应的可能性。初始假设为,地高辛在1小时时实现VRR控制的概率为0.10(95%置信区间0.04 - 0.20),在24小时时为0.70(95%CI 0.56 - 0.80);地尔硫䓬在1小时时实现VRR控制的概率为0.94(95%CI 0.82 - 0.99),在24小时时为0.83(95%CI 0.68 - 0.94);地高辛无严重药物不良反应的概率为0.90(95%CI 0.80 - 0.96),地尔硫䓬为0.96(95%CI 0.86 - 0.98)。

结果

在1小时(91.20对17.29)和24小时(81.65对66.43)时,地尔硫䓬在复合终点评分方面优于地高辛。仅当地高辛的VRR假设为其95%CI上限且地尔硫䓬的VRR假设为其95%CI下限时,地高辛在24小时时才优于地尔硫䓬(74.62对(此处原文可能有误,推测为68.63))。

结论

临床决策分析表明,静脉用地尔硫䓬在控制心房颤动或扑动患者的VRR方面优于静脉用地高辛。

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