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基于体重的肝素剂量计算图与“标准护理”剂量计算图的比较。一项随机对照试验。

The weight-based heparin dosing nomogram compared with a "standard care" nomogram. A randomized controlled trial.

作者信息

Raschke R A, Reilly B M, Guidry J R, Fontana J R, Srinivas S

机构信息

Good Samaritan Regional Medical Center, Phoenix, Arizona.

出版信息

Ann Intern Med. 1993 Nov 1;119(9):874-81. doi: 10.7326/0003-4819-119-9-199311010-00002.

Abstract

OBJECTIVE

To determine whether an intravenous heparin dosing nomogram based on body weight achieves therapeutic anticoagulation more rapidly than a "standard care" nomogram.

DESIGN

Randomized controlled trial.

SETTING

Two community teaching hospitals in Phoenix, Arizona, and Rochester, New York.

PARTICIPANTS

One hundred fifteen patients requiring intravenous heparin treatment for venous or arterial thromboembolism or for unstable angina.

INTERVENTION

Patients were randomized to the weight-based nomogram (starting dose, 80 units/kg body weight bolus, 18 units/kg per hour infusion) or the standard care nomogram (starting dose, 5000-unit bolus, 1000 units per hour infusion). Activated partial thromboplastin time (APTT) values were monitored every 6 hours, and heparin dose adjustments were determined by the nomograms.

MEASUREMENTS

Activated partial thromboplastin times were measured using a widely generalizable laboratory method. The primary outcomes were the time to exceed the therapeutic threshold (APTT > 1.5 times the control) and the time to achieve therapeutic range (APTT, 1.5 to 2.3 times the control). Bleeding complications and recurrent thromboembolism were also compared.

RESULTS

Kaplan-Meier curves for the primary outcomes favored the weight-based nomogram (P < 0.001 for both). In the weight-based heparin group, 60 of 62 patients (97%) exceeded the therapeutic threshold within 24 hours, compared with 37 of 48 (77%) in the standard care group (P < 0.002). Only one major bleeding complication occurred (in a standard care patient). Recurrent thromboembolism was more frequent in the standard care group; relative risk, 5.0 (95% CI, 1.1 to 21.9).

CONCLUSIONS

The weight-based heparin nomogram is widely generalizable and has proved to be effective, safe, and superior to one based on standard practice.

摘要

目的

确定基于体重的静脉肝素剂量表是否比“标准护理”剂量表能更快地实现治疗性抗凝。

设计

随机对照试验。

地点

亚利桑那州凤凰城和纽约州罗切斯特的两家社区教学医院。

参与者

115例因静脉或动脉血栓栓塞或不稳定型心绞痛而需要静脉肝素治疗的患者。

干预措施

患者被随机分配至基于体重的剂量表组(起始剂量,80单位/千克体重静脉推注,18单位/千克每小时输注)或标准护理剂量表组(起始剂量,5000单位静脉推注,1000单位每小时输注)。每6小时监测活化部分凝血活酶时间(APTT)值,并根据剂量表确定肝素剂量调整。

测量指标

采用广泛通用的实验室方法测量活化部分凝血活酶时间。主要结局指标为超过治疗阈值(APTT>对照值的1.5倍)的时间和达到治疗范围(APTT为对照值的1.5至2.3倍)的时间。还比较了出血并发症和复发性血栓栓塞情况。

结果

主要结局指标的Kaplan-Meier曲线支持基于体重的剂量表(两者P<0.001)。在基于体重的肝素组中,62例患者中有60例(97%)在24小时内超过治疗阈值,而标准护理组48例中有37例(77%)(P<0.002)。仅发生1例严重出血并发症(在标准护理组患者中)。标准护理组复发性血栓栓塞更常见;相对风险为5.0(95%CI,1.1至21.9)。

结论

基于体重的肝素剂量表具有广泛的通用性,已证明有效、安全且优于基于标准做法的剂量表。

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