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低分子量肝素(达肝素)每日一次用于治疗深静脉血栓形成。门诊环境下的可行性和卫生经济学研究。瑞典静脉血栓形成达肝素试验组。

Use of low molecular weight heparin (dalteparin), once daily, for the treatment of deep vein thrombosis. A feasibility and health economic study in an outpatient setting. Swedish Venous Thrombosis Dalteparin Trial Group.

作者信息

Lindmarker P, Holmström M

机构信息

Department of Medicine, Karolinska University Hospital, Sweden.

出版信息

J Intern Med. 1996 Dec;240(6):395-401. doi: 10.1046/j.1365-2796.1996.81877000.x.

Abstract

OBJECTIVES

To test the safety and feasibility of treating deep vein thrombosis (DVT) in an outpatient setting, using the low molecular weight heparin dalteparin, to calculate the potential and actual cost reductions achievable as a result of such a treatment regimen.

DESIGN

An open, nonrandomized, multicentre trial.

SETTING

Fourteen hospitals in central Sweden.

SUBJECTS

Ambulant patients, aged 18 years or older. with symptomatic DVT in the leg, diagnosed using phlebography or ultrasound (Duplex-Doppler).

INTERVENTIONS

Dalteparin (Fragmin) at a fixed dose of 200 i.u. kg-1 body weight, was administered once daily subcutaneously for at least 4 consecutive days. Treatment with warfarin was initiated from the first day of dalteparin administration. Outpatient treatment was encouraged whenever possible Financial calculations were performed independently at two hospitals, giving an average cost for all actions.

OUTCOME MEASURES

Increasing severity of symptoms (or thromboembolic recurrences during the 3-months follow-up period), pulmonary embolism (PE), bleeding events, and death during the initial phase and follow-up period.

RESULTS

Of 434 patients, 35% and 64% were treated in hospital within 24 and 72 h, respectively, and thereafter as outpatients. The overall frequency of serious complications was 0.92% (exact 95% confidence interval, 0.25-2.35%) during the initial phase and one patient suffered a PE and three patients had a recurrent DVT during the follow-up period. A cost reduction of 2705529 Swedish crowns (34.5%) was achieved in this study compared with traditional in-patient treatment.

CONCLUSIONS

Dalteparin, administered subcutaneously, once daily, for the initial treatment of DVT yields large cost reductions and is well tolerated and effective in an outpatient setting.

摘要

目的

使用低分子量肝素达肝素,在门诊环境中测试治疗深静脉血栓形成(DVT)的安全性和可行性,计算由于这种治疗方案可实现的潜在和实际成本降低。

设计

一项开放、非随机、多中心试验。

地点

瑞典中部的14家医院。

受试者

年龄在18岁及以上的门诊患者,腿部有症状性DVT,通过静脉造影或超声(双功多普勒)诊断。

干预措施

达肝素(法安明)以固定剂量200国际单位/千克体重,每日一次皮下注射,至少连续4天。从达肝素给药的第一天开始使用华法林治疗。尽可能鼓励门诊治疗。两家医院独立进行财务计算,得出所有行动的平均成本。

观察指标

症状严重程度增加(或在3个月随访期内血栓栓塞复发)、肺栓塞(PE)、出血事件以及初始阶段和随访期内的死亡情况。

结果

434例患者中,分别有35%和64%在24小时和72小时内住院治疗,此后作为门诊患者治疗。初始阶段严重并发症的总体发生率为0.92%(精确95%置信区间,0.25 - 2.35%),随访期间1例患者发生PE,3例患者复发DVT。与传统住院治疗相比,本研究实现了2705529瑞典克朗的成本降低(34.5%)。

结论

皮下每日一次给予达肝素用于DVT的初始治疗可大幅降低成本,在门诊环境中耐受性良好且有效。

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