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低分子量肝素与普通肝素在初始治疗深静脉血栓形成中的疗效和安全性比较:一项荟萃分析。

Comparison of efficacy and safety of low molecular weight heparins and unfractionated heparin in initial treatment of deep venous thrombosis: a meta-analysis.

作者信息

Leizorovicz A, Simonneau G, Decousus H, Boissel J P

机构信息

Service de Pharmacologie Clinique, Lyons, France.

出版信息

BMJ. 1994 Jul 30;309(6950):299-304. doi: 10.1136/bmj.309.6950.299.

Abstract

OBJECTIVE

To compare the efficacy and safety of low molecular weight heparins and unfractionated heparin in the initial treatment of deep venous thrombosis for the reduction of recurrent thromboembolic events, death, extension of thrombus, and haemorrhages.

DESIGN

Meta-analysis of results from 16 randomised controlled clinical studies.

SUBJECTS

2045 patients with established deep venous thrombosis.

INTERVENTION

Treatment with low molecular weight heparins or unfractionated heparin.

MAIN OUTCOME MEASURES

Incidences of thromboembolic events (deep venous thrombosis or pulmonary embolism, or both); major haemorrhages; total mortality; and extension of thrombus.

RESULTS

A significant reduction in the incidence of thrombus extension (common odds ratio 0.51, 95% confidence interval 0.32 to 0.83; P = 0.006) in favour of low molecular weight heparin was observed. Non-significant trends also in favour of the low molecular weight heparins were observed for the recurrence of thromboembolic events (0.66, 0.41 to 1.07; P = 0.09), major haemorrhages (0.65, 0.36 to 1.16; P = 0.15), and total mortality (0.72, 0.46 to 1.4; P = 0.16).

CONCLUSIONS

Low molecular weight heparins seem to have a higher benefit to risk ratio than unfractionated heparin in the treatment of venous thrombosis. These results, however, remain to be confirmed by using clinical outcomes in suitably powered clinical trials.

摘要

目的

比较低分子量肝素与普通肝素在初始治疗深静脉血栓形成时减少复发性血栓栓塞事件、死亡、血栓扩展和出血方面的疗效及安全性。

设计

对16项随机对照临床研究结果进行荟萃分析。

研究对象

2045例确诊为深静脉血栓形成的患者。

干预措施

采用低分子量肝素或普通肝素治疗。

主要观察指标

血栓栓塞事件(深静脉血栓形成或肺栓塞,或两者皆有)的发生率;大出血;总死亡率;以及血栓扩展情况。

结果

观察到低分子量肝素组血栓扩展发生率显著降低(共同比值比0.51,95%置信区间0.32至0.83;P = 0.006)。在血栓栓塞事件复发(0.66,0.41至1.07;P = 0.09)、大出血(0.65,0.36至1.16;P = 0.15)和总死亡率(0.72,0.46至1.4;P = 0.16)方面,也观察到了有利于低分子量肝素的非显著趋势。

结论

在治疗静脉血栓形成方面,低分子量肝素似乎比普通肝素具有更高的效益风险比。然而,这些结果仍有待通过适当规模的临床试验中的临床结局来证实。

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