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低分子量肝素与普通肝素治疗急性静脉血栓栓塞症患者的荟萃分析结果

Low-molecular-weight heparins and unfractionated heparin in the treatment of patients with acute venous thromboembolism: results of a meta-analysis.

作者信息

Siragusa S, Cosmi B, Piovella F, Hirsh J, Ginsberg J S

机构信息

Department of Internal Medicine, IRCCS Policlinico S. Matteo, Pavia, Italy.

出版信息

Am J Med. 1996 Mar;100(3):269-77. doi: 10.1016/S0002-9343(97)89484-3.

Abstract

PURPOSE

To obtain reliable estimates of the relative efficacy and safety of low-molecular-weight heparins (LMWHs) and unfractionated heparin (UFH) in the treatment of patients with venous thromboembolism.

METHODS

A literature search of randomized trials evaluating LMWH and UFH for the period from 1980 to 1994 was conducted to obtain data for a meta-analysis. Studies were classified as level 1 if they were double-blind or if there was blinded assessment of outcome measures, and level 2 if they did not provide assurance of blinded outcome assessment.

RESULTS

In level 1 studies, the relative risk (RR) of recurrent venous thromboembolism during the first 15 days and over the entire period of anticoagulant therapy was 0.24 (95% confidence intervals [CI] 0.06 to 0.80, P = 0.02) and 0.39 (95% CI 0.30 to 0.80, P = 0.006), respectively, in favor of LMWH treatment. The RR for major bleeding was 0.42 (95% CI 0.2 to 0.9, P = 0.01), in favor of LMWH. In level 2 studies, no significant differences in the rates of recurrent venous thromboembolism or major bleeding were observed. Pooling level 1 and level 2 studies, the RR for overall mortality and mortality in cancer patients was 0.51 (95% CI 0.2 to 0.9, P = 0.01), and 0.33 (95% CI 0.1 to 0.8, P = 0.01), respectively in favor of LMWH.

CONCLUSIONS

LMWH are likely to be more effective than UFH in preventing recurrent venous thromboembolism, to produce less major bleeding, and to be associated with a lower mortality rate, particularly in the subgroup of patients with cancer.

摘要

目的

获得低分子量肝素(LMWHs)和普通肝素(UFH)治疗静脉血栓栓塞患者相对疗效和安全性的可靠估计。

方法

对1980年至1994年期间评估LMWH和UFH的随机试验进行文献检索,以获取荟萃分析的数据。如果研究为双盲或对结局指标进行了盲法评估,则分类为1级;如果未提供盲法结局评估的保证,则分类为2级。

结果

在1级研究中,抗凝治疗的前15天和整个期间复发性静脉血栓栓塞的相对风险(RR)分别为0.24(95%置信区间[CI]0.06至0.80,P = 0.02)和0.39(95%CI 0.30至0.80,P = 0.006),支持LMWH治疗。大出血的RR为0.42(95%CI 0.2至0.9,P = 0.01),支持LMWH。在2级研究中,未观察到复发性静脉血栓栓塞或大出血发生率的显著差异。汇总1级和2级研究,总体死亡率和癌症患者死亡率的RR分别为0.51(95%CI 0.2至0.9,P = 0.01)和0.33(95%CI 0.1至0.8,P = 0.01),均支持LMWH。

结论

LMWH在预防复发性静脉血栓栓塞方面可能比UFH更有效,大出血更少,死亡率更低,特别是在癌症患者亚组中。

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