Siragusa S, Cosmi B, Piovella F, Hirsh J, Ginsberg J S
Department of Internal Medicine, IRCCS Policlinico S. Matteo, Pavia, Italy.
Am J Med. 1996 Mar;100(3):269-77. doi: 10.1016/S0002-9343(97)89484-3.
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.
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.
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.
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.
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。
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。
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。
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。