Low-molecular-weight heparins compared with unfractionated heparin for treatment of acute deep venous thrombosis - A meta-analysis of randomized, controlled trials

Low-molecular-weight heparins compared with unfractionated heparin for treatment of acute deep venous thrombosis - A meta-analysis of randomized, controlled trials
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DOI:
10.7326/0003-4819-130-10-199905180-00003
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发表时间:
1999-05-18
影响因子:
39.2
通讯作者:
Garber, AM
Garber, AM
中科院分区:
医学1区
文献类型:
--
作者:
Gould, MK;Dembitzer, AD;Garber, AM

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背景:低分子量肝素可以简化深静脉血栓形成的治疗。一个关键的临床问题是这种更方便的治疗方法是否与普通肝素治疗一样安全有效。目的:比较低分子量肝素与普通肝素治疗急性深静脉血栓的安全性和有效性。数据来源:评审员通过检索MEDLINE、从检索到的文章中查阅参考文献、从会议记录中扫描摘要,并联系研究人员和制药公司。研究选择:随机对照试验,比较低分子量肝素制剂与普通肝素治疗急性深静脉血栓形成的效果。数据提取:两名评论者独立提取数据。评价者使用经过验证的四项工具评价研究质量。数据综合:37项研究中有11项符合三个主要结果的纳入标准。大多数研究使用了适当的随机化程序,但只有一项是双盲的。与普通肝素相比,低分子量肝素在3至6个月的患者随访中降低了死亡率(比值比,0.71 [95%CI,0.53至0.94]; P = 0.02)。对于大出血并发症,比值比支持低分子肝素(0.57 [CI,0.33至0.99]; P = 0.047),但绝对风险降低较小且无统计学显著性(0.61% [CI,-0.04%至1.26%]; P = 0.07)。对于预防血栓栓塞复发,低分子肝素似乎与普通肝素一样有效(比值比,0.85 [CI,0.63至1.14]; P > 0.2)。结论:低分子肝素治疗可降低急性深静脉血栓形成后的死亡率。这些药物在大出血并发症方面似乎与普通肝素一样安全,在预防血栓栓塞复发方面似乎同样有效。
Background: Low-molecular-weight heparins may simplify the management of deep venous thrombosis. A critical clinical issue is whether this more convenient therapy is as safe and effective as treatment with unfractionated heparin.Purpose: To compare the safety and efficacy of low-molecular-weight heparins with those of unfractionated heparin for treatment of acute deep venous thrombosis.Data Sources: Reviewers identified studies by searching MEDLINE, reviewing references from retrieved articles, scanning abstracts from conference proceedings, and contacting investigators and pharmaceutical companies.Study Selection: Randomized, controlled trials that compared a low-molecular-weight heparin preparation with unfractionated heparin for treatment of acute deep venous thrombosis.Data Extraction: Two reviewers extracted data independently. Reviewers evaluated study quality using a validated four-item instrument.Data Synthesis: Eleven of 37 studies met inclusion criteria for three major outcomes. Most studies used proper randomization procedures, but only one was double-blinded. Compared with unfractionated heparin, low-molecular-weight heparins reduced mortality rates over 3 to 6 months of patient follow-up (odds ratio, 0.71 [95% CI, 0.53 to 0.94]; P = 0.02). For major bleeding complications, the odds ratio favored low-molecular-weight heparins (0.57 [CI, 0.33 to 0.99]; P = 0.047), but the absolute risk reduction was small and not statistically significant (0.61% [CI, -0.04% to 1.26%]; P = 0.07). For preventing thromboembolic recurrences, low-molecular-weight heparins seemed as effective as unfractionated heparin (odds ratio, 0.85 [CI, 0.63 to 1.14]; P > 0.2).Conclusions: Low-molecular-weight heparin treatment reduces mortality rates after acute deep venous thrombosis. These drugs seem to be as safe as unfractionated heparin with respect to major bleeding complications and appear to be as effective in preventing thromboembolic recurrences.