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撤回:抗凝剂与阿司匹林预防妇科大手术后血栓栓塞

WITHDRAWN: Anticoagulant and aspirin prophylaxis for preventing thromboembolism after major gynaecological surgery.

作者信息

Oates-Whitehead R M, D'Angelo A, Mol B

出版信息

Cochrane Database Syst Rev. 2007 Jul 18;2003(4):CD003679. doi: 10.1002/14651858.CD003679.pub2.

Abstract

BACKGROUND

The reported overall risk of deep venous thrombosis in gynaecological surgery ranges from 7 to 45%. Fatal pulmonary embolism is estimated to occur in nearly 1% of these women. Pharmaceutical interventions are one possible prophylactic measure for preventing emboli in women undergoing major gynaecological surgery. Agents include unfractionated heparin (low -dose and adjusted-dose), low-molecular-weight heparins, heparinoids and warfarin.

OBJECTIVES

The objective of this review was to evaluate the effectiveness of warfarin, heparin and aspirin in preventing thromboembolism after major gynaecological surgery.

SEARCH STRATEGY

We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (searched 15 August 2003), the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library issue 2, 2003), MEDLINE (1966 to April 2003), EMBASE (1985 to April 2003), and CINAHL (1982 to April 2003). References from relevant articles were searched and authors contacted where necessary. In addition we contacted experts in the field for unpublished works.

SELECTION CRITERIA

Randomised controlled trials of heparins, warfarin or aspirin to prevent thromboembolism after major gynaecological surgery were eligible for inclusion.

DATA COLLECTION AND ANALYSIS

Thirty-three trials were identified in the initial search. On careful inspection only eight of these met the inclusion criteria. Trials were data extracted and assessed for quality by at least two reviewers. Data were combined for meta-analysis using odds ratios for dichotomous data or weighted mean difference for continuous data. A random effects statistical model was used.

MAIN RESULTS

The meta-analysis of heparin versus placebo found a statistically significant decrease in the number of DVTs in both the all women group (including those with and without malignancy) (OR 0.30, 95% CI 0.12 to 0.76) and the subgroup of only women with malignancy (OR 0.30, 95% CI 0.10 to 0.89). There was no significant difference in the incidence of PE. Oral warfarin reduced DVT when compared to placebo in all women (OR 0.22, 95% CI 0.06 to 0.86) and in women with malignancy (OR 0.18, 95% CI 0.04 to 0.87). Meta-analyses of UH and LMWH showed no statistical difference in any comparison. No studies compared aspirin alone to placebo, heparin or warfarin. There was a statistically significant increase in injection site haematomas associated with heparin compared to placebo (OR 0.30, 95% CI 0.10 to 0.89).

AUTHORS' CONCLUSIONS: Women, undergoing major gynaecological surgery and without contraindications to anticoagulants should be offered thromboprophylaxis. Evidence suggests that UH and LMWH are equally as effective in preventing DVT and the one trial available suggests that warfarin is as effective as UH. There is no evidence as yet to suggest that warfarin, heparin or aspirin reduce incidence of PE.

摘要

背景

据报道,妇科手术中深静脉血栓形成的总体风险在7%至45%之间。据估计,这些女性中近1%会发生致命性肺栓塞。药物干预是预防接受大型妇科手术女性发生栓子的一种可能的预防措施。药物包括普通肝素(低剂量和调整剂量)、低分子量肝素、类肝素和华法林。

目的

本综述的目的是评估华法林、肝素和阿司匹林在预防大型妇科手术后血栓栓塞方面的有效性。

检索策略

我们检索了Cochrane月经紊乱与生育力低下研究组试验注册库(2003年8月15日检索)、Cochrane对照试验中心注册库(CENTRAL)(Cochrane图书馆2003年第2期)、MEDLINE(1966年至2003年4月)、EMBASE(1985年至2003年4月)和CINAHL(1982年至2003年4月)。检索了相关文章的参考文献,并在必要时与作者联系。此外,我们还联系了该领域的专家以获取未发表的研究成果。

入选标准

肝素、华法林或阿司匹林预防大型妇科手术后血栓栓塞的随机对照试验符合纳入标准。

数据收集与分析

在初步检索中识别出33项试验。经仔细检查,其中只有8项符合纳入标准。试验数据由至少两名评审员提取并评估质量。使用二分数据的比值比或连续数据的加权平均差对数据进行合并以进行荟萃分析。采用随机效应统计模型。

主要结果

肝素与安慰剂的荟萃分析发现,在所有女性组(包括有和没有恶性肿瘤的女性)(比值比0.30,95%可信区间0.12至0.76)和仅患有恶性肿瘤的女性亚组中(比值比0.30,95%可信区间0.10至0.89),深静脉血栓形成的数量在统计学上有显著减少。肺栓塞的发生率没有显著差异。与安慰剂相比,口服华法林在所有女性中(比值比0.22,95%可信区间从0.06至0.86)和患有恶性肿瘤的女性中(比值比0.18,95%可信区间0.04至0.87)均降低了深静脉血栓形成。普通肝素和低分子量肝素的荟萃分析在任何比较中均未显示统计学差异。没有研究将单独使用阿司匹林与安慰剂(肝素或华法林)进行比较。与安慰剂相比,与肝素相关的注射部位血肿在统计学上有显著增加(比值比0.30,95%可信区间0.10至0.89)。

作者结论

接受大型妇科手术且无抗凝剂禁忌证的女性应接受血栓预防。证据表明,普通肝素和低分子量肝素在预防深静脉血栓形成方面同样有效,现有一项试验表明华法林与普通肝素一样有效。尚无证据表明华法林、肝素或阿司匹林能降低肺栓塞发生率。

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