新型口服抗凝剂与标准抗血栓预防治疗在全髋关节或膝关节置换患者中的比较效果：系统评价。

Comparative effectiveness of new oral anticoagulants and standard thromboprophylaxis in patients having total hip or knee replacement: a systematic review.

出版信息

Ann Intern Med. 2013 Aug 20;159(4):275-84. doi: 10.7326/0003-4819-159-4-201308200-00008.

DOI:10.7326/0003-4819-159-4-201308200-00008

Abstract

BACKGROUND

Pharmacologic thromboprophylaxis reduces the risk for venous thromboembolism after total hip replacement (THR) or total knee replacement (TKR). New oral anticoagulants (NOACs), including direct thrombin inhibitors and factor Xa inhibitors, are emerging options for thromboprophylaxis after these procedures.

PURPOSE

To compare the benefits and risks of NOACs versus standard thromboprophylaxis for adults having THR or TKR.

DATA SOURCES

MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews from January 2009 through March 2013.

STUDY SELECTION

English-language systematic reviews.

DATA EXTRACTION

Two independent reviewers abstracted data and rated study quality and strength of evidence.

DATA SYNTHESIS

Six good-quality systematic reviews compared NOACs with low-molecular-weight heparin (LMWH) for thromboprophylaxis after THR or TKR. Risk for symptomatic deep venous thrombosis, but not risk for death or nonfatal pulmonary embolism, was reduced with factor Xa inhibitors compared with LMWH (4 fewer events per 1000 patients). Conversely, the risk for major bleeding increased (2 more events per 1000 patients). Outcomes of dabigatran did not significantly differ from those of LMWH. Indirect evaluation of NOACs by common comparison with LMWH showed nonsignificantly reduced risks for venous thromboembolism with rivaroxaban compared with dabigatran (risk ratio [RR], 0.68 [95% CI, 0.21 to 2.23]) and apixaban (RR, 0.59 [CI, 0.26 to 1.33]) but increased major bleeding. New oral anticoagulants have not been compared with warfarin, aspirin, or unfractionated heparin.

LIMITATIONS

Head-to-head comparisons among NOACs were not available. Efficacy is uncertain in routine clinical practice.

CONCLUSION

New oral anticoagulants are effective for thromboprophylaxis after THR and TKR. Their clinical benefits over LMWH are marginal and offset by increased risk for major bleeding.

PRIMARY FUNDING SOURCE

U.S. Department of Veterans Affairs.

摘要

背景

在全髋关节置换术（THR）或全膝关节置换术（TKR）后，药物性血栓预防可降低静脉血栓栓塞的风险。新型口服抗凝剂（NOAC），包括直接凝血酶抑制剂和因子 Xa 抑制剂，是这些手术中血栓预防的新兴选择。

目的

比较 NOAC 与标准抗血栓预防药物在接受 THR 或 TKR 的成人中的益处和风险。

数据来源

2009 年 1 月至 2013 年 3 月的 MEDLINE、EMBASE 和 Cochrane 系统评价数据库。

研究选择

英语系统评价。

数据提取

两名独立审查员提取数据并对研究质量和证据强度进行评级。

数据综合

6 项高质量的系统评价比较了 NOAC 与低分子肝素（LMWH）在 THR 或 TKR 后预防血栓的效果。与 LMWH 相比，因子 Xa 抑制剂降低了有症状的深部静脉血栓形成的风险，但不降低死亡或非致命性肺栓塞的风险（每 1000 例患者减少 4 例事件）。相反，大出血的风险增加（每 1000 例患者增加 2 例事件）。达比加群的结果与 LMWH 无显著差异。通过与 LMWH 的共同比较间接评估 NOAC，与达比加群相比，利伐沙班（RR，0.68 [95%CI，0.21 至 2.23]）和阿哌沙班（RR，0.59 [CI，0.26 至 1.33]）的静脉血栓栓塞风险显著降低，但大出血风险增加。新型口服抗凝剂尚未与华法林、阿司匹林或未分级肝素进行比较。