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择期髋关节置换术后患者院外延长使用低分子量肝素预防深静脉血栓形成的系统评价

Extended out-of-hospital low-molecular-weight heparin prophylaxis against deep venous thrombosis in patients after elective hip arthroplasty: a systematic review.

作者信息

Hull R D, Pineo G F, Stein P D, Mah A F, MacIsaac S M, Dahl O E, Butcher M, Brant R F, Ghali W A, Bergqvist D, Raskob G E

机构信息

Thrombosis Research Unit, University of Calgary, Foothills Hospital, Room 601 South Tower, 1403- 29th Street NW, Calgary, T2N 2T9 Alberta, Canada.

出版信息

Ann Intern Med. 2001 Nov 20;135(10):858-69. doi: 10.7326/0003-4819-135-10-200111200-00006.

Abstract

PURPOSE

Evidence-based medicine guidelines based on venographic end points recommend in-hospital prophylaxis with low-molecular-weight heparin (LMWH) in patients having elective hip surgery. Emerging data suggest that out-of-hospital use may offer additional protection; however, uncertainty remains about the risk-benefit ratio. To provide clinicians with a practical pathway for translating clinical research into practice, we systematically reviewed trials comparing extended out-of-hospital LMWH prophylaxis versus placebo.

DATA SOURCES

Studies were identified by 1) searching PubMed, MEDLINE, and the Cochrane Library Database for reports published from January 1976 to May 2001; 2) reviewing references from retrieved articles; 3) scanning abstracts from conference proceedings; and 4) contacting pharmaceutical companies and investigators of the original reports.

STUDY SELECTION

Randomized, controlled trials comparing extended out-of-hospital prophylaxis with LMWH versus placebo in patients having elective hip arthroplasty.

DATA EXTRACTION

Two reviewers extracted data independently. Reviewers evaluated study quality by using a validated four-item instrument.

DATA SYNTHESIS

Six of seven original articles met the defined inclusion criteria. The included studies were double-blind trials that used proper randomization procedures. Compared with placebo, extended out-of-hospital prophylaxis decreased the frequency of all episodes of deep venous thrombosis (placebo rate, 150 of 666 patients [22.5%]; relative risk, 0.41 [95% CI, 0.32 to 0.54; P < 0.001]), proximal venous thrombosis (placebo rate, 76 of 678 patients [11.2%]; relative risk, 0.31 [CI, 0.20 to 0.47; P < 0.001]), and symptomatic venous thromboembolism (placebo rate, 36 of 862 patients [4.2%]; relative risk, 0.36 [CI, 0.20 to 0.67; P = 0.001]). Major bleeding was rare, occurring in only one patient in the placebo group.

CONCLUSIONS

Extended LMWH prophylaxis showed consistent effectiveness and safety in the trials (regardless of study variations in clinical practice and length of hospital stay) for venographic deep venous thrombosis and symptomatic venous thromboembolism. The aggregate findings support the need for extended out-of-hospital prophylaxis in patients undergoing hip arthroplasty surgery.

摘要

目的

基于静脉造影终点的循证医学指南推荐,择期髋关节手术患者应在院内使用低分子量肝素(LMWH)进行预防。新出现的数据表明,院外使用可能提供额外的保护;然而,风险效益比仍不确定。为给临床医生提供一条将临床研究转化为实践的实用途径,我们系统回顾了比较延长院外LMWH预防与安慰剂的试验。

数据来源

通过以下方式确定研究:1)检索PubMed、MEDLINE和Cochrane图书馆数据库,查找1976年1月至2001年5月发表的报告;2)查阅检索文章的参考文献;3)浏览会议论文摘要;4)联系原报告的制药公司和研究者。

研究选择

比较择期髋关节置换术患者延长院外LMWH预防与安慰剂的随机对照试验。

数据提取

两名评价者独立提取数据。评价者使用经过验证的四项工具评估研究质量。

数据综合

七篇原始文章中有六篇符合既定的纳入标准。纳入的研究为采用适当随机程序的双盲试验。与安慰剂相比,延长院外预防降低了所有深静脉血栓形成事件的发生率(安慰剂组发生率为666例患者中的150例[22.5%];相对危险度为0.41[95%CI,0.32至0.54;P<0.001])、近端静脉血栓形成发生率(安慰剂组发生率为678例患者中的76例[11.2%];相对危险度为0.31[CI,0.20至0.47;P<0.001])以及有症状静脉血栓栓塞发生率(安慰剂组发生率为862例患者中的36例[4.2%];相对危险度为0.36[CI,0.20至0.67;P = 0.001])。严重出血罕见,仅在安慰剂组的一名患者中发生。

结论

在静脉造影深静脉血栓形成和有症状静脉血栓栓塞的试验中(无论临床实践和住院时间的研究差异如何),延长LMWH预防显示出一致的有效性和安全性。总体研究结果支持对接受髋关节置换手术的患者进行延长院外预防的必要性。

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