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人工髋关节和膝关节置换术后抗栓药物用于血栓预防的疗效和安全性:一项符合 PRISMA 原则的贝叶斯网状Meta 分析。

Efficacy and safety of anticoagulants for postoperative thrombophylaxis in total hip and knee arthroplasty: A PRISMA-compliant Bayesian network meta-analysis.

机构信息

Department of Orthopaedic Surgery, Xiangya Hospital, Central South University, Changsha, China.

Department of Cardiothoracic Surgery, Xiangya Hospital, Central South University, Changsha, China.

出版信息

PLoS One. 2021 Jun 17;16(6):e0250096. doi: 10.1371/journal.pone.0250096. eCollection 2021.

Abstract

OBJECTIVE

To search, review, and analyze the efficacy and safety of various anticoagulants from randomized clinical trials (RCTs) of anticoagulants for THA and TKA.

DESIGN

PRISMA-compliant Bayesian Network Meta-analysis.

DATA SOURCES AND STUDY SELECTION

The databases of The Medline, Embase, ClinicalTrial, and Cochrane Library databases were searched until March 2017 for RCTs of patients undergoing a THA or TKA.

MAIN OUTCOMES AND MEASURES

The primary efficacy measurement was the venous thromboembolism Odds ratio (OR). The safety measurement was the odds ratio of major or clinically relevant bleeding. OR with 95% credibility intervals (95%CrIs) were calculated. Findings were interpreted as associations when the 95%CrIs excluded the null value.

RESULTS

Thirty-five RCTs (53787 patients; mean age range, mostly 55-70 years; mean weight range, mostly 55-90 kg; and a higher mean proportion of women than men, around 60%) included the following Anticoagulants categories: fondaparinux, edoxaban, rivaroxaban, apixaban, dabigatran, low-molecular-weight heparin, ximelagatran, aspirin, warfarin. Anticoagulants were ranked for effectiveness as follows: fondaparinux (88.89% ± 10.90%), edoxaban (85.87% ± 13.34%), rivaroxaban (86.08% ± 10.23%), apixaban (68.26% ± 10.82%), dabigatran (41.63% ± 12.26%), low-molecular-weight heparin (41.03% ± 9.60%), ximelagatran (37.81% ± 15.87%), aspirin (35.62% ± 20.60%), warfarin (9.89% ± 9.07%), and placebo (4.56% ± 6.37%). Ranking based on clinically relevant bleeding events was as follows: fondaparinux (14.53% ± 15.25%), ximelagatran (18.93% ± 17.49%), rivaroxaban (23.86% ± 15.14%), dabigatran (28.30% ± 14.18%), edoxaban (38.76% ± 24.25%), low-molecular-weight heparin (53.28% ± 8.40%), apixaban (71.81% ± 10.92%), placebo (76.26% ± 14.61%), aspirin (86.32% ± 25.74%), and warfarin (87.95% ± 11.27%). No statistically significant heterogeneity was observed between trials.

CONCLUSIONS AND RELEVANCE

According to our results, all anticoagulant drugs showed some effectiveness for VTE prophylaxis. Our ranking indicated that fondaparinux and rivaroxaban were safer and more effective than other anticoagulant drugs for patients undergoing THA or TKA.

摘要

目的

通过对接受全髋关节置换术(THA)或全膝关节置换术(TKA)的患者进行抗凝治疗的随机临床试验(RCT)进行检索、评价和分析,评估各种抗凝剂的疗效和安全性。

设计

符合 PRISMA 原则的贝叶斯网状荟萃分析。

数据来源和研究选择

检索了 Medline、Embase、ClinicalTrials 和 Cochrane Library 数据库,截止日期为 2017 年 3 月,检索内容为接受 THA 或 TKA 的患者的 RCT。

主要结局和测量指标

主要疗效测量指标为静脉血栓栓塞的比值比(OR)。安全性测量指标为主要或临床相关出血的比值比(OR)。采用 95%可信区间(95%CrI)计算 OR。如果 95%CrI 排除了零值,则认为结果为关联。

结果

纳入了 35 项 RCT(53787 例患者;平均年龄范围为 55-70 岁,平均体重范围为 55-90kg,女性比例高于男性,约为 60%),涉及以下抗凝剂类别:磺达肝癸钠、依度沙班、利伐沙班、阿哌沙班、达比加群、低分子肝素、西米拉坦、阿司匹林、华法林。根据有效性对抗凝剂进行了排序:磺达肝癸钠(88.89%±10.90%)、依度沙班(85.87%±13.34%)、利伐沙班(86.08%±10.23%)、阿哌沙班(68.26%±10.82%)、达比加群(41.63%±12.26%)、低分子肝素(41.03%±9.60%)、西米拉坦(37.81%±15.87%)、阿司匹林(35.62%±20.60%)、华法林(9.89%±9.07%)和安慰剂(4.56%±6.37%)。根据临床相关出血事件进行排序的结果如下:磺达肝癸钠(14.53%±15.25%)、西米拉坦(18.93%±17.49%)、利伐沙班(23.86%±15.14%)、达比加群(28.30%±14.18%)、依度沙班(38.76%±24.25%)、低分子肝素(53.28%±8.40%)、阿哌沙班(71.81%±10.92%)、安慰剂(76.26%±14.61%)、阿司匹林(86.32%±25.74%)和华法林(87.95%±11.27%)。试验间未见明显异质性。

结论和相关性

根据我们的结果,所有抗凝药物在预防静脉血栓栓塞方面均有一定的疗效。我们的排序表明,磺达肝癸钠和利伐沙班在预防接受 THA 或 TKA 的患者发生静脉血栓栓塞方面比其他抗凝药物更安全、更有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f14e/8211213/dfd6f27a4089/pone.0250096.g001.jpg

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