1 University of Minnesota College of Pharmacy Minneapolis MN.
2 College of Pharmacy University of Houston TX.
J Am Heart Assoc. 2019 May 21;8(10):e012184. doi: 10.1161/JAHA.119.012184.
Background Fondaparinux sodium has been compared with low-molecular-weight heparins ( LMWH ) in randomized controlled trials for perioperative surgical thromboprophylaxis. However, the results from these studies are inconsistent in terms of efficacy and safety to reach a clinical decision. The objective of this study was to systematically review the randomized controlled trials comparing the efficacy and safety of fondaparinux and LMWH for perioperative surgical thromboprophylaxis. Methods and Results Systematic search in various databases was done to identify randomized controlled trials comparing fondaparinux and LMWH published during the years 2000 to 2017. Outcomes of interest in this study included venous thromboembolism up to day 15, all-cause mortality up to day 90, major bleeding, and minor bleeding during the treatment period. Analyses were performed with the relative odds based on a random-effects model using Mantel-Haenszel statistics. Results were presented as odds ratios with their 95% CIs. The assessment of study quality was performed as per Cochrane collaboration. After screening 10 644 articles, 12 randomized controlled trials including 14 906 patients were included in the final analyses. Pooled analyses showed the odds of venous thromboembolism in the fondaparinux group were 0.49 times the odds in LMWH group ( OR =0.49 [0.38-0.64]). However, the odds of major bleeding in the fondaparinux group were 1.48 times the odds in the LMWH group ( OR =1.48 [1.15-1.90]). Conclusions Fondaparinux was associated with a superior efficacy in terms of reduction of venous thromboembolism in this meta-analysis. However, it was also associated with increased odds of major bleeding.
在围手术期外科血栓预防中,磺达肝素钠已在随机对照试验中与低分子肝素(LMWH)进行了比较。然而,这些研究在疗效和安全性方面的结果不一致,无法做出临床决策。本研究的目的是系统地综述比较磺达肝素钠和 LMWH 用于围手术期外科血栓预防的随机对照试验,以评估其疗效和安全性。
在各种数据库中进行系统检索,以确定 2000 年至 2017 年期间发表的比较磺达肝素钠和 LMWH 的随机对照试验。本研究的观察终点包括术后 15 天内静脉血栓栓塞、90 天内全因死亡率、大出血和治疗期间的轻微出血。采用随机效应模型下的 Mantel-Haenszel 统计学方法进行相对比值分析。结果表示为比值比及其 95%置信区间。根据 Cochrane 协作组的标准评估研究质量。经过筛选 10644 篇文章,最终有 12 项随机对照试验(共纳入 14906 例患者)纳入最终分析。汇总分析显示,磺达肝素钠组静脉血栓栓塞的风险比 LMWH 组低 0.49 倍(OR=0.49[0.38-0.64])。然而,磺达肝素钠组大出血的风险比 LMWH 组高 1.48 倍(OR=1.48[1.15-1.90])。
在本荟萃分析中,磺达肝素钠在降低静脉血栓栓塞方面的疗效优于 LMWH。然而,它也与大出血风险增加相关。