Augmentium Pharma Consulting, Toronto, Canada.
Clin Appl Thromb Hemost. 2012 Jun;18(3):233-42. doi: 10.1177/1076029611426869. Epub 2012 Mar 2.
Dalteparin and enoxaparin are recommended as thromboprophylaxis for at least 10 days in patients undergoing abdominal surgery (AS) or hospitalized patients with acute medical illnesses. Even though both agents have proven clinical effectiveness through randomized trials, there have been no head-to-head studies. In this evaluation, indirect statistical techniques were used to compare safety and efficacy between dalteparin and enoxaparin in these 2 high-risk patient populations.
A literature search was conducted from January 1980 to November 2010 for randomized trials evaluating dalteparin or enoxaparin prophylaxis following AS or in hospitalized patients. Binary outcomes for safety and efficacy were statistically pooled using fixed or random effects models in cases of significant heterogeneity. In trials where a common control was used (eg, unfractionated heparin [UH]), indirect statistical comparisons between dalteparin and enoxaparin were performed using meta-regression analysis with active drug as the primary independent variable.
The meta-analysis in AS patients showed that enoxaparin or dalteparin had comparable efficacy to UH in terms of venous thromboembolic events (VTEs; relative risk reduction [RR] = 0.87, P = .46). The indirect statistical comparison was unable to find significant differences between enoxaparin and dalteparin in terms of risk for VTE (P = .84), major bleeding (P = .38), heparin-induced thrombocytopenia ([HIT]; P = .084), or death (P = .97). In acutely ill medical patients, treatment with enoxaparin or dalteparin had a 52% VTE risk reduction compared to placebo (RR = 0.48, P < .001). The indirect comparison was also unable to find significant differences between enoxaparin and dalteparin in terms of VTEs (P = .15), major bleeds (P = .39), HIT (P = .48), and death (P = .41).
The findings suggest comparable safety and efficacy between dalteparin and enoxaparin in AS and in acutely ill medical patients.
达肝素和依诺肝素均被推荐用于腹部手术（AS）或住院急性内科疾病患者的至少 10 天的血栓预防。尽管这两种药物都通过随机试验证明了临床疗效，但还没有头对头的研究。在这项评估中，间接统计技术用于比较达肝素和依诺肝素在这两种高危患者人群中的安全性和疗效。
从 1980 年 1 月到 2010 年 11 月，我们对评估 AS 后或住院患者中达肝素或依诺肝素预防的随机试验进行了文献检索。在存在显著异质性的情况下，使用固定或随机效应模型对安全性和疗效的二项结局进行统计学汇总。在使用共同对照（如未分级肝素 [UH]）的试验中，通过使用活性药物作为主要独立变量的荟萃回归分析进行达肝素和依诺肝素之间的间接统计比较。
AS 患者的荟萃分析表明，依诺肝素或达肝素在静脉血栓栓塞事件（VTE）方面与 UH 具有相当的疗效（相对风险降低[RR] = 0.87，P =.46）。间接统计比较未能发现依诺肝素和达肝素在 VTE 风险（P =.84）、大出血（P =.38）、肝素诱导的血小板减少症（[HIT]；P =.084）或死亡（P =.97）方面的显著差异。在急性内科疾病患者中，与安慰剂相比，依诺肝素或达肝素治疗可降低 52%的 VTE 风险（RR = 0.48，P <.001）。间接比较也未能发现依诺肝素和达肝素在 VTE 方面的显著差异（P =.15）、大出血（P =.39）、HIT（P =.48）和死亡（P =.41）。
这些发现表明达肝素和依诺肝素在 AS 和急性内科疾病患者中具有相当的安全性和疗效。
