O'Brien B J, Anderson D R, Goeree R
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ont.
CMAJ. 1994 Apr 1;150(7):1083-90.
To compare the efficacy and cost-effectiveness of enoxaparin, a low-molecular-weight heparin derivative, with that of low-dose warfarin in the prevention of deep-vein thrombosis (DVT) after total hip replacement.
English-language articles on enoxaparin and warfarin prophylaxis is patients undergoing total hip replacement published from January 1982 to December 1992.
Four trials of enoxaparin (involving 567 patients) and six trials of warfarin (involving 630) met the following criteria: randomized controlled trial, prophylaxis started no later than 24 hours after surgery and continued for at least 7 days, warfarin dose monitored and adjusted appropriately, enoxaparin dosage 30 mg twice daily, and DVT confirmed by bilateral venography.
Rates of DVT, cost of prophylaxis, diagnosis and treatment per patient, rate of pulmonary embolism (PE), number of deaths and incremental cost-effectiveness (cost per life-year gained).
The pooled rate of DVT was 13.6% with enoxaparin (95% confidence interval [CI] 10.9% to 16.3%) and 20.6% with warfarin (95% CI 17.4% to 23.8%). At a cost of $19.55 per day for enoxaparin the total cost per patient, including prophylaxis and management of DVT, exceeded that per patient receiving warfarin by about $121. For every 10,000 patients treated the use of enoxaparin will prevent 47 cases of DVT, 3 cases of PE and 4 deaths. Thus, the estimated incremental cost-effectiveness of enoxaparin is $29 120 per life-year gained.
On the basis of current Canadian cost-effectiveness guidelines the results of this study would be considered moderate to strong evidence to adopt enoxaparin prophylaxis against DVT after total hip replacement. However, because of the limited data the estimates are uncertain. Future trials should compare enoxaparin and warfarin and incorporate a prospective economic appraisal.
比较低分子肝素衍生物依诺肝素与小剂量华法林在预防全髋关节置换术后深静脉血栓形成(DVT)方面的疗效和成本效益。
1982年1月至1992年12月发表的关于依诺肝素和华法林用于全髋关节置换患者预防的英文文章。
四项依诺肝素试验(涉及567例患者)和六项华法林试验(涉及630例患者)符合以下标准:随机对照试验,预防措施在术后24小时内开始并持续至少7天,华法林剂量得到监测并适当调整,依诺肝素剂量为每日两次30毫克,且通过双侧静脉造影确诊DVT。
DVT发生率、每位患者的预防、诊断和治疗成本、肺栓塞(PE)发生率、死亡人数以及增量成本效益(每获得一个生命年的成本)。
依诺肝素组DVT的合并发生率为13.6%(95%置信区间[CI]为10.9%至16.3%),华法林组为20.6%(95%CI为17.4%至23.8%)。依诺肝素每天的费用为19.55美元,每位患者的总成本,包括DVT的预防和管理,比接受华法林治疗的患者高出约121美元。每治疗10000例患者,使用依诺肝素可预防47例DVT、3例PE和4例死亡。因此,依诺肝素的估计增量成本效益为每获得一个生命年29120美元。
根据加拿大当前的成本效益指南,本研究结果将被视为采用依诺肝素预防全髋关节置换术后DVT的中度至有力证据。然而,由于数据有限,估计值不确定。未来的试验应比较依诺肝素和华法林,并纳入前瞻性经济评估。