Anderson D R, O'Brien B J, Levine M N, Roberts R, Wells P S, Hirsh J
McMaster University Medical Centre, Hamilton, Ontario, Canada.
Ann Intern Med. 1993 Dec 1;119(11):1105-12. doi: 10.7326/0003-4819-119-11-199312010-00008.
To compare the efficacy, safety, and cost-effectiveness of low-molecular-weight heparin with standard heparin for the prevention of deep vein thrombosis after total hip arthroplasty.
Studies were identified by MEDLINE search and review of bibliographies of retrieved articles. Hospital resources used in treating deep vein thrombosis and bleeding complications after total hip arthroplasty were estimated using retrospectively collected data from 447 patients who participated in a recently completed randomized controlled deep vein thrombosis prophylaxis trial at our center.
Randomized controlled trials directly comparing a low-molecular-weight heparin preparation with standard heparin for the prevention of deep vein thrombosis after total hip arthroplasty were potentially eligible for the meta-analysis.
Data from eligible studies were extracted independently by two of the authors. Multiple regression analysis of data from the patient cohort was used to estimate the effect of deep vein thrombosis and bleeding on length of hospital stay. A hypothetical North American price for low-molecular-weight heparin was determined based on the ratio between low-molecular-weight heparin and standard heparin in France. Costs were based on weighted per-diem hospital expenditures and physician fees for procedures and reported in 1992 U.S. dollars.
Meta-analysis of six eligible trials determined that low-molecular-weight heparin was significantly more effective than standard heparin at preventing deep vein thrombosis after total hip arthroplasty (common odds ratio, 0.72; 95% CI, 0.53 to 0.95). However, this benefit was restricted to the prevention of proximal deep vein thrombosis (common odds ratio, 0.40; CI, 0.28 to 0.59). No significant differences were found in the rates of distal deep vein thrombosis or total, major, or minor bleeding between the two groups. Based on a 2.6 to 1 price ratio between low-molecular-weight heparin and standard heparin, use of low-molecular-weight heparin would save the health care system about $50,000 per 1000 patients treated. Sensitivity analysis shows that if the low-molecular-weight heparin/standard heparin price ratio exceeds 3.7 (the threshold value lies between 0.8 and 5.5 based on the extremes of the 95% CI of the common odds ratios for deep vein thrombosis and bleeding complications), use of low-molecular-weight heparin is more expensive. At a price ratio of 10, it would cost more than $250,000 to treat 1000 patients with low-molecular-weight heparin compared with standard heparin or about $5000 for each additional deep vein thrombosis prevented with low-molecular-weight heparin.
Low-molecular-weight heparin is more effective and is at least as safe as standard heparin for the prevention of deep vein thrombosis after total hip arthroplasty. Based on the current French price ratio of low-molecular-weight heparin to standard heparin, the use of low-molecular-weight heparin in North America would result in overall savings in cost; however, the relative cost-effectiveness is critically dependent on the price ratio between the two drugs. Further research is needed to compare the cost-effectiveness of low-molecular-weight heparin with other prophylactic regimens and postoperative deep vein thrombosis management strategies.
比较低分子量肝素与标准肝素在预防全髋关节置换术后深静脉血栓形成方面的疗效、安全性和成本效益。
通过医学文献数据库检索及对检索文章的参考文献进行回顾来识别研究。利用从我们中心最近完成的一项随机对照深静脉血栓形成预防试验的447例患者中回顾性收集的数据,估算全髋关节置换术后治疗深静脉血栓形成和出血并发症所使用的医院资源。
直接比较低分子量肝素制剂与标准肝素预防全髋关节置换术后深静脉血栓形成的随机对照试验有资格纳入荟萃分析。
两名作者独立提取符合条件研究的数据。对患者队列数据进行多元回归分析,以评估深静脉血栓形成和出血对住院时间的影响。根据法国低分子量肝素与标准肝素的比例确定低分子量肝素的假设北美价格。成本基于加权每日医院支出和手术医生费用,并以1992年美元报告。
对六项符合条件的试验进行荟萃分析确定,在预防全髋关节置换术后深静脉血栓形成方面,低分子量肝素比标准肝素显著更有效(共同优势比,0.72;95%可信区间,0.53至0.95)。然而,这种益处仅限于预防近端深静脉血栓形成(共同优势比,0.40;可信区间,0.28至0.59)。两组之间在远端深静脉血栓形成或总的、严重或轻微出血发生率方面未发现显著差异。基于低分子量肝素与标准肝素2.6比1的价格比,每治疗1000例患者,使用低分子量肝素可为医疗系统节省约50000美元。敏感性分析表明,如果低分子量肝素/标准肝素价格比超过3.7(基于深静脉血栓形成和出血并发症共同优势比95%可信区间的极值,阈值在0.8至5.5之间),使用低分子量肝素会更昂贵。在价格比为10时,与标准肝素相比,用低分子量肝素治疗1000例患者的费用将超过250000美元,即使用低分子量肝素预防每例额外深静脉血栓形成的费用约为5000美元。
在预防全髋关节置换术后深静脉血栓形成方面,低分子量肝素比标准肝素更有效且至少同样安全。根据目前法国低分子量肝素与标准肝素的价格比,在北美使用低分子量肝素将导致总体成本节省;然而,相对成本效益严重依赖于两种药物的价格比。需要进一步研究以比较低分子量肝素与其他预防方案及术后深静脉血栓形成管理策略的成本效益。