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在接受再次心脏手术的患者中,抑肽酶与氨甲环酸相比的成本效益和疗效:一项随机、盲法临床试验。

Cost-benefit and efficacy of aprotinin compared with epsilon-aminocaproic acid in patients having repeated cardiac operations: a randomized, blinded clinical trial.

作者信息

Bennett-Guerrero E, Sorohan J G, Gurevich M L, Kazanjian P E, Levy R R, Barberá A V, White W D, Slaughter T F, Sladen R N, Smith P K, Newman M F

机构信息

The Mount Sinai Medical Center, New York, New York 10029-6574, USA.

出版信息

Anesthesiology. 1997 Dec;87(6):1373-80. doi: 10.1097/00000542-199712000-00017.

DOI:10.1097/00000542-199712000-00017
PMID:9416723
Abstract

BACKGROUND

Aprotinin and epsilon-aminocaproic acid are routinely used to reduce bleeding during cardiac surgery. The marked difference in average wholesale cost between these two drug therapies (aprotinin, $1,080 vs. epsilon-aminocaproic acid, $11) has generated significant controversy regarding their relative efficacies and costs.

METHODS

In a multicenter, randomized, prospective, blinded trial, patients having repeated cardiac surgery received either a high-dose regimen of aprotinin (total dose, 6 x 10(6) kallikrein inactivator units) or epsilon-aminocaproic acid (total dose, 270 mg/kg).

RESULTS

Two hundred four patients were studied. Overall (data are median [25th-75th percentiles]), aprotinin-treated patients had less postoperative thoracic drainage (511 ml [383-805 ml] vs. 655 ml [464-1,045 ml]; P = 0.016) and received fewer platelet transfusions (0 [range, 0-1] vs. 1 [range, 0-2]; P = 0.036). The surgical field was more likely to be considered free of bleeding in aprotinin-treated patients (44% vs. 26%; P = 0.012). No differences, however, were seen in allogeneic erythrocyte transfusions or in the time required for chest closure. Overall, direct and indirect bleeding-related costs were greater in aprotinin- than in epsilon-aminocaproic acid-treated patients ($1,813 [$1,476-2,605] vs. $1,088 [range, $511-2,057]; P = 0.0001). This difference in cost per case varied in magnitude among sites but not in direction.

CONCLUSIONS

Aprotinin was more effective than epsilon-aminocaproic acid at decreasing bleeding and platelet transfusions. Epsilon-aminocaproic acid, however, was the more cost-effective therapy over a broad range of estimates for bleeding-related costs in patients undergoing repeated cardiac surgery. A cost-benefit analysis using the lower cost of half-dose aprotinin ($540) still resulted in a significant cost advantage using epsilon-aminocaproic therapy (P = 0.022).

摘要

背景

抑肽酶和氨甲环酸常用于减少心脏手术期间的出血。这两种药物疗法的平均批发成本存在显著差异(抑肽酶,1080美元;氨甲环酸,11美元),这引发了关于它们相对疗效和成本的重大争议。

方法

在一项多中心、随机、前瞻性、盲法试验中,接受再次心脏手术的患者接受高剂量抑肽酶方案(总剂量,6×10⁶激肽释放酶灭活单位)或氨甲环酸(总剂量,270mg/kg)。

结果

共研究了204例患者。总体而言(数据为中位数[第25-75百分位数]),接受抑肽酶治疗的患者术后胸腔引流量较少(511ml[383-805ml]对655ml[464-1045ml];P=0.016),接受血小板输注的次数也较少(0[范围,0-1]对1[范围,0-2];P=0.036)。在接受抑肽酶治疗的患者中,手术视野更有可能被认为无出血(44%对26%;P=0.012)。然而,在异体红细胞输注或关闭胸腔所需时间方面未观察到差异。总体而言,与出血相关的直接和间接成本在接受抑肽酶治疗的患者中高于接受氨甲环酸治疗的患者(1813美元[1476-2605美元]对1088美元[范围,511-2057美元];P=0.0001)。这种每例成本的差异在不同地点的幅度有所不同,但方向相同。

结论

在减少出血和血小板输注方面,抑肽酶比氨甲环酸更有效。然而,对于接受再次心脏手术的患者,在广泛的出血相关成本估计范围内,氨甲环酸是更具成本效益的治疗方法。使用半剂量抑肽酶的较低成本(540美元)进行成本效益分析,氨甲环酸治疗仍具有显著的成本优势(P=0.022)。

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