氨甲环酸减少剖宫产产后失血的效果：TRAAP2 试验的成本效益分析。
Tranexamic acid for reduction of blood loss after Caesarean delivery: a cost-effectiveness analysis of the TRAAP2 trial.
机构信息
Department of Obstetrics and Gynaecology, Bordeaux University Hospital, Bordeaux, France.
CHU Bordeaux, Clinical Epidemiology Unit (USMR), INSERM, Bordeaux Population Health, Bordeaux, France.
出版信息
Br J Anaesth. 2023 Nov;131(5):893-900. doi: 10.1016/j.bja.2023.07.028. Epub 2023 Sep 9.
BACKGROUND
Prophylactic administration of tranexamic acid is associated with a reduction of blood loss after Caesarean delivery, but cost-effectiveness for this indication has not been assessed.
METHODS
We used data from the TRAAP2 trial, a multicentre, double-blinded, RCT aimed at estimating the efficacy of tranexamic acid for preventing postpartum haemorrhage among women undergoing Caesarean delivery. Women recruited at 27 French maternity hospitals from 2018 to 2020 were enrolled before the procedure if they had a Caesarean delivery before or during labour at 34 or more weeks of gestation. The main outcomes were the cost of hospital stay for delivery and the incremental cost per delivery without complication within 90 days after delivery with tranexamic acid compared with placebo. Differences in costs and the incremental net monetary benefit (INMB) were estimated using linear regression models, and the cost-effectiveness probability of tranexamic acid compared with placebo was estimated through the parametric distribution of the INMB.
RESULTS
The proportion of women without complications at day 90 was 70.7% in the tranexamic acid group and 66.0% in the placebo group. Mean total costs until occurrence of a complication of interest were €3321 in the tranexamic acid group and €3260 in the placebo group, resulting in a difference between the two groups of 7.2% and €55 after multiple imputation. The adjusted incremental cost-effectiveness ratio was €762 per additional Caesarean delivery without a complication at 90 days after delivery. At a cost-effectiveness threshold of €10,000, the cost-effectiveness probability of tranexamic acid compared with placebo was 99.9%, varying from 5.8% to 100.0% for thresholds from €0 to €10,000 per additional delivery without a complication at day 90.
CONCLUSION
Tranexamic acid for the prevention of blood loss is cost-effective in reducing complications after Caesarean delivery at day 90 postpartum. However, the effect size (in cost and effectiveness) is very low.
CLINICAL TRIAL REGISTRATION
NCT03431805.
背景
预防性使用氨甲环酸可减少剖宫产术后的失血量，但尚未评估其在该适应证下的成本效益。
方法
我们使用了来自 TRAAP2 试验的数据，该试验是一项多中心、双盲、RCT，旨在估计氨甲环酸预防 34 周及以上妊娠、临产或剖宫产时产妇产后出血的疗效。2018 年至 2020 年，27 家法国产科医院招募了符合条件的产妇，在剖宫产术前，如果预计在产程中或产程中进行剖宫产，且孕周≥34 周，则在术前入组。主要结局为使用氨甲环酸与安慰剂相比，在 90 天内无并发症的分娩时住院费用和无并发症分娩的增量成本。使用线性回归模型估计成本和增量净货币收益（INMB）的差异，并通过 INMB 的参数分布估计氨甲环酸与安慰剂相比的成本效益概率。
结果
氨甲环酸组 90 天无并发症的比例为 70.7%，安慰剂组为 66.0%。氨甲环酸组和安慰剂组的总费用直到发生感兴趣的并发症为止，分别为 3321 欧元和 3260 欧元，两组之间的差异为 7.2%，经多重插补后为 55 欧元。调整后的增量成本效益比为每增加一例 90 天无并发症的剖宫产手术，氨甲环酸增加 762 欧元。在成本效益阈值为 10,000 欧元时，氨甲环酸与安慰剂相比的成本效益概率为 99.9%，从 0 至 10,000 欧元每增加一例 90 天无并发症的剖宫产手术的成本效益概率为 5.8%至 100.0%。
结论
氨甲环酸预防剖宫产产后 90 天内的失血具有成本效益，可降低并发症的发生。然而，其效果（在成本和效果方面）非常小。
临床试验注册
NCT03431805。
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