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瑞芬太尼患者自控镇痛与硬膜外分娩镇痛用于分娩镇痛的经济学分析(RAVEL 试验):一项随机对照试验。

An economic analysis of patient controlled remifentanil and epidural analgesia as pain relief in labour (RAVEL trial); a randomised controlled trial.

机构信息

Leiden University Medical Centre, obstetrics, Leiden, the Netherlands.

Onze Lieve Vrouwe Gasthuis, gynaecology and obstetrics, Amsterdam, the Netherlands.

出版信息

PLoS One. 2018 Oct 11;13(10):e0205220. doi: 10.1371/journal.pone.0205220. eCollection 2018.

Abstract

OBJECTIVE

To compare the costs of a strategy of patient controlled remifentanil versus epidural analgesia for pain relief in labour.

DESIGN

We performed a multicentre randomised controlled trial in 15 hospitals in the Netherlands, the RAVEL trial. Costs were analysed from a health care perspective alongside the RAVEL trial.

POPULATION

Pregnant women of intermediate to high risk beyond 32 weeks gestation who planned vaginal delivery.

METHODS

Women were randomised before the onset of labour, to receive either patient controlled remifentanil or epidural analgesia when pain relief was requested during labour.

MAIN OUTCOME MEASURES

Primary outcome for effectiveness was satisfaction with pain relief, expressed as the area under the curve (AUC). A higher AUC represents higher satisfaction with pain relief. Here, we present an economic analysis from a health care perspective including costs from the start of labour to ten days postpartum. Health-care utilization was documented in the Case Report Forms and by administering an additional questionnaire.

RESULTS

The costs in the patient controlled remifentanil group (n = 687) and in the epidural group (n = 671) were €2900 versus €3185 respectively (mean difference of -€282 (95% CI -€611 to €47)). The (non-significant) higher costs in the epidural analgesia group could be mainly attributed to higher costs of neonatal admission.

CONCLUSION

From an economic perspective, there is no preferential pain treatment in labouring intermediate to high risk women. Since patient controlled remifentanil is not equivalent to epidural analgesia with respect to AUC for satisfaction with pain relief we recommend epidural analgesia as the method of choice. However, if appropriately counselled on effect and side effects there is, from an economic perspective, no reason to deny women patient controlled remifentanil.

摘要

目的

比较患者自控瑞芬太尼与硬膜外镇痛用于分娩镇痛的成本。

设计

我们在荷兰的 15 家医院进行了一项多中心随机对照试验,即 RAVEL 试验。成本分析是在与 RAVEL 试验同时进行的医疗保健视角下进行的。

人群

怀孕 32 周以上,有中高危因素,计划阴道分娩的孕妇。

方法

在分娩开始前,孕妇被随机分为两组,一组在分娩时要求镇痛时接受患者自控瑞芬太尼,另一组接受硬膜外镇痛。

主要观察指标

有效性的主要结局指标是疼痛缓解的满意度,用曲线下面积(AUC)表示。AUC 越高,疼痛缓解满意度越高。在这里,我们从医疗保健角度提出了一项经济分析,包括从分娩开始到产后十天的成本。病例报告表和额外的问卷调查记录了医疗保健的利用情况。

结果

患者自控瑞芬太尼组(n=687)和硬膜外组(n=671)的成本分别为 2900 欧元和 3185 欧元(平均差异为-282 欧元(95%CI -611 至 47 欧元))。硬膜外镇痛组(non-significant)较高的成本主要归因于新生儿入院的成本较高。

结论

从经济角度来看,在中高危孕妇分娩时,没有首选的镇痛治疗方法。由于患者自控瑞芬太尼在疼痛缓解满意度的 AUC 方面与硬膜外镇痛并不等效,我们建议硬膜外镇痛作为首选方法。然而,如果对效果和副作用进行适当的咨询,从经济角度来看,没有理由拒绝妇女使用患者自控瑞芬太尼。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a71f/6181333/ee6d1416ad93/pone.0205220.g001.jpg

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