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孕激素预防早孕出血妇女流产的成本效益:基于 PRISM 试验的经济学评价。

The cost-effectiveness of progesterone in preventing miscarriages in women with early pregnancy bleeding: an economic evaluation based on the PRISM trial.

机构信息

Health Economics Unit, College of Medical and Dental Sciences, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Health Economics Unit, Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Vic., Australia.

出版信息

BJOG. 2020 May;127(6):757-767. doi: 10.1111/1471-0528.16068. Epub 2020 Jan 30.

DOI:10.1111/1471-0528.16068
PMID:32003141
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7187468/
Abstract

OBJECTIVES

To assess the cost-effectiveness of progesterone compared with placebo in preventing pregnancy loss in women with early pregnancy vaginal bleeding.

DESIGN

Economic evaluation alongside a large multi-centre randomised placebo-controlled trial.

SETTING

Forty-eight UK NHS early pregnancy units.

POPULATION

Four thousand one hundred and fifty-three women aged 16-39 years with bleeding in early pregnancy and ultrasound evidence of an intrauterine sac.

METHODS

An incremental cost-effectiveness analysis was performed from National Health Service (NHS) and NHS and Personal Social Services perspectives. Subgroup analyses were carried out on women with one or more and three or more previous miscarriages.

MAIN OUTCOME MEASURES

Cost per additional live birth at ≥34 weeks of gestation.

RESULTS

Progesterone intervention led to an effect difference of 0.022 (95% CI -0.004 to 0.050) in the trial. The mean cost per woman in the progesterone group was £76 (95% CI -£559 to £711) more than the mean cost in the placebo group. The incremental cost-effectiveness ratio for progesterone compared with placebo was £3305 per additional live birth. For women with at least one previous miscarriage, progesterone was more effective than placebo with an effect difference of 0.055 (95% CI 0.014-0.096) and this was associated with a cost saving of £322 (95% CI -£1318 to £673).

CONCLUSIONS

The results suggest that progesterone is associated with a small positive impact and a small additional cost. Both subgroup analyses were more favourable, especially for women who had one or more previous miscarriages. Given available evidence, progesterone is likely to be a cost-effective intervention, particularly for women with previous miscarriage(s).

TWEETABLE ABSTRACT

Progesterone treatment is likely to be cost-effective in women with early pregnancy bleeding and a history of miscarriage.

摘要

目的

评估孕激素与安慰剂在预防早孕阴道出血妇女流产中的成本效益。

设计

大型多中心随机安慰剂对照试验的经济评估。

地点

英国 48 家国家医疗服务体系(NHS)早期妊娠单位。

人群

4153 名年龄在 16-39 岁之间的有妊娠早期出血且超声显示宫内囊的女性。

方法

从国家医疗服务体系(NHS)和 NHS 及个人社会服务的角度进行增量成本效益分析。对有一次或多次自然流产史的女性进行亚组分析。

主要观察指标

每增加一例≥34 周妊娠的活产成本。

结果

孕激素干预组与安慰剂组在试验中的效果差异为 0.022(95%CI-0.004 至 0.050)。孕激素组女性的平均治疗成本比安慰剂组高£76(95%CI-£559 至 £711)。与安慰剂相比,孕激素的增量成本效益比为每增加一例活产需花费£3305。对于至少有一次既往流产史的女性,孕激素比安慰剂更有效,效果差异为 0.055(95%CI 0.014-0.096),且节省成本£322(95%CI-£1318 至 £673)。

结论

结果表明,孕激素具有较小的积极影响和较小的额外成本。两个亚组分析都更有利,特别是对于有一次或多次既往流产史的女性。鉴于现有证据,孕激素可能是一种具有成本效益的干预措施,尤其是对于有既往流产史的女性。

推文摘要

对于有早期妊娠出血和流产史的女性,孕激素治疗可能具有成本效益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3af3/7187468/c80ecbc2be23/BJO-127-757-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3af3/7187468/ac6dce1ff27b/BJO-127-757-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3af3/7187468/c80ecbc2be23/BJO-127-757-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3af3/7187468/ac6dce1ff27b/BJO-127-757-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3af3/7187468/c80ecbc2be23/BJO-127-757-g002.jpg

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引用本文的文献

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Progesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT.孕激素预防早孕期出血孕妇流产:PRISM RCT。
Health Technol Assess. 2020 Jun;24(33):1-70. doi: 10.3310/hta24330.

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A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy.一项孕激素治疗早孕期出血患者的随机临床试验。
N Engl J Med. 2019 May 9;380(19):1815-1824. doi: 10.1056/NEJMoa1813730.
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Scientists rise up against statistical significance.科学家们奋起反对统计显著性。
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A Randomized Trial of Progesterone in Women with Recurrent Miscarriages.孕激素治疗复发性流产的随机临床试验。
N Engl J Med. 2015 Nov 26;373(22):2141-8. doi: 10.1056/NEJMoa1504927.
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