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在英国和澳大利亚,使用枸橼酸西地那非预防足月妊娠胎儿窘迫和紧急手术分娩:一项初步的成本效益分析。

Intrapartum use of sildenafil citrate to prevent fetal compromise and emergency operative birth in term pregnancies in the United Kingdom and Australia: A preliminary cost-effectiveness analysis.

机构信息

School of Public Health, University of Technology Sydney, Sydney, New South Wales, Australia.

NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.

出版信息

Int J Gynaecol Obstet. 2024 Mar;164(3):1010-1018. doi: 10.1002/ijgo.15135. Epub 2023 Sep 18.

DOI:10.1002/ijgo.15135
PMID:37723993
Abstract

OBJECTIVE

To compare cost-effectiveness of oral sildenafil citrate, administered after onset of labor, with standard care to health system funders in the UK and Australia.

METHODS

We conducted a modeled cost-effectiveness analysis, measuring costs and quality adjusted life years (QALYs), using a decision-analytic model covering onset of labor to 1 month post-birth. The relative risk of emergency cesarean section and operative vaginal birth was taken from a Phase 2 placebo controlled double blinded randomized control trial.

RESULTS

Both options of care resulted in the same QALYs gained over the model time period (0.08). Sildenafil citrate was cost-saving compared with standard care, saving £92 per birth in the UK (AU$303 per birth in Australia). Sensitivity analyses did not identify any areas of uncertainty that stopped sildenafil citrate being cost saving compared with standard care. Threshold analysis revealed that sildenafil citrate would be cost saving up to a per birth drug or administration cost of £152.32 in the UK (AU$333.61 in Australia).

CONCLUSION

Oral sildenafil citrate may be cost saving compared with standard care; however, the effects on neonatal outcomes still need to be demonstrated in large randomized trials.

摘要

目的

比较在英国和澳大利亚,卫生系统资助者在分娩开始后使用口服西地那非与标准护理的成本效益。

方法

我们进行了一项模型成本效益分析,使用涵盖分娩开始到产后 1 个月的决策分析模型来衡量成本和质量调整生命年(QALYs)。紧急剖宫产和阴道手术分娩的相对风险来自 2 期安慰剂对照双盲随机对照试验。

结果

两种护理方案在模型时间内获得的 QALYs 相同(0.08)。与标准护理相比,西地那非具有成本效益,在英国每例分娩可节省 92 英镑(在澳大利亚每例分娩可节省 303 澳元)。敏感性分析并未发现任何不确定性领域阻止西地那非与标准护理相比具有成本效益。阈值分析表明,在英国,西地那非每例分娩的药物或管理费用达到 152.32 英镑(在澳大利亚为 333.61 澳元)时,将具有成本效益。

结论

与标准护理相比,口服西地那非可能具有成本效益;然而,其对新生儿结局的影响仍需要在大规模随机试验中证明。

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引用本文的文献

1
The iSEARCH randomised controlled trial protocol: a pragmatic Australian phase III clinical trial of intrapartum sildenafil citrate to improve outcomes potentially related to intrapartum hypoxia.iSEARCH 随机对照试验方案:一项实用的澳大利亚三期临床研究,评估产时西地那非治疗对产时缺氧相关结局的潜在改善作用。
BMJ Open. 2024 Sep 28;14(9):e082943. doi: 10.1136/bmjopen-2023-082943.