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普伐他汀预防高危孕妇子痫前期的作用:一项荟萃分析与试验序贯分析。

The role of pravastatin in preventing preeclampsia in high-risk pregnant women: a meta-analysis with trial sequential analysis.

机构信息

Barao de Maua University Center, Ribeirao Preto, Brazil (Dr H Provinciatto).

University Potiguar, Natal, Brazil (Dr Barbalho).

出版信息

Am J Obstet Gynecol MFM. 2024 Feb;6(2):101260. doi: 10.1016/j.ajogmf.2023.101260. Epub 2023 Dec 17.

DOI:10.1016/j.ajogmf.2023.101260
PMID:38109997
Abstract

OBJECTIVE

We aimed to perform a systematic review and meta-analysis of randomized controlled trials to evaluate the prophylactic use of pravastatin in pregnant women with high-risk of preeclampsia.

DATA SOURCES

PubMed, Embase, Cochrane Central, and Web of Science were searched from inception to August 2023 with no language or filters restriction. The references from included studies, previous systematic reviews, and meta-analyses were manually searched for any additional studies.

STUDY ELIGIBILITY CRITERIA

Randomized controlled trials comparing pravastatin in any dose with placebo or no treatment in pregnant women with high risk for preeclampsia and up to 20 weeks of gestation were included in this meta-analysis.

METHODS

We used RStudio version 4.2.2 with random effects models to compute pooled risk ratios for prespecified outcomes data. The quality assessment was conducted using version 2 of the Cochrane Risk of Bias Assessment Tool. We also performed a trial sequential analysis to evaluate the reliability of our findings.

RESULTS

We included 3 randomized controlled trials comprising 213 patients, of whom 106 (49.8%) were allocated to the pravastatin group. There was no significant effect of pravastatin on the incidence of preeclampsia (risk ratio, 0.62; 95% confidence interval, 0.33-1.14; P=.12).

CONCLUSION

Our study was unable to demonstrate the benefit of pravastatin for preventing preeclampsia in high-risk pregnant women. Nevertheless, these findings comprised only preliminary studies with a small number of subjects, highlighting the need of well-designed, and adequately powered clinical trials.

摘要

目的

我们旨在进行系统评价和荟萃分析,以评估在有子痫前期高危风险的孕妇中预防性使用普伐他汀的效果。

数据来源

从建库到 2023 年 8 月,我们在 PubMed、Embase、Cochrane 中央和 Web of Science 上进行了无语言或过滤器限制的搜索。还手动搜索了纳入研究的参考文献、先前的系统评价和荟萃分析,以查找任何其他研究。

研究入选标准

随机对照试验将任何剂量的普伐他汀与安慰剂或无治疗在有子痫前期高危风险和妊娠 20 周内的孕妇进行比较,纳入本荟萃分析。

方法

我们使用 RStudio 版本 4.2.2 和随机效应模型,计算了预先指定的结局数据的汇总风险比。使用 Cochrane 风险偏倚评估工具版本 2 进行质量评估。我们还进行了试验序贯分析,以评估我们发现的可靠性。

结果

我们纳入了 3 项随机对照试验,共 213 名患者,其中 106 名(49.8%)被分配到普伐他汀组。普伐他汀对子痫前期的发生率没有显著影响(风险比,0.62;95%置信区间,0.33-1.14;P=.12)。

结论

我们的研究未能证明普伐他汀对预防高危孕妇子痫前期的有益效果。然而,这些发现仅包括初步的研究,且研究对象数量较少,这凸显了需要进行设计良好且充分有力的临床试验的必要性。

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