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孕激素预防早产和妊娠期糖尿病发病风险的Meta 分析。

Progestogens for the prevention of preterm birth and risk of developing gestational diabetes mellitus: a meta-analysis.

机构信息

Laboratory of Experimental Surgery and Surgical Research N. S. Christeas, National and Kapodistrian University of Athens, Athens, Greece.

Laboratory of Experimental Surgery and Surgical Research N. S. Christeas, National and Kapodistrian University of Athens, Athens, Greece.

出版信息

Am J Obstet Gynecol. 2019 Nov;221(5):429-436.e5. doi: 10.1016/j.ajog.2019.05.033. Epub 2019 May 24.

DOI:10.1016/j.ajog.2019.05.033
PMID:31132340
Abstract

BACKGROUND

Several articles have implied that progestogen supplementation during pregnancy to reduce the risk of preterm birth may increase the risk for developing gestational diabetes mellitus.

OBJECTIVE

The purpose of the present meta-analysis was to accumulate existing evidence concerning this correlation.

DATA SOURCES

We searched Medline (1966-2019), Scopus (2004-2019), Clinicaltrials.gov (2008-2019), EMBASE (1980-2019), Cochrane Central Register of Controlled Trials CENTRAL (1999-2019), and Google Scholar (2004-2019) databases.

STUDY ELIGIBILITY CRITERIA

Randomized trials and observational studies were considered eligible for inclusion in the present meta-analysis. To minimize the possibility of article losses, we avoided language, country, and date restrictions.

STUDY APPRAISAL AND SYNTHESIS METHODS

The methodological quality of included studies was evaluated with the Cochrane risk of bias and the Risk Of Bias In Non-Randomized Studies of Interventions (ROBINS-I) tool. Meta-analysis was performed with the RevMan 5.3 and secondary analysis with the Open Meta-Analyst software. Trial sequential analysis was conducted with the trial sequential analysis program.

RESULTS

Overall, 11 studies were included in the present meta-analysis that recruited 8085 women. The meta-analysis revealed that women who received 17-alpha hydroxyprogesterone caproate had increased the risk of developing gestational diabetes mellitus (risk ratio, 1.73, 95% confidence interval, 1.32-2.28), whereas women who received vaginal progesterone had a decreased risk, although the effect did not reach statistical significance because of the unstable estimate of confidence intervals (risk ratio, 0.82, 95% confidence interval, 0.50-1.12). Meta-regression analysis indicated that neither the methodological rationale for investigating the prevalence of gestational diabetes mellitus (incidence investigated as primary or secondary outcome) (coefficient of covariance, -0.36, 95% confidence interval, -0.85 to 0.13, P = .154) nor the type of investigated study (randomized controlled trial/observational) (coefficient of covariance -0.361, 95% confidence interval, -1.049 to 0.327, P = .304) significantly altered the results of the primary analysis. Trial sequential analysis suggested that the meta-analysis concerning the correlation of 17-alpha hydroxyprogesterone caproate was of adequate power to reach firm conclusions, whereas this was not confirmed in the case of vaginal progesterone.

CONCLUSION

The results of the present meta-analysis clearly indicate that women who receive supplemental 17-alpha hydroxyprogesterone caproate for the prevention of preterm birth have an increased risk of developing gestational diabetes mellitus. On the other hand, evidence concerning women treated with vaginal progesterone remains inconclusive.

摘要

背景

有几篇文章暗示,在怀孕期间补充孕激素以降低早产风险可能会增加患妊娠期糖尿病的风险。

目的

本荟萃分析的目的是积累关于这种相关性的现有证据。

资料来源

我们检索了 Medline(1966-2019 年)、Scopus(2004-2019 年)、Clinicaltrials.gov(2008-2019 年)、EMBASE(1980-2019 年)、Cochrane 对照试验中心注册数据库 CENTRAL(1999-2019 年)和谷歌学术(2004-2019 年)数据库。

研究入选标准

随机试验和观察性研究被认为有资格纳入本荟萃分析。为了最大程度地减少文章遗漏的可能性,我们避免了语言、国家和日期的限制。

研究评估和综合方法

使用 Cochrane 偏倚风险工具和非随机干预研究的偏倚风险(ROBINS-I)工具评估纳入研究的方法学质量。使用 RevMan 5.3 进行荟萃分析,使用 Open Meta-Analyst 软件进行二次分析。使用试验序贯分析程序进行试验序贯分析。

结果

总体而言,本荟萃分析纳入了 11 项研究,共招募了 8085 名女性。荟萃分析显示,接受 17-α羟孕酮己酸酯治疗的女性患妊娠期糖尿病的风险增加(风险比,1.73,95%置信区间,1.32-2.28),而接受阴道孕酮治疗的女性患病风险降低,但由于置信区间的估计不稳定,效果未达到统计学意义(风险比,0.82,95%置信区间,0.50-1.12)。元回归分析表明,无论是调查妊娠期糖尿病患病率的方法学原理(作为主要或次要结局调查)(协方差系数,-0.36,95%置信区间,-0.85 至 0.13,P =.154),还是所调查研究的类型(随机对照试验/观察性研究)(协方差系数-0.361,95%置信区间,-1.049 至 0.327,P =.304),都不能显著改变主要分析的结果。试验序贯分析表明,关于 17-α羟孕酮己酸酯相关性的荟萃分析具有足够的效力来得出明确的结论,而关于阴道孕酮的分析则没有得到证实。

结论

本荟萃分析的结果清楚地表明,接受 17-α羟孕酮己酸酯治疗以预防早产的女性患妊娠期糖尿病的风险增加。另一方面,关于阴道孕酮治疗的证据仍然不确定。

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