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二甲双胍对多囊卵巢综合征女性高雄激素血症的影响:一项随机临床试验的系统评价和荟萃分析

Influence of metformin on hyperandrogenism in women with polycystic ovary syndrome: a systematic review and meta-analysis of randomized clinical trials.

作者信息

Fontes Adriana F S, Reis Fernando M, Cândido Ana Lúcia, Gomes Karina B, Tosatti Jéssica A G

机构信息

Department of Clinical and Toxicological Analyses - Faculty of Pharmacy, Federal University of Minas Gerais, Presidente Antônio Carlos Avenue, 6627, Pampulha, Belo Horizonte, Minas Gerais, Brazil.

Department of Gynecology and Obstetrics - Faculty of Medicine, Federal University of Minas Gerais, Professor Alfredo Balena Avenue, 190, Santa Efigênia, Belo Horizonte, Minas Gerais, Brazil.

出版信息

Eur J Clin Pharmacol. 2023 Apr;79(4):445-460. doi: 10.1007/s00228-023-03461-z. Epub 2023 Feb 10.

Abstract

PURPOSE

To summarize the effects of metformin treatment on markers of hyperandrogenism in patients diagnosed with polycystic ovary syndrome (PCOS).

METHODS

A systematic review, with meta-analysis, of randomized placebo-controlled clinical trials that evaluated the effects of metformin treatment in adult patients with PCOS on the levels of hyperandrogenism markers was conducted. The literature search, data extraction, risk of bias, and the assessment of certainty of evidence were performed independently by two reviewers using a structured form. The results were combined by applying the random effect, and the effect measure presented as a standardized mean difference (SMD). Significant values were considered as p < 0.05 with 95% CI. Furthermore, sensitivity analyses were performed in order to explore possible heterogeneity between studies.

RESULTS

Were included 18 studies in the quantitative evaluation and 17 studies (23 reports) in the quantitative evaluation. A significant reduction in total testosterone levels was seen in the metformin-treated group when compared to the control group after combining the results by the sensitivity analysis [SMD: - 0.46 (95% CI: - 0.89 to - 0.02)]. Therefore, FAI values were also regulated by metformin treatment.

CONCLUSION

We showed that metformin proved to be effective in reducing total testosterone levels, and the same was observed for free androgen index (FAI) values-a measure influenced by testosterone levels. The protocol of this study was registered at Prospero (CRD42021235761).

摘要

目的

总结二甲双胍治疗对多囊卵巢综合征(PCOS)患者高雄激素血症标志物的影响。

方法

对评估二甲双胍治疗成年PCOS患者对高雄激素血症标志物水平影响的随机安慰剂对照临床试验进行系统评价和荟萃分析。两名评价者使用结构化表格独立进行文献检索、数据提取、偏倚风险和证据确定性评估。采用随机效应合并结果,效应量以标准化均数差(SMD)表示。显著性值以p<0.05及95%置信区间为准。此外,进行敏感性分析以探讨研究间可能存在的异质性。

结果

定量评价纳入18项研究,定性评价纳入17项研究(23篇报告)。经敏感性分析合并结果后,与对照组相比,二甲双胍治疗组总睾酮水平显著降低[SMD:-0.46(95%CI:-0.89至-0.02)]。因此,游离雄激素指数(FAI)值也受二甲双胍治疗调控。

结论

我们发现二甲双胍可有效降低总睾酮水平,游离雄激素指数(FAI)值——一项受睾酮水平影响的指标——亦如此。本研究方案已在国际前瞻性系统评价注册库(Prospero)注册(注册号:CRD42021235761)。

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