Department of Endocrinology, Shengjing Hospital of China Medical University, Shenyang, China.
Department of Endocrinology, Shengjing Hospital of China Medical University, Shenyang, China
BMJ Open. 2022 Apr 25;12(4):e058260. doi: 10.1136/bmjopen-2021-058260.
Polycystic ovary syndrome (PCOS) is a heterogeneous reproductive endocrine disorder. Several ongoing trials test sodium-glucose cotransporter-2 (SGLT-2) inhibitors for women with PCOS. However, their effectiveness has not been fully elucidated owing to the lack of high-confidence evidence. Our group agrees with the statement that SGLT-2 inhibition could treat PCOS as it is supported by reports demonstrating the benefits of SGLT-2 inhibition on metabolic status and weight control. Moreover, the functions of chronic inflammation amelioration and cardiovascular system protection make it a more attractive candidate for PCOS therapy. Therefore, to provide physicians with a reference, we intend to perform a meta-analysis on the efficacy and safety of SGLT-2 inhibitors on the endocrine and metabolic profiles of patients with PCOS.
We will search for randomised controlled trials performed until September 2022 using PubMed, Web of Science, EMBASE, the Cochrane Library, Google Scholar, the PhRMA Clinical Study Results Database (www.
gov), the China National Knowledge Infrastructure, the Wanfang, the Weipu and the Chinese biomedical literature databases. The outcomes will include androgen-associated outcomes, body fat, glucose and lipid homoeostasis, inflammatory outcomes and adverse events. In addition, two investigators will independently assess methodological quality using the revised Cochrane risk-of-bias tool 2. The analysis will be performed using RevMan V.5.3 software, and subgroup and sensitivity analyses and a meta-regression will be used to determine the heterogeneity source.
Ethical approval is not required because this is a meta-analysis. We will disseminate these results by publishing them in a peer-reviewed journal.
CRD42021281176.
多囊卵巢综合征（PCOS）是一种异质性生殖内分泌疾病。目前有几项正在进行的试验正在测试钠-葡萄糖共转运蛋白-2（SGLT-2）抑制剂在 PCOS 患者中的疗效。然而，由于缺乏高可信度的证据，其有效性尚未完全阐明。我们小组同意 SGLT-2 抑制可以治疗 PCOS 的观点，因为有报道表明 SGLT-2 抑制对代谢状态和体重控制有益。此外，其改善慢性炎症和保护心血管系统的功能，使其成为治疗 PCOS 更具吸引力的候选药物。因此，为了给医生提供参考，我们计划对 SGLT-2 抑制剂治疗 PCOS 患者内分泌和代谢特征的疗效和安全性进行荟萃分析。
我们将在截至 2022 年 9 月，通过 PubMed、Web of Science、EMBASE、Cochrane 图书馆、Google Scholar、PhRMA 临床研究结果数据库（www.clinicaltrials.gov）、中国国家知识基础设施、万方、维普和中国生物医学文献数据库搜索随机对照试验。结局将包括雄激素相关结局、体脂、葡萄糖和脂质稳态、炎症结局和不良事件。此外，两名研究者将使用修订后的 Cochrane 偏倚风险工具 2 独立评估方法学质量。分析将使用 RevMan V.5.3 软件进行，将进行亚组和敏感性分析以及荟萃回归分析，以确定异质性的来源。
由于这是一项荟萃分析，因此不需要伦理批准。我们将通过在同行评议的期刊上发表这些结果来传播这些结果。
PROSPERO 注册号：CRD42021281176。
