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格美列净的降糖作用:基于质量管理系统的贝叶斯推断的随机对照试验的系统评价和荟萃分析。

Antidiabetic effect of gemigliptin: a systematic review and meta-analysis of randomized controlled trials with Bayesian inference through a quality management system.

机构信息

College of Pharmacy and Research Institute of Life and Pharmaceutical Sciences, Sunchon National University, 255 Jungang-ro, Suncheon, Jeollanam-do, 57922, Republic of Korea.

Unimedi Plastic Surgery Clinic, Suite 302, 3rd Floor, 833 Nonhyeon-ro, Sinsa-dong, Gangnam-gu, Seoul, 06032, Republic of Korea.

出版信息

Sci Rep. 2021 Oct 22;11(1):20938. doi: 10.1038/s41598-021-00418-z.

Abstract

Gemigliptin is one of the latest dipeptidyl peptidase-4 inhibitors developed by LG Life Sciences. Since the early 2000s, several randomized controlled trials (RCTs) of gemigliptin have been conducted. However, no study has directly compared its antidiabetic effects through a systematic review and meta-analysis. Therefore, in this study, we performed a systematic review and meta-analysis on RCTs. In particular, a subsequent meta-analysis was performed using Bayesian inference, and an updated quality management system model was integrated throughout our study. The mean differences and 95% confidence intervals for glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), homeostatic model assessment beta cell function (HOMA-β), and low-density lipoprotein (LDL) were evaluated for the efficacy outcomes of gemigliptin as compared to those of placebo and other oral antidiabetic drugs (OADs). In conclusion, we found that gemigliptin was superior to placebo and comparable to other OADs in terms of the effect on HbA1c, FPG, HOMA-β, and LDL. Further, gemigliptin was more effective than other OADs in HbA1c and HOMA-β in Bayesian inference analysis and statistically significant to other OADs in HbA1c and HOMA-β in sensitivity analysis excluding metformin. However, to confirm the results, more studies need to be analysed and the minimum clinically important difference must be applied.

摘要

杰格利汀是 LG 生命科学公司开发的最新的二肽基肽酶-4 抑制剂之一。自 21 世纪初以来,已经进行了几项杰格利汀的随机对照试验(RCT)。然而,没有研究通过系统评价和荟萃分析直接比较其降糖效果。因此,在这项研究中,我们对 RCT 进行了系统评价和荟萃分析。特别是,我们使用贝叶斯推断进行了后续的荟萃分析,并在整个研究中集成了更新的质量管理系统模型。我们评估了杰格利汀与安慰剂和其他口服降糖药(OAD)相比在糖化血红蛋白(HbA1c)、空腹血糖(FPG)、稳态模型评估β细胞功能(HOMA-β)和低密度脂蛋白(LDL)方面的疗效结局的平均差异和 95%置信区间。总之,我们发现杰格利汀在降低 HbA1c、FPG、HOMA-β 和 LDL 方面优于安慰剂,与其他 OAD 相当。此外,在贝叶斯推断分析中,杰格利汀在 HbA1c 和 HOMA-β 方面比其他 OAD 更有效,在排除二甲双胍的 HbA1c 和 HOMA-β 方面的敏感性分析中,杰格利汀与其他 OAD 相比具有统计学意义。然而,为了确认这些结果,需要进一步分析更多的研究,并应用最小临床重要差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/959c/8536696/9412abcdc5e9/41598_2021_418_Fig1_HTML.jpg

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