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[司美格鲁肽——根据SUSTAIN、PIONEER、STEP研究使用时的减肥效果及副作用]

[Semaglutide - effectiveness in weight loss and side effects when used according to studies by SUSTAIN, PIONEER, STEP].

作者信息

Shabutdinova O R, Dautov A R, Samkov A A, Kononenko A V, Sargaliev A F, Davletshin A R, Andresova P A, Zarbeeva K R, Torshkhoeva D A, Rakhmonkulov U A, Afanasyev A A

机构信息

Bashkir state medical university.

Dagestan state medical university.

出版信息

Probl Endokrinol (Mosk). 2023 Jun 30;69(3):68-82. doi: 10.14341/probl13197.

DOI:10.14341/probl13197
PMID:37448249
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10350618/
Abstract

Overweight and obesity are a worldwide common problem and are diagnosed with a body mass index (BMI) value in the range of 25.0-29.9 kg/m2 and ≥30.0 kg/m2, respectively. Obese patients are at high risk of developing concomitant diseases, such as hypertension, type 2 diabetes mellitus (DM2), hyperlipidemia, stroke and even some types of cancer. In the Russian Federation in 2016, the proportion of overweight people was 62.0%, with obesity - 26.2%. The authors performed an electronic search in the PubMed information database. Two search elements were used: «Semaglutide» and «Obesity». The search included studies published from the date of foundation of the database to August 2022. The search was limited only to the results of clinical trials. The authors obtained 26 results, but only the studies of SUSTAIN, PIONEER (Peptide Innovation for Early Diabetes Treatment) and STEP were considered, since they were original, randomized, controlled clinical trials conducted before the approval of semaglutide for the treatment of DM2 and obesity.

摘要

超重和肥胖是一个全球性的常见问题,分别通过体重指数(BMI)值在25.0 - 29.9 kg/m²和≥30.0 kg/m²范围内来诊断。肥胖患者患伴发疾病的风险很高,如高血压、2型糖尿病(DM2)、高脂血症、中风甚至某些类型的癌症。2016年在俄罗斯联邦,超重人群的比例为62.0%,肥胖人群为26.2%。作者在PubMed信息数据库中进行了电子检索。使用了两个检索词:“司美格鲁肽”和“肥胖”。检索范围包括从数据库建立之日到2022年8月发表的研究。检索仅限于临床试验结果。作者获得了26个结果,但仅考虑了SUSTAIN、PIONEER(早期糖尿病治疗的肽创新)和STEP的研究,因为它们是在司美格鲁肽被批准用于治疗DM2和肥胖之前进行的原始、随机、对照临床试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be19/10350618/3b4b10224ec6/problendo-69-13197-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be19/10350618/329b6b9d0837/problendo-69-13197-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be19/10350618/1697d228e8b9/problendo-69-13197-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be19/10350618/fdbc91b4b4e9/problendo-69-13197-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be19/10350618/b987cacb2555/problendo-69-13197-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be19/10350618/3b4b10224ec6/problendo-69-13197-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be19/10350618/329b6b9d0837/problendo-69-13197-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be19/10350618/1697d228e8b9/problendo-69-13197-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be19/10350618/fdbc91b4b4e9/problendo-69-13197-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be19/10350618/b987cacb2555/problendo-69-13197-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be19/10350618/3b4b10224ec6/problendo-69-13197-g005.jpg

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本文引用的文献

1
Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial.超重或肥胖成年人中司美格鲁肽的 2 年疗效:STEP 5 试验。
Nat Med. 2022 Oct;28(10):2083-2091. doi: 10.1038/s41591-022-02026-4. Epub 2022 Oct 10.
2
Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial.持续每周皮下注射司美格鲁肽与安慰剂对超重或肥胖成年人体重维持的影响:STEP 4 随机临床试验。
JAMA. 2021 Apr 13;325(14):1414-1425. doi: 10.1001/jama.2021.3224.
3
Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial.
司美格鲁肽 2·4 毫克每周一次治疗超重或肥胖、以及 2 型糖尿病成人患者(STEP 2):一项随机、双盲、双模拟、安慰剂对照、3 期临床试验。
Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.
4
Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial.皮下司美格鲁肽与安慰剂作为强化行为疗法辅助手段对超重或肥胖成人体重的影响:STEP 3 随机临床试验。
JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831.
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Once-Weekly Semaglutide in Adults with Overweight or Obesity.每周一次司美格鲁肽在超重或肥胖成人中的应用。
N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.
6
Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as add-on to metformin in patients with type 2 diabetes in SUSTAIN China: A 30-week, double-blind, phase 3a, randomized trial.SUSTAIN China 研究:每周一次司美格鲁肽对比每日一次西格列汀作为二甲双胍添加治疗在中国 2 型糖尿病患者中的疗效和安全性:一项 30 周、双盲、3a 期、随机临床试验。
Diabetes Obes Metab. 2021 Feb;23(2):404-414. doi: 10.1111/dom.14232. Epub 2021 Jan 3.
7
Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial.口服司美格鲁肽对比度拉鲁肽在日本 2 型糖尿病患者中的安全性和有效性(PIONEER 10):一项开放标签、随机、阳性对照、3a 期临床试验。
Lancet Diabetes Endocrinol. 2020 May;8(5):392-406. doi: 10.1016/S2213-8587(20)30074-7.
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Lancet Diabetes Endocrinol. 2020 May;8(5):377-391. doi: 10.1016/S2213-8587(20)30075-9.
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Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.
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Lancet Diabetes Endocrinol. 2019 Nov;7(11):834-844. doi: 10.1016/S2213-8587(19)30311-0. Epub 2019 Sep 17.