抗甲状腺药物对格雷夫斯病患者脂蛋白及胰岛素抵抗的影响：一项随机临床试验
The Effects of Anti-thyroid Drugs on Lipoproteins and Insulin Resistance in Graves' Disease: A Randomized Clinical Trial.
作者信息
Wisnu Wismandari, Alwi Idrus, Nafrialdi Nafrialdi, Pemayun Tjokorda Gde Dalem, Pantoro Nico Iswanto, Wijaya Calysta Nadya, Tahapary Dicky Levenus, Tarigan Tri Juli Edi, Subekti Imam
机构信息
Division of Endocrinology, Metabolism, and Diabetes, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia.
Metabolic Disorder, Cardiovascular and Aging Research Center, Indonesian Medical Education and Research Institute, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
出版信息
J Lipid Atheroscler. 2024 Sep;13(3):358-370. doi: 10.12997/jla.2024.13.3.358. Epub 2024 Jun 12.
OBJECTIVE
Graves' disease (GD) is characterized by thyroid overactivity. Anti-thyroid drugs (ATDs), such as propylthiouracil (PTU) and methimazole (MMI), are commonly used for GD treatment, and studies have suggested a link between these drugs and elevated lipoprotein levels. However, data on their effects on lipoproteins, insulin resistance, or low-density lipoprotein receptor (LDL-R) levels are lacking, both in Indonesia and in other countries. This study investigated changes in lipoproteins, LDL-R, and insulin resistance markers with ATD treatment.
METHODS
This study is a secondary analysis of a randomized clinical trial entitled "The Differential Effects of Propylthiouracil and Methimazole as Graves' Disease Treatment on Vascular Atherosclerosis Markers" conducted in Jakarta, Indonesia. Thirty-seven newly diagnosed GD patients received MMI or PTU for 3 months.
RESULTS
After 3 months of ATD treatment, LDL-R levels significantly decreased compared to baseline (197 vs. 144 ng/mL, <0.001), while most lipoproteins, including TC, LDL-C, HDL-C, non-HDL-C, the cholesterol ratio, and the LDL-C/HDL-C ratio, increased. Unexpectedly, neither the PTU nor MMI groups showed an increased dyslipidemia prevalence. Although body mass index increased significantly and fasting plasma glucose decreased slightly, no significant post-treatment change in insulin resistance was observed. The study received ethical approval from the Ethics Committee of the Faculty of Medicine, Universitas Indonesia (ref KET-784/UN.2.F1/ETIK/PPM.00.02/2019) and was registered on clinicaltrials.gov (NCT05118542).
CONCLUSION
ATD treatment for GD led to a significant increase in total cholesterol, LDL-cholesterol, and high-density lipoprotein-cholesterol levels, along with a reduction in LDL-R levels. Both PTU and MMI showed similar effects. These findings provide valuable insights into the effects of ATDs on lipoproteins and insulin resistance in GD patients.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT05118542.
目的
格雷夫斯病（GD）的特征是甲状腺功能亢进。抗甲状腺药物（ATD），如丙硫氧嘧啶（PTU）和甲巯咪唑（MMI），常用于GD的治疗，且研究表明这些药物与脂蛋白水平升高之间存在关联。然而，无论是在印度尼西亚还是其他国家，关于它们对脂蛋白、胰岛素抵抗或低密度脂蛋白受体（LDL-R）水平影响的数据都很缺乏。本研究调查了ATD治疗后脂蛋白、LDL-R和胰岛素抵抗标志物的变化。
方法
本研究是对一项在印度尼西亚雅加达进行的名为“丙硫氧嘧啶和甲巯咪唑作为格雷夫斯病治疗对血管动脉粥样硬化标志物的差异影响”的随机临床试验的二次分析。37名新诊断的GD患者接受MMI或PTU治疗3个月。
结果
ATD治疗3个月后，与基线相比，LDL-R水平显著降低（197对144 ng/mL，<0.001），而大多数脂蛋白，包括总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）、非HDL-C、胆固醇比值以及LDL-C/HDL-C比值均升高。出乎意料的是，PTU组和MMI组的血脂异常患病率均未增加。虽然体重指数显著增加且空腹血糖略有下降，但未观察到治疗后胰岛素抵抗有显著变化。该研究获得了印度尼西亚大学医学院伦理委员会的伦理批准（参考编号KET-784/UN.2.F1/ETIK/PPM.00.02/2019），并在clinicaltrials.gov上注册（NCT05118542）。
结论
GD的ATD治疗导致总胆固醇、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇水平显著升高，同时LDL-R水平降低。PTU和MMI均显示出相似的效果。这些发现为ATD对GD患者脂蛋白和胰岛素抵抗的影响提供了有价值的见解。
试验注册
ClinicalTrials.gov标识符：NCT05118542。
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