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西洛他唑对 2 型糖尿病患者颈动脉斑块体积的影响的 FANCY 研究:三维超声研究。

Effect of cilostazol on carotid plaque volume measured by three-dimensional ultrasonography in patients with type 2 diabetes: The FANCY study.

机构信息

Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, South Korea.

Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.

出版信息

Diabetes Obes Metab. 2020 Dec;22(12):2257-2266. doi: 10.1111/dom.14147. Epub 2020 Sep 17.

DOI:10.1111/dom.14147
PMID:32700396
Abstract

AIMS

To conduct a prospective randomized study to evaluate cilostazol, a phosphodiesterase 3 inhibitor, and compare it with aspirin for the prevention of the progression of atherosclerosis in patients with type 2 diabetes (T2D).

MATERIALS AND METHODS

Fifty patients with T2D and carotid atherosclerotic plaques were randomly assigned to either a 200 mg/d cilostazol (CTZ) group or a 100 mg/d aspirin (ASA) group for 6 months. The primary endpoint was change in plaque volume measured by carotid three-dimensional ultrasonography. The secondary endpoints were changes in carotid intima-media thickness (IMT) and endothelial function, assessed by laser Doppler.

RESULTS

Twenty-four patients in the CTZ group and 23 in the ASA group were included in the final analysis. The mean ± SD age of male (n = 20) and female (n = 16) patients was 62.2 and 59.1 years, respectively. The total plaque volume was slightly decreased in the CTZ group (from 183.8 ± 52.5 to 181.5 ± 54.0 mm ; P = .567), but significantly increased in the ASA group (from 112.9 ± 21.2 to 128.5 ± 23.3 mm ; P = .043). A significant regression in the maximum IMT was observed only in the CTZ group (right: from 2.19 ± 0.17 to 1.96 ± 0.12 mm; left: from 2.02 ± 0.20 to 1.72 ± 0.19 mm). The CTZ group exhibited an increase in HDL cholesterol and a decrease in triglycerides and liver enzymes.

CONCLUSIONS

Cilostazol treatment for 6 months significantly attenuated the progression of carotid plaque compared with aspirin in patients with T2D (NCT03248401).

摘要

目的

进行一项前瞻性随机研究,评估磷酸二酯酶 3 抑制剂西洛他唑,并将其与阿司匹林进行比较,以预防 2 型糖尿病(T2D)患者动脉粥样硬化的进展。

材料和方法

50 例 T2D 合并颈动脉粥样硬化斑块患者被随机分为西洛他唑 200mg/d(CTZ)组或阿司匹林 100mg/d(ASA)组,治疗 6 个月。主要终点是通过颈动脉三维超声测量斑块体积的变化。次要终点是通过激光多普勒评估颈动脉内膜-中层厚度(IMT)和内皮功能的变化。

结果

CTZ 组和 ASA 组分别有 24 例和 23 例患者进入最终分析。20 例男性和 16 例女性患者的平均(SD)年龄分别为 62.2 和 59.1 岁。CTZ 组总斑块体积略有减少(从 183.8±52.5 降至 181.5±54.0mm;P=.567),但 ASA 组显著增加(从 112.9±21.2 增至 128.5±23.3mm;P=.043)。仅在 CTZ 组观察到最大 IMT 显著回归(右侧:从 2.19±0.17 降至 1.96±0.12mm;左侧:从 2.02±0.20 降至 1.72±0.19mm)。CTZ 组表现为高密度脂蛋白胆固醇升高,甘油三酯和肝酶降低。

结论

与阿司匹林相比,西洛他唑治疗 6 个月可显著减缓 T2D 患者颈动脉斑块的进展(NCT03248401)。

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