超声评价贝前列素钠联合阿司匹林对 2 型糖尿病患者动脉闭塞及僵硬的保护作用-前瞻性、随机研究。

Ultrasonography evaluation on the protective effect of combination therapy of beraprost sodium and aspirin on arteries occlusion and stiffness in patients with type 2 diabetes mellitus - a prospective, randomized study.

机构信息

Department of Ultrasound, Guangdong Province Traditional Chinese Medical Hospital, 111, Dade Road, Yuexiu District, Guangzhou, Guangdong, China.

Department of Endocrinology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, 107, Yanjiangxi Road, Yuexiu District, Guangzhou, Guangdong, PR China.

出版信息

BMC Endocr Disord. 2022 Apr 2;22(1):87. doi: 10.1186/s12902-022-01007-5.

DOI:10.1186/s12902-022-01007-5

PMID:35366853

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8977025/

Abstract

BACKGROUND

Patients with type 2 diabetes mellitus (T2DM) are susceptible to developing symptomatic peripheral arterial disease (PAD). As a proven vasodilator and antiplatelet agent, the efficiency of Beraprost sodium (BPS) on the prevention of arteries occlusion and stiffness in T2DM patients with PAD has not yet been fully investigated.

METHODS

From July 2010 to April 2012, 64 Patients enrolled were randomly assigned to the combined therapy group (n=32), which received combination therapy with BPS (60 μg/day) and aspirin (100 mg/day), or to the control group (n=32), which only received aspirin (100 mg/day). After randomization, the patients were followed up at years 0, 1, 2, 3, 4, and 5 with the evaluation of carotid intima-media thickness (CIMT), pulse wave velocity (PWV), inner artery diameter, stenosis rate, and medial arterial calcification (MAC) of lower limb arteries via high-resolution ultrasound measurement. Adverse events were also recorded in each visit.

RESULTS

There was no significant change of the CIMT during the follow-up in both groups when compared to the baseline. Similar results were also observed in the PWV measurement. Significantly increases in the inner artery diameter of the dorsal pedal artery and posterior tibial artery were observed in patients with BPS and aspirin administration during the follow-up. Patients in the combined therapy group experienced marked improvement of MAC in the dorsal pedal artery and posterior tibial artery at the end of the follow-up. No significant difference in the adverse events was found between the combined therapy group and the aspirin group.

CONCLUSION

The combined therapy of BPS and aspirin showed a protective effect on arteries occlusion and stiffness in T2DM patients with PAD, along with a significant improvement of inner artery diameter and MAC in lower limbs.

TRIAL REGISTRATION

http://www.chictr.org.cn , ChiCTR-TRC-10000919. Prospectively registered on 2010/06/29.

摘要

背景

2 型糖尿病（T2DM）患者易发生有症状的外周动脉疾病（PAD）。贝前列素钠（BPS）作为一种已被证实的血管扩张剂和抗血小板药物，其在预防 T2DM 合并 PAD 患者动脉闭塞和僵硬方面的疗效尚未得到充分研究。

方法

2010 年 7 月至 2012 年 4 月，纳入 64 例患者，随机分为联合治疗组（n=32），给予 BPS（60μg/天）和阿司匹林（100mg/天）联合治疗；或对照组（n=32），仅给予阿司匹林（100mg/天）。随机分组后，通过高分辨率超声测量，对颈动脉内膜中层厚度（CIMT）、脉搏波速度（PWV）、内动脉直径、狭窄率和下肢动脉中层动脉钙化（MAC）进行随访评估，随访时间分别为 0 年、1 年、2 年、3 年、4 年和 5 年。在每次就诊时还记录不良事件。