Sonodynamic therapy promotes luminal gain in carotid and femoral atherosclerotic plaques: a single-center prospective clinical study
10.3760/cma.j.cn112148-20250721-00519
- VernacularTitle:声动力疗法促进颈/股动脉粥样硬化斑块处管腔获得：一项单中心前瞻性临床研究
- Author:
Yu WANG
1
;
Yihan SUN
;
Ying LIU
;
Jingxue FAN
;
Yuanqi WANG
;
Yongxing JIANG
;
Hui WANG
;
Jiemei YANG
;
Liuying WANG
;
Shuyuan GUO
;
Wei WANG
;
Ye TIAN
Author Information
1. 哈尔滨医科大学附属第一医院心血管内科 黑龙江省心血管病声光电磁诊疗重点实验室哈尔滨 150001
- Publication Type:Journal Article
- Keywords:
Atherosclerosis;
Ultrasonic therapy;
Peripheral vascular diseases;
Prospective studies
- From:
Chinese Journal of Cardiology
2025;53(11):1216-1224
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To preliminarily evaluate the lumen gain of sonodynamic therapy (SDT) mediated by sinoporphyrin sodium at carotid and femoral atherosclerotic plaque sites, and to assess whether concomitant statin use, lesion location, plaque echogenicity/type, and baseline stenosis severity modify the therapeutic response.Methods:This single-center, prospective, exploratory pilot clinical study enrolled patients with peripheral artery disease who attended the outpatient cardiology clinic of the First Affiliated Hospital of Harbin Medical University between February and September 2016. All enrolled patients received optimized oral medical therapy in combination with a single session of SDT. Vascular evaluation was performed using color Doppler ultrasound before treatment and 1 and 4 weeks after treatment. The primary efficacy endpoint was the percent change from baseline in luminal diameter stenosis at the site of the atherosclerotic plaque (%Δ) at week 4, while the secondary efficacy endpoint was %Δ at week 1. Subgroup analyses were conducted according to prior statin use, plaque location, plaque characteristics, and baseline degree of luminal stenosis.Results:A total of 24 patients, aged (70.7±2.2) years were enrolled. There were 20 (83%) males. Compared to baseline, luminal diameter stenosis at the plaque site reduced by week 4 ((50.1±1.2)% vs. (57.2±1.1)%, P<0.001), %Δ was(12.32±1.05)%; and luminal diameter stenosis also reduced by week 1 ((51.7±1.2)% vs. (57.2±1.1)%, P<0.001)), %Δ was(9.61±0.85)%. In subgroup analyses, the treatment effect on diameter stenosis was independent of prior statin use; SDT reduced stenosis in both carotid and femoral plaques; with superior efficacy observed in hypoechoic and mixed-echo plaques; and efficacy was observed across mild, moderate, and severe baseline stenosis categories (all P<0.05). Conclusion:In this single-center pilot study, SDT demonstrates therapeutic efficacy across mild, moderate, and severe stenoses, as well as in hypoechoic and mixed-echo plaques, showing potential to rapidly promote luminal gain at carotid and femoral atherosclerotic plaque sites.
