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血管紧张素受体拮抗剂缬沙坦对下肢动脉硬化闭塞症介入治疗后再狭窄的影响:前瞻性、随机、单盲试验。

Effects of Valsartan on Restenosis in Patients with Arteriosclerosis Obliterans of the Lower Extremities Undergoing Interventional Therapy: A Prospective, Randomized, Single-Blind Trial.

机构信息

Department of Cardiology, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, Hebei, China (mainland).

Department of Interventional Vascular Surgery, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, Hebei, China (mainland).

出版信息

Med Sci Monit. 2020 Jun 16;26:e919977. doi: 10.12659/MSM.919977.

Abstract

BACKGROUND The aim of this study was to further clarify the effects of valsartan on restenosis in patients with arteriosclerosis obliterans of the lower extremities. MATERIAL AND METHODS Patients with arteriosclerosis obliterans of the lower extremities undergoing continuous stent implantation in the superficial femoral artery were enrolled and randomly divided into an ARB group and a control group. Patients in the ARB group received valsartan orally in a single-blind manner and were followed up for 6 months. An evaluation was performed based on the criteria for clinical efficacies designed by the Committee of Vascular Disease, Chinese Association of Integrative Medicine. The total clinical effective rate was calculated, and ankle brachial index (ABI) of the patients was assessed. The concentrations of interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) were measured using enzyme-linked immunosorbent assay. The in-stent restenosis of patients was examined by angiography. RESULTS One patient in the control group died due to acute cerebral hemorrhage 4 months after enrollment, and 1 patient was lost to follow-up due to acute myocardial infarction during follow-up 5 months after enrollment. Age, sex, Fontaine stage, and underlying diseases were comparable between the 2 groups. Hs-CRP (3.93±1.43) and IL-6 (11.26±2.29) levels were significant different in the ARB group compared with the control group. The postoperative follow-up showed that ABI was 0.98±0.20 in the ARB group and 0.62±0.48 in the control group. CONCLUSIONS Valsartan inhibited the increase in hs-CRP and IL-6 levels, improved clinical efficacies, increased ABI, and decreased the restenosis rate after the interventional therapy in patients with arteriosclerosis obliterans of the lower extremities.

摘要

背景

本研究旨在进一步阐明缬沙坦对下肢动脉硬化闭塞症患者再狭窄的影响。

材料和方法

纳入行股浅动脉支架植入术的下肢动脉硬化闭塞症患者,采用随机数字表法分为 ARB 组和对照组,ARB 组患者采用缬沙坦单盲口服,随访 6 个月。根据中华中医药学会周围血管病分会制定的临床疗效评定标准进行评价,计算总有效率,评估踝肱指数(ABI)。采用酶联免疫吸附法检测白细胞介素-6(IL-6)和高敏 C 反应蛋白(hs-CRP)的浓度。采用血管造影检查患者的支架内再狭窄情况。

结果

对照组有 1 例患者在入组后 4 个月因急性脑出血死亡,1 例患者在入组后 5 个月因急性心肌梗死失访。2 组年龄、性别、Fontaine 分期、基础疾病比较差异无统计学意义。ARB 组 hs-CRP(3.93±1.43)和 IL-6(11.26±2.29)水平明显低于对照组。术后随访 ARB 组 ABI 为 0.98±0.20,对照组为 0.62±0.48。

结论

缬沙坦可抑制 hs-CRP 和 IL-6 水平的升高,提高临床疗效,增加 ABI,降低下肢动脉硬化闭塞症患者介入治疗后的再狭窄率。

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