扶阳软坚饮联合阿司匹林+氯吡格雷片预防下肢动脉支架成形术后再狭窄的临床随机对照研究

A Clinical Trial of Using Fuyang Ruanjian Drink Combined with Aspirin + Clopidogrel Tablets Treatment to Prevent Restenosis Following Artery of Lower Extremity Angioplasty and Endovascular Stent

目的:考察扶阳软坚饮联合阿司匹林+氯吡格雷片在预防下肢动脉支架成形术后再狭窄的作用。方法:选取2013年7月—2014年4月来医院血管外科因患肢体动脉硬化闭塞症接受下肢动脉支架成形术的患者100例,患者被随机分为对照组和实验组,对照组接受阿司匹林+氯吡格雷片治疗,实验组接受扶阳软坚饮联合阿司匹林+氯吡格雷片治疗,记录患者术后第1、3、6和12个月随访记录动脉再闭塞、再狭窄及不良出血事件。结果:两组患者在年龄、男女比、高血压、糖尿病、高脂血症、吸烟史和肢体缺血时间均无统计学差异(P>0.05);两组患者在病变部位、血管狭窄程度、主干闭塞率、治疗长度及植入支架数均无统计学差异(P>0.05);两组患者在1月、3月、6月和12月再闭塞率和出血无统计学差异(P>0.05),实验组在累计再狭窄显著低于对照组(P<0.05)。术后3月,实验组在皮温、踝/肱指数、疼痛指数和溃疡评分均显著优于对照组(P<0.01);术后6月,实验组在踝/肱指数显著优于对照组(P<0.01)。结论:扶阳软坚饮联合阿司匹林+氯吡格雷片可有效预防下肢动脉支架成形术后再狭窄,安全有效。

Objective ：To investigate the effect of Fuyang Ruanjian drink combined with Aspirin ＋ Clopidogrel tablets in preventing lower extremity arterial stent restenosis. Methods ： 100 case of patients suffering from vascular surgery limb arte- riosclerosis obliterans which accepted lower extremity arterial stenting from July 2013 to April 2014 in our hospital were randomly divided into the control group and the experimental group, and the control group received aspirin ＋ clopidogrel tablets, the experimental group received Fuyang Ruanfian drink in combination with aspirin ＋ clopidogrel. Weercorded 1, 3,6 and 12 month follow- up, recording arterial occlusion, restenosis rates and adverse bleeding events. Results：There were no statistica differences （ P 〉 0. 05 ） in age, gender ratio, hypertension, diabetes, hyperlipidemia, smoking history and limb ischemia time. In the lesion, degree of stenosis, occlusion trunk rate, length of treatment and the number of stents im- planted were not statistically different （ P 〉 0.05 ）. There was no statistical difference occlusion rate and bleeding rate （ P 〉 0.05 ） in 1,3,6 and 12 month between two groups （ P 〉 0.05 ）. The experimental group cumulative restenosis rate was significantly lower than that of the control group （ χ2 = 4.4, P 〈 0.05 ）. After treated for 3 months, the experimental group was significantly better than the control group （P 〈 0. 01 ） in skin temperature, ankle/brachial index, pain and ulcer index score ; after 6 months, the experimental group was significantly better than the control group in the ankle / brachial index （P 〈0.01 ）. Conclusion： Fuyang Ruanjian drink combined with Aspirin ＋ Clopidogrel tablets is effective and safe in pre- venting restenosis following artery of lower extremity angioplasty and endovascular stent.