Farkas Katalin, Kolossváry Endre, Járai Zoltán
Department of Angiology, Szent Imre University Teaching Hospital, Budapest, Hungary.
Department of Cardiology, Szent Imre University Teaching Hospital, Budapest, Hungary.
Vasa. 2020 Apr;49(3):235-242. doi: 10.1024/0301-1526/a000845. Epub 2020 Jan 27.
: Symptomatic peripheral arterial disease (intermittent claudication) is a major cause of disability and mobility loss in older men and women and thus has a significant negative impact on the patients' quality of life. Both surgical and endovascular revascularization procedures and noninvasive medical therapies, such as supervised training and drug treatment, can improve walking capacity. Cilostazol is the only drug having a class I (level of evidence A) recommendation for the treatment of intermittent claudication (IC). The aim of this study was to evaluate the effect of three-month cilostazol treatment on the health-related quality of life and on the lower limb functional capacity in patients with IC in the clinical practice. : The study was a multicenter, non-interventional trial, performed in Hungary in 2018. 812 PAD patients (Fontaine II stage, mean age: 67.17 years, male/female: 58.25/41.75 %) were enrolled, who received cilostazol (50 or 100 mg b.i.d.) for 3 months. 802 patients completed the study. Quality of life was evaluated with the EQ-5D-3L questionnaire functional capacity with the WELCH (Walking Estimated-Limitation Calculated by History) questionnaire. Pain-free and maximal walking distance, ankle-brachial index (ABI) were measured at baseline and after 3-month treatment. : Upon conclusion of the study, the EQ-5D-3L index improved (baseline: -0.46 ± 0.22, 3rd month: -0.26 ± 0.18; p < 0.0001) and there was a significant increase in the WELCH score as well (19 ± 14, 31 ± 18; respectively, p < 0.0001). Both pain-free and maximal walking distance improved significantly by 54.52 % (median: 53.85 %) and 42.5 % (median: 34.68 %); respectively (p < 0.001). Adverse events occurred in 10 patients, 1 patient stopped cilostazol treatment because of side effects. : Three months cilostazol treatment significantly improved quality of life and lower limb functional capacity in patients with intermittent claudication. The WELCH questionnaire is a useful tool for the evaluation of intermittent claudication treatment in the clinical practice.
有症状的外周动脉疾病（间歇性跛行）是老年男性和女性残疾及行动能力丧失的主要原因，因此对患者的生活质量有重大负面影响。外科和血管内血运重建手术以及非侵入性药物治疗，如监督训练和药物治疗，都可以提高行走能力。西洛他唑是唯一一种被列为I类（证据水平A）推荐用于治疗间歇性跛行（IC）的药物。本研究的目的是在临床实践中评估三个月西洛他唑治疗对IC患者健康相关生活质量和下肢功能能力的影响。
该研究是一项多中心、非干预性试验，于2018年在匈牙利进行。招募了812名外周动脉疾病患者（Fontaine II期，平均年龄：67.17岁，男性/女性：58.25/41.75%），他们接受西洛他唑（50或100毫克，每日两次）治疗3个月。802名患者完成了研究。使用EQ-5D-3L问卷评估生活质量，使用WELCH（根据病史计算的步行估计限制）问卷评估功能能力。在基线和3个月治疗后测量无痛和最大步行距离、踝臂指数（ABI）。
研究结束时，EQ-5D-3L指数有所改善（基线：-0.46±0.22，第3个月：-0.26±0.18；p<0.0001），WELCH评分也显著增加（分别为19±14、31±18；p<0.0001）。无痛和最大步行距离分别显著改善了54.52%（中位数：53.85%）和42.5%（中位数：34.68%）（p<0.001）。10名患者发生不良事件，1名患者因副作用停止西洛他唑治疗。
三个月的西洛他唑治疗显著改善了间歇性跛行患者的生活质量和下肢功能能力。WELCH问卷是临床实践中评估间歇性跛行治疗的有用工具。
