Department of Pharmacy, University of Naples Federico II, Via D. Montesano 49, 80131 Naples, Italy.
Department of Internal Medicine, Hospital Cardarelli, Via Antonio Cardarelli, 80131 Naples, Italy.
Am J Cardiol. 2019 Mar 1;123(5):847-853. doi: 10.1016/j.amjcard.2018.11.034. Epub 2018 Dec 3.
Peripheral arterial disease (PAD) is an atherosclerotic process involving both modifiable and nonmodifiable risk factors. Prospective cohort studies show that patients with PAD have a 6-fold greater risk of death from cardiovascular disease than those without PAD. Currently, there is no effective treatment for PAD. The study was a randomized, placebo-controlled trial, involving 180 patients, aged 35 to 75. The subjects were divided into 2 groups. One group underwent 24 weeks of nutraceutical treatment consisting in the administration of 4 capsules of Annurca apple polyphenolic extract (AMS)/day. The placebo group was administered with identically appearing capsules containing only maltodextrin. Primary outcome measures were: walking autonomy, ankle-brachial index, acceleration time. In the AMS group, at the end of the treatment period, walking autonomy was increased on average by 69% (p <0.05), while slighter effects were registered as regards ankle-brachial index (+25%; p <0.05) and acceleration time (-3.6%; p <0.05), when compared with baseline. Placebo group revealed no significant differences as regards variations of all outcomes measures (p >0.05). Our preliminary results may indicate AMS product as a promising natural and safe tool for treatment of symptoms related to PAD.
外周动脉疾病(PAD)是一种涉及可改变和不可改变危险因素的动脉粥样硬化过程。前瞻性队列研究表明,PAD 患者死于心血管疾病的风险比无 PAD 患者高 6 倍。目前,尚无有效的 PAD 治疗方法。该研究是一项随机、安慰剂对照试验,涉及 180 名年龄在 35 至 75 岁之间的患者。受试者分为两组。一组接受 24 周的营养治疗,包括每天服用 4 粒安努卡苹果多酚提取物(AMS)。安慰剂组服用外观相同的仅含麦芽糊精的胶囊。主要观察指标为:步行自主性、踝肱指数、加速时间。在 AMS 组中,治疗结束时,步行自主性平均增加了 69%(p<0.05),而踝肱指数(+25%;p<0.05)和加速时间(-3.6%;p<0.05)的变化则略小。与基线相比。安慰剂组所有观察指标的变化均无显著差异(p>0.05)。我们的初步结果可能表明 AMS 产品是一种有前途的天然、安全的治疗 PAD 相关症状的工具。