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[西洛他唑是治疗间歇性跛行的有效且安全的选择。NOCLAUD研究结果]

[Cilostazol is effective and safe option for the treatment of intermittent claudication. Results of the NOCLAUD study].

作者信息

Farkas Katalin, Járai Zoltán, Kolossváry Endre

机构信息

Angiológia, Szent Imre Egyetemi Oktató Kórház Budapest, Tétényi út 12-16., 1115.

Kardiológia, Szent Imre Egyetemi Oktató Kórház Budapest.

出版信息

Orv Hetil. 2017 Jan;158(4):123-128. doi: 10.1556/650.2017.30660.

Abstract

Intermittent claudication can seriously impair the patients' quality of life. Cilostazol was registered in Hungary in 2014. This study aimed to evaluate the efficacy and safety of cilostazol in patients with intermittent claudication. 1405 patients were enrolled to the 6 months, multicenter, non-interventional trial. From the 1331 patients, who completed the study, the data of 674 patients were subjected to efficacy analysis. Pain free and maximal walking distance and the 6 minute walking test improved significantly at 3 months (78.65%, 65.23%, 56.09%; respectively, p<0.001), and a further increase was observed after 6 months treatment (129.74%, 107.2, 80.38% respectively, p<0.001). Adverse events occured in 7.26% of the patients. The most frequent adverse events were headache, diarrhea, dizziness, tachycardia or palpitation. 24 patients (1.7%) stopped cilostazol treatment because of side effects. 6 month cilostazol treatment significantly increased the walking distance in patients with intermittent claudication, without important safety problems. Orv. Hetil., 2017, 158(4), 123-128.

摘要

间歇性跛行可严重损害患者的生活质量。西洛他唑于2014年在匈牙利注册。本研究旨在评估西洛他唑治疗间歇性跛行患者的疗效和安全性。1405例患者纳入了这项为期6个月的多中心非干预性试验。在完成研究的1331例患者中,对674例患者的数据进行疗效分析。无痛行走距离、最大行走距离和6分钟步行试验在3个月时显著改善(分别为78.65%、65.23%、56.09%;p<0.001),治疗6个月后进一步增加(分别为129.74%、107.2、80.38%,p<0.001)。7.26%的患者发生不良事件。最常见的不良事件为头痛、腹泻、头晕、心动过速或心悸。24例患者(1.7%)因副作用停止西洛他唑治疗。西洛他唑治疗6个月可显著增加间歇性跛行患者的行走距离,且无重大安全问题。《匈牙利医学周报》,2017年,158(4),123 - 128。

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