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长效西洛他唑与单硝酸异山梨酯治疗血管痉挛性心绞痛患者的随机对照试验。

Long-acting cilostazol versus isosorbide mononitrate for patients with vasospastic angina: a randomized controlled trial.

机构信息

Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju.

Department of Internal Medicine, Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital, Changwon.

出版信息

Coron Artery Dis. 2024 Sep 1;35(6):459-464. doi: 10.1097/MCA.0000000000001366. Epub 2024 Apr 9.

DOI:10.1097/MCA.0000000000001366
PMID:38595079
Abstract

BACKGROUND

Cilostazol has a vasodilatory function that may be beneficial for patients with vasospastic angina (VSA). We conducted a randomized, open-label, controlled trial to compare the efficacy and safety of long-acting cilostazol and isosorbide mononitrate (ISMN) for VSA.

METHODS

The study included patients with confirmed VSA between September 2019 and May 2021. Participants were randomly assigned to receive long-acting cilostazol (test group, 200 mg once daily) or conventional ISMN therapy (control group, 20 mg twice daily) for 4 weeks. The clinical efficacy and safety were evaluated using weekly questionnaires.

RESULTS

Forty patients were enrolled in the study (long-acting cilostazol, n  = 20; ISMN, n  = 20). Baseline characteristics were balanced between the two groups. Long acting cilostazol showed better angina symptom control within the first week compared to ISMN [reduction of pain intensity score, 6.0 (4.0-8.0) vs. 4.0 (1.0-5.0), P  = 0.005; frequency of angina symptom, 0 (0-2.0) vs. 2.0 (0-3.0), P  = 0.027, respectively]. The rate of neurological adverse reactions was lower in the cilostazol group than in the ISMN group (headache or dizziness, 40 vs. 85%, P  = 0.009; headache, 30 vs. 70%, P  = 0.027).

CONCLUSION

Long-acting cilostazol provided comparable control of angina and fewer adverse neurologic reactions within 4 weeks compared to ISMN. Long-acting cilostazol provides more intensive control of angina within 1 week, suggesting that it may be an initial choice for the treatment of VSA.

摘要

背景

西洛他唑具有血管扩张作用,可能对血管痉挛性心绞痛(VSA)患者有益。我们进行了一项随机、开放标签、对照试验,比较长效西洛他唑和单硝酸异山梨酯(ISMN)治疗 VSA 的疗效和安全性。

方法

该研究纳入了 2019 年 9 月至 2021 年 5 月期间确诊为 VSA 的患者。参与者被随机分配接受长效西洛他唑(试验组,每天 200mg 一次)或常规 ISMN 治疗(对照组,每天 20mg 两次),疗程为 4 周。每周通过问卷评估临床疗效和安全性。

结果

共有 40 名患者入组研究(长效西洛他唑组,n = 20;ISMN 组,n = 20)。两组患者的基线特征平衡。与 ISMN 相比,长效西洛他唑在第 1 周内对心绞痛症状的控制更好[疼痛强度评分降低,6.0(4.0-8.0)比 4.0(1.0-5.0),P = 0.005;心绞痛症状发作频率,0(0-2.0)比 2.0(0-3.0),P = 0.027]。西洛他唑组的神经系统不良反应发生率低于 ISMN 组(头痛或头晕,40%比 85%,P = 0.009;头痛,30%比 70%,P = 0.027)。

结论

与 ISMN 相比,长效西洛他唑在 4 周内提供了类似的心绞痛控制效果,且神经系统不良反应更少。长效西洛他唑在 1 周内提供了更强烈的心绞痛控制,提示其可能是治疗 VSA 的初始选择。

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