Department of Cardiology, Wuhan Puai Hospital, Huazhong University Of Science and Technology, Wuhan, China.
PLoS One. 2012;7(6):e38851. doi: 10.1371/journal.pone.0038851. Epub 2012 Jun 27.
The aim of this study is to observe the chronic effects of diltiazem release capsules on patients with coronary slow flow (CSF) phenomenon.
From 2004 to 2009, 80 consecutive patients with chest pain and normal coronary arteries evidenced by coronary angiography and CSF were included in this randomized, double-blind, placebo-controlled trial. CSF patterns were evaluated by the corrected TIMI frame count. Patients were randomly assigned at 1:1 ratio to diltiazem sustained-release capsules treatment group (Dil, 90 mg twice daily) or placebo control group. Holter, liver and kidney function, treadmill exercise test, coronary angiography and left ventricular angiography were measured at baseline and after 6 months. The incidence of cardiovascular events (re-admission or progress in coronary heart disease, myocardial infarction, malignant arrhythmia or cardiac death) was evaluated during the 6 months follow up.
Thirty-nine patients in control and 40 patients in Dil group completed the 6 months follow-up. There was no medication induced drug withdraw during follow up. Left ventricular ejection fraction was similar between the 2 groups at baseline and during follow up. Heart rate was significantly lower in Dil group than in control group and there was no symptomatic bradycardia and II and III degree atrioventricular conduction block in both groups. Significant improvement was observed in the onset of chest pain, treadmill exercise test and coronary blood flow in Dil group while these parameters remained unchanged in control group at the end of 6 months follow up. The incidence of cardiovascular events was similar between the two groups.
Diltiazem slow-release capsules improved coronary blood flow and alleviated angina in patients with CSF.
Chinese Clinical Trial Registry ChiCTR-TCC-11001864.
本研究旨在观察地尔硫卓缓释胶囊对冠状动脉慢血流（CSF）现象患者的慢性影响。
2004 年至 2009 年，80 例胸痛患者连续入选，冠状动脉造影和 CSF 显示正常冠状动脉，CSF 模式通过校正的 TIMI 帧数进行评估。患者随机以 1:1 的比例分为地尔硫䓬缓释胶囊治疗组（Dil，每日 2 次，每次 90mg）或安慰剂对照组。在基线和 6 个月时测量动态心电图、肝肾功能、平板运动试验、冠状动脉造影和左心室造影。在 6 个月的随访期间评估心血管事件（再入院或冠心病进展、心肌梗死、恶性心律失常或心脏性死亡）的发生率。
对照组 39 例和 Dil 组 40 例完成 6 个月随访。随访期间无药物诱导停药。两组在基线和随访期间左心室射血分数相似。Dil 组心率明显低于对照组，两组均无症状性心动过缓及 II 度和 III 度房室传导阻滞。Dil 组胸痛发作、平板运动试验和冠状动脉血流均有明显改善，而对照组这些参数在 6 个月随访结束时无变化。两组心血管事件发生率相似。
地尔硫䓬缓释胶囊可改善 CSF 患者的冠状动脉血流并缓解心绞痛。
中国临床试验注册中心 ChiCTR-TCC-11001864。
