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Double-blind, multicenter, active-controlled, randomized clinical trial to assess the safety and efficacy of orally administered nicorandil in patients with stable angina pectoris in China

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机构: [1]Division of Cardiology, Peking Union Medical College Hospital, [2]Research Center for Clinical Pharmacology, Peking Union Medical College Hospital, [3]Division of Cardiology, The Third Hospital of the Peking University, [4]Division of Cardiology, The Xuan Wu Hospital of The Capital University, [5]Division of Cardiology, The Beijing Chao Yan Hospital of The Capital University, [6]Division of Cardiology, The PLA General Hospital, [7]Division of Cardiology, The Beijing Friendship Hospital of the Capital University of Medical Sciences, [8]Division of Cardiology, The Beijing Hospital, Beijing, [9]Division of Cardiology, The No. 1 Hospital of the Zhen Jiang University, Hangzhou, [10]Division of Cardiology, The Shanghai Changzheng Hospital, Shanghai [11]Division of Cardiology, The Ren Min Hospital of Liao Ning Province, Shenyang, China
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关键词: angina pectoris China exercise tolerance test isosorbide mononitrate nicorandil

摘要:
Background The efficacy and safety of nicorandil were evaluated in Chinese patients with stable angina pectoris (AP) in a double-blind, multicenter, active-controlled, randomized clinical trial. Methods and Results After a 2-week washout period, 232 patients with stable AP were randomized to receive either nicorandil (5 mg tid; 115 patients) or isosorbide mononitrate (ISMN: 20 mg bid; 117 patients) for 2 weeks. Exercise capacity, number of weekly anginal attacks, nitroglycerin (NTG) consumption, and safety were evaluated. Nicorandil and ISMN significantly prolonged the time to I mm ST-segment depression in an exercise tolerance test. Both drugs improved the total exercise time and the time to onset of chest pain. There was no significant difference between the 2 groups. Nicorandil significantly decreased the number of anginal attacks and NTG consumption. ISMN decreased the number of anginal attacks significantly; however, there was no significance in NTG consumption, and the ratio of anginal attack reduction was at least 50% was significantly higher with nicorandil. Nicorandil was well tolerated and there was no safety profile difference compared with ISMN. Thus, nicorandil may have equivalent or better antianginal effect than ISMN. Conclusions Nicorandil is beneficial as treatment for AP.

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出版当年[2006]版:
大类 | 4 区 医学
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 心脏和心血管系统
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出版当年[2005]版:
Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
最新[2023]版:
Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

影响因子: 最新[2023版] 最新五年平均 出版当年[2005版] 出版当年五年平均 出版前一年[2004版] 出版后一年[2006版]

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第一作者机构: [1]Division of Cardiology, Peking Union Medical College Hospital, [*]Division of Cardiology, Peking Union Medical College Hospital, Shuai Fu Yuan Wang Fu Jing, Beijing 100730, China.
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通讯机构: [*]Division of Cardiology, Peking Union Medical College Hospital, Shuai Fu Yuan Wang Fu Jing, Beijing 100730, China.
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