5－单硝酸异山梨酯治疗心绞痛随机双盲对照多中心临床试验

A DOUBLE BLIND RANDOMIZED CONTROLLED MULTI-CENTER CLINICAL TRIAL OF THE TREATMENT IN ANGINA WITH ISOSORBIDE 5-MONONITRATE

采用安慰剂、对照组、随机双盲法，观察治疗组（ｎ＝１００）国产５－硝酸异山梨酯和对照组（ｎ＝１０１）进口５－单硝酸异山梨酯（ｐｅｎｔａｃａｒｄ）治疗稳定型心绞痛的疗效。疗程４周，剂量４０ｍｇ／ｄ（２０ｍｇｂｉｄ）。观察用药前后心绞痛症状，平板运动试验，动态心电图，血压和心率，血尿常规和肝肾功能及不良反应。结果显示治疗组心绞痛发作次数和硝酸甘油消耗量分别减少７３．２％和９０．８％（对照组６９．２％和８８．４％），平板运动试验总运动时间和总运动负荷分别提高１３．０％和１３．０％（对照组１０．７％和９．９％），运动后最大ＳＴ段压低减轻２５．０％（对照组３１．６％）；动态心电图ＳＴ段压低总时间及程度×时间明显减少；治疗组总有效率为７４．０％（对照组７４．３％）；血压和心率、血尿常规和肝肾功能指标无明显变化。不良反应有头痛、头晕、颜面潮红、心悸等，治疗组发生率３６．０％（对照组４１．６％）。国产５－单硝酸异山梨酯与国外同类产品对照治疗心绞痛各项观察指标均无统计学差异。

To study the efficacy and safety of domestic isosorbide 5-mononitrate(IS,5-MN)in patients with stable angina,a double blind randomized controlled multi-center clinical trial on oral IS-5-MN(n=100)compared with pentacard(n=101)was performed.After one week placebo run in period and four weeks treatment period,it was found that in IS-5-MN group angina attacks and the exhaustion of nitroglycerin was decreased 73.2% and 90.8%(pentacard 69.2%and88.4%).total exercises time and total METS of treadmill exercise were increased13.0% and 13.0%(pentacard 10.7% and9.9%),maximal ST segment depression was decreased25.0%(pentacard31.6%),and all the ambulatory electrocardiogram index was improved.The results indicated the total efficacy rates of IS-5-MN and pentacard were 74.0% and 74.3%,respectively.The incidences of adverse effects were 36.0% and 41.6%。respectively.There were no statistical difference of the efficacy and safety between two drugs.