Akhras F, Chambers J, Jefferies S, Jackson G
Department of Cardiology, Guy's Hospital, London, U.K.
Int J Cardiol. 1989 Aug;24(2):191-6. doi: 10.1016/0167-5273(89)90304-5.
In order to evaluate and compare the efficacy and safety of nifedipine retard and isosorbide-5-mononitrate as monotherapy in the treatment of stable angina, 18 patients with abnormal exercise electrocardiograms and angiographically proven coronary arterial disease were studied in a randomised placebo controlled double-blind crossover study comparing isosorbide 20 mg twice a day, sustained released isosorbide 40 mg once daily and nifedipine 20 mg twice a day each given for two weeks. Patients were assessed subjectively by counting the frequency of anginal attacks and glyceryl trinitrate consumed and objectively by maximal symptom-limited treadmill stress tests performed at "trough" therapeutic blood levels on the last day of each treatment period. There were no significant differences in all parameters between entry and run-out placebo. Compared to placebo, all three active treatments showed significant improvement in exercise time to 1 mm ST segment depression, amount of maximum ST segment depression and exercise duration. All three active treatments also significantly reduced the consumption of glyceryl trinitrate and frequency of anginal attacks. There were no significant differences between active treatments. Thus similar clinical improvements were produced by nifedipine retard and isosorbide, both being shown to be equally effective starting therapy for the treatment of patients with stable angina pectoris. Although anginal frequency was reduced by one third and exercise time increased residual symptoms and exercise ischaemia suggest that nifedipine retard and isosorbide may be more clinically useful in combination therapy. Neither demonstrated tolerance after two weeks of therapy.
为了评估和比较硝苯地平缓释片和5-单硝酸异山梨酯作为单一疗法治疗稳定型心绞痛的疗效和安全性,在一项随机、安慰剂对照、双盲交叉研究中,对18例运动心电图异常且经血管造影证实患有冠状动脉疾病的患者进行了研究,比较了每日两次服用20mg异山梨酯、每日一次服用40mg缓释异山梨酯和每日两次服用20mg硝苯地平,每种药物服用两周。通过计算心绞痛发作频率和硝酸甘油消耗量对患者进行主观评估,并在每个治疗期的最后一天,于“谷值”治疗血药浓度时进行最大症状限制平板运动试验进行客观评估。在进入和退出安慰剂阶段时,所有参数均无显著差异。与安慰剂相比,所有三种活性治疗在运动至ST段压低1mm的时间、最大ST段压低程度和运动持续时间方面均显示出显著改善。所有三种活性治疗还显著减少了硝酸甘油的消耗量和心绞痛发作频率。活性治疗之间无显著差异。因此,硝苯地平缓释片和异山梨酯产生了相似的临床改善效果,两者均被证明是治疗稳定型心绞痛患者的同等有效的起始治疗方法。尽管心绞痛频率降低了三分之一,运动时间增加,但残余症状和运动性缺血表明,硝苯地平缓释片和异山梨酯在联合治疗中可能更具临床实用性。两种药物在治疗两周后均未显示出耐受性。