Handler C E, Sowton E
Eur J Clin Pharmacol. 1984;27(4):415-7. doi: 10.1007/BF00549587.
The safety, tolerability and efficacy of PN 200-110, a new calcium antagonist with minimal negative inotropic effects, were studied in twelve patients with stable angina pectoris and coronary artery disease. The study design was single-blind and placebo-controlled and increasing doses of the drug were used on consecutive days to investigate a dose response relationship. Eleven patients completed the trial. Response to the drug was evaluated using symptom limited cycle ergometric exercise. PN 200-110 in all three tested doses of 2.5 mg, 5.0 mg and 10.0 mg significantly increased the resting heart rate (p less than 0.02) and the exercise time to the onset of angina pectoris (p less than 0.02). Doses above 2.5 mg did not appear to improve the exercise parameters evaluated. Four patients had side effects probably due to PN 200-110 but these were mild and included dizziness, headache and flushing. There were no abnormal results from haematological and biochemical screening or from urine testing. We conclude that PN 220-110 can be given safely to patients with coronary artery disease without producing deleterious effects on blood pressure either at rest or during exercise.
对12例稳定型心绞痛和冠心病患者研究了PN 200 - 110（一种新型钙拮抗剂，负性肌力作用极小）的安全性、耐受性及疗效。研究设计为单盲、安慰剂对照，连续数日递增药物剂量以研究剂量反应关系。11例患者完成了试验。采用症状限制的踏车运动评估对药物的反应。PN 200 - 110的三个测试剂量2.5毫克、5.0毫克和10.0毫克均显著提高静息心率（p<0.02）以及心绞痛发作前的运动时间（p<0.02）。2.5毫克以上的剂量似乎并未改善所评估的运动参数。4例患者出现可能由PN 200 - 110导致的副作用，但均较轻微，包括头晕、头痛和面部潮红。血液学和生化筛查以及尿液检测均未出现异常结果。我们得出结论，PN 220 - 110可安全用于冠心病患者，在静息或运动时均不会对血压产生有害影响。
