Göbel E J, van Gilst W H, de Kam P J, ter Napel M G, Molhoek G P, Lie K I
Department of Cardiology, University Hospital Groningen, The Netherlands.
Eur Heart J. 1998 Aug;19(8):1208-13. doi: 10.1053/euhj.1998.0874.
In a double-blind randomized trial in unstable angina it was shown that intravenous diltiazem reduced ischaemic events in the first 48 h after inclusion better than intravenous nitroglycerin. The present study was performed to establish the long-term prognosis of the randomized patients, with respect to their initial treatment assignment.
One year follow-up data on ischaemic end-points and anti-ischaemic medication were recorded. Results were available for all of the 121 randomized patients. One hundred and sixty-seven primary endpoint events were recorded, of which 54 occurred in the first 48 h and 113 during the follow-up. Survival analysis showed that event-free survival was significantly better in the diltiazem group (45.0%) than in the nitroglycerin group (34.4%), P=0.04. The incidence rate after 48 h and one year for cardiac death are, respectively, 0% and 4.1%. The trend in anti-ischaemic medication was higher in the nitroglycerin group. For beta-blockers, this trend became significant after 12 months (P=0.03).
These results show that the initial benefit obtained by early treatment with intravenous diltiazem was preserved during the first year after the initial hospitalization, and that, despite the high risk of cardiac events in our population, the overall mortality 12 months after inclusion was low.
在一项针对不稳定型心绞痛的双盲随机试验中，结果显示静脉注射地尔硫䓬在纳入研究后的最初48小时内比静脉注射硝酸甘油能更好地减少缺血事件。本研究旨在根据随机患者最初的治疗分配情况确定其长期预后。
记录了关于缺血终点和抗缺血药物治疗的一年随访数据。121名随机分组患者的所有结果均可用。共记录了167例主要终点事件，其中54例发生在最初48小时内，113例发生在随访期间。生存分析显示，地尔硫䓬组的无事件生存率（45.0%）显著高于硝酸甘油组（34.4%），P = 0.04。48小时后和一年时的心源性死亡率分别为0%和4.1%。硝酸甘油组抗缺血药物治疗的使用趋势更高。对于β受体阻滞剂，12个月后这种趋势变得显著（P = 0.03）。
这些结果表明，静脉注射地尔硫䓬早期治疗所获得的初始益处在首次住院后的第一年得以保持，并且，尽管我们研究人群中心脏事件风险很高，但纳入研究12个月后的总体死亡率较低。
