Gong L, Zhang W, Zhu Y, Zhu J, Kong D, Pagé V, Ghadirian P, LeLorier J, Hamet P
Shanghai Institute of Hypertension, Rui Jun Hospital of Shanghai, Shanghai Second Medical University, People's Republic of China.
J Hypertens. 1996 Oct;14(10):1237-45. doi: 10.1097/00004872-199610000-00013.
To assess the effectiveness of nifedipine treatment in elderly hypertensives.
A single-blind trial was conducted under the direction of the Shanghai Institute of Hypertension in 1632 subjects aged 60-79 years alternatively allocated to either nifedipine or placebo after a 4-week placebo run-in period between 1987 and 1990 with mean follow-up of 30 months. Clinical events and risk modification were analysed in collaboration with the University of Montreal. Seventy-four patients with severe hypertension were reallocated to active nifedipine treatment after placebo run-in.
Cox's proportional hazards model accounting for covariates demonstrated a highly significant decrease in the probability of events: 'original treatment assignment' analysis indicated that 77 events occurred in the placebo and 32 in the nifedipine group. Similar significances were achieved with 'actual treatment' or 'changes excluded' (excluding reallocated subjects) analyses. A significant reduction in relative risk was observed for strokes and severe arrhythmia with an overall decrease from 1.0 to 0.41 (95% confidence interval 0.27-0.61).
Nifedipine treatment diminished the number of severe clinical outcomes in elderly hypertensives significantly.
评估硝苯地平治疗老年高血压患者的疗效。
1987年至1990年间，在上海高血压研究所指导下进行了一项单盲试验，1632名年龄在60 - 79岁的受试者在经过4周安慰剂导入期后，被交替分配至硝苯地平组或安慰剂组，平均随访30个月。与蒙特利尔大学合作分析临床事件和风险变化。74名重度高血压患者在安慰剂导入期后被重新分配至硝苯地平活性治疗组。
考虑协变量的Cox比例风险模型显示事件发生概率显著降低：“原始治疗分配”分析表明，安慰剂组发生77起事件，硝苯地平组发生32起事件。“实际治疗”或“排除变化”（排除重新分配的受试者）分析也得出了类似的显著性结果。观察到中风和严重心律失常的相对风险显著降低，总体从1.0降至0.41（95%置信区间0.27 - 0.61）。
硝苯地平治疗显著减少了老年高血压患者严重临床结局的数量。
