Campbell D B, Lowe S, Taylor D, Turner P, Walsh N
Hypertension. 1985 Nov-Dec;7(6 Pt 2):II143-51. doi: 10.1161/01.hyp.7.6_pt_2.ii143.
Clinical studies on the use and activity of drugs often rely on data generated from a relatively small number of patients, and definitive conclusions are drawn that are assumed to represent the population at large. Similarly, interpretation and comparison of studies are made difficult when end points of effectiveness, particularly with antihypertensive agents, are arbitrarily chosen. The results from a clinical study of more than 1400 hypertensive patients after indapamide therapy for 3 months, alone or in combination with a beta blocker, are presented using a different graphic approach. This is based on the assumption that the magnitude of the fall in blood pressure after hypertensive therapy is dependent on initial blood pressure. Diastolic and systolic pressures were plotted as a scattergram against the change in blood pressure. Predetermined response lines were drawn with a slope of 1 and intercepts on the initial blood pressure axis of 90 mm Hg for diastolic and 140 mm Hg for systolic pressures with tolerance limits of +/- 10 mm Hg drawn about it. Subdivisions of response can be achieved by counting the number of patients above and below these lines. This allows a drug to be "finger-printed" in terms of its pattern of activity in all degrees of severity of hypertension and, more relevant, direct comparisons with other drugs can be made. Similarly, the potential activity of the drug can be determined by computing the slope and intercept of the actual regression line through the data points.(ABSTRACT TRUNCATED AT 250 WORDS)
药物使用和活性的临床研究通常依赖于相对少数患者产生的数据,并得出被认为代表总体人群的确定性结论。同样,当随意选择有效性终点,尤其是抗高血压药物的终点时,研究的解释和比较就会变得困难。本文采用一种不同的图表方法展示了对1400多名高血压患者进行3个月吲达帕胺治疗(单独或与β受体阻滞剂联合使用)后的临床研究结果。这基于高血压治疗后血压下降幅度取决于初始血压的假设。将舒张压和收缩压作为散点图绘制在血压变化上。绘制预定的反应线,斜率为1,在初始血压轴上的截距为舒张压90毫米汞柱、收缩压140毫米汞柱,并在其周围绘制±10毫米汞柱的公差界限。通过计算高于和低于这些线的患者数量可以实现反应细分。这使得一种药物能够根据其在所有高血压严重程度下的活性模式被“指纹识别”,更重要的是,可以与其他药物进行直接比较。同样,通过计算穿过数据点的实际回归线的斜率和截距,可以确定药物的潜在活性。(摘要截短至250字)