Remington R D
Department of Preventive Medicine and Environmental Health, University of Iowa, Iowa City 52242.
Hypertension. 1989 May;13(5 Suppl):I66-8. doi: 10.1161/01.hyp.13.5_suppl.i66.
Recent trials of antihypertensive therapy, including the Veterans Administration trials, the Hypertension Detection and Follow-up Program, the Multiple Risk Factor Intervention Trial, the Australian Mild Hypertension Trial, and the British Medical Research Council Trial, are reviewed with a particular emphasis on the criteria leading to the exclusion of potentially eligible participants. The observation of all-cause and cause-specific mortality rates in the group ultimately selected to participate in the trial is suggested as an index to the general applicability of trial results. Because end-point rates are fundamental for determining sample size, substantial reduction in these end-point rates by patient exclusion should be taken into account by the trial design. Some recent trials may have generated end-point-event rates so low that the power of the trial to detect reasonable treatment effects was substantially reduced. Future trials should attempt to take this important factor into account at the design stage.
本文回顾了近期的抗高血压治疗试验，包括退伍军人管理局试验、高血压检测与随访项目、多重危险因素干预试验、澳大利亚轻度高血压试验以及英国医学研究委员会试验，特别强调了导致排除潜在合格参与者的标准。建议将最终入选参与试验的组中全因死亡率和特定病因死亡率的观察结果作为试验结果普遍适用性的指标。由于终点发生率是确定样本量的基础，试验设计应考虑到通过排除患者使这些终点发生率大幅降低的情况。近期的一些试验可能产生了极低的终点事件发生率，以至于试验检测合理治疗效果的效力大幅降低。未来的试验应在设计阶段尝试考虑这一重要因素。
