Bulpitt C J
University of London, Hammersmith Hospital.
Drugs. 1988;35 Suppl 6:142-6. doi: 10.2165/00003495-198800356-00019.
Responders to antihypertensive treatment have been defined as any patient with a fall in mean arterial pressure, however small; any patient with a fall in mean arterial pressure of 5%, 10% or greater; and any patient achieving a goal blood pressure, usually a diastolic pressure less than 90 mm Hg. Non-responders are normally defined as those who do not fit into the category of a responder. Blood pressure, however, varies considerably during follow-up, and diastolic pressure has a within-subject standard deviation of 8 mm Hg. Blood pressure varies according to environmental factors such as temperature, diet and stress, and tends to drift downwards during follow-up as the patient becomes accustomed to having blood pressure taken, to the place of measurement and to the observer. In a statistical sense, responders may be defined as the 2.5% with a fall in DBP greater than 16 mm Hg, yet in clinical studies of a low sodium diet reports have indicated that 50% have experienced an increase in pressure and 50% a fall (responders). Although the characteristics of those with a fall in pressure are of interest and should be compared with those who do not respond, a 50:50 division is unlikely to help. Methods of identifying true responders and non-responders are discussed in this brief review, along with the errors that may arise from a misclassification and problems of conducting further trials of treatment on the non-responders.
抗高血压治疗的有效者被定义为任何平均动脉压下降的患者,无论下降幅度多小;平均动脉压下降5%、10%或更多的任何患者;以及任何达到目标血压的患者,通常是舒张压低于90毫米汞柱。无反应者通常被定义为不符合有效者类别的患者。然而,在随访期间血压变化很大,舒张压的个体内标准差为8毫米汞柱。血压会根据温度、饮食和压力等环境因素而变化,并且在随访期间往往会随着患者逐渐习惯测量血压、测量地点和测量者而下降。从统计学意义上讲,有效者可定义为舒张压下降超过16毫米汞柱的2.5%的患者,但在低钠饮食的临床研究中,报告显示50%的患者血压升高,50%的患者血压下降(有效者)。尽管血压下降者的特征令人关注,应该与无反应者进行比较,但50:50的划分不太可能有帮助。本简要综述讨论了识别真正有效者和无反应者的方法,以及错误分类可能产生的误差和对无反应者进行进一步治疗试验时存在的问题。