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高血压最佳治疗(HOT)研究中阿司匹林或安慰剂的依从性。

Compliance with aspirin or placebo in the Hypertension Optimal Treatment (HOT) study.

作者信息

Waeber B, Leonetti G, Kolloch R, McInnes G T

机构信息

Division of Clinical Physiopathology and Medical Teaching, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.

出版信息

J Hypertens. 1999 Jul;17(7):1041-5. doi: 10.1097/00004872-199917070-00022.

DOI:10.1097/00004872-199917070-00022
PMID:10419079
Abstract

OBJECTIVE

The Hypertension Optimal Treatment (HOT) study is a large, prospective trial aimed at defining the level of diastolic blood pressure required during anti-hypertensive therapy in order to achieve maximal protection against cardiovascular complications. A further aim is to assess the effects on morbidity and mortality of a 75 mg daily dose of aspirin compared with placebo.

SUBJECTS AND METHODS

Compliance with double-blind administration of aspirin or placebo added to anti-hypertensive treatment was evaluated for 1 year in a subset (n = 530) of the study population (n = 18 790) by placing the medication in a container closed with an electronic cap that records precisely the time of each opening.

RESULTS

The 1-year compliance rate (percentage of days with one opening per day) could be assessed in 501 patients. It averaged 78.3 +/- 25% in aspirin-treated patients (n = 236, mean +/- SD), compared with 78.5 +/- 25% in patients having received placebo (n = 265), and was not influenced by age, sex or country (Germany, Italy, Switzerland, UK). The compliance rate was also similar irrespective of whether the patients had reached their target blood pressure, but was significantly better during the first than the second 6-month monitoring period (84.1 +/- 22% versus 72.3 +/- 32%, n = 501).

CONCLUSIONS

The high rate of compliance with aspirin or placebo observed in the HOT study suggests that the patients were highly motivated and may account for the unusually good blood pressure control achieved in this trial during long-term anti-hypertensive treatment.

摘要

目的

高血压最佳治疗(HOT)研究是一项大型前瞻性试验,旨在确定抗高血压治疗期间所需的舒张压水平,以实现对心血管并发症的最大程度保护。另一个目的是评估每日75毫克阿司匹林剂量与安慰剂相比对发病率和死亡率的影响。

受试者与方法

在研究人群(n = 18790)的一个子集(n = 530)中,通过将药物放置在一个用电子帽封闭的容器中,该电子帽精确记录每次打开的时间,对添加到抗高血压治疗中的阿司匹林或安慰剂的双盲给药依从性进行了1年的评估。

结果

501名患者可评估1年的依从率(每天打开一次的天数百分比)。阿司匹林治疗组患者(n = 236,均值±标准差)的依从率平均为78.3±25%,接受安慰剂治疗的患者(n = 265)为78.5±25%,且不受年龄、性别或国家(德国、意大利、瑞士、英国)的影响。无论患者是否达到目标血压,依从率也相似,但在第一个6个月监测期内明显优于第二个6个月监测期(84.1±22%对72.3±32%,n = 501)。

结论

HOT研究中观察到的阿司匹林或安慰剂的高依从率表明患者积极性很高,这可能是该试验在长期抗高血压治疗期间实现异常良好血压控制的原因。

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