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首页> 外文期刊>Risk analysis >Relation Between Benchmark Dose and No-Observed-Adverse-Effect Level in Clinical Research: Effects of Daily Alcohol Intake on Blood Pressure in Japanese Salesmen
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Relation Between Benchmark Dose and No-Observed-Adverse-Effect Level in Clinical Research: Effects of Daily Alcohol Intake on Blood Pressure in Japanese Salesmen

机译：临床研究中基准剂量与未观察到的不良反应水平之间的关系：日本商人每日饮酒对血压的影响

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The benchmark dose (BMD) is defined as the dose that corresponds to a specific change in an adverse response compared to the response in unexposed subjects, and the lower 95% confidence limit is termed the benchmark dose level (BMDL). In this study, the threshold of daily ethanol intake affecting blood pressure was calculated by both the BMD approach and multiple logistic regression analysis to clarify the relation between the BMDL and no-observed-adverse-effect level (NOAEL). Systolic and diastolic blood pressures (SBP and DBP) and daily ethanol intake were explored in 1,100 Japanese salesmen. The SBP and DBP were positively related to daily ethanol intake (p < 0.001) when adjusting for possible con-founders such as age, body mass index, and smoking status. The adjusted risk for hypertension (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg) increased significantly when daily ethanol intake exceeded 60 g/day, and the categorical dose of interest was 60.1-90 g/day. The BMDL and BMD of ethanol intake for increased SBP and DBP were estimated to be approximately 60 and 75 g/day, respectively. These findings suggest that the BMDL and BMD correspond to the NOAEL and lowest-observed-adverse-effect level, respectively, if the sample number of clinical data is large enough to confirm the dose-response association.
机译：基准剂量（BMD）定义为与未暴露受试者的反应相比，不良反应的特定变化所对应的剂量，较低的95％置信度称为基准剂量水平（BMDL）。在这项研究中，通过BMD方法和多元logistic回归分析计算了每天摄入乙醇影响血压的阈值，以阐明BMDL与未观察到的不良反应水平（NOAEL）之间的关系。在1,100名日本推销员中研究了收缩压和舒张压（SBP和DBP）以及每日乙醇摄入量。调整年龄，体重指数和吸烟状况等可能的混杂因素后，SBP和DBP与每日乙醇摄入量呈正相关（p <0.001）。当每日乙醇摄入量超过60克/天时，调整后的高血压风险（SBP≥140 mmHg或DBP≥90 mmHg）显着增加，并且感兴趣的分类剂量为60.1-90 g /天。增加的SBP和DBP摄入的乙醇的BMDL和BMD分别约为60和75 g /天。这些发现表明，如果临床数据的样本数量足以确认剂量反应关联，则BMDL和BMD分别对应于NOAEL和最低观察到的不良反应水平。

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