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首页> 外文期刊>Hepatology: Official Journal of the American Association for the Study of Liver Diseases >How Healthy Are the 'Healthy Volunteers'? Penetrance of NAFLD in the Biomedical Research Volunteer Pool
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How Healthy Are the 'Healthy Volunteers'? Penetrance of NAFLD in the Biomedical Research Volunteer Pool

机译：“健康的志愿者”是多么健康？ 生物医学研究志愿者游泳池中的NAFLD的渗透

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Healthy volunteers are crucial for biomedical research. Inadvertent inclusion of subjects with nonalcoholic fatty liver disease (NAFLD) as controls can compromise study validity and subject safety. Given the rising prevalence of NAFLD in the general population, we sought to identify its prevalence and potential impact in volunteers for clinical trials. We conducted a cross-sectional study of subjects who were classified as healthy volunteers between 2011 and 2015 and had no known liver disease. Subjects were classified as presumed NAFLD (pNF; alanine aminotransferase [ALT] level >= 20 for women or >= 31 for men and body mass index [BMI] > 25 kg/m(2)), healthy non-NAFLD controls (normal ALT and BMI), or indeterminate. A total of 3160 subjects participated as healthy volunteers in 149 clinical trials (1-29 trials per subject); 1732 of these subjects (55%) had a BMI>25 kg/m(2) and 1382 (44%) had abnormal ALT. pNF was present in 881 subjects (27.9%), and these subjects were older than healthy control subjects and had higher triglycerides, low-density lipoprotein cholesterol, and HbA1c and lower high-density lipoprotein cholesterol (P < 0.001 for all). The 149 trials included 101 non-interventional, 33 interventional, and 15 vaccine trials. The impact on study validity of recruiting NAFLD subjects as controls was estimated as likely, probable, and unlikely in 10, 41, and 98 trials, respectively. The proportion of pNF subjects (28%-29%) did not differ by impact. Only 14% of trials used both BMI and ALT for screening. ALT cutoffs for screening were based on local reference values. Grade 3-4 ALT elevations during the study period were rare but more common in pNF subjects than in healthy control subjects (4 versus 1). Conclusion: NAFLD is common and often overlooked in volunteers for clinical trials, despite its potential impact on subject safety and validity of study findings. Increased awareness of NAFLD prevalence and stricter ALT cutoffs may ameliorate this problem.
机译：健康的志愿者对于生物医学研究至关重要。无意中包含非酒精性脂肪肝疾病（NAFLD）作为对照，可以损害研究有效性和主语安全性。鉴于一般人群中NAFLD的普遍存在，我们试图确定其对临床试验志愿者的流行和潜在影响。我们对2011年至2015年之间被归类为健康志愿者的科目进行了横断面研究，并且没有已知的肝病。受试者被归类为假定的NAFLD（PNF;丙氨酸氨基转移酶[ALT]水平> = 20，男女和体重指数[BMI]> 25kg / m（2）），健康的非NAFLD控制（正常ALT和BMI）或不确定。共有3160名受试者参加了149项临床试验中的健康志愿者（每项主题1-29次试验）;这些受试者的1732（55％）具有BMI> 25kg / m（2）和1382（44％）异常。 PNF在881名受试者中存在（27.9％），这些受试者比健康对照受试者更旧，具有较高的甘油三酯，低密度脂蛋白胆固醇和HBA1C和较低的高密度脂蛋白胆固醇（全部P <0.001）。 149项试验包括101个非介入性，33例介入和15项疫苗试验。在10,41和98项试验中，估计，估计NAFLD受试者作为对照的招募NAFLD受试者的研究有效性的影响分别估计。 PNF受试者的比例（28％-29％）没有差异的影响。只有14％的试验使用BMI和ALT进行筛选。筛选的ALT截止值基于局部参考值。在研究期间3-4级Alt升级在PNF受试者中罕见，而不是在健康对照受试者（4与1）中的pNF受试者。结论：尽管其对研究调查结果的主题安全性和有效性潜在影响，NAFLD是常见的并且经常忽视志愿者进行临床试验。提高对NAFLD患病率和更严格的ALT截止的认识可能会改善这个问题。

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