Department of Clinical Medicine (Pharmaceutical Medicine), Kitasato University Graduate School of Pharmaceutical Sciences, Tokyo, Japan.
Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd, Osaka, Japan.
J Clin Pharm Ther. 2021 Oct;46(5):1319-1325. doi: 10.1111/jcpt.13434. Epub 2021 May 7.
Estimates of the prevalence of diseases can be affected by non-biological factors such as change in diagnostic criteria and change in awareness of the diseases. The launch of a new drug is a potential contributory factor to the estimated prevalence of the target disease, but there appears to be no reports on this possible relationship.
To investigate the relationship between the change in the number of patients diagnosed and factors such as the number of drugs indicated and the number of relevant scientific articles, focused on 45 intractable diseases in Japan.
The number of patients with 1 of 45 intractable diseases from 2004 to 2013 was collected from publicly available data. The number of drugs indicated, the number of scientific articles, and diagnostic and certificate criteria for the disease were collected from publicly available sources from 2004 to 2013. Using these data, the correlation coefficient was calculated, and linear regression analyses were performed.
The rate of increase in the number of drugs and the increase rate of the number of articles were found to be associated with an increase in the number of patients from 2004 to 2013. Linear regression analysis showed that the increase rate of the number of drugs available (2004-2008) was a statistically significant factor correlated with the rate of increase in the number of patients diagnosed in the following period (2009-2013). However, the increase rate of the number of patients (2004-2008) was not associated with the rate of increase in the number of drugs (2009-2013). One possible reason as to why the number of new drugs was correlated with the patient diagnosis numbers thereafter was proposed to be due to an increased awareness of diseases among physicians.
This is the first study to investigate the relationship between the number of new drugs and the number of patients diagnosed based on data from multiple diseases. The investigation of data on 45 intractable diseases in Japan indicated that the increased availability of drugs was correlated with the increase in the number of patients in the future.
疾病的患病率估计可能受到非生物学因素的影响，如诊断标准的变化和对疾病的认识变化。新药的推出是导致目标疾病估计患病率变化的一个潜在因素，但似乎没有关于这种可能关系的报告。
本研究旨在调查在日本的 45 种难治性疾病中，以患者数量变化为研究对象，探讨患者诊断数量与药物数量和相关科学文献数量等因素的关系。
从公开数据中收集 2004 年至 2013 年的 45 种难治性疾病中 1 种疾病的患者数量。从 2004 年至 2013 年的公开来源中收集药物数量、科学文献数量和疾病诊断及证书标准。使用这些数据计算相关系数，并进行线性回归分析。
研究结果显示，从 2004 年到 2013 年，药物数量的增长率和文献数量的增长率与患者数量的增加呈正相关。线性回归分析显示，可用药物数量的增长率（2004-2008 年）是与随后诊断出的患者数量增长率（2009-2013 年）呈统计学相关的重要因素。然而，患者数量的增长率（2004-2008 年）与药物数量的增长率（2009-2013 年）无关。推测药物数量增加与随后的患者诊断数量增加相关的一个可能原因是医生对疾病的认识提高了。
这是第一项基于多种疾病数据研究新药数量与患者诊断数量关系的研究。对日本 45 种难治性疾病数据的调查表明，药物的可获得性增加与未来患者数量的增加相关。
