Department of Global Agricultural Sciences, Graduate School of Agricultural and Life Sciences, The University of Tokyo, Tokyo, Japan.
Department of Veterinary Medical Sciences, Graduate School of Agricultural and Life Sciences, The University of Tokyo, Tokyo, Japan.
PLoS One. 2021 Apr 16;16(4):e0245105. doi: 10.1371/journal.pone.0245105. eCollection 2021.
Monitoring of antimicrobial use is essential in the management of the development and selection of antimicrobial resistance. A variety of indicators has become available to monitor antimicrobial use in human and animal medicine. One of them is an indicator based on defined daily dose (DDD). By using the number of DDDs administered and normalising it by the population at risk of being treated over a defined period, one can estimate the number of treatment days with antimicrobial agents in a population. For veterinary medicine, the European Medicines Agency (EMA) has published the European values of DDD (DDDvet) for food-producing animals. In this study, we defined Japanese defined daily doses for antimicrobial agents (DDDjp) using DDD values that we previously assigned for antimicrobial products approved for use in pigs, cattle and poultry in Japan and compared them with DDDvet values. For the comparison, the quotient of Japanese and European values (QDDD) was calculated and the effect of the administration route and the number of active substances contained in the preparation was investigated. A total of 59 DDDjp values were defined for 43 antimicrobial agents using the data of 276 products approved for use in pigs. Likewise, a total of 55 DDDjp values were defined for 32 antimicrobial agents using the data of 196 products for use in cattle, and a total of 27 DDDjps values were defined for 25 antimicrobial agents using the data of 131 products approved for use in poultry. A comparison was made for 42, 28 and 17 pairs of DDDjp and DDDvet values for antimicrobial agents used for pigs, cattle and poultry respectively. The comparison showed median QDDD value of 0.61 and 0.66 for antimicrobial agents used for pigs and cattle respectively (p<0.01), indicating that the Japanese daily doses are significantly lower than the corresponding EMA values in these species. For the antimicrobial agents used for poultry, no significant difference was observed between DDDjp and DDDvet values with a median QDDD value of 1.15. The difference between DDDvet and DDDjp values and absence of DDDvet values for some antimicrobial agents marketed in Japan indicate that DDDjp rather than DDDvet should be used as the basis for the calculation of antimicrobial use monitoring in farm animals in Japan.
监测抗菌药物的使用对于管理抗菌药物的发展和选择具有重要意义。目前已经有多种指标可用于监测人用和兽用抗菌药物的使用情况。其中一个指标是基于限定日剂量（DDD）的指标。通过使用给予的 DDD 数量，并将其除以在特定时间段内接受治疗的风险人群数量，可以估计人群中使用抗菌药物的治疗天数。对于兽医学，欧洲药品管理局（EMA）已发布了适用于食用动物的欧洲 DDD 值（DDDvet）。在本研究中，我们使用先前为日本批准用于猪、牛和家禽的抗菌药物产品分配的 DDD 值定义了日本抗菌药物的限定日剂量（DDDjp），并将其与 DDDvet 值进行了比较。为了进行比较，计算了日本和欧洲值的商（QDDD），并研究了给药途径和制剂中所含的活性物质数量的影响。使用 276 种批准用于猪的产品的数据，共为 43 种抗菌药物定义了 59 个 DDDjp 值。同样，使用 196 种用于牛的产品的数据，共为 32 种抗菌药物定义了 55 个 DDDjp 值，使用 131 种批准用于家禽的产品的数据，共为 25 种抗菌药物定义了 27 个 DDDjp 值。比较了用于猪、牛和家禽的抗菌药物分别为 42、28 和 17 对 DDDjp 和 DDDvet 值。结果显示，用于猪和牛的抗菌药物的 QDDD 值中位数分别为 0.61 和 0.66（p<0.01），表明日本的日剂量明显低于这些物种中相应的 EMA 值。对于用于家禽的抗菌药物，DDDjp 和 DDDvet 值之间没有观察到显著差异，QDDD 值中位数为 1.15。日本市场上销售的一些抗菌药物的 DDDvet 值与 DDDjp 值存在差异，并且没有 DDDvet 值，这表明在日本，应该使用 DDDjp 而不是 DDDvet 作为计算农场动物抗菌药物使用监测的基础。
