臨床薬理 Vol. 48(2017) No. 3

Original Article

Elimination of Ritodrine in Mothers Pregnant with Twins and Their Neonatal Twins

Satoko FUJIEDA, Mitsuaki KEIRA, Mayuko SOMA, Yoichi SASAKI, Ainari KONDA, Yuji MUKAI, Takaki TODA, Nobuo INOTSUME, Hiroshi YOSHIDA

公開日: 2017年06月21日

p.91-94

This study aimed to clarify the individual elimination kinetics of serum ritodrine in women pregnant with twins and their twin neonates. Serum ritodrine concentrations in 10 twin pregnant women and their twin neonates were measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) using 100μL of serum. The ritodrine elimination half-life in mothers was 5.0±2.2 (3.7-11.1) h［mean±SD(range)], while the half-lives of ritodrine in the first and second newborns were 9.0± 8.4(4.2-29.6) and 7.2±4.3(4.3-13.2)h, respectively. Large individual differences in the half-life of ritodrine were observed in both mothers and their newborns. Since ritodrine remained in newborn serum for 24-48 h after birth, newborns need to be carefully monitored for ritodrine-related complications during this period.

Feasibility of Converting Data of National Center Biobank Network Catalog to Analysis Data Model

Iori SAKAKIBARA, Kazuki IDE, Yohei KAWASAKI

公開日: 2017年06月21日

p.95-98

The National Center Biobank Network (NCBN) was launched in Japan in 2012 and currently comprises the biobanks of six national centers. The NCBN collects and controls information of patients' biological specimens along with a supplemental catalog of disease names, medical examinatian forms, and diagnostic information. However, these data do not comply with universal standard data formats. In this study, we investigated the possibility of data sharing or collaboration between the NCBN and other biobanks, and whether the data collected and controlled at the NCBN can be standardized following the international standard guidelines of the Clinical Data Interchange Standards Consortium (CDISC) to allow use of these data in future clinical studies. We also evaluated whether data mapped to the Study Data Tabulation Model (SDTM), a standard specification regulated under the CDISC, can be converted to Analysis Data Models (ADaMs) to facilitate searches for the feasibility of data adaptation to clinical trials, and determined the advantages and drawbacks of this conversion. In addition, we examined the potential of utilizing standardized data sets in clinical trials. As a result, we classified the 202 NCBN catalog data items into seven SDTM domains, which were subsequently converted into four ADaM domains. While we expect that conversion of NCBN catalog data to ADaM is possible, the NCBN catalog data currently lack items that can be utilized in actual clinical trials. Thus it is necessary to retain the medical data required for clinical trials at each national center. Standardization of these data is essential, but is currently difficult given the lack of standard clinical trial protocols. Thus, standardization of the data at national center would help promote their usage for planning clinical trials.