Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
Virtual issue
Current issue
Displaying 1-9 of 9 articles from this issue
Special Article
Original Article
  • Atsushi SUZUKI, Tsuyoshi SHIGA, HIJ-HF II investigators
    Article type: research-article
    2025 Volume 56 Issue 2 Pages 63-69
    Published: March 31, 2025
    Released on J-STAGE: May 03, 2025
    JOURNAL RESTRICTED ACCESS
    Objective: Carperitide, an α-human A-type natriuretic peptide, is commonly used for the treatment of acute decompensated heart failure (ADHF). The aim of this study was to investigate the effects of carperitide administration on mortality and outcomes in patients with ADHF in a multicenter observational study in Japan using propensity score matching.
    Methods: We performed a subanalysis of the HIJ-HF II (The Heart Institute of Japan Heart Failure II) study of hospitalized patients with ADHF in 10 Japanese hospitals. Patients receiving carperitide for the treatment of ADHF and those not receiving carperitide were selected from this database. The primary outcome was in-hospital death. The secondary outcomes were length of hospital stay, EuroQol five-dimensional (EQ-5D) index score and EQ visual analog scale (VAS) score at hospital discharge, one-year postdischarge mortality and rehospitalization due to worsening HF within 1 year of discharge.
    Results: Of the 1,245 patients, 371 (29.8%) received intravenous carperitide. Propensity score matching resulted in 168 pairs. In-hospital death was not significantly different between the carperitide and noncarperitide groups (odds ratio[OR]1.07, 95%CI 0.51-2.25). The length of hospital stay, EQ-5D index score and EQ VAS score were not significantly different between the two groups. One-year mortality after hospital discharge or one-year rehospitalization due to worsening HF was not significantly different between both groups (OR 0.69, 95%CI 0.32-1.49; OR 1.06, 95%CI 0.56-2.03).
    Conclusions: The findings of this propensity score-matched substudy suggested no significant difference in in-hospital mortality or long-term outcomes between carperitide and noncarperitide therapy in ADHF patients.
    Download PDF (169K)
  • Momoko KOBAYASHI, Haruka KAMO, Tatsunori SUZUKI
    Article type: research-article
    2025 Volume 56 Issue 2 Pages 71-77
    Published: March 31, 2025
    Released on J-STAGE: May 03, 2025
    JOURNAL RESTRICTED ACCESS

    Background: Previous studies have shown a high correlation between blood glucose (BG) and interstitial fluid glucose (ISFG). However, ISFG may better indicate overall glucose status than BG, which is strongly influenced by homeostatic mechanisms. We aimed to evaluate the relationship between BG and ISFG and to examine site-specific differences in ISFG by simultaneously measuring the ISFG in the leg and arm during running exercise, which transiently elevates BG.
    Methods: Twelve adult women who regularly performed moderate-to-vigorous exercise were included. A lactate curve test was performed to determine the running speed in subsequent running tests. Continuous glucose-monitoring sensors were simultaneously attached to two sites on each subject's upper arm and thigh. BG was measured by fingertip blood sampling before, and every 30 min up to 120 min after running, with ISFG, also measured in the arms and legs.
    Results: After high-speed running, BG rose transiently, and ISFG increased in both the arms and legs, similar to BG. The increase in BG and ISFG persisted for 15 min after running, with ISFG exhibiting a more pronounced elevation. There were no apparent changes in BG after low-speed running. However, the ISFG of the arms and legs increased compared to before running, with a more significant increase in the legs than in the arms.
    Conclusion: This study revealed that the ISFG levels remain elevated, even when BG levels do not. Moreover, under conditions in which the BG is transiently elevated, the ISFG is elevated similarly, but the elevation persists longer in the legs than in the arms.

    Download PDF (185K)
  • Toshiaki SUDOH, Nobuyoshi KURIHARA, Seiichi KATOH, Taito HONDA, Kana O ...
    Article type: research-article
    2025 Volume 56 Issue 2 Pages 81-87
    Published: March 31, 2025
    Released on J-STAGE: May 03, 2025
    JOURNAL RESTRICTED ACCESS
    Supplementary material

    The incidence of stroke including cerebral embolism with atrial fibrillation (AF) is very high among the Japanese population. Although direct oral anticoagulants (DOACs) have become widely used in recent years, their adherence and compliance rates are unclear. Therefore, we conducted a multicenter study to investigate medication adherence among outpatients treated with oral anticoagulant therapy in Tochigi Prefecture. The subjects were 500 outpatients who were receiving oral anticoagulant treatment with warfarin or DOAC at insurance dispensing pharmacies, i.e., collaborating institutions, in the prefecture. Patients who consented to the study were asked to complete a self-administered questionnaire between December 2019 and February 2020. A total of 462 survey forms were collected from 10 pharmacies. Of these, all 462 cases were evaluated and analyzed; 280 patients (60.6%) were suffering from AF and 20 patients (4.3%) had venous thromboembolism. The most common reason for missed doses was simply forgetting to take the medication (115 patients, 24.9%), and a small number of patients (9 patients, 1.9%) reported that they had not taken any medication. Less than 10% of the patients (8.4%) requested medication counselling. Next, with respect to medication compliance, 424 (91.8%) of the 462 patients had good compliance and 18 (3.9%) had poor compliance. The proportion of non-adherent patients with twice-daily dabigatran was higher (14.3%) than with other oral anticoagulants and significantly greater than that with once-daily DOAC (p=0.014). AF was highly associated with poor medication adherence (odds ratio: 3.91, 95% confidence interval: 0.88-17.25). The relatively high medication adherence rate in this survey may have been due to the self-reporting by patients, which may be supported by the fact that the survey was conducted with highly adherent patients. It may be necessary in the future to conduct adherence surveys using other objective methods.

    Download PDF (396K)
  • Takayuki SUGAI, Jun MIURA, Takuya MIZUGAMI, Yuri YOSHIZAWA, Yasunobu A ...
    Article type: research-article
    2025 Volume 56 Issue 2 Pages 89-95
    Published: March 31, 2025
    Released on J-STAGE: May 03, 2025
    JOURNAL RESTRICTED ACCESS
    Background: Yokukansan is a traditional Kampo medicine used to treat various psychological symptoms and conditions, including agitation, hallucination, and dementia. However, its sedative effects remain unclear. SPV, an index measured using an eye-tracking device that provides information on the cognitive and neurological states of individuals, is widely used as an objective measurement of alertness. This study aimed to investigate the impact of yokukansan on alertness by measuring the saccadic eye movement peak velocity (SPV) for the objective and quantitative evaluation of central nervous system alertness.
    Methods: In this prospective, blinded, three-arm, three-period, crossover, placebo-controlled clinical trial, the participants were divided into three groups and administered yokukansan, etizolam, or placebo in a single dose in three periods in a blinded and randomized sequence. Etizolam was used as a positive control. SPV was measured in serial time points before and after administration to quantify alertness. The primary (SPV change) and secondary (subjective alertness) outcomes were assessed using the Bond and Lader scale.
    Results: Six participants with a mean age of 22.3±2.3 years and body mass index of 20.9±1.7 were enrolled in this study. The SPV decreased after etizolam administration but not after yokukansan administration (yokukansan: 5.1±8.1%, p=0.79; etizolam: 31.4±4.7%, p<0.001). Subjective alertness change was 1.8 (interquartile range [IQR]: 0.2-3.8) with yokukansan, 8.2 (IQR: 2.6-23.8) with etizolam, and 2.2 (IQR: -1.2 to 4.5) with the placebo, with yokukansan causing similar alertness change as the placebo (p=NS).
    Conclusion: Yokukansan administration had less impact on objective and subjective alertness measurements in healthy young adults.
    Download PDF (794K)
  • Ikuko NORO, Tomomi IIOKA, Satoko HORI, Shigeyuki NAKANO, Hayato KIZAKI ...
    Article type: research-article
    2025 Volume 56 Issue 2 Pages 97-108
    Published: March 31, 2025
    Released on J-STAGE: May 03, 2025
    JOURNAL RESTRICTED ACCESS

    It has been observed that CRCs, pivotal figures in clinical research, often grapple with a substantial mental burden. This study, which investigates the resilience factors of CRCs, aims to provide practical suggestions for their education and resilience development, empowering them with actionable knowledge. Ten CRCs, who had been working as CRCs for many years, were interviewed individually. They were asked about their challenging experiences while working as CRCs, how they successfully adapted to those challenges, and the factors involved in the process. We then inductively coded the factors involved in successfully adapting to challenges as the analysis theme. The qualitative analysis reveals that the factors of resilience of CRCs were classified into four groups: (1) individual characteristics and ways of thinking, (2) meaning, goals, and motivation, (3) ways of dealing with work, and (4) support from those around them. Among the factors, the following were considered to be particularly important for CRCs: meaning, continuing attempt to find meaning in one's work, even in the face of adversity; metacognition, handling reflection on one's own and others' cognitive activities from a bird's-eye view; and balancing professional and patient perspectives that maintains the rigor of carrying out clinical research as a medical professional with empathy for patients' feelings.

    Download PDF (513K)
Forum
  • Shinichi TSUCHIWATA, Yasuhisa TANABE, Yumiko HOSOYA, Takatoshi YONEKUR ...
    Article type: research-article
    2025 Volume 56 Issue 2 Pages 109-116
    Published: March 31, 2025
    Released on J-STAGE: May 03, 2025
    JOURNAL RESTRICTED ACCESS

    Generative Artificial Intelligence (AI) is anticipated to enhance productivity across all industries. This paper investigates the application of generative AI in the field of new drug development, focusing on five areas of use: data processing, text analysis, documentation for professionals (e.g. investigators and regulators), generating meeting minutes, and documentation for clinical trial participants. In data processing, generative AI can be used to assist in the creation of analysis programs (codes) and to interpret codes created by others. In text analysis, the application of generative AI to unstructured data collected from free-text responses, such as questionnaire answers, enables classification and information extraction. The scope of generative AI application in documentation is diverse, facilitating efficiency in translation, summarization, searchability, structure modification, information updating, and review of professional texts. Furthermore, employing generative AI that can refer to technical terms and company's abbreviations can result in precise meeting minutes in a shorter time. Generative AI can also support to create documents that are easy for patients and patient's family to understand and to generate anticipated questions from a patient's perspective about clinical trials, making it a useful communication tool with trial participants. The application of generative AI in drug development is believed to enable efficiency in various situations. However, it is important to understand the advantages and limitations of generative AI and to find appropriate application and operational methods.

    Download PDF (470K)
  • Akiko HATTORI-SHIME, Keiji OZEKI, Toshie ARAKI, Masumi MAKITA, Naomi K ...
    Article type: research-article
    2025 Volume 56 Issue 2 Pages 117-123
    Published: March 31, 2025
    Released on J-STAGE: May 03, 2025
    JOURNAL RESTRICTED ACCESS
    We recently underwent an FDA inspection. Because the previously scheduled FDA inspection was canceled due to the COVID-19 pandemic, it had been quite a while since we had an FDA inspection. Here, we report the details of this valuable experience to share it with other clinical trial sites in Japan. Although the inspection covered general check items, some areas were thoroughly examined from a risk-based perspective. No issues were identified during this inspection.
    Download PDF (463K)
Report
feedback
Top