古関 竹直

Background/Objectives: The risk of fractures associated with immune checkpoint inhibitors (ICIs) is increasing; however, the relationship between fracture risk and potential factors, such as osteoporosis and hyperthyroidism, remains unclear. Methods: Using VigiBase, the World Health Organization's global pharmacovigilance database, we investigated the signals for osteoporosis, hyperthyroidism, and fractures associated with ICIs (nivolumab, pembrolizumab, atezolizumab, durvalumab, ipilimumab, and tremelimumab) by calculating information components (ICs) and their 95% confidence intervals (CIs). Furthermore, we estimated the association between the occurrence of fractures in patients receiving ICIs and osteoporosis or hyperthyroidism. Results: Signals of hyperthyroidism (IC = 4.66, 95% CI: 4.58–4.73), but not osteoporosis (IC = −1.79, 95% CI: −2.22 to −1.36) or fractures (IC = −0.21, 95% CI: −0.36 to −0.06), were detected in patients using ICIs. Osteoporosis (odds ratio: 118.00, 95% CI: 61.00–230.00) was associated with an increased reporting frequency of fractures related to ICIs, whereas hyperthyroidism (odds ratio: 0.60, 95% CI: 0.19–1.87) was not associated with such an increase. Conclusions: The VigiBase analysis indicates that the use of ICIs does not increase the reporting frequency of osteoporosis or fractures. Additionally, hyperthyroidism did not increase the reporting frequency of fractures associated with ICIs.

BACKGROUND: Immune checkpoint inhibitors (ICIs) play a central role in cancer immunotherapy. However, the occurrence of immune-related adverse events, especially ICI-induced interstitial lung disease (ICI-ILD), is life-threatening and affects the effectiveness of ICI treatment. This study aimed to explore potential drugs to mitigate ICI-ILD occurrence using data from the Japanese Adverse Drug Event Report (JADER) and the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS [JAPIC AERS]). RESEARCH DESIGN AND METHODS: We investigated concomitant drugs that reduce ILD associated with four ICIs - nivolumab, pembrolizumab, atezolizumab, and durvalumab - across the JADER and FAERS databases. Subsequently, the identified common concomitant drugs that reduce the occurrence of ICI-ILD were detected and analyzed. RESULTS: We found omega-3 fatty acids, loperamide, and amlodipine as common concomitant drugs that reduced ICI-ILD occurrence in both the JADER and FAERS databases. Omega-3 fatty acids reportedly have many effects in animal models of drug-induced ILD, including their association with ILD in humans and anti-inflammatory effects against ICI-ILD. However, loperamide and amlodipine reportedly have minimal effects against ILD, thereby necessitating further evaluation. CONCLUSION: Omega-3 fatty acids have emerged as potential agents for reducing ICI-ILD occurrence, as evidenced by findings from two different pharmacovigilance databases.

Abstract Background This study aimed to clarify the effectiveness of nutrition support team (NST) facilities for preventing central line-associated bloodstream infection (CLABSI). Methods We retrospectively analyzed the incidence of CLABSI as well as the presence or absence of additional medical fees for NST activity between 2019 and 2021, including the period before and after the COVID-19 pandemic. Subsequently, we performed between-group comparisons of the CLABSI incidence. CLABSI rates were compared based on cumulative per 1000 catheter uses during the relevant period. Results Among 47 facilities that were registered for participation, there were 34 and 13 facilities with and without additional medical fees for NST activity (NST and non-NST groups, respectively). The CLABSI incidence rate was significantly lower in the NST group 0.96 [0.28–1.73] than in the non-NST group 1.25 [075–6.10] (p < 0.05). Before the pandemic, the NST group had a lower CLABSI rate per 1000 catheter uses than the non-NST group 2019: 0.70 [0.12–1.26] vs 2.10 [0.62–5.97]. During the pandemic, the CLABSI incidence showed no significant between-group difference 2020: 0.99 [0.51–1.61] vs 1.01 [0.80–4.16]; 2021: 1.24 [0.44–2.35] vs 1.96 [1.23–5.31]; however, the CLABSI rates in the NST group remained low. Conclusion During the COVID-19 pandemic, the incidence of CLABSI was lower in the NST group than in the non-NST group, indicating the effectiveness of NST in preventing the occurrence of CLABSI.