Adverse Event Profile of Atezolizumab, Bevacizumab, Carboplatin, and Paclitaxel Combination Therapy Based on JADER.

Background/aim: There have been advances in the development of immune checkpoint inhibitors for monotherapy and combination therapy with other anticancer agents in recent years. The combination of bevacizumab, carboplatin, and paclitaxel with atezolizumab, an anti-programmed death ligand 1 antibody (ABCP therapy), has been reported to be effective for treating non-small cell lung cancer. However, reports on its adverse events are limited.

Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitors and Hypothyroidism: An Analysis of the Japanese Pharmacovigilance Database.

Background/aim: Hypothyroidism induced by roxadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, was recently reported; however, information regarding roxadustat-associated hypothyroidism is still lacking. We explored the risk and time to onset of hypothyroidism associated with HIF-PH inhibitors using the Japanese Adverse Drug Event Report (JADER), a pharmacovigilance database.

Patients And Methods: The participants of this study were registered in the JADER database between April 2004 and March 2023.

Bibliometric analysis of Kampo medicine hotspots and trends for the decade: 2013-2022.

Background: Kampo medicine is a traditional medicine that originated in ancient China and has since developed as a uniquely Japanese medicine. Although Kampo medicine is one of Japan's most important therapeutic modalities and numerous papers have been published recently, information on current hotspots and trends in Kampo research is lacking. This bibliometric analysis of Kampo medicine surveyed the latest research hotspots and trends.

Characteristics of adverse event reports among people living with human immunodeficiency virus (HIV) in Japan: Data mining of the Japanese Adverse Drug Event Report database.

The development of new anti-HIV drugs and advances in antiretroviral therapy (ART) regimens have enabled longer and more effective treatments in people living with HIV (PLWH). However, the aging of PLWHs is another issue that needs to be addressed. In addition to ART, many PLWHs frequently receive medications for various comorbidities.

Bleeding events associated with recombinant human soluble thrombomodulin, classified according to renal function, in sepsis-induced disseminated intravascular coagulation.

Objective: Recombinant human soluble thrombomodulin (rhsTM) is a therapeutic agent for sepsis-induced disseminated intravascular coagulation (DIC) and is associated with bleeding events. rhsTM is a renal excretion drug; however, information on the role of rhsTM in renal function is limited.

Materials And Methods: In this retrospective observational study, we assessed rhsTM-associated bleeding events according to the renal function of patients with sepsis-induced DIC.

Accuracy of Therapeutic Drug Monitoring of Teicoplanin at the Onset of Febrile Neutropenia.

: Teicoplanin (TEIC) is an effective drug for patients with febrile neutropenia (FN); however, it has been reported that these patients may have increased TEIC clearance compared with patients who do not have FN. The purpose of this study was to study therapeutic drug monitoring in patients with FN when the TEIC dosing design was based on the population mean method. : Thirty-nine FN patients with hematological malignancy were included in the study.

Time to Onset of Gemcitabine-induced Thrombotic Microangiopathy in a Japanese Population: A Case Series and Large-scale Pharmacovigilance Analysis.

Background/aim: Gemcitabine-induced thrombotic microangiopathy (G-TMA) is associated with a high mortality rate. However, owing to its low incidence, data on G-TMA remain limited. Therefore, a detailed review of G-TMA cases is critical to understand this adverse event.

Understanding the Actual Use of Anti-HIV Drugs in Japan from 2016 to 2019: Demonstrating Epidemiological Relevance of NDB Open Data Japan for Understanding Japanese Medical Care.

The National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) Open Data Japan is helpful for attaining simple and comprehensive understanding of medical care in Japan. Herein, we investigated the transition of anti-HIV-drug use in Japan over a 4-year period from fiscal year (FY) 2016 to FY 2019 using data on anti-HIV drugs that were extracted from the 3rd, 4th, 5th, and 6th NDB Open Data Japan. Then, the data were stratified by mechanism of action, single-tablet regimen (STR) or non-STR, age groups, and sex and analyzed.

Comprehensive evaluation of antioxidant effects of Japanese Kampo medicines led to identification of Tsudosan formulation as a potent antioxidant agent.

Oxidative stress due to the overproduction of reactive oxygen species plays an important role in the pathogenesis of various diseases. In the present study, we comprehensively evaluated the antioxidant activities of 147 oral formulations of Japanese traditional herbal medicines (Kampo medicines), representing the entire panel of oral Kampo medicines listed in the Japanese National Health Insurance Drug List, using in vitro radical scavenging assays, including the 2,2-diphenyl-1-picrylhydrazyl free radical scavenging activity assay, the superoxide anion scavenging activity assay, and the oxygen radical absorption capacity assay. Three of the formulations tested, namely, Tsudosan, Daisaikoto, and Masiningan, showed the most potent in vitro antioxidant activities and were selected for further investigation of their intracellular and in vivo antioxidant effects.

Identification and evaluation of magnolol and chrysophanol as the principle protein tyrosine phosphatase-1B inhibitory compounds in a Kampo medicine, Masiningan.

Ethnopharmacological Relevance: Masiningan is a traditional medicine consisting of six crude drugs that have been used for treating constipation and diabetes mellitus in both Japan and China. Masiningan has been reported to have significant PTP1B inhibitory activity and to affect cells in the insulin-signaling pathway. The aim of the present study is to identify the PTP1B inhibitory compounds in Masiningan.

Inhibitory activities of selected Kampo formulations on human aldose reductase.

Background: Diabetes complications include various symptoms such as diabetic neuropathy and cognitive disorders. Aldose reductase (AR) is the rate-limiting enzyme of the polyol pathway and is one of the causal factors of diabetes complications. In this study, the bioactivities of eight selected Kampo formulations that are currently in clinical use for diabetes complications were assessed using human AR (hAR) inhibitory activity as the primary parameter to explore the possibilities of novel clinical applications of these formulations in the treatment of diabetes complications.

Evaluation of 147 Kampo prescriptions as novel protein tyrosine phosphatase 1B (PTP1B) inhibitory agents.

Background: Protein tyrosine phosphatase (PTP) 1B, a negative regulator of the insulin and leptin signaling pathways, is currently considered a promising target for the development of novel therapeutic approaches used to treat insulin-resistant type 2 diabetes mellitus (IR-T2DM). In this study, we examined the PTP1B inhibitory activity of 147 Japanese prescription Kampo formulations to evaluate their potential for clinical application in IR-T2DM treatment.

Methods: We specifically defined the prescribed daily dose as 1 Unit (U), and 147 Japanese prescription Kampo formulations were screened for PTP1B inhibitory activity at a final concentration of 0.

A new flavonoid glycoside and other chemical constituents from leaves of Rosa davurica and their antioxidant activity.

A 70% ethanol extract from the leaves of Rosa davurica showed significant antioxidant activity in both superoxide anion and 1,1-diphenyl-2-picrylhydrazyl (DPPH) free radical-scavenging assays. Phytochemical study of this extract resulted in the isolation of eight compounds, including a new flavonoid glycoside. The chemical structure was determined by various spectroscopic analyses.