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☐ ☆ ✇ BMJ Open

Possible preventive effect of surgical glove compression therapy on oxaliplatin-induced peripheral neuropathy: study protocol of a multicentre, phase II/III, randomised controlled trial-the Hiroshima Surgical Study Group of Clinical Oncology (HiSCO)-12 tr

Por: Shimomura · M. · Ishikawa · S. · Miguchi · M. · Shinozaki · K. · Ikeda · S. · Kobayashi · H. · Nakahara · M. · Sumitani · D. · Shimizu · W. · Kohyama · M. · Saito · Y. · Mukai · S. · Hirata · Y. · Kochi · M. · Shimizu · Y. · Takakura · Y. · Yoshimitsu · M. · Kodama · S. · Uegami · S. · Yano — Febrero 16th 2026 at 14:29
Background

Oxaliplatin, a key drug in the treatment of colorectal cancer (CRC), can cause oxaliplatin-induced peripheral neuropathy (OIPN) in a dose-dependent manner. These symptoms can severely affect daily life, and chronic OIPN often limits treatment continuation because of its correlation with the cumulative dose of oxaliplatin. Currently, effective preventive measures are unavailable. However, surgical glove compression therapy may reduce paclitaxel-induced neuropathy, suggesting its potential in preventing OIPN.

Methods

This multicentre, randomised, open-label, phase II/III trial evaluates surgical glove compression therapy to investigate the possible preventive effects of OIPN in patients with CRC receiving adjuvant capecitabine plus oxaliplatin chemotherapy. Patients with stage III CRC undergoing curative surgery will be enrolled and randomised into two groups. The intervention group will wear two layers of tight-fitting surgical gloves from 30 min before to 30 min after oxaliplatin infusion, whereas the control group will receive standard care. The primary endpoint is the incidence of grade ≥2 chemotherapy-induced peripheral neuropathy (CIPN) based on the Common Terminology Criteria for Adverse Events criteria. Secondary endpoints include quality of life assessments (Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item), duration and extent of OIPN as assessed using the Debiopharm Neurologic and Sensory Toxicity Criteria, chemotherapy completion rates, and adverse events. To detect a significant reduction in the incidence of CIPN, 170 patients will be enrolled (36% in the control group vs 15% in the intervention group). The planned case enrolment period is from 1 November 2024 to 31 October 2026.

Ethics and dissemination

This trial was approved by the Institutional Review Board of Hiroshima University, Japan (approval no. CRB2024-0008), and has been registered with the Japan Registry of Clinical Trials (jRCTs062240066). The results of this study will be submitted for publication in a peer-reviewed journal and shared with the scientific community at international conferences.

Trial registration number

jRCTs062240066

☐ ☆ ✇ BMJ Open

Risk of developing pneumococcal disease in individuals under 19 years of age with chronic medical conditions: a retrospective cohort study using a Japanese insurance claims database

Por: Yano · A. · Imai · K. · Kim · Y. · Sando · M. · Ishiwada · N. — Enero 23rd 2026 at 12:55
Objectives

To evaluate the risk of invasive pneumococcal disease (IPD) and non-bacteraemic pneumonia (NBP)/acute otitis media (AOM)/sinusitis in Japanese individuals under 19 years of age with chronic medical conditions (CMCs) compared with those without.

Design

An observational, retrospective, cohort study.

Setting

A large, longitudinal health insurance claims database in Japan (JMDC database).

Participants

A total of 12.3 million individuals aged

Primary outcome measure

Adjusted incidence rate ratios (IRRs) for IPD and NBP/AOM/sinusitis for individuals with CMCs versus those without CMCs were calculated using multivariate Poisson regression models with age and sex as covariates.

Results

The incidence rate of IPD was higher in individuals with a CMC (0.9 (95% CI: 0.8 to 0.9)) than in those without (0.1 (95% CI: 0.1 to 0.1)). A similar trend was observed for the incidence rate of NBP/AOM/sinusitis, with rates of 928.7 (95% CI: 927.4 to 929.9) in individuals with a CMC compared with 433.2 (95% CI: 432.8 to 433.7) in those without. The risk of IPD increases with the number of CMCs. The IRRs for IPD for those with one CMC and with two or more CMCs were 7.2 (95% CI: 6.4 to 8.1) and 128.1 (95% CI: 114.8 to 143.0), respectively, compared with individuals without a CMC. The IRRs for IPD in the immunocompromised and immunocompetent groups were 156.1 (95% CI: 133.4 to 182.7) and 16.3 (95% CI: 14.6 to 18.1), respectively. The IRRs for NBP/AOM/sinusitis were 1.9 (95% CI: 1.9 to 1.9) and 2.1 (95% CI: 2.1 to 2.2) for individuals with one CMC and with two or more CMCs, respectively.

Conclusion

Individuals aged

☐ ☆ ✇ BMJ Open

Clinical characteristics, treatments and outcomes of hospitalised COVID-19 patients across pandemic waves at a tertiary acute care hospital in Narita, Japan: a single-centre retrospective observational study

Por: Hase · R. · Kurata · R. · Niiyama · Y. · Matsuda · N. · Ueda · H. · Kikuchi · K. · Ishida · K. · Kubota · Y. · Fujii · M. · Kurita · T. · Muranaka · E. · Sasazawa · H. · Mito · H. · Yano · Y. · Oku · R. · Tateishi · Y. · Toishi · S. · Obata · S. · Noguchi · Y. · Nakanishi · K. · Sunami · S. — Enero 8th 2026 at 13:18
Objective

This study aims to describe the characteristics of hospitalised COVID-19 patients in a tertiary care hospital close to an international airport in Japan and to compare these characteristics among different waves during the pandemic.

Design

Retrospective observational study.

Setting

Tertiary care centre in Japan.

Participants

All patients diagnosed with COVID-19 who were hospitalised between January 2020 and April 2022 were included.

Measurements

Clinical characteristics, characteristics of admission, treatments and outcomes were investigated and compared among six pandemic waves.

Results

A total of 827 patients were included. The median age was 58.0 years. More than half of the patients (58.3%) had at least one comorbidity. The majority of patients (89.0%) were domestically infected patients admitted under the Infectious Diseases Law, while the remaining patients (11.0%) were those diagnosed during airport quarantine and admitted under the Quarantine Act. Hospital-acquired COVID-19 infection occurred in 7.0% of cases, and mainly during the sixth wave. Overall, some form of oxygen therapy, high-flow oxygen devices, invasive mechanical ventilation (IMV) and extracorporeal membrane oxygenation was provided in 46.3%, 10.4%, 4.5% and 1.5% of cases, respectively. Only 1.8% of patients were treated in the intensive care unit (ICU), and 59.5% of patients on IMV were managed in the non-ICU ward. The in-hospital mortality rate was 5.8%. Median age, percentages of some comorbidities, vaccination coverage, medications for COVID-19, types of supportive care and ICU admissions differed significantly among waves.

Conclusions

This study suggests that patient characteristics, vaccination coverage, standard of treatment and severity of illness changed across waves during the COVID-19 pandemic. Intensive care delivery in non-ICU wards was unavoidable due to limited ICU capacity, which may be a key consideration when preparing for future pandemics.

☐ ☆ ✇ BMJ Open

Time-dependent predictive performance of inflammatory markers for 30-day all-cause mortality in patients with suspected infection in a Japanese emergency department: a retrospective cohort study

Por: Omiya · M. · Takada · T. · Yano · T. · Fujii · K. · Fujiishi · R. · Fukuhara · S. — Diciembre 25th 2025 at 05:45
Objectives

To evaluate the time-dependent predictive performance of inflammatory markers for 30-day all-cause mortality in patients with suspected infection.

Design

Retrospective cohort study.

Setting

The ambulatory care division of the department of general medicine or the emergency department of a single acute care hospital in Japan, from April 2015 to March 2017.

Participants

The participants were 977 consecutive adult patients with suspected infection defined as those who underwent at least two sets of blood culture.

Primary outcome measures

The primary outcome, ascertained from electronic medical records, was 30-day all-cause mortality. The predictive performance of three inflammatory markers (C-reactive protein (CRP), neutrophil-to-lymphocyte ratio and red cell distribution width (RDW)) was assessed across four time intervals from symptom onset to hospital presentation: ≤6, >6 to ≤24, >24 to ≤72, and >72 hours.

Results

Time from symptom onset to hospital presentation influenced the predictive performance of inflammatory markers for 30-day all-cause mortality, and CRP ≥15 mg/dL was the most useful for identifying patients at higher risk of mortality within 6 hours (positive likelihood ratio (LR+) 7.7); however, this association weakened over time (LR+ 1.3 at >72 hours). Conversely, RDW ≥16% became more informative later in the course (LR+ 4.1 at >72 hours). For identifying patients at lower risk of 30-day all-cause mortality, CRP

Conclusion

These findings suggest the potential utility of CRP for ruling in high-risk patients within 6 hours from symptom onset, and of RDW for both ruling in and ruling out patients after 72 hours, thereby suggesting that time-dependent variations are important when interpreting inflammatory markers in emergency care settings. However, caution is needed when interpreting these findings because of the retrospective design of this study and potential selection bias.

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