Efficacy and Safety of Sodium Zirconium Cyclosilicate in the Management of Hyperkalemia in Patients with Heart Failure with Reduced and Mildly Reduced Ejection Fraction and Chronic Kidney Disease Treated with Spironolactone: rational for and design of the REGISTA-K trial.

Background: To evaluate whether sodium zirconium cyclosilicate (SZC) enables the uptitration of spironolactone without increasing the risk of hyper- and hypokalemia in patients with heart failure with reduced and mildly reduced ejection fraction (HFrEF and HFmrEF) and moderate/severe chronic kidney disease (CKD) who developed hyperkalemia during treatment with suboptimal spironolactone dose.

Methods: The REGISTA-K is a randomized, double-blind, placebo-controlled, multicenter trial that examined the efficacy and safety of SZC in uptitrating spironolactone without the occurrence of hyperkalemia or hypokalemia. A total of 266 patients with HFrEF and HFmrEF and hyperkalemia will be randomized in a 1:1 ratio to receive either SZC or placebo after treating hyperkalemia with SZC at 25 sites in Japan.

Estimating the Timeframe of Lactate Reduction in Acute Cardiovascular Disease Using Functional Data Analysis Based on Nonlinear Mixed Effects Models.

In patients with acute cardiovascular disease, treatment aimed at reducing lactate levels is crucial for improving prognosis. Trends in blood lactate levels for each specific cardiovascular disease can provide an accurate evaluation of the patient's condition. We used functional data analysis with nonlinear mixed effects models to estimate the timeframe of lactate reduction in 3 cardiovascular diseases (acute heart failure, aortic dissection, and ischemic heart disease) by analyzing lactate trends.

Preferable effect of CTLA4-Ig on both bone erosion and bone microarchitecture in rheumatoid arthritis revealed by HR-pQCT.

This exploratory study aimed to examine the impact of abatacept treatment on bone structure in patients with rheumatoid arthritis (RA) using high-resolution peripheral quantitative computed tomography (HR-pQCT). RA patients initiating either abatacept or newly introduced csDMARDs were enrolled in this prospective, non-randomized, two-group study. Bone structure in the 2nd and 3rd metacarpal heads was assessed using HR-pQCT at 0, 6, and 12 months after enrollment.

Prognostic impact of postoperative management by an intensive care unit intensivist after colonic perforation.

Purpose: Postoperative management for colonic perforation is an important prognostic factor, but whether intensivists perform postoperative management varies between institutions.

Methods: We investigated 291 patients with colonic perforation between 2018 and 2022. Patients were divided into those managed by an intensivists (ICU group; n = 40) and those not managed by an intensivists (non-ICU group; n = 251).

Investigating the impact of tocilizumab on serum cytokines concentrations in Japanese FMF patients: a sub-analysis of the NUH01FMF study.

Familial Mediterranean Fever (FMF) is the most common hereditary autoinflammatory disease, characterized by recurrent fever, arthritis, rash, and serositis, and is caused by mutations in the MEFV gene coding for the pyrin protein. The primary treatment goal is to prevent acute attacks and minimize subclinical inflammation to avoid secondary amyloidosis with colchicine as the first-line treatment. However, 10-20% of patients are colchicine-resistant or intolerant.

Favorable impact of azithromycin on patients in the intensive care unit with coronavirus disease 2019: Insights from the first wave using a Japanese database.

Background: Azithromycin has favorable effects on critical respiratory diseases owing to its antimicrobial and anti-inflammatory properties. During the early stages of the coronavirus disease 2019 (COVID-19) pandemic, azithromycin was frequently administered before specific treatments were developed. However, the efficacy of this treatment has not been verified.

Feasibility of a problem-solving exercise program based on short physical performance battery for older patients with chronic respiratory diseases: A multicenter, pilot clinical trial.

Background: This study aimed to assess the feasibility and safety of a problem-solving exercise program based on the items in the short physical performance battery (SPPB) for older patients with chronic respiratory diseases (CRDs) to inform future randomized controlled trials.

Methods: This was a multicenter, prospective, non-randomized feasibility study. Participants with CRD received an enhancement program based on the SPPB decline items (balance, walk, and/or chair stand) for 4 weeks.

Associations between fatty infiltration of rotator cuff muscles and tear size or location of rotator cuff tendon.

Background: Fatty infiltration (FI) of rotator cuff muscles in patients with rotator cuff tears is an important imaging factor for determining surgical indications. However, the associations between FI grade and the size or location of adjacent rotator cuff tears are not well-known. This study aimed to primarily determine whether tear size and location, especially for the SSc tendon, are associated with FI of adjacent rotator cuff muscles.

A novel stimulating electrode attachment method designed to maintain electromyography-based neuromuscular monitoring detectability during laparoscopic surgery: a single-center randomized, double-blind, controlled pilot study.

Purpose: We evaluated the electromyography (EMG)-based neuromuscular monitoring detectability of our novel stimulating electrode attachment method compared to the original Nihon-Kohden (Tokyo, Japan) attachment method.

Methods: This single-center randomized, double-blind, controlled pilot study enrolled 32 patients aged ≥ 18 years, undergoing scheduled laparoscopic surgery. The EMG electrode NM-345Y™ was attached to one forearm using the Nihon-Kohden method (Pattern N-K) and the other forearm using our novel method (Pattern Cross).

A Randomized Controlled Trial on the Effect of Luseogliflozin on Bone Microarchitecture Evaluated Using HR-pQCT in Elderly Type 2 Diabetes.

Introduction: Bone fragility is a critical issue in the treatment of elderly people with type 2 diabetes (T2D). In the Canagliflozin Cardiovascular Assessment Study, the subjects with T2D who were treated with canagliflozin showed a significant increase in fracture events compared to a placebo group as early as 12 weeks post-initiation. In addition, it has been unclear whether sodium-glucose co-transporter 2 (SGLT2) inhibitors promote bone fragility.

Effects of daily teriparatide, weekly high-dose teriparatide, or bisphosphonate on cortical and trabecular bone of vertebra and proximal femur in postmenopausal women with fragility fracture: Sub-analysis by quantitative computed tomography from the TERABIT study.

Purpose: The effects of daily teriparatide (D-PTH, 20 μg/day), weekly high-dose teriparatide (W-PTH, 56.5 μg/week), or bisphosphonate (BP) on the vertebra and proximal femur were investigated using quantitative computed tomography (QCT).

Methods: A total of 131 postmenopausal women with a history of fragility fractures were randomized to receive D-PTH, W-PTH, or bisphosphonate (oral alendronate or risedronate).

Effect of Inspiratory Muscle Training on Cough Strength in Older People With Frailty: A Single-Blind Randomized Controlled Trial.

Objective: To investigate the effect of inspiratory muscle training (IMT) on cough strength in older people with frailty.

Design: Single-blind randomized controlled trial.

Setting: Day health care centers at 2 sites.

Cardioprotective Effects of Sodium-Glucose Cotransporter Subtype Inhibition on Ischemic and Pharmacological Preconditioning.

Background: Sodium-glucose cotransporter (SGLT) 2 inhibitors partially inhibit SGLT1 expression; however, whether a clinical dose of SGLT2 inhibitor abrogates ischemic preconditioning (IPC) is unknown, and the pharmacological cardioprotective effect under SGLT1 inhibition has not been examined. In this study, we investigated whether a clinical dose of tofogliflozin abrogates IPC and whether pharmacological preconditioning with olprinone has cardioprotective effects under SGLT1 inhibition.

Methods: Male Wistar rats were divided into seven groups (seven rats per group) and subjected to the following treatments before inducing ischemia/reperfusion (I/R; 30 minutes of coronary artery occlusion followed by 120 minutes of reperfusion): saline infusion control treatment (Con); ischemic preconditioning (IPC); IPC after phlorizin infusion (IPC+Phl); IPC after low-dose tofogliflozin infusion (IPC+L-Tof); IPC after high-dose tofogliflozin infusion (IPC+H-Tof); olprinone infusion (Olp); and Olp infusion after phlorizin infusion (Olp+Phl).

Relationship of Mild to Moderate Impairment of Left Ventricular Ejection Fraction With Fatal Ventricular Arrhythmic Events in Cardiac Sarcoidosis.

Background: Current guidelines recommend placing an implantable cardiac defibrillator for patients with cardiac sarcoidosis and a severely impaired left ventricular ejection fraction (LVEF) of ≤35%. In this study, we determined the association between mild or moderate LVEF impairment and fatal ventricular arrhythmic event (FVAE).

Methods And Results: We retrospectively analyzed 401 patients with cardiac sarcoidosis without sustained ventricular arrhythmia at diagnosis.

Multisystemic Inflammation Influences Prognosis in Fulminant Lymphocytic Myocarditis.

Background: Multisystem inflammatory syndrome (MIS) is a hyperinflammatory shock associated with cardiac dysfunction and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, there are no reports on using MIS criteria, such as multisystemic inflammation (MSI) in fulminant myocarditis, without SARS-CoV-2 infection. This study investigated the differences in clinical characteristics and course between patients with fulminant lymphocytic myocarditis (FLM) plus MSI and those without MSI.

Evaluating the safety profile of calcineurin inhibitors: cancer risk in patients with systemic lupus erythematosus from the LUNA registry-a historical cohort study.

Background: Previous studies have shown conflicting evidence regarding the incidence of cancer in patients with systemic lupus erythematosus (SLE) compared with that in healthy individuals. Calcineurin inhibitors (CNIs) such as cyclosporine and tacrolimus have been widely used to treat SLE; however, their effects on cancer risk remain unclear. We aimed to investigate the incidence of cancer in patients with SLE and determine the potential association between CNI use and cancer risk.

Comparison design and evaluation power in cohort and self-controlled case series designs for post-authorization vaccine safety studies.

Background: Post-authorization safety studies (PASSs) of vaccines are important. PASSs enable the evaluation of association between vaccination and adverse events following immunization through common study designs. Clinical trials during vaccine development typically include a few thousand to 10,000 participants while a PASS might aim to detect a few adverse events per 100,000 vaccine recipients.

Platypnoea-orthodeoxia syndrome in COVID-19 pneumonia patients: An observational study.

This retrospective observational study aimed to assess the clinical characteristics of platypnea-orthodeoxia syndrome in patients with coronavirus disease 2019 (COVID-19) treated using mechanical ventilation or high-flow nasal canula. We analyzed 42 consecutive patients with COVID-19 from January 2020 to March 2022. The primary outcomes were the incidence of platypnea-orthodeoxia syndrome, the time with required long-term oxygen therapy, and short-term prognosis.

Immune thrombocytopenic purpura and Guillain-Barré syndrome after 23-valent pneumococcal polysaccharide vaccination in Japan: The vaccine effectiveness, networking, and universal safety (VENUS) study.

Background: To address the lack of an active vaccine safety surveillance system in Japan, the Vaccine Effectiveness, Networking, and Universal Safety (VENUS) study was initiated in 2021 as a pilot system using existing health insurance claims data and vaccination records.

Methods: This study evaluated the value of the VENUS study by assessing the incidence of immune thrombocytopenic purpura (ITP) and Guillain-Barré syndrome (GBS) following vaccination with the 23-valent pneumococcal polysaccharide vaccine (PPSV23) using a self-controlled case series (SCCS) design.

Results: Incidence rate ratios for ITP during 28-day and 42-day risk periods were 0.

Three Signs to Help Detect Sjögren's Syndrome: Incidental Findings on Magnetic Resonance Imaging and Computed Tomography.

This study aimed to retrospectively investigate the prevalence of Sjögren's syndrome (SS) among patients with ranulas, parotid cysts, or parotid calcifications; identify the characteristic magnetic resonance imaging (MRI) or computed tomography (CT) findings of the lesions associated with SS; and compare the SS disease stages among SS patients with the three lesion types. A total of 228 patients with the lesions were classified into SS, possible SS, and non-SS groups. The prevalence of SS among patients with ranulas, parotid cysts, or parotid calcifications was 16%, 24%, and 40%, and the rates of either SS or possible SS were 25%, 41%, and 64%, respectively.

Effectiveness of BNT162b2 Against Infection, Symptomatic Infection, and Hospitalization Among Older Adults Aged ≥65 Years During the Delta Variant Predominance in Japan: The VENUS Study.

Background: We evaluated the effectiveness of the BNT162b2 vaccine against infection, symptomatic infection, and hospitalization in older people during the Delta-predominant period (July 1 to September 30, 2021).

Methods: We performed a population-based cohort study in an older adult population aged ≥65 years using data from the Vaccine Effectiveness, Networking, and Universal Safety Study conducted from January 1, 2019, to September 30, 2021, in Japan. We matched BNT162b2-vaccinated and -unvaccinated individuals in a 1:1 ratio on the date of vaccination of the vaccinated individual.

EFFICACY AND SAFETY OF A DEXAMETHASONE-BASED MOUTHWASH TO PREVENT CHEMOTHERAPY-INDUCED STOMATITIS IN WOMEN WITH BREAST CANCER: A MULTICENTRE, OPEN-LABEL, RANDOMISED PHASE 2 STUDY.

Purpose: No standard approach other than oral care is available for preventing chemotherapy-induced stomatitis in patients with breast cancer. In this randomized, controlled phase 2 trial, we aimed to assess the efficacy and safety of a dexamethasone-based mouthwash in preventing chemotherapy-induced stomatitis in patients with early breast cancer.

Basic Procedures: Patients with breast cancer scheduled for epirubicin and cyclophosphamide (EC) or docetaxel and cyclophosphamide (TC) therapy were selected and allocated in a 1:1 ratio to the intervention and control groups.

Effects of the attachment method of the stimulating electrodes Nihon-Kohden NM-345Y™ and changes in forearm position on stimulus current values during calibration in electromyography-based neuromuscular monitoring: a single-center experimental study.

Purpose: The traditionally recommended method for attaching electromyography (EMG) electrodes (NM-345Y™) during EMG-based neuromuscular monitoring developed by Nihon-Kohden may decrease the monitoring accuracy when forearm limb position changes. This study investigated methods for attaching stimulating electrodes that maintained stable EMG-based neuromuscular monitoring accuracy, regardless of forearm limb position changes.

Methods: This single-center experimental study recruited 28 healthy adults from October 2022 to December 2022.

Examination of stabilization of sedation by Nasal High Flow in patients with endoscopic retrograde cholangiopancreatography during sedation using Dexmedetomidine.

Introduction: Dexmedetomidine is used for the sedation method in the case of endoscopic retrograde cholangiopancreatography (ERCP) for the purpose of relieving patient anxiety. It has been reported that CO2 accumulated during sedation causes an arousal reaction, so how to normalize CO2 during sedation can be improved by administration of the minimum necessary sedative.Nasal High Flow oxygen therapy (NHF) uses a mild positive pressure load that improves carbon dioxide washout and reduces rebreathing to improve respiratory function and therefore is widely used to prevent hypoxemia and hypercapnia.