Relationship between physical functional status indicators and bone mineral density in older women.

Background: Osteoporosis significantly predisposes patients to fragility fractures and a reduced quality of life. Therefore, osteoporosis prevention plays an important role in extending healthy life expectancy. The purpose of this study was to identify whether physical functional status was associated with low bone mineral density, and to determine cut-off values of physical status indicators for osteoporosis. Methods: This cross-sectional study evaluated 343 women aged 60 years or older who were able to walk independently. The measured variables were the body mass index, lumbar and total hip bone mineral density, grip strength, 5-m normal walking speed, one-leg standing time, timed up-and-go test, and skeletal muscle mass using bioelectrical impedance analysis. The associations between physical status indicators and low bone mineral density were analyzed and the cut-off values for detecting osteoporosis were calculated using receiver operating characteristic curve analyses. Results: The prevalence of osteoporosis was 29.2 %. All measured variables significantly differed between the osteoporotic and non-osteoporotic groups (p < 0.05). Multivariate logistic regression analysis showed that the factors associated with osteoporosis were the skeletal muscle mass index, walking speed, and body mass index. In the receiver operating characteristic curve analysis, the cut-off values of the skeletal muscle mass index, walking speed, and body mass index associated with osteoporosis were 6.31 kg/m2, 1.29 m/s, and 22.6 kg/m2, respectively. Conclusions: Older women with low bone mineral density have lower skeletal muscle mass, slower walking speed, and lower body mass index. Measuring the skeletal muscle mass index, walking speed, and body mass index might be useful for daily exercise guidance or osteoporosis screening.

Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in diabetic macular edema: 2-year results from the Japan subgroup of the phase 3 YOSEMITE trial.

PURPOSE: To evaluate the 2-year efficacy, durability, and safety of faricimab in patients with diabetic macular edema (DME) in the YOSEMITE Japan subgroup. STUDY DESIGN: YOSEMITE/RHINE (NCT03622580/NCT03622593) subgroup analysis: global, multicenter, randomized, double-masked, active-comparator-controlled, phase 3 faricimab trials. METHODS: Patients were randomized 1:1:1 to intravitreal faricimab 6.0 mg every 8 weeks (Q8W) and per treat-and-extend (T&E) dosing, or aflibercept 2.0 mg Q8W. Outcomes were assessed through year 2 for the YOSEMITE Japan subgroup (N = 60) and the pooled YOSEMITE/RHINE global cohort (N = 1891). RESULTS: In the YOSEMITE Japan subgroup, 21, 19, and 20 patients were randomized to faricimab Q8W, faricimab T&E, and aflibercept Q8W, respectively (632, 632, and 627 patients in the pooled YOSEMITE/RHINE cohort). Vision gains and anatomic improvements with faricimab at year 1 were maintained over 2 years and were generally consistent between groups. Mean best-corrected visual acuity changes from baseline at year 2 (weeks 92-100 average) for the YOSEMITE Japan subgroup were +12.5, +9.0, and +5.0 letters in the faricimab Q8W, faricimab T&E and aflibercept Q8W arms, respectively (+10.8, +10.4, and +10.3 letters in the pooled YOSEMITE/RHINE cohort). At week 96, 61.1% of the YOSEMITE Japan subgroup and 78.1% of the pooled YOSEMITE/RHINE cohort were on ≥ Q12W dosing. Faricimab was well-tolerated with a safety profile comparable with aflibercept. CONCLUSION: Faricimab up to Q16W offered durable vision gains and anatomic improvements up to 2 years in patients with DME in the YOSEMITE Japan subgroup. Outcomes were generally consistent with the pooled YOSEMITE/RHINE cohort.

FDA, CDC, and NIH Co-sponsored Public Workshop Summary-Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.

There is an unmet need for developing drugs for the treatment of gonorrhea, due to rapidly evolving resistance of Neisseria gonorrhoeae against antimicrobial drugs used for empiric therapy, an increase in globally reported multidrug resistant cases, and the limited available therapeutic options. Furthermore, few drugs are under development. Development of antimicrobials is hampered by challenges in clinical trial design, limitations of available diagnostics, changes in and varying standards of care, lack of robust animal models, and clinically relevant pharmacodynamic targets. On April 23, 2021, the U.S. Food and Drug Administration; Centers for Disease Control and Prevention; and National Institute of Allergy and Infectious Diseases, National Institutes of Health co-sponsored a workshop with stakeholders from academia, industry, and regulatory agencies to discuss the challenges and strategies, including potential collaborations and incentives, to facilitate the development of drugs for the treatment of gonorrhea. This article provides a summary of the workshop.

The dynamics of perioperative serum albumin before and after total knee arthroplasty.

Background: Previous studies have evaluated preoperative serum albumin (SA) for predicting postoperative complications of total knee arthroplasty (TKA). This study aimed to investigate the dynamics of perioperative SA and changes in SA (ΔSA) and identify any influential patient or surgical factors. Methods: In total, 381 patients (483 knees) undergoing primary TKA were recruited. SA values preoperatively (SA0), 1 week postoperatively (SA1W), and 4 weeks postoperatively (SA4W) were investigated. SA values were converted to a percentage of SA0 and differences between timepoints were calculated and expressed as follows: ΔSA1W-0, ΔSA4W-1W, and ΔSA4W-0. Patient and surgical factors previously identified or with the potential to influence SA were evaluated. Results: The median values of SA0, SA1W, and SA4W were 4.4, 3.8, and 4.2 g/dL, respectively; SA0 was significantly different between groups (p < 0.001). The incidence of low SA0 (<3.5 g/dL) was less than 1 %. Median ΔSA values were -13.7 %, 9.6 %, and -4.5 % for ΔSA1W-0, ΔSA4W-1W and ΔSA4W-0, respectively; ΔSA was significantly different between groups (p < 0.001). SA4W recovered to 95.5 % of SA0 with less than 2 % of patients having low SA4W (<3.5 g/dL). Multiple regression analyses showed SA concentration at each timepoint was significantly associated with the other SA timepoint values; age was significantly associated with SA4W and SA1W (all p < 0.001). Conclusions: We identified SA0 and age as significant factors affecting SA dynamics in the perioperative period. Low SA (<3.5 g/dL) was uncommon both preoperatively and at 4 weeks postoperatively; therefore, conventional cutoff values and preventive measures for low SA may need reconsideration.

Fourth national Japanese antimicrobial susceptibility pattern surveillance program: Bacterial isolates from patients with complicated urinary tract infections.

INTRODUCTION: Antimicrobial susceptibility patterns of bacterial pathogens isolated from patients with complicated urinary tract infections were analyzed using the national surveillance data, comprising 793 bacterial strains from eight clinically relevant species. MATERIALS AND METHODS: Data were collected for the fourth national surveillance project from July 2020 to December 2021 by the Japanese Society of Chemotherapy, the Japanese Association for Infectious Disease, and the Japanese Society of Clinical Microbiology. Surveillance was supervised with the cooperation of 43 medical institutions throughout Japan. RESULTS: Fluoroquinolone required a minimum inhibitory concentration (MIC) of 2-64 mg/L to inhibit the 330 tested Escherichia coli strains. The proportion of levofloxacin-resistant E. coli strains increased from 28.6% in 2008 to 29.6% in 2011, 38.5% in 2015, and 44.5% in 2021. The proportion of levofloxacin-resistant strains of Pseudomonas aeruginosa also increased from previous survey results, showing a continuing downward trend. Conversely, the proportion of levofloxacin-resistant strains of Enterococcus faecalis decreased relative to previous reports. Neither multidrug-resistant P. aeruginosa nor carbapenem-resistant Enterobacteriaceae were detected. For methicillin-resistant Staphylococcus aureus (MRSA), the proportion of vancomycin-susceptible strains (MIC of 2 µg/mL) decreased from 14.7% to 7.7%. DISCUSSION: Bacterial strains that produced extended-spectrum ß-lactamase included E. coli (82/330 strains, 24.8%), Klebsiella pneumoniae (11/68 strains, 16.2%), and Proteus mirabilis (4/26 strains, 15.4%). As compared to previous surveillance reports, these strains showed an increase in proportion over the years.

Protocol of a Prospective Observational Study on Lifestyle and Quality of Life in Adults with Type 1 Diabetes in Japan.

INTRODUCTION: Recent studies have shown that the quality of life (QOL) of people living with type 1 diabetes (T1D) is poor and must be improved. However, the living situation and QOL of adults living with T1D in Japan have not been fully clarified. This study will examine their lifestyle, QOL, and clinical situation, as well as the relationships between them. METHODS: This is a prospective, 5-year follow-up observational study. Between December 2019 and September 2021, we enrolled adults in Japan who were living with T1D and receiving insulin therapy, and are acquiring longitudinal clinical data and the responses to seven questionnaires regarding lifestyle and QOL. The primary study outcomes are (1) the relationship between Problem Areas in Diabetes (PAID) scores and various factors including demographic data, clinical characteristics, medical history, lifestyle habits, treatment history, biochemical data, and the scores of questionnaires; and (2) the relationship between Beck Depression Inventory (BDI)-II scores and various factors aforementioned. The secondary outcomes are the relationships between various factors aforementioned and each of the following: (1) blood glucose control, (2) blood lipid control, (3) dietary patterns, (4) fear of hypoglycemia, (5) sleep patterns, and (6) physical activity. PLANNED OUTCOME: We registered 352 participants. The median age was 49 (41-63) years, and the median duration of T1D was 13 (8-20) years. All the results will be available in 2026. We expect to clarify the factors associated with decreased QOL, and that this knowledge will contribute to improving QOL in adults in Japan who are living with T1D and receiving insulin therapy. TRIAL REGISTRATION: Clinical Trials.gov identifier, UMIN000044088.

Third nationwide surveillance of bacterial pathogens in patients with acute uncomplicated cystitis conducted by the Japanese surveillance committee during 2020 and 2021: Antimicrobial susceptibility of Escherichia coli, Klebsiella pneumoniae, and Staphylococcus saprophyticus.

The Japanese surveillance committee conducted a third nationwide surveillance of antimicrobial susceptibility of acute uncomplicated cystitis at 55 facilities throughout Japan between April 2020 and September 2021. In this surveillance, we investigated the susceptibility of Escherichia coli (E. coli), Klebsiella pneumoniae (K. pneumoniae), and Staphylococcus saprophyticus (S. saprophyticus) for various antimicrobial agents by isolating and culturing bacteria from urine samples. In total, 823 strains were isolated from 848 patients and 569 strains of target bacteria, including E. coli (n = 529, 92.9 %), K. pneumoniae (n = 28, 4.9 %), and S. saprophyticus (n = 12, 2.2 %) were isolated. The minimum inhibitory concentrations of 18 antibacterial agents were determined according to the Clinical and Laboratory Standards Institute manual. In premenopausal patients, there were 31 (10.5 %) and 20 (6.8 %) fluoroquinolone (FQ)-resistant E. coli and extended-spectrum ß-lactamase (ESBL)-producing E. coli, respectively. On the other hand, in postmenopausal patients, there were 75 (32.1 %) and 36 (15.4 %) FQ-resistant E. coli and ESBL-producing E. coli, respectively. The rate of FQ-resistant E. coli and ESBL-producing E. coli in post-menopausal women was higher than that for our previous nationwide surveillance (20.7 % and 32.1 %: p = 0.0004, 10.0 % and 15.4 %; p = 0.0259). For pre-menopausal women, there was no significant difference in the rate of FQ-resistant E. coli and ESBL-producing E. coli between this and previous reports, but the frequency of FQ-resistant E. coli and ESBL-producing E. coli exhibited a gradual increase. For appropriate antimicrobial agent selection and usage, it is essential for clinicians to be aware of the high rate of these antimicrobial-resistant bacteria in acute uncomplicated cystitis in Japan.

Arterial Stiffness, Assessed Using the Cardio-Ankle Vascular Index, before and 2 Years after Total Knee Arthroplasty in Patients with Knee Osteoarthritis.

Purpose: Cardiovascular disease (CVD) is a major risk factor for mortality in patients with osteoarthritis, and such comorbidities increase the risk of postoperative complications following total knee arthroplasty (TKA). Arteriosclerosis plays a major role in hemodynamic dysfunction and CVD; however, the postoperative changes in arteriosclerosis following TKA have not been evaluated. Therefore, we assessed the postoperative changes in arteriosclerosis using the cardio-ankle vascular index (CAVI) in patients undergoing TKA, and its relationships with preoperative patient characteristics. Methods: Arteriosclerosis was prospectively evaluated in 119 consecutive patients (140 knees) (15 males (17), 104 females (123); median age 73 years) with knee osteoarthritis who underwent TKA. CAVI was measured before and 2 years after TKA, and the relationships between CAVI and preoperative age, sex, BMI, physical activity status, comorbidities, clinical score, triglyceride concentration, cholesterol concentration, and smoking history were analyzed. Results: CAVI remained stable or improved in 54 joints (39%) and worsened in 86 joints (61%) 2 years post-operation. The median difference between pre- and postoperative CAVI was 0.2 (-0.3, 0.8), and the only preoperative factor associated with this change was preoperative CAVI (r = -0.469, p < 0.001). No other preoperative factor had a significant effect on postoperative arteriosclerosis. Conclusions: The results suggest that patients who undergo TKA subsequently show less severe arteriosclerosis, and the protective effect of TKA on arterial stiffness is greater in those with a higher preoperative CAVI. TKA may be an effective means of reducing the deterioration of arteriosclerosis associated with knee osteoarthritis, at least in the relatively short term.