28 research outputs found

    Effect of BNT162b2 mRNA COVID-19 vaccine on sperm morphokinetics and DNA integrity: A prospective observational study in Japan

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    Objective: To assess whether the coronavirus disease 2019 (COVID-19) mRNA vaccine affects sperm morphokinetics using a computer-assisted semen analyzer and other semen parameters using a sperm chromatin structure assay. Methods: Healthy male volunteers in two Japanese clinics between May 2021 and December 2021 were prospectively analyzed. Participants donated sperm twice, two days apart, in the following phases: before vaccination, 2 weeks after the first vaccine dose, and 2, 4, and 12 weeks after the second dose. Basic sperm parameters, sperm motility characteristics, and the percentage of DNA-damaged sperm were compared among the different phases. Results: Ninety-six semen samples from ten volunteers, who were vaccinated with the BNT162b2 mRNA vaccine, were evaluated. There were no significant differences between any phases in basic semen findings and parameters of the sperm chromatin structure assays. Regarding sperm motion characteristics, the average linear velocity, beat-cross frequency, and sperm motility index significantly decreased after the second vaccine dose (P=0.018, P=0.003, and P=0.027, respectively), with no significant differences between any two phases by post-hoc pairwise comparisons. Conclusions: After COVID-19 mRNA vaccination, while sperm motion characteristics might fluctuate, no apparent deterioration of basic sperm parameters or sperm DNA integrity was observed. Given the adverse effects of COVID-19 on sperm, our findings suggest that there might be no reason to refrain from vaccination for healthy individuals

    Comparison of baseline characteristics and clinical course in Japanese patients with type 2 diabetes among whom different types of oral hypoglycemic agents were chosen by diabetes specialists as initial monotherapy (JDDM 42)

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    Little is known about the relationships between patient factors and the antihyperglycemic agents that have been prescribed as initial therapy by diabetes specialists for patients with type 2 diabetes. Moreover, there has been little clarification of the subsequent usage patterns and related factors that influenced the continuation or discontinuation of the drug or the addition of another drug. To provide information on these issues, we evaluated the clinical characteristics of Japanese patients with type 2 diabetes for whom different types of oral hypoglycemic agents (i.e., either sulfonylureas, biguanides, or DPP-4 inhibitors (DPP-4Is)) were chosen as initial monotherapy by diabetes specialists and evaluated subsequent usage patterns. Prescription data on 3 different antidiabetic agents from December 2009 to March 2015 from diabetes specialists' patient registries were used to identify variables at baseline related to initial prescriptions; also, the addition of another hypoglycemic drug or discontinuation of the initial therapy was evaluated 1 year after the initial prescription. Analyzed were data on 2666 patients who received initial monotherapy with either a sulfonylurea (305 patients), biguanide (951 patients), or DPP-4I (1410 patients). Patients administered sulfonylureas were older, had a lower body mass index (BMI), longer duration of diabetes, and worse glycemic control than recipients of biguanides. Use of biguanides was related to younger age, short duration of diabetes, and obesity but was negatively associated with poor glycemic control. Older age but neither obesity nor poor glycemic control was associated with DPP- 4Is. In all 3 groups a high HbA1c value was related to adding another hypoglycemic agent to the initial therapy. Moreover, adding another drug to a DPP-4I was related to a younger age and higher BMI. Patients' age, duration of diabetes, obesity, and glycemic control at baseline influenced the choice of hypoglycemic agents. Selection of a biguanide differs greatly from that of a sulfonylurea or DPP-4I with regard to age and obesity

    Pulse Pressure is a Stronger Predictor Than Systolic Blood Pressure for Severe Eye Diseases in Diabetes Mellitus

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    Background: Evidence of the role of systolic blood pressure (SBP) in development of severe diabetic retinopathy is not strong, although the adverse effect of low diastolic blood pressure has been a partial explanation. We assessed the predictive ability of incident severe diabetic retinopathy between pulse pressure (PP) which considers both SBP and diastolic blood pressure, compared with SBP. Methods and Results: Eligible patients (12 242, 83% men) aged 19 to 72 years from a nationwide claims database were analyzed for a median observational 4.8‐year period. Severe diabetic retinopathy was defined as vision‐threatening treatment‐required diabetic eye diseases. Multivariate Cox regression analysis revealed that hazard ratios (95% CI) of treatment‐required diabetic eye diseases for 1 increment of standard deviation and the top tertile compared with the bottom tertile were 1.39 (1.21–1.60) and 1.72 (1.17–2.51), respectively, for PP and 1.22 (1.05–1.41) and 1.43 (0.97–2.11), respectively, for SBP adjusted for age, sex, body mass index, hemoglobin A1c, fasting plasma glucose, lipids, and smoking status. In a model with SBP and PP simultaneously as covariates, the hazard ratios of only PP (hazard ratios [95% CI], 1.57 [1.26–1.96]) but not SBP (0.85 [0.68–1.07]) were statistically significant. Delong test revealed a significant difference in the area under the receiver operating characteristic curve between PP and SBP (area under the receiver operating characteristic curve [95% CI], 0.58 [0.54–0.63] versus 0.54 [0.50–0.59]; P=0.03). The strongest predictor remained as hemoglobin A1c (area under the receiver operating characteristic curve [95% CI], 0.80 [0.77–0.84]). Conclusions: After excluding the significant impact of glycemic control, PP in comparison with SBP is a better predictor of severe diabetic retinopathy, suggesting a role of diastolic blood pressure and arterial stiffness in pathology

    Psychological Effects of Heart Rate and Physical Vibration on the Operation of Construction Machines: Experimental Study

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    BackgroundA construction method has emerged in which a camera is installed around a construction machine, and the operator remotely controls the machine while synchronizing the vibration of the machine with the images seen from the operator's seat using virtual reality (VR) technology. Indices related to changes in heart rate (HR) and physical vibration, such as heart rate variability (HRV) and multiscale entropy (MSE), can then be measured among the operators. As these indices are quantitative measures of autonomic regulation in the cardiovascular system, they can provide a useful means of assessing operational stress. ObjectiveIn this study, we aimed to evaluate changes in HR and body vibration of machine operators and investigate appropriate methods of machine operation while considering the psychological load. MethodsWe enrolled 9 remote operators (18-50 years old) in the experiment, which involved 42 measurements. A construction machine was driven on a test course simulating a construction site, and three patterns of operation—riding operation, remote operation using monitor images, and VR operation combining monitor images and machine vibration—were compared. The heartbeat, body vibration, and driving time of the participants were measured using sensing wear made of a woven film-like conductive material and a three-axis acceleration measurement device (WHS-2). We used HRV analysis in the time and frequency domains, MSE analysis as a measure of the complexity of heart rate changes, and the ISO (International Standards Organization) 2631 vibration index. Multiple regression analysis was conducted to model the relationship among the low frequency (LF)/high frequency (HF) HRV, MSE, vibration index, and driving time of construction equipment. Efficiency in driving time was investigated with a focus on stress reduction. ResultsMultiple comparisons conducted via the Bonferroni test and Kruskal-Wallis test showed statistically significant differences (P=.05) in HRV-LF/HF, the vibration index, weighted acceleration, motion sickness dose value (MSDVz), and the driving time among the three operation patterns. The riding operation was found to reduce the driving time of the machine, but the operation stress was the highest in this case; operation based on the monitor image was found to have the lowest operation stress but the longest operation time. Multiple regression analysis showed that the explanatory variables (LH/HF), RR interval, and vibration index (MSDVz by vertical oscillation at 0.5-5 Hz) had a negative effect on the driving time (adjusted coefficient of determination R2=0.449). ConclusionsA new method was developed to calculate the appropriate operating time by considering operational stress and suppressing the physical vibration within an acceptable range. By focusing on the relationship between psychological load and physical vibration, which has not been explored in previous studies, the relationship of these variables with the driving time of construction machines was clarified

    Performance of Ultra-Rapid Idylla™ EGFR Mutation Test in Non-Small-Cell Lung Cancer and Its Potential at Clinical Molecular Screening

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    Background: The Idylla™ EGFR Mutation Test is an ultra-rapid single-gene test that detects epidermal growth factor receptor (EGFR) mutations using formalin-fixed paraffin-embedded specimens. Here, we compared the performance of the Idylla EGFR Mutation Test with the Cobas® EGFR Mutation Test v2. Methods: Surgically resected NSCLC specimens obtained at two Japanese institutions (N = 170) were examined. The Idylla EGFR Mutation Test and the Cobas EGFR Mutation Test v2 were performed independently and the results were compared. For discordant cases, the Ion AmpliSeq Colon and Lung Cancer Research Panel V2 was performed. Results: After the exclusion of five inadequate/invalid samples, 165 cases were evaluated. EGFR mutation analysis revealed 52 were positive and 107 were negative for EGFR mutation in both assays (overall concordance rate: 96.4%). Analyses of the six discordant cases revealed that the Idylla EGFR Mutation Test was correct in four and the Cobas EGFR Mutation Test v2 was correct in two. In a trial calculation, the combination of the Idylla EGFR Mutation Test followed by a multi-gene panel test will reduce molecular screening expenses if applied to a cohort with EGFR mutation frequency >17.9%. Conclusions: We demonstrated the accuracy and potential clinical utility of the Idylla EGFR Mutation Test as a molecular screening platform in terms of turnaround time and molecular testing cost if applied to a cohort with a high EGFR mutation incidence (>17.9%)
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