•Reduced handgrip strength is associated with adverse clinical outcomes. We analyzed and compared associations of handgrip strength with mortality risk in a cohort of 446 incident dialysis patients, ...using different normalization methods of handgrip strength.•The results of this study confirm that muscle strength measured by handgrip strength is a strong predictor of survival.•Because muscle strength differs between the sexes and between individuals with different body size, results of handgrip strength are usually presented for women and men separately and with normalization of handgrip strength according to body size dimensions such as body weight.•We compared different normalization methods and found that an alternative approach, namely handgrip strength converted to percentage of mean handgrip strength in controls of same sex and similar age had the strongest association with outcome.•These results may have practical implications for clinical practice and for studies using handgrip strength to predict clinical outcomes in kidney failure patients and other patient populations.
Reduced handgrip strength (HGS) is associated with adverse clinical outcomes. We analyzed and compared associations of HGS with mortality risk in dialysis patients, using different normalization methods of HGS.
HGS and clinical and laboratory parameters were measured in a cohort of 446 incident dialysis patients (median age 56 y, 62% men). The area under the receiver operating characteristic curve (AUROC) was used to compare different normalization methods of HGS as predictors of mortality: absolute HGS in kilograms; HGS normalized to height, weight, or body mass index; and HGS of a reference population of sex-matched controls (percentage of the mean HGS value HGS%). Multivariate linear regression analysis was used to assess HGS predictors. Competing risk regression analysis was used to evaluate 5-year all-cause mortality risk. Differences in survival time between HGS% tertiles were quantitated by analyzing the restricted mean survival time.
The AUROC for HGS% was higher than the AUROCs for absolute or normalized HGS values. Compared with the high HGS% tertile, low HGS% (subdistribution hazard ratio sHR = 2.36; 95% CI, 1.19–3.70) and middle HGS% (sHR = 1.79; 95% CI, 1.12–2.74) tertiles were independently associated with higher all-cause mortality and those with high HGS% tertile survived on average 7.95 mo (95% CI, 3.61–12.28) and 18.99 mo (95% CI, 14.42–23.57) longer compared with middle and low HGS% tertile, respectively.
HGS% was a strong predictor of all-cause mortality risk in incident dialysis patients and a better discriminator of survival than absolute HGS or HGS normalized to body size dimensions.
The extract of Polypodium leucotomos is used as a dietary supplement for its ultraviolet radiation‐protective properties. Polypodium leucotomos extract reportedly inhibits CYP3A, which is important ...for drug metabolism in vitro in human microsomes and in vivo in rats. In this study, we explored the inhibitory effect of the P. leucotomos extract on CYP3A4‐mediated midazolam metabolism in humans. This open‐label, two‐period, fixed‐sequence study was performed on six healthy, Japanese, male volunteers. During period 1 (control), midazolam (1 mg) was orally administered. After a wash‐out period of at least 5 days, period 2 was initiated. Subjects ingested P. leucotomos extract (240 mg) once in the morning and once at noon on the day before midazolam administration, and once the next morning (thrice overall). Midazolam was administered as in period 1. Blood samples were regularly collected for 8 hours after drug administration, and serum midazolam concentration was determined by ultra‐fast liquid chromatography‐tandem mass spectrometry. The pharmacokinetic parameters of midazolam were calculated and compared between the two periods. The area under the concentration‐time curve was 19.18 ± 3.65 ng h/ml, maximum serum concentration was 7.81 ± 1.25 ng/ml, and half‐life was 2.32 ± 0.35 hours during period 2. These parameters did not differ from those recorded in period 1 (area under the concentration‐time curve: 18.74 ± 2.97 ng h/ml, maximum serum concentration: 8.78 ± 1.67 ng/ml, half‐life: 2.52 ± 0.52 h). Therefore, short‐term oral administration of P. leucotomos extract did not cause food‐drug interactions mediated by CYP3A4 inhibition in humans.
Fractional exhaled nitric oxide （FeNO） is a clinically established noninvasive marker of airway inflammation in bronchial asthma. In allergic rhinitis, lower airways contain inflammatory cell ...infiltrates such as CD4＋ lymphocytes and eosinophils, which are purported to affect the FeNO levels. In this study, we investigated whether exposure to cedar pollen affects the interpretation of FeNO levels and thus improves the accuracy of FeNO clinical test results. Accordingly, FeNO was measured in 14 healthy adults and 33 patients with cedar pollinosis during the pollen-free and dispersal periods from September, 2015, to April, 2016. The allergenic factors were evaluated through various blood tests. Symptoms of rhinitis were also evaluated by calculating the total nasal symptom score. The FeNO level of the healthy group was 17.1ppb and 17.7ppb during the pollen dispersal period and pollen-free period, respectively. Meanwhile, the FeNO level of the pollinosis group was 24.4ppb during the pollen dispersal period and 23.9ppb during the pollen-free period. These findings suggest that there are no seasonal variations in FeNO levels between the pollinosis and healthy groups. Although no significant difference was observed between the two groups in both periods, FeNO in the pollinosis group was consistently above the cutoff value of 22ppb, which was used as a threshold for differentiating between the healthy group and the asthmatic group in both periods. In the specific allergen test administered to cedar pollinosis patients, the positivity rate for cedar was determined to be 100％. However, 97％ of the individuals were also detected as positive for inhalant allergens besides cedar. Various confounding factors, such as smoking and eosinophilic diseases, could contribute to abnormal levels of FeNO. Thus, the seasonal variations in FeNO levels of pollinosis patients should be evaluated and analyzed in a larger cohort of patients to adjust for possible confounding patient data.
The oral environment is one of the key factors that affect the performance of athletes. Oral health should thus be incorporated into medical science to improve competitiveness and prevent injuries ...among athletes. We herein report the details of our analysis of the oral health of college rugby players based on their dental check-up. The study sample included 45 college rugby players from the same team who had visited the Research Institute for Sports and Exercise Sciences of Showa University for a medical check-up in 2019. All of them were male, and their mean age was 19.3 years. Of the players, only 73.3％ used mouth guards — 84.8％ of whom used custom-made mouth guards. The sample’s mean plaque control record score was 60.3％±18.4％; mean decayed, missing, and filled teeth （DMFT） index was 18.3％; and mean total number of DMFT per person was 5.4. Statistical analysis revealed a significantly positive correlation between the CariScreen Caries Susceptibility Test score and the plaque control record score. Salivary flow was negatively correlated with the DMFT index and bleeding on probing. Furthermore, the occlusal contact area in the front teeth was significantly larger than that in the back teeth. Our results indicate the need for early improvement of the oral environment of university athletes, which is in congruence with previous reports. Our group intends to create a database that includes the dental check-up results of university athletes. We believe that this initiative would contribute to future medical perspectives in sports dentistry.
The emergence of the next generation sequencer (NGS) and its technological progress have caused a major change in genetic analysis. Technological innovation by NGS had an enormous influence on the ...study of classification and analysis of intestinal bacteria inhabiting the intestine. It has been reported that in the intestines of humans, approximately 1,000 species, 100 trillion bacteria may coexist, and the intestinal bacteria could be about three times more than the number of cells constituting a human being. Following development of NGS, novel areas have been discovered in microbiota; however, in oncology, the relationships between microbiota and cancer have not been fully clarified. In recent literature, surprisingly, detection of gut microbiota in tumor issue itself has been reported. Microbiota might play a significant role in carcinogenesis. However, this phenomenon is not well understood, and research in this area has just begun. Gut microbiota and human beings are co-evolutionary, in a win-win symbiosis. Recently, there have been many studies and much research on the relationships between the gut microbiota and human disease. Gut microbiota seem to be strongly correlated with various kinds of disease, such as inflammatory bowel disease, diabetes mellitus, central nervous disorder, allergic diseases, and infectious diseases. On the other hand, the relationship between tumor and microbiota is not well clarified, and there has been yet clarified the relationship between Japanese patients and diseases. To clarify those, we have attempted to establish the big data base of Microbiota, we call, Showa U bank. We have sequenced V1 and V2 of 16s rRNA to determine the bacteria from specimen by NGS. In Showa University, we have 3,200 beds in the affiliated 8 hospitals. Our collaborations in Showa University makes possible accelerate the amounts of data of Microbiota related to clinical data from patients. From one of these data, microbiota from healthy subjects and cancer patients is much different. In this presentation, we will demonstrate the present data from Showa U bank.
The “Clinical Trials Act” was enacted in April 2018. We considered the current issues and future correspondence to conduct clinical studies in accordance with the Clinical Trials Act in the future. ...This Questionnaire survey was carried out with 409 doctors and dentist concerning diagnosis and treatment of cancer at Showa University Hospitals, East Hospital, Fujigaoka Hospital, Fujigaoka Rehabilitation Hospital, Northen Yokohama Hospital, Karasuyama Hospital, Dental Hospital, Koto Toyosu Hospital, Toyosu Clinic Preventive Medicine Center, Clinial Research Institute of Clinical Pharmacology and Therapeutics, Institute of Molecular Oncology from March 1 to March 12, 2018. We obtained responses from 214 of the 409 doctors who received the questionnaire （response rate: 52％）. The doctors who replied to the questionnaire were working in diagnosis and treatment departments associated with the treatment of cancer. Also, approximately 60％ of those were research principal investigator or sub investigator. Many doctors cannot understand the meaning of “specified clinical trials” as used in this Act; they expected establishment of a support system by the support department of Showa University. A certified review board is needed to review “specified clinical trials” in this Act; 97％ of Questionnaire respondents had the opinion to establish such a board at Showa University. Furthermore, a certified review board would need evaluations from technical experts to review clinical trials, and 55％ of respondent answered that they would cooperate for the cooperation request. It was shown that doctors at Showa University need information on the procedures of “specified clinical trials”, and there is immediate necessity for the establishment of a support system for doctors and dentists who conduct clinical studies.
HOW TO IMPLEMENT CLINICAL RESEARCH MONITORING TAKENOSHITA, Sachiko; RYU, Kakei; YAMAZAKI, Taigi ...
Journal of The Showa University Society,
2018, Letnik:
78, Številka:
6
Journal Article
Recenzirano
Odprti dostop
In clinical studies with the invasive intervention, it is necessary to monitor for quality assurance research according to the guidelines for human research. One of the present problems is that only ...a few researchers can perform monitoring due to the lack of experience. We obtained opportunities to monitor some clinical studies conducted in anesthesiology; we were able to carry out risk-based monitoring in collaboration with the principal investigator. In clinical research, it is not only the science that is significant, but also the ethical and safety viewpoints are very important. Thus, we checked informed consent, data, randomization and serious adverse effects in the monitoring. Further, we recommended the use of a worksheet to avert lack of data. We performed the monitoring immediately after entry of the first subject, at the entry of half of the subjects and after the end of the study of the final subject. Between the monitor and the principal investigator, consistently good communication was established, which led to not only education of the monitor but also it provided know-how for the principal investigator regarding monitoring. We would like to contribute to quality assurance by using monitoring as one support for clinical studies.
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