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1.
Leg Med (Tokyo) ; 45: 101715, 2020 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-32413723

RESUMO

The identification of vaginal fluid from casework samples of sexual assaults provides important probative evidence of vaginal intercourse. The aim of this study was to establish a more specific procedure for identifying vaginal fluids for forensic purposes. Vaginal fluid marker candidates have been evaluated quantitatively and five of these markers (ESR1, SERPINB13, KLK13, CYP2B7P1, MUC4) have been amplified simultaneously by a multiplex reverse transcription-polymerase chain reaction (RT-PCR) procedure. Each amplicon has been separated and quantified automatically using chip electrophoresis. Subsequently, in the present study, detectability and cross-reactivity of the developed multiplex procedure were assessed in detail using various forensically relevant body fluids. Then, a cutoff value for the positive detection of vaginal fluids was set for each marker by Youden index. The ability of the multiplex RT-PCR assay to distinguish between vaginal and other body fluids was evaluated statistically using a likelihood ratio (LR) that was estimated using a Bayesian estimation approach to consider the infrequency of detection. A high LR was obtained when all five markers showed positive results (LR = 4.33 × 109; 95% credible interval, 3.95 × 107 -2.87 × 1012). The developed procedure was validated using vaginal fluid samples under various conditions. High LRs were found for aged vaginal fluid stains, although each amplicon peak was low. It was also able to identify vaginal stains mixed with other body fluids. In conclusion, the multiplex RT-PCR-based procedure followed by the statistical evaluation using LR could be a powerful tool for the objective identification of vaginal fluids.

2.
Int J Clin Oncol ; 2020 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-32232691

RESUMO

BACKGROUND: The aim of this study is to establish new risk tables for the current clinical setting, enabling short- and long-term risk stratification for recurrence, progression, and cancer-specific death after transurethral resection in non-muscle invasive bladder cancer (NMIBC). Currently available risk tables lack input from the 2004 World Health Organization grading system and risk prediction for cancer-specific death. METHODS: This was a multi-institutional database study of 1490 patients diagnosed with NMIBC (the development cohort). A multivariate Fine and Gray subdistribution hazard model was used to assess the prognostic impact of various factors. Patients were classified into low-, intermediate-, and high-risk groups according to a sum of the weight of selected factors, and predicted cumulative rates were calculated. Internal validation was conducted using 200 bootstrap resamples to assess the optimism for the c-index and estimate a bias-corrected c-index. External validation of the developed risk table was performed on an independent dataset of 91 patients. RESULTS: The Japanese NIshinihon uro-onCology Extensive collaboration group (J-NICE) risk stratification table was derived from six, five, and two factors for recurrence, progression, and cancer-specific death, respectively. The internal validation bias-corrected c-index values were 0.619, 0.621, and 0.705, respectively. The application of the J-NICE table to an external dataset resulted in c-indices for recurrence, progression, and cancer-specific death of 0.527, 0.691, and 0.603, respectively. CONCLUSIONS: We propose a novel risk stratification model that predicts outcomes of treated NMIBC and may overcome the shortcomings of existing risk models. Further external validation is required to strengthen its clinical impact.

3.
PLoS One ; 15(4): e0231074, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32240243

RESUMO

PURPOSE: To evaluate the diagnostic ability of the ratio of anterior and posterior corneal surface areas (As/Ps) comparing with other keratoconus screening indices in distinguishing forme fruste keratoconus (FFKC) from normal eyes. METHODS: In this comparative study, 13 eyes of 13 patients with FFKC, 29 eyes of 29 patients with keratoconus (KC) and 88 eyes of 88 patients with normal subjects were involved. The As/Ps measured by the anterior segment optical coherence tomography (AS-OCT) and other indices measured by AS-OCT and rotating Scheimpflug-based corneal tomography were evaluated. The area under receiver-operating-characteristics (AU-ROC) was calculated to assess the diagnostic ability in discriminating FFKC from normal eyes. RESULTS: The As/Ps, the Belin/Ambrosio display enhanced ectasia total derivation value (BAD-D) and posterior and anterior elevation values showed the AU-ROC 0.9 or more in differentiating FFKC from normal eyes (0.980, 0.951, 0.924 and 0.903, respectively). The sensitivity and specificity were 0.92 and 0.96 for the As/Ps, 1.00 and 0.90 for BAD-D, 0.85 and 0.86 for posterior elevation value, and 0.85 and 0.96 for anterior elevation value, respectively. CONCLUSIONS: Among the several indices for keratoconus screening which we evaluated, the As/Ps obtained by AS-OCT had the large AU-ROC with high sensitivity and specificity in detecting FFKC, which was comparable with BAD-D obtained by rotating Scheimpflug-based corneal tomography. The As/Ps may provide information for improving the diagnostic accuracy of KC, even in the initial stage of the disease.

4.
Intensive Crit Care Nurs ; 59: 102830, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32217019

RESUMO

OBJECTIVES: Currently, light sedation is typically given to patients in intensive care units and studies have not extensively examined the factors related to absences or abnormalities of their memories. We, therefore, analysed the factors related to the absence/abnormalities of patients' memories in intensive care units. RESEARCH METHODOLOGY: A secondary analysis of previously collected survey data examining patients' experiences in an intensive care unit was undertaken (n = 405; women = 38%; median age = 70 years). To observe absent or distorted memories, patients were interviewed after leaving the intensive care unit. We analysed key factors through content analysis of the interviews and field notes. SETTING: The intensive care unit of a university hospital. MAIN OUTCOME MEASURE: Patients' absent or distorted memories after leaving the intensive care unit. RESULTS: Half the patients reported an absence of memories. This was associated with old age and with longer duration of mechanical ventilation. Absent or fragmentary memories were not distressing. Fragmentary and fearful intensive care unit memories were associated with being older. Delusional memories, some of which reflected actual events, were present in 3% of patients. CONCLUSION: Absence of memories were not distressing, delusional memories occurred less and these memories could comprise of an event in ICU that is difficult for patients to understand.

5.
Hepatol Res ; 2020 Mar 23.
Artigo em Inglês | MEDLINE | ID: mdl-32202371

RESUMO

This study aimed to determine the optimal psoas muscle mass index (PMI) cut-off values for diagnosis of skeletal muscle mass loss. METHODS: We evaluated PMI in two groups of normal controls: a medical check-up group and a liver donation candidate group. We analyzed two novel PMI cut-off values, one based on the mean - two standard deviations (2SD) and one based on the lower 5%. Skeletal muscle mass index (SMI) evaluations using computed tomography (sliceOmatic; TomoVision) and bioelectrical impedance analysis and PMI evaluation were undertaken simultaneously. We analyzed the correlation between our PMI cut-off values and the Japan Society of Hepatology-defined SMI cut-off values. The prevalence of skeletal muscle mass loss in patients with liver disease was assessed using the novel PMI cut-off values. RESULTS: In 504 normal controls aged ≤50 years, the PMI cut-off values based on mean -2SD and the lower 5% were set at 3.30 cm2 /m2 for men and 1.69 cm2 /m2 for women and 3.74 cm2 /m2 for men and 2.29 cm2 /m2 for women, respectively. The PMI cut-off values based on the lower 5% alone showed that skeletal muscle mass loss increased with age. Furthermore, they correlated well with Japan Society of Hepatology-defined SMI (sliceOmatic) cut-off values and showed a significantly higher prevalence of skeletal muscle mass loss in patients with liver cirrhosis than those without liver cirrhosis. CONCLUSIONS: We propose the following PMI cut-off values: 3.74 cm2 /m2 for male individuals and 2.29 cm2 /m2 for female individuals. These cut-off values can facilitate accurate diagnosis and management of sarcopenia in patients with chronic liver disease.

6.
Clin Exp Rheumatol ; 2020 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-32083551

RESUMO

OBJECTIVES: To clarify the efficacy and safety of calcineurin inhibitors (CNI) for treating adult-onset Still's disease (AOSD). METHODS: This multicentre historical cohort study enrolled the consecutive patients with AOSD according to Yamaguchi classification criteria. The endpoints were set as the time from the initiation of treatment to events, the persistency rate of CNI and safety. Based on the recurrent event data analysis, these endpoints were evaluated for each event. We divided the events into two groups according to the treatment that included CNI or conventional therapy without CNI. RESULTS: One hundred seventy-eight patients with 247 events were analysed. CNI were predominantly used in 72 events with a recurrent history, typical skin rash, high ferritin levels, and/or severe complications such as macrophage activation syndrome, disseminated intravascular coagulation, serositis, meningitis. CNI led to a significantly longer event-free survival (hazard ratio: 0.57, 95% confidential interval: 0.32-0.99) after adjustment of concomitant medications. Subgroup analysis showed that CNI were effective for AOSD patients with high ALT level (hazard ratio: 0.11, 95% confidential interval: 0.02-0.59) and severe complications (hazard ratio: 0.11, 95% confidential interval: 0.01-0.94). The persistency rate of CNI was 71% at 5th year. Adverse events occurred more frequently in the CNI group (18% versus 8%, p=0.02); however, CNI did not involve in increased risk of adverse events, including nephrotoxicity, after adjustment (p=0.23). CONCLUSIONS: Our retrospective analysis suggested that CNI could be an effective and safe option for treating AOSD.

7.
Cornea ; 39(6): 745-753, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32028281

RESUMO

PURPOSE: To investigate the details of the long-term progression of ocular surface cicatrization in eyes with ocular sequelae caused by Stevens-Johnson syndrome (SJS)/toxic epidermal necrosis (TEN). METHODS: In 105 eyes of 66 patients with SJS/TEN, the severity of ocular sequelae was retrospectively evaluated using an ocular surface grading score (OSGS) at 2 time points separated by a greater than 5-year interval. The OSGS included 7 ocular surface components (conjunctivalization, neovascularization, opacification, keratinization, symblepharon, and upper/lower conjunctival-sac shortening) evaluated into grades 0 to 3 (maximum total OSGS: 21), with the worsening of each component and total OSGS evaluated at the greater than 5-year interval. Moreover, we evaluated whether upper-tarsus and lid-margin scarring are factors that affect ocular surface cicatrization progression. RESULTS: In 35 (33.3%) of 105 eyes, the total OSGS worsened during the follow-up period. Partial conjunctivalization (score 1-2) progressed more frequently to total conjunctivalization (score 3) than to no conjunctivalization (score 0) (OR [95% CI]; 5.6 [1.6-20.3]). Partial keratinization (score 1-2) also had a high risk of progression into total keratinization (41.0 [6.3-266.5]). In all cases, keratinization progressed only in the eyes with total conjunctivalization (conjunctivalization score 3). Severity of upper-tarsus scarring or lid-margin scarring affected the worsening of the total OSGS. CONCLUSIONS: In 66 patients with chronic-phase SJS/TEN, ocular surface cicatrization progressed in 33.3% of the 105 eyes during the long-term follow-up period of over 5 years. More than 50% of the partial conjunctivalization eyes progressed toward total conjunctivalization. The partial keratinization eyes had a high possibility of progressing to total keratinization; that is, the so-called "end-stage" status.

8.
Breast ; 49: 219-224, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31901783

RESUMO

BACKGROUND: Recently, the efficacy of cryotherapy and compression therapy to prevent taxane-induced peripheral neuropathy has been reported. We prospectively compared the efficacy of cryotherapy using a frozen glove (FG) and compression therapy using a surgical glove (SG) to prevent nanoparticle albumin-bound paclitaxel (nab-PTX)-induced peripheral neuropathy. PATIENTS AND METHODS: Breast cancer patients who received 260 mg/m2 of nab-PTX were eligible to participate in this trial. Patients wore a FG on one hand (60 min) without changing and two SGs of the same size (i.e., one size smaller than the size that best fit their hand) on the other hand (90 min) during chemotherapy. Peripheral neuropathy was evaluated at each treatment cycle using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, the Patient Neurotoxicity Questionnaire (PNQ), and the Functional Assessment of Cancer Therapy-Taxane subscale. Temperatures at each fingertip in both groups were measured thermographically. RESULTS: Between August 2017 and March 2019, 43 patients were enrolled and 38 were evaluated. No cases showed discordance of peripheral neuropathy between each gloved group in cases of CTCAE ≥ grade 2. In cases of PNQ ≥ grade D, using the Nam equivalence test, the upper test (P = 0.0329) and lower test (P = 0.0052) both showed negative results in comparisons between each gloved group. Fingertip temperature was significantly lower in the FG group than in the SG group after treatment (P < 0.0001). CONCLUSIONS: It seems to be no difference in incidence of nab-PTX-induced peripheral neuropathy using either cryotherapy or compression therapy.

9.
Mod Rheumatol ; 30(1): 109-115, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30472908

RESUMO

Objective: To assess risk factors for cytomegalovirus (CMV) disease with CMV re-activation in patients with rheumatic disease.Methods: The clinical data of consecutive patients with rheumatic disease who experienced CMV re-activation were examined. We evaluated the difference in various baseline factors at the first detection of CMV pp65 antigenemia on the development of CMV disease using logistic regression models. The changes of laboratory data in the 4 weeks before CMV re-activation were also assessed.Results: We identified 80 patients (median age [interquartile range] = 65.0 years [51.5-74.0]) with CMV re-activation. Oral candidiasis, serum albumin ≤30 g/L, and CMV pp65-positive cell count >5.6/105 polymorphonuclear leukocyte cells were found to be associated with CMV disease (odds ratio [OR] [95% CI] = 9.99 [2.02-49.50], 11.4 [1.94-67.40] and 6.80 [1.63-28.30], respectively). Moreover, decreases in serum albumin level and blood lymphocyte count in the 4 weeks before CMV re-activation also predicted CMV disease (OR [95% CI] = 2.02 [1.07-3.8] and 1.96 [1.09-3.54], respectively).Conclusion: In CMV re-activation patients with rheumatic disease, the presence of oral candidiasis, high CMV pp65 positive cell count, and hypoalbuminemia are possible risk factors for CMV disease.

10.
Mod Rheumatol ; 30(2): 338-344, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30929541

RESUMO

Objectives: To identify the factors associated with the risk of diffuse alveolar hemorrhage (DAH) in patients with microscopic polyangiitis (MPA), focusing on other preexisting lung involvements such as interstitial lung disease (ILD) and airway disease.Methods: In this retrospective cohort study, we analyzed consecutive patients with myeloperoxidase-antineutrophil cytoplasmic antibody-positive MPA who had undergone chest computed tomography (CT) before starting treatment between 2006 and 2016. Patients who already had DAH at initial CT imaging were excluded. CT images were evaluated for the presence of ILD and airway disease. The association between preexisting lung involvements and the development of DAH was assessed using logistic regression models adjusted for various clinical characteristics.Results: We identified 113 patients (median age 72 years; median follow-up duration 39 months), and 27 (24%) of them developed DAH during the follow-up. Airway disease was identified in 41 (36%) patients and was independently associated with the development of DAH (adjusted odds ratio 6.86, 95% confidence interval 1.85-25.4). However, ILD identified in 45 (40%) patients was not associated with DAH.Conclusion: Our findings suggest that DAH in MPA occurs frequently in patients with airway disease. Attention to preexisting airway disease may help predict the development of DAH.

11.
Diab Vasc Dis Res ; 17(1): 1479164119883986, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31726868

RESUMO

Our aim was to examine the seasonal variations in home blood pressure measurements and the relationship of ambient temperature or room temperature with the seasonal variations in home blood pressure measurements using a home blood pressure telemonitoring system in patients with type 2 diabetes. The home blood pressure measurements of 41 patients with type 2 diabetes were self-measured. Patients performed triplicate morning and evening blood pressure measurements at least 5 days per month for 12 consecutive months. The lowest values of both systolic blood pressure and diastolic blood pressure were observed in August (126.3 and 70.4 mmHg, respectively), and the highest systolic and diastolic blood pressure values were observed in January (140.3 and 76.9 mmHg, respectively). The root mean squared error between the mean systolic blood pressure and room temperature was 6.50 mmHg and between mean systolic blood pressure and ambient temperature was 6.55 mmHg. Using a home blood pressure telemonitoring system, this study revealed for the first time that home blood pressure varied seasonally, with the highest values observed in January and the lowest values observed in August, and that the seasonal variations in home blood pressure were related to room temperature as well as ambient temperature.

12.
Trials ; 20(1): 761, 2019 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-31870424

RESUMO

BACKGROUND: Hypertension is present in more than 50% of patients with type 2 diabetes mellitus. Dietary salt restriction is recommended for the management of high blood pressure. Instructions on dietary salt restriction, provided by a dietitian, have been shown to help patients reduce their salt intake. However, appointments for the dietitians in hospitals are often already fully booked, making it difficult for patients to receive instructions on the same day as the outpatient clinic visit. AIM: The aim of this trial is to test a new intervention to assess whether guidance on dietary salt restriction provided by physicians during outpatient visits is effective in reducing salt intake in patients with type 2 diabetes mellitus who have an excessive salt intake. METHODS: In this unblinded randomized controlled trial (RCT), a total of 200 patients, male or female, aged between 20 and 90 years, who have type 2 diabetes mellitus and consume excessive salt will be randomly assigned to two groups: an intervention group and a control group. In addition to being given routine treatment, participants in the intervention group will be given individual guidance on restricting their dietary salt intake by a physician upon enrollment. The control group will only be given routine treatment. Participants will be followed up for 24 weeks. The primary outcome will be dietary salt intake, which will be assessed at baseline and at 8, 16, and 24 weeks. The secondary outcomes, including body weight, body mass index, hemoglobin A1c level, blood pressure, blood glucose level, serum lipid profile, and urinary albumin excretion level, will be assessed at baseline and at 8, 16, and 24 weeks. DISCUSSION: The results of this RCT have the potential to provide a simple and novel clinical approach to reduce salt intake among patients with type 2 diabetes, making regular visits to their physician, in outpatient facilities. This protocol will contribute to the literature because it describes a practical intervention that has not been tested previously, and it may serve as guidance to other researchers interested in testing similar interventions. TRIAL REGISTRATION: University Hospital Medical Information Network (UMIN), UMIN000028809. Registered retrospectively on 24 August 2017. http://www.umin.ac.jp.

13.
J Clin Biochem Nutr ; 65(3): 252-257, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31777428

RESUMO

The aim of the present study was to examine whether dietary salt restriction guidance is beneficial for dietary salt restriction and lowering of home blood pressure in patients with diabetes with excessive salt intake. We performed an intervention trial of 37 people with type 2 diabetes and excessive salt intake. National registered dietitians provided dietary salt restriction guidance to each patient at the start of the study. All participants were instructed to perform triplicate morning and evening home blood pressure measurements using home blood pressure telemonitoring system. Daily salt intake at 2 months and 6 months was significantly lower than that at baseline; the difference was 0.8 [95% confidence interval (CI): 0.2-1.4, p = 0.009] g and 0.7 (95% CI: 0.1-1.3, p = 0.009) g, respectively. Morning systolic blood pressure at 2 months and 6 months was significantly lower than that at baseline; the difference was 2.7 (95% CI: 0.2-5.1, p = 0.034) mmHg and 5.8 (95% CI: 0.5-11.1, p = 0.034) mmHg, respectively. This intervention study revealed, for the first time, that dietary salt restriction guidance provided by a national registered dietitian is beneficial for reducing daily salt intake and home blood pressure in people with diabetes with excessive salt intake.

14.
Diabetes Res Clin Pract ; 158: 107920, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31711859

RESUMO

BACKGROUND: Isolated high home systolic blood pressure (IH-HSBP) has been revealed to be correlated with cardiovascular disease and diabetic nephropathy, however, the prognostic significance of IH-HSBP with the development of diabetic nephropathy is unclear. METHODS: In this prospective 2-year cohort study of 477 patients with normoalbuminuria, we investigated the effect of IH-HSBP on the development of diabetic nephropathy defined by diabetic nephropathy advanced from normoalbuminuira to micro or macroalbuminuria. RESULTS: Among 477 patients, 67 patients showed the development of diabetic nephropathy. In the multivariate logistic regression analyses, IH-HSBP was prognostic factor for the development of nephropathy after adjusting for sex, age, duration of diabetes mellitus, body mass index, total cholesterol, hemoglobin A1c, creatinine, smoking habits and use of renin-angiotensin-aldosterone system inhibitors (odds ratio: 2.53, 95% confidence interval: 1.16-5.56, p = 0.020). CONCLUSION: IH-HSBP in patients with type 2 diabetes with normoalbuminuria was prognostic factor for the development of diabetic nephropathy. We should pay more attention to IH-HSBP to prevent the development of diabetic nephropathy.

15.
Geriatr Gerontol Int ; 19(12): 1236-1242, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31746115

RESUMO

AIM: Cognitive decline increases mortality risk through dementia-related pathways and might be associated with increased healthcare costs. Using up to 12 years of repeated measures data, we identified trajectories in cognitive function among community-dwelling older Japanese adults. We then examined whether these trajectories were associated with all-cause and cause-specific mortality, and differences in healthcare costs. METHODS: A total of 1736 adults aged ≥65 years who were free of disabling dementia completed annual assessments during 2002-2014. Cognitive function was assessed with the Mini-Mental State Examination. The average number of follow-up assessments was 3.9, and the total number of observations was 6824 during the follow-up period. RESULTS: We identified five trajectory patterns in cognitive function (high, second, third, fourth, and low) during the 12-year follow-up period. The low (2.0%) and fourth (2.2%) trajectory groups had higher hazard ratios for cardiovascular disease mortality, and hazard ratios for other cause mortality were significantly higher for the third (16.8%) and second (38.8%) trajectory groups than for the high trajectory group (40.3%). Until 5 years of follow up, participants in the two lower-trajectory groups had higher mean combined monthly medical and long-term care costs. After 8 years of follow up, mean costs were highest for the third trajectory. CONCLUSIONS: The risk of death from cardiovascular disease was higher in the two lower-trajectory groups in cognitive function, and they showed higher healthcare costs during the first 5 years of follow up. After 8 years of follow up, the third trajectory had the highest healthcare costs, perhaps because of hospitalizations attributable to gradual cognitive decline. Geriatr Gerontol Int 2019; 19: 1236-1242.

16.
BMJ Open ; 9(11): e031698, 2019 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-31694850

RESUMO

INTRODUCTION: Anticoagulant therapy in patients with cancer with venous thromboembolism (VTE) increases the risk of both VTE recurrence and haemorrhagic complication. Direct oral anticoagulants (DOACs) have been shown to be effective in preventing VTE recurrence, and comparable to conventional therapy in preventing VTE recurrence in patients with advanced cancer. Rivaroxaban is a DOAC that causes thrombus regression, possibly through a profibrinolytic effect. Thrombus regression with initial treatment is essential for VTE patients. However, the thrombolytic effect of DOAC for VTE patients with cancer has not been fully examined. Therefore, in this study, we investigate the thrombolytic effect of rivaroxaban in patients with cancer who develop VTE. METHODS AND ANALYSIS: This study is a single-arm, open-label, prospective interventional study. Forty patients aged from 20 to 75 years old at the time of consent who have been diagnosed with acute VTE and have active cancer are included. Patients are excluded if they have received thrombolytic therapy, have creatinine clearance of less than 30 mL/min, have expected a life expectancy of less than 6 months or have deep vein thrombosis limited to the distal lower leg. Eligible patients receive standard treatment with rivaroxaban (15 mg two times daily for 3 weeks, followed by 15 mg QD). The primary study endpoint is clot regression ratio as evaluated by contrast-enhanced CT imaging. CT imaging is obtained at baseline, 21±4 and 90±14 days after the start of rivaroxaban treatment. Secondary endpoints are the recurrence of VTE and haemorrhagic complications. ETHICS AND DISSEMINATION: This study was approved by the institutional review board of the Kyoto Prefectural University of Medicine. Study results will be disseminated through peer-reviewed journals.Trial registration numberUMIN000027793.

17.
Biom J ; 2019 Oct 14.
Artigo em Inglês | MEDLINE | ID: mdl-31608505

RESUMO

Basket trials simultaneously evaluate the effect of one or more drugs on a defined biomarker, genetic alteration, or molecular target in a variety of disease subtypes, often called strata. A conventional approach for analyzing such trials is an independent analysis of each of the strata. This analysis is inefficient as it lacks the power to detect the effect of drugs in each stratum. To address these issues, various designs for basket trials have been proposed, centering on designs using Bayesian hierarchical models. In this article, we propose a novel Bayesian basket trial design that incorporates predictive sample size determination, early termination for inefficacy and efficacy, and the borrowing of information across strata. The borrowing of information is based on the similarity between the posterior distributions of the response probability. In general, Bayesian hierarchical models have many distributional assumptions along with multiple parameters. By contrast, our method has prior distributions for response probability and two parameters for similarity of distributions. The proposed design is easier to implement and less computationally demanding than other Bayesian basket designs. Through a simulation with various scenarios, our proposed design is compared with other designs including one that does not borrow information and one that uses a Bayesian hierarchical model.

18.
PLoS One ; 14(10): e0223947, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31665172

RESUMO

BACKGROUND: Rocuronium induces venous pain and the withdrawal reflex during injection. MR13A10A, generic rocuronium with a novel solution, reduced the injection-induced withdrawal reflex in rodents. We hypothesized that MR13A10A would reduce the frequency and severity of injection-induced withdrawal reflexes compared with original rocuronium during clinical anesthesia induction. METHODS: This prospective, open (but assessor-blinded), randomized, controlled study was conducted at a single academic hospital. The assessor was blinded to the study condition in order to minimize observer bias. Participants were allocated to either MR13A10A or traditional formula groups by a blocked stratified randomization method. Participants in the MR13A10A group received MR13A10A, whereas the original rocuronium group received the same amount of original rocuronium. The primary outcome was presence of the withdrawal reflex after rocuronium injection. Severity of the withdrawal reflex, changes in blood pressure and heart rate, and the train of four (TOF) ratio were measured as secondary outcomes. The withdrawal reflex was assessed using a video recording in a blinded manner. RESULTS: Of the 149 participants, 76 were allocated to the MR13A10A group and 73 to the original rocuronium group. The frequency of the withdrawal reflex was significantly lower with MR13A10A compared with original rocuronium (19.7% and 54.8% for MR13A10A and original rocuronium groups, respectively, p<0.001). The odds ratio adjusted for cannulation site, cannula size, induction agent and age was 6.27 (95% CI, 2.87, 13.73 p<0.001). Original rocuronium was an independent factor related to a higher post-treatment heart rate. The proportions of TOF ratios = 0 were similar between the two groups. CONCLUSION: The frequency and severity of the withdrawal reflex after injection were significantly reduced by using MR13A10A. MR13A10A might contribute to safe and less invasive anesthesia management.

19.
Endocr J ; 66(11): 995-1000, 2019 Nov 28.
Artigo em Inglês | MEDLINE | ID: mdl-31292303

RESUMO

We investigated the factors associated with fatty liver remission via treatment with ipragliflozin. The analysis was obtained from our multi-center prospective observational study, including 200 Japanese patients with type 2 diabetes treated with ipragliflozin (50 mg/day) for 24 weeks. The extent of fatty liver was estimated using a fatty liver index (FLI). Based on the FLI after the treatment with ipragliflozin, patients were classified into remission group (FLI < 30) and non-remission group (FLI ≥ 30). After treatment with ipragliflozin for 24 weeks, FLI significantly improved from 64.5 ± 21.6 to 51.9 ± 26.5 (p < 0.01). Body weight, body mass index, waist circumference, aspartate aminotransferase, alanine aminotransferase, and FLI in the remission group were significantly lower compared with those of the non-remission group. Stepwise analysis showed that the baseline FLI (Odds ratio 0.86; 95% confidence interval 0.81-0.90, p < 0.01) was an independent factor associated with FLI remission. Using a receiver operating characteristic (ROC) analysis, the adequate cut-off value for the remission was 50. The area under the ROC curve was 0.93 with the sensitivity and specificity 84.6% and 90.1% respectively. In conclusion, ipragliflozin ameliorated fatty liver. These results suggest that patients with fatty liver with a lower FLI are more likely to attain remission by the treatment with ipragliflozin.

20.
Dement Geriatr Cogn Disord ; 47(4-6): 233-242, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31315125

RESUMO

BACKGROUND: Serum albumin and hemoglobin levels are independently associated with subsequent cognitive deterioration in older adults. This prospective study used repeated measures analysis to identify aging trajectories in serum albumin and hemoglobin levels and investigated if these trajectories were associated with incident disabling dementia among community-dwelling older Japanese. METHODS: A total of 2,005 adults aged 65-90 years participated in annual geriatric health assessments during the period from June 2002 through July 2017; the total number of observations was 9,330. A review of a municipal database of the Japanese public long-term care insurance system identified 1,999 of 2,005 adults without dementia at baseline, 278 (13.9%) of whom developed disabling dementia during the follow-up period (June 2002 through December 2017). RESULTS: We identified three trajectory patterns (high, moderate, and low) for serum albumin and hemoglobin levels for the age period 65 through 90 years. After controlling for potential confounders, participants with moderate and low trajectories for serum albumin level had hazard ratios of 1.27 (95% confidence interval 0.94-1.72) and 2.07 (1.37-3.11), respectively, for the development of incident disabling dementia, with the high trajectory group as reference. The respective hazard ratios for hemoglobin level were 1.31 (0.93-1.85) and 1.58 (1.04-2.40), respectively. CONCLUSION: Dementia risk was higher for individuals with low trajectories for serum albumin and hemoglobin levels. This finding highlights the importance of interventions that improve nutritional status and control relevant diseases in middle-aged and older adults with low serum albumin and hemoglobin levels.


Assuntos
Demência/sangue , Hemoglobinas/análise , Estudos Prospectivos , Albumina Sérica/análise , Idoso , Idoso de 80 Anos ou mais , Grupo com Ancestrais do Continente Asiático , Biomarcadores/sangue , Bases de Dados Factuais , Pessoas com Deficiência , Feminino , Avaliação Geriátrica , Humanos , Vida Independente , Japão , Masculino , Modelos de Riscos Proporcionais , Medição de Risco
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