1.Information: Recommendations for developing postmarketing surveys and clinical investigations using SS-MIX standardized storage
Kiyoshi Kubota ; Daisuke Koide ; Akira Kokan ; Shigeru Kageyama ; Shinichiro Ueda ; Michio Kimura ; Ken Toyoda ; Yasuo Ohashi ; Hiroshi Ohtsu ; Kotonari Aoki ; Osamu Komiyama ; Koji Shomoto ; Takeshi Hirakawa ; Hidenori Shinoda ; Tsugumichi Sato
Japanese Journal of Pharmacoepidemiology 2013;18(1):65-71
The Standardized Structured Medical record Information eXchange (SS-MIX) was started in 2006 as the project supported by the Ministry of Health, Labour and Welfare (MHLW) for promoting the exchange of the standardized medical information. Free soft wares developed in the project allow the storage of medical information to receive HL7 messages for prescription, laboratory test results, diagnoses and patient demographics in the hospital information system (HIS). We encourage the use of the SS-MIX standardized storage for postmarketing surveys and clinical studies. The recommendations consist of the following 7 parts. [1] In surveys and clinical studies, the information of drugs and laboratory test results in the SS-MIX standardized storage can be directly transferred to the electronic questionnaire and the investigators may obtain the information with high accuracy and granularity. [2] The SS-MIX standardized storage works as the backup system for the HIS because it can provide the minimum information essential in patient care even under the disastrous condition like earthquake or unexpected network failure. [3] The SS-MIX standardized storage may be useful to conduct a good pharmacoepidemiology study not only because it provides the information in the storage efficiently but also it can be used to identify “new users” who started the drug after some period of non-use.The “new user” design is often essential to have the unbiased results. [4] When the drug company conducts postmarketing surveys according to the current regulation, the use of the SS-MIX standardized storage will facilitate the fast and efficient collection of data to develop the timely measure to minimize the drug-related risk. With the SS-MIX standardized storage, it is also expected that many types of study design can be employed and the quality of data is improved in the survey. [5] The SS-MIX standardized storage maybe also useful to evaluate the risk minimization action plan by comparing the prescription pattern or incidence of the targeted adverse event between two periods before and after the implementation of the action plan. [6] In planning clinical trials, the SS-MIX standardized storage may be used to estimate the size of eligible patients. The storage may also allow conducting cross-sectional studies to know characteristics of diseases or drug treatment. In addition, cohorts of those who had coronary artery angiography, new users of a drug and those with a rare disease may be readily identified. Using such cohorts, investigators can initiate a case-control study nested within the cohort, pharmacogenomic studies and comparative effectiveness researches. [7] The SS-MIX standardized storage may be used as the formal data source in clinical trials in the future when some conditions are satisfied. For instance, the formal agreement should be reached between industry, government and academia on the use of standards of data structure in Clinical Data Interchange Standards Consortium (CDISC) and on the operation of computerized system validation (CSV) in the clinical trials.
2.Stereolithographic biomodeling of equine ovary based on 3D serial digitizing device.
Junpei KIMURA ; Nobunori KAKUSHO ; Kenji YAMAZAWA ; Yuuko HIRANO ; Yasuo NAMBO ; Hideo YOKOTA ; Ryutaro HIMENO
Journal of Veterinary Science 2009;10(2):161-163
The 3D internal structure microscopy (3D-ISM) was applied to the equine ovary, which possesses peculiar structural characteristics. Stereolithography was applied to make a life-sized model by means of data obtained from 3D-ISM. Images from serially sliced surfaces contributed to a successful 3D reconstruction of the equine ovary. Photopolymerized resin models of equine ovaries produced by stereolithography can clearly show the internal structure and spatial localizations in the ovary. The understanding of the spatial relationship between the ovulation fossa and follicles and/or corpora lutea in the equine ovary was a great benefit. The peculiar structure of the equine ovary could be thoroughly observed and understood through this model.
Animals
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Computer Simulation
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Female
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Horses/*anatomy & histology
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Imaging, Three-Dimensional/veterinary
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Models, Anatomic
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Ovary/*anatomy & histology
3.RELATIONSHIP BETWEEN DAILY STEPS AND PHYSICAL FITNESS IN COMMUNITY-DWELLING ELDERY
HIROSHI NAGAYAMA ; YASUO KIMURA ; MIEKO SHIMADA ; NAOKI NAKAGAWA ; MAMORU NISHIMUTA ; MASAHARU OHASHI ; HIDEO MIYAZAKI ; TAKAFUMI HAMAOKA ; YUTAKA YOSHITAKE
Japanese Journal of Physical Fitness and Sports Medicine 2008;57(1):151-162
The purpose of this study was to examine the association between the pedometer-determined steps per day and physical fitness in order to evaluate the usefulness of the pedometer-determined physical activity to help individuals meet the recommended exercise target level of the Ministry of Health, Labour and Welfare (MHLW). The subjects consisted of 222 men and 172 women aged 71 years in community-dwelling elderly. The subjects wore a pedometer for 7 consecutive days to measure daily steps. The functional capacity was assessed based on the Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG-IC) and self-reported performance of tasks (stair-climbing and chair-rising). Physical fitness tests included handgrip strength, knee extensor strength, leg extensor power, stepping, one-leg standing time with eyes open and maximal walking speed at 10 m. The men and women took on average 6,561±2,907 and 6,329±2,451 steps/day, respectively. Our subjects seemed to be highly functioning elderly, because the total scores of TMIG-IC (maximum : 13 scores) were on average 12 for men and women. The average of steps/day was significantly correlated with stair-climbing, chair-rising and knee extensor strength in men and women, and with body weight, body mass index (BMI), percent body fat (%Fat) and leg extensor power in women. The BMI and %Fat levels were significantly lower while the handgrip strength and knee extensor strength were significantly higher in women who attained to the level of the pedometer-determined physical activity as recommended by the MHLW.The present study suggests that both men and women who take a lot of steps on a daily basis tend to demonstrate excellent leg strength and thus have a good ability to perform the tasks of daily living. In addition, the degree of obesity tends to be lower in women who regularly take a lot of steps. In addition, the number of daily steps taken has been recognized to be linked to gender, and such a link has also been suggested to be stronger in women than in men.
4.THE ASSOCIATION BETWEEN INCIDENCE OF FALLS AND PHYSICAL FITNESS IN COMMUNITY- DWELLING ELDERLY
TOMOKO HATAYAMA ; MAYUMI NAGANO ; HIROSHI UNE ; YUTAKA YOSHITAKE ; YASUO KIMURA ; YOSHITO MOMOSE ; YUKO KAI ; MASATAKA SUWA ; SHUZO KUMAGAI
Japanese Journal of Physical Fitness and Sports Medicine 2008;57(4):503-510
This prospective study was designed to clarify the association between the incidence of falls and physical fitness in healthy community-dwelling elderly people without history of fall-related injuries within 1-5 years before the baseline assessment. Six hundred and one elderly subjects aged 60-79 years who lived independently participated in baseline assessments from March 2002 to March 2004, and were followed up for one year to detect falling. Demographic items (age and sex), chronic disease, self-rated health, difficulty in performing any activity, tendency to stay at home, body mass index (BMI), %vital capacity, handgrip and knee extension strength, stepping rate, one-leg standing with eyes opened, trunk flexion at sitting position, maximum walking speed, instrumental activity of daily living (IADL), and General Health Questionnaire (GHQ30) were assessed at baseline. Four hundred and eighty-one participants (80.0%) completed the 1-year follow-up.The fall incidence was 13.1%. In men, fallers had lower BMI and decreased maximum walking speed, however, neither showed significant odds ratio (OR) for fall. In women, fallers had lower knee extension strength and the ratio of weak side to strong side (WS/SS ratio) in knee extension strength compared to non-fallers. The age-adjusted OR for fallers in the lowest quartile (knee extension strength<0.681kg/BW) was 3.07 (95%CI : 1.02-9.22) compared to highest quartile (>0.980 kg/BW), while the multiple-adjusted OR was not significant (OR=2.88, 95%CI : 0.94-8.79). However, the multiple-adjusted OR for fallers in the lowest quartile of the WS/SS ratio in knee extension strength (<0.771) was 4.49 (95%CI : 1.40-14.37) compared to highest quartile (>0.947).As for conclusion, without history of fall-related injuries, only a weak association between falls and physical fitness was observed in men. In women, the unbalanced knee extension strength was associated with falls. The WS/SS ratio in knee extension strength might be a key factor in predicting falls in women.
5.INCLINATION OF EXPONENTIAL CURVE-FITTING MODEL FOR HEART RATE AND OXYGEN UPTAKE DURING INCREMENTAL EXERCISE AS INDEX OF CARDIO-PULMONARY FUNCTIONAL IN PATIENTS WITH ISCHEMIC HEART DISEASE
KAZUO TSUYUKI ; YASUO KIMURA ; HIROYOSHI YANO ; TOMOMI SAKAMOTO ; KENJI NINOMIYA ; KUNIO EBINE ; KOHTETSU CHOH ; TOSHIHIRO ARAI ; SAKAE OHSAKI
Japanese Journal of Physical Fitness and Sports Medicine 2006;55(1):117-124
This study was conducted to clarify the validity and availability of inclination of exponential curve-fitting model for oxygen uptake (VO2) and heart rate (HR) during incremental exercise (I-ECOH) as an index of cardio-pulmonary functional reserve in patients with ischemic heart disease (IHD). A treadmill exercise test was used to measure the VO2(L/kg/min) and HR (beat/min) during incremental exercise of all subjects. I-ECOH was derived from the following equation : HR=A·expB·VO2. The constant "B" represents I-ECOH. The following two identifications were made : 1) the relation between peak oxygen uptake (VO2peak) and I-ECOH in IHD patients with normal left ventricular function and with chronic heart failure (CHF); 2) the relation between I-ECOH and the New York Heart Association (NYHA) functional classification of IHD patients with CHF.There were significant differences among IHD patients with normal left ventricular function, CHF patients, normal controls and long distance runners in I-ECOH and VO2peak, respectively (p<0.001). There were inverse correlations between I-ECOH and VO2peak in IHD patients with normal left ventricular function (r=-0.64, p<0.001) and CHF (r=-0.63, p<0.001). I-ECOH could be used to discriminate effectively between NYHA functional classes (p<0.001).In conclusion, these results suggest that I-ECOH is adequate and useful as an index of cardio-pulmonary functional reserve in patients with ischemic heart disease.
6.Cardiac Output Measurement Using the Non-Invasive Cardiac Output (NICO) Monitor: A Comparative Study with the Standard Thermodilution Technique
Chieri Kimura ; Fumio Kunimoto ; Yasuo Morishita
Japanese Journal of Cardiovascular Surgery 2004;33(1):6-8
The non-invasive cardiac output (NICO) monitor is a new device in order to measure cardiac output (CO). A rebreathing circuit is built in the NICO monitor and CO is calculated using the Fick CO2 equation. We compared this technique with the standard thermodilution (TDCO) technique in patients with thoracic and abdominal surgery. Thirty-two paired data were obtained in 17 patients. Correlation between the two methods in patients with controlled mechanical ventilation (CMV) was fair, with a correlation coefficient of 0.85. However, the correlation coefficient of the two methods was 0.60 in spontaneous breathing patients. Bland-Altman analysis showed a bias of 0.24±0.68 (mean±2SD) in CMV patients and 1.44±1.28 in spontaneous breathing patients. The NICO value was inversely proportional to an end-tidal CO2 difference (ΔETCO2) between pre-rebreathing and post-rebreathing. The large bias in spontaneously breathing patients might be due to a small ΔETCO2 in spontaneously breathing patients. The NICO monitor has a tendency to measure higher CO values in spontaneously breathing patients.
7.INCLINATION OF EXPONENTIAL CURVE-FITTING MODEL FOR OXYGEN UPTAKE AND HEART RATE DURING INCREMENTAL EXERCISE AS INDEX OF CARDIO-PULMONARY FUNCTIONAL RESERVE
KAZUO TSUYUKI ; YASUO KIMURA ; TOMOMI KAMEYAMA ; KENJI NINOMIYA ; SHINICHI WATANABE ; KOHTETSU CHOH ; HIROKAZU KOZAKAI ; KUNIO EBINE
Japanese Journal of Physical Fitness and Sports Medicine 2003;52(5):575-584
A study was conducted to clarify the validity and availability of inclination of exponential curve-fitting model for oxygen uptake (VO2) and heart rate (HR) during incremental exercise (IECOH) as an index of cardio-pulmonary functional reserve in healthy subjects. A treadmill exercise test was used to measure the VO2 (L/kg/min) and HR (beat /min) during incremental exercise of all subjects. The IECOH was derived from the following equation : HR=A⋅expB·VO2. The constant “B” represents the IECOH. The following three identifications were made : 1) the relationship between maximal oxygen uptake (VO2max) and IECOH in 82 healthy males ; 2) the relationship between IECOH and age in 428 healthy males and females ; 3) the effect of physical training in 8 healthy males.
There was inverse correlation between IECOH and VO2max (r= -0.824) . And also, there were inverse correlations between IECOH detected from submaximal tests and VO2max (above r=-0.6) . There were no differences in the IECOH detected from maximal and submaximal tests. In Bland-Altman plot method, accuracy of measurment in the IECOH detected from submaximal exercise test was precise. There was a significant relationship between IECOH and age in male and female subjects (r=0.499 and r=0.310, respectively) . Physical training increased VO2max and decreased IECOH significantly. The VO2max before and after physical training correlated inversely with the IECOH before and after physical training (r=-0.514) .
In conclusion, these results suggest that IECOH is adequate and useful as an index of cardio-pulmonary functional reserve which can be measured by the submaximal exercise test in healthy subjects.
8.Effects of physical training on the ventilatory response to exercise in patients on chronic hemodialysis.
KAZUO TSUYUKI ; KOHTETSU CHOH ; HIROKI HASE ; YASUO KIMURA ; ATSUO KASUGAI ; KOUICHI CHIASHI ; KENJI NINOMIYA ; SHINICHI WATANABE ; KUNIO EBINE
Japanese Journal of Physical Fitness and Sports Medicine 2002;51(4):377-384
This study examined the effects of physical training on exercise hyperpnea (EH) in patients on hemodialysis (HD) . In baseline, 17 (trained group) and 12 (control group) patients on HD performed symptom limited exercise test using a treadmill. Trained group, but not control group, exercised 2 to 3 times weekly on non-dialysis days under medical supervision. Exercise testing was repeated 20 weeks after the baseline. Ventilatory response to exercise was evaluated using the regression slope relating minute ventilation (VE) to carbon dioxide output (VCO2 ) during incremental exercise (VE/VCO2 slope) below the point of respiratory compensation. In trained group, VE, oxygen uptake ( VO2) and VCO2 at peak exercise increased and VE/VO2 and VE/VCO2 decreased after physical training, respectively. No change was observed in control group. VO2 at the anaerobic threshold increased in trained group, but not in control group. The post training VE/VCO2 slope (33.9±5.0) was significantly (p<0.05) lower than the pre-training slope (38.0± 4.8) and remained constant in control group. In trained group, changes in the VE/VCO2 slope correlated with those in peak VO2 (p<0.05) . These results suggest that physical training decreases EH in patients on HD and that it correlates with changes in exercise tolerance.
9.Relationship Between Exercise Hyperpnea and Exercise Tolerance in Patients on Chronic Hemodialysis.
KAZUO TSUYUKI ; HIROYOSHI YANO ; ATSUO KASUGAI ; YASUO KIMURA ; SHINICHI WATANABE ; HIROKI HASE ; KUNIO EBINE ; KWANGCHOL CHANG
Japanese Journal of Physical Fitness and Sports Medicine 2001;50(2):255-258
10.The effects of hyperoxia on exercise tolerance in serious ischemic heart disease patient.
KAZUO TSUYUKI ; NAOKO ONO ; SUSUMU IKEDA ; SACHIKO KAMEDA ; TAMAE OGATA ; YASUO KIMURA ; HIROKI HASE ; TAKAHIRO OKUDA ; MASAHIKO AIHARA ; KENJI NINOMIYA ; KWANGCHOL CHANG ; KUNIO EBINE
Japanese Journal of Physical Fitness and Sports Medicine 1996;45(2):319-328
A study was conducted to clarify the effect of hyperoxia (HO) on exercise tolerance andhemodynamics in patients with ischemic heart disease (IHD) . The subjects were 10 patients with serious IHD who showed ischemic ST depression during low-intensity exercise testing. In all subjects, cardiopulmonary exercise testing (CPX) was performed using two types of inhalation : normoxia (NO) and HO (O2: 60%, N2: 40%) . Heart rate (HR), blood pressure (BP), rating of perceived exertion (RPE), elapsed exercise duration and pressure rate product (PRP) were measured, and ECG was recorded during CPX according to the Bruce protocol. The peak oxygen uptake (VO2peak) was calculated using the appropriate formula. These data were compared between the NO and HO groups, and the following results were obtained.
ST depressions on ECG, BP, HR and PRP after 20 min of rest showed no changes under NO. The other hand, only ST depression was improved after 20 min of rest under HO. The exercise duration in HO group was longer than in the NO group, and the VO2peak in the HO group was higher than in the NO group. However, peak RPE showed no significant difference between the HO and NO groups. The incidence of ST depression as an endpoint of CPX showed no significant difference between the two groups. BP, HR and PRP at the CPX endpoint showed no significant differences between the HO and NO groups. In patients whose exercise duration was prolonged beyond the mean value by HO, peak HR and PRP were increased significantly. However, this tendency was not seen in patients whose exercise was prolonged for less than the mean value.
In conclusion, these results suggest that an increase in the oxygen supply to peripheral working muscles may play an important role in increasing exercise tolerance under HO in IHD patients.


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