1.Comparative Study of the Safety Information in the Private Import through the Internet of the Melatonin from which a Classification between Drugs and Food Differs in Japan and the United States
Kuniko Otsuka ; Yasuyuki Nomura ; Naoki Uchida ; Hajime Yasuhara ; Shinichi Kobayashi
Japanese Journal of Social Pharmacy 2014;33(1):21-29
Classification of food and pharmaceutical products are different. In the proper use of pharmaceutical products, it is essential for a medical consumer to receive the drug information about effectiveness, safety and quality of it. On the other hand, since legal classification between medicines and dietary supplements was based their cultures, the classification of each drug is different in each country. Melatonin is a hormone produced by the pineal gland and used for improvement of the jet lag. We searched melatonin product information of Japan and the United States by using Internet search mainly and investigated the relationship between amount of product information and product classification. Melatonin is classified as a dietary supplement in the United States, the product information of efficacy and safety is displayed as “Supplement Facts” and the use of melatonin in children is not recommended. On the other hand, melatonin is classified as a pharmaceutical product in Japan, but is not produced in Japan. Therefore, it is difficult to have it for Japanese customers, and then they personally import using the Internet with their self-responsibility. However it is difficult to obtain its appropriate information for consumers, because of the regulation of the Pharmaceutical Affairs Law. It has been reported that the poisoning accident by the excessive intake of melatonin already. It will increase the risk of the health problem to purchase melatonin through the Internet more. Therefore, we concluded that Internet purchase of Medicines had a high risk for Japanese customers since there was not sufficient drug information.
2.ADL Ability Characteristics of Partially Dependent Older People: Gender and Age Differences in ADL Ability
Susumu SATO ; Shinichi DEMURA ; Kiyoji TANAKA ; Kohsho KASUGA ; Hidetsugu KOBAYASHI
Environmental Health and Preventive Medicine 2001;6(2):92-96
Age and gender differences in ADL ability were investigated using 568 Japanese partially dependent older people (PD, Mean age=82.2 ±7.76 years) living in welfare institutions. The subjects were asked about 17 ADL items representing 7 ADL domains by the professional staff working at subjects’ institutions. Each item was assessed by a dichotomous scale of “possible” or “impossible”. Item proportions of “possible” response were calculated for gender and age groups (60s, 70s, 80s and 90s). Two-way analysis of variance (ANOVA) using the arcsine transformation method indicated no gender differences. Significant decreases in ADL ability with aging were found in 13 of the 17 items. The dependency of ADL in the PD significantly increases with aging, and there is no significant difference in this trend between men and women. The dependency of more difficult activities using lower limb increase from the 70s, and independency of low-difficult activities such as manual activities, feeding and changing posture while lying is maintained until the 80s and over.
Activities of Daily Living
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Ability
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Gender
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PUPILLARY DISTANCE
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age differences
3.Development of ADL index for older community people.
SHINICHI DEMURA ; SUSUMU SATO ; MASAKI MINAMI ; HIDETSUGU KOBAYASHI ; YOHEI NODA ; JINZABURO MATSUZAWA ; KANDO KOBAYASHI ; JYUNICHIRO AOKI
Japanese Journal of Physical Fitness and Sports Medicine 2000;49(3):375-384
The purposes of this study were to examine reliability and validity of ADL index for older people at home, and relationships between ADL score and various factors (ex. self-assessment of health status and physical fitness level, and exercise frequency/week), and to examine the screening basis for execution of physical fitness test based on distribution of ADL score. A questionnaire consisting of 12 ADL items and a physical fitness test of Ministry of Education, Science and Clture were administered to 5, 715 subjects 65 years or more age (male: 2, 745; female: 2, 970) . As a result of examining test-retest reliability of the ADL index, significant high correlations were shown among 12 ADL items (0.674≤r≤0.886), and in overall score (r=0.943) . The ADL score was significantly related to age and physical fitness test scores, and tended to be higher in subjects with a higher self-assessment of health status and physical fitness level, and with more frequency. It was suggested that these results prove the utility of the present ADL index. Further, as the result of examining relationships between distribution of overall ADL score and physical fitness test scores, the following screening bases were considered to be valid for judgement whether the physical fitness tests could be executed. The three screening bases using overall ADL score were: 1) 12 or under; 2) over 13 to under 24; 3) 24 and over. The four bases using item score were: 1) a category 1 response for items 1, 5 and 6; 2) a category 2 or 3 response for items 1, 5 and 6, and a category 1 response for items 3 and 4; 3) a category 3 response for items 2 and 14; 4) a category 1 response for items 10 and 12.
4.Cost-effectiveness Analysis of Pregabalin for Treatment of Peripheral Neuropathic Pain
Shunya IKEDA ; Setsuro OGAWA ; Toyoshi HOSOKAWA ; Kazushige MURAKAWA ; Nigishi HOTTA ; Shinichi KONNO ; Kazuhisa TAKAHASHI ; Shinichi KIKUCHI ; Kazuo HANAOKA ; Makoto KOBAYASHI
Japanese Journal of Pharmacoepidemiology 2011;16(1):1-9
This study aimed to estimate the cost-effectiveness of pregabalin treatment for neuropathic pain.
Design:Long-term simulations based on state transition models.
Methods:We examined the cost-effectiveness of pregabalin for treatment of three common peripheral neuropathic pains, postherpetic neuralgia(PHN), painful diabetic peripheral neuropathy(DPN), and radiculopathy, using the incremental cost-effectiveness ratio(ICER). We used quality-adjusted life years(QALYs)as an index of effectiveness, and also estimated medical costs. For PHN and DPN, we constructed state transition models comprising two states, with and without pregabalin treatment, and performed 52-week simulations. The pain scores reported in Japanese phaseIII studies were used to set patients' weekly pain scores. The results of utility surveys conducted overseas were used as utility scores, while values randomly sampled from probability distributions were used to set weekly pain scores and drop-out rates. In base-case analyses, we performed 1000 1st-order Monte Carlo simulations using 1000 values randomly sampled from probability distributions, and calculated QALYs and medical costs for 52 weeks for each group. For radiculopathy, the ICER was calculated from changes in QALYs for 12 weeks reported overseas and medical costs estimated separately for the identical period.
Results:The ICERs for PHN, DPN, and radiculopathy were 1,116,886 Yen/QALY, 1,100,420 Yen/QALY, and 1,095,943 Yen/QALY, respectively, which were well below the upper limits of ICER ranges for treatments considered cost-effective. There were no cases in which ICERs obtained from scenario and sensitivity analyses differed significantly.
Conclusion:Pregabalin was shown to be cost-effective treatment for neuropathic pain.
5.Sex differences in subjective symptoms of fatigue and associated factors in adolescence.
HIDETSUGU KOBAYASHI ; SHINICHI DEMURA ; FUMIO GOSHI ; MASAKI MINAMI ; YOSHINORI NAGASAWA ; SUSUMU SATO ; SHUNSUKE YAMAJI
Japanese Journal of Physical Fitness and Sports Medicine 1999;48(5):619-630
The purpose of this study was to examine sex differences in subjective symptoms of fatigue (SSF) in high school and college students by considering the relationship between subjective feeling of fatigue and life habits.
A questionnaire on SSF (54 items), dealing with subjective feeling of fatigue and life habits (frequency of exercise, going to sleep, waking in the morning and physical condition) was administered to 5622 healthy students aged 15-20 yr, and data of 5335 properly completed questionnaires was analyzed.
The following was determined :
1) Sex differences were confirmed in most SSF items. SSF complaints for females was generally higher than that of males.
2) The relationship between SSF and the age was low in both sexes.
3) Subjective feeling of fatigue is somewhat related to SSF.
4) The going to sleep last night influence on SSF was different in both sexes and related largely to the next day SSF in males.
5) Waking this morning and today's physical condition are related to SSF in both sexes.
6) In males, the influence of exercise habits on SSF regarding drowsiness is relatively large.
6.Effect of linear polarized near-infrared light irradiation on the recovery of isokinetic muscle exertion after strenuous exercise.
SHINICHI DEMURA ; SHUNSUKE YAMAJI ; YOSHINORI NAGASAWA ; HIDETSUGU KOBAYASHI ; MASAKI MINAMI ; YOSHIO TOYOSHIMA
Japanese Journal of Physical Fitness and Sports Medicine 2000;49(4):459-468
This study aimed to examine the effect of linear polarized near-infrared light (PL) irradiation on the recovery of isokinetic muscle exertion and subjective fatigue sensation in muscles after strenuous exercise. Eighteen healthy college students participated in the experiment for all conditions of meridian point irradiation (MPI), femurs muscles irradiation (FMI), and no irradiation (NI) . They all took isokinetic knee extension and flexion tests (IK test) before and after strenuous exercise up to exhaustion. Each subject was irradiated at the meridian point or in femurs muscles after the second IK test. The third IK test was carried out after ten-minutes rest.
The effects of PL irradiation were confirmed on the recovery rate of muscle fatigue in knee extension motion with high load intensity (PT 60 d/s and TW 60 d/s : MPI, FMI> NI, p<0.05 16.2%, 13.4%>8.5%, and 16.1%, 14.1%>8.3%, respectively) . Also, in flexion motion, significant differences in the recovery-degree for each condition were found, and the effect of PL irradiation was suggested. There was no difference between the effect of MPI and FMI. In addition, subjective fatigue sensation in muscles after rest decreased significantly in MPI as compared with NI (MPI: 52.1%>NI : 36.6%, p<0.05) . From the above, it was suggested that PL irradiation is effective on recovery in muscle fatigue after strenuous exercise regardless of irradiation conditions, MPI or FMI.
7.A Case of Blow-Out Type Cardiac Rupture after Acute Myocardial Infarction
Motohiko Goda ; Kiyotaka Imoto ; Shinichi Suzuki ; Keiji Uchida ; Kensuke Kobayashi ; Koichiro Date ; Toshiki Hatsune ; Makoto Okiyama ; Makoto Kato
Japanese Journal of Cardiovascular Surgery 2007;36(5):269-272
A 83-year-old woman suffered pulseless-electrical-activity (PEA) because of cardiac tamponade after acute myocardial infarction with blow-out type cardiac rupture. Immediately median sternotomy was performed and active bleeding from the postero-lateral wall was found. It was impossible to stop bleeding only by putting pressure on the aperture of the myocardium with a piece of TachoComb coated with gelatin-resorcinol-formaldehyde (GRF) glue, however, the chemical action of GRF glue made the delicate myocardium after acute infarction stronger and we managed to stop that bleeding with mattress sutures that had initially seemed to be impossible. She was discharged on POD 103 uneventfully. We think this is a useful and safe operation procedure for blow-out type cardiac rupture.
8.Examination of useful ADL items and scales to assess ADL ability in older community people. Regarding aging, physical fitness level, and interrelationships among ADL items.
SHINICHI DEMURA ; SUSUMU SATO ; JINZABURO MATSUZAWA ; YOHEI NODA ; HISAYOSHI MIYAGUCHI ; NOBUHIKO TADA ; HIDETSUGU KOBAYASHI ; FUMIO GOSHI ; MASAKI MINAMI
Japanese Journal of Physical Fitness and Sports Medicine 2000;49(2):237-246
The purpose of this study was to propose useful ADLs (activities of daily living) and scales to estimate ADL ability on community older people from the viewpoints of aging, physical fitness level, and interrelationship among ADL. The survey constructing of 15 ADL items and physical fitness test of Ministry of Education, Science and Culture were carried out on 458 older people. Each ADL item was constructed with 3 level scales.
As the results of this study, the following 12 ADLs were proposed as useful ADL items; in the locomotion domain, jumping across a ditch, walking, running, up and down stairs, and transfer; in the manipulation domain, taking bedding in and out, buttoning a shirt; in stability domain, standing in the bus or train, dressing while standing (trousers), standing on one foot with eyes open; in the posture-change domain, sitting up, standing up from the floor. These items were significantly related to age and physical fitness elements contributed largely to achievement of each ADL. Since significant high correlation was found between the index using 12 ADL items and that using 15 items, it is considered that the 12 items scale can account for the variance corresponded enough to that of 15 items scale, and that the new index is practical and simple.
In further research, it will be required to examine validity of each ADL item and index by using more large sample, and to clarify the relation to various factors influenced to ADL ability level.
9.A Case of Intravenous Leiomyomatosis with Intracardiac Progression
Yuko Hirayama ; Kiyotaka Imoto ; Shinichi Suzuki ; Keiji Uchida ; Kensuke Kobayashi ; Koichiro Date ; Motohiko Goda ; Toshiki Hatsune ; Makoto Okiyama ; Makoto Kato
Japanese Journal of Cardiovascular Surgery 2008;37(1):60-64
A 76-year-old woman presented because of bilateral lower-extremity edema and dyspnea. Transthoracic echocardiography revealed a mobile mass in the right atrium. A right atrial mass associated with heart failure was diagnosed. Surgery was performed. Intraoperative transesophageal echocardiography showed that the mass was contiguous with the inferior vena cava. However, the primary lesion was unclear. Therefore, only the intracardiac mass was resected. The margins of the residual tumor were marked with clips. Computed tomography performed immediately after surgery revealed a clip in structures contiguous with the region from a uterine myoma to the inferior vena cava. Intravenous leiomyomatosis was diagnosed on histopathological examination of the resected specimens. Computed tomography 6 months after surgery showed that the clip had moved from the inferior vena cava to a vein contiguous with the uterus. The tumor regressed slightly. Close follow-up is required.
10.Coronary Artery Bypass Grafting in a Patient with Malignant Rheumatoid Arthritis
Tomoki Choh ; Kiyotaka Imoto ; Shinichi Suzuki ; Keiji Uchida ; Hiromasa Yanagi ; Kensuke Kobayashi ; Kouichirou Date ; Motohiko Gouda ; Munetaka Masuda
Japanese Journal of Cardiovascular Surgery 2008;37(5):259-263
The patient was a 39 -year-old woman. Malignant rheumatoid arthritis was diagnosed when she was 32 years old, and the patient was treated with oral steroids. She presented at our center with sudden precordial pain. Coronary angiography revealed severe stenosis of the left main coronary artery (segment 5, 99%). Acute myocardial infarction and pulmonary edema were diagnosed. The patient underwent off-pump coronary-artery bypass grafting, with anastomosis of the left internal thoracic artery to the left anterior descending artery. One year 3 months later, the patient was readmitted to the hospital because of recurrent angina pectoris and heart failure. Coronary angiography showed patency of the left internal thoracic artery and severe stenoses of the left main coronary artery(segment 5, 100%), circumflex artery (segment 11, 99%), and right coronary artery (segment 1, 90%), suggesting angiitis. On-pump coronary-artery bypass grafting was done, with anastomosis of the right internal thoracic artery to the right coronary artery (segment 2) and the gastro-omental artery to the obtuse marginal branch (segment 12). The patient is being followed up on an outpatient basis. There are few reports describing patients with rheumatoid arthritis who underwent coronary artery bypass surgery. However, the most common cause of death in patients with rheumatoid arthritis is coronary-artery disease. Although the patient was still young, coronary-artery disease progressed rapidly. Such rapid progression was attributed to difficulty in controlling the inflammatory response after initial surgery, as well as to changes in vascular endothelial cells caused directly by treatment with steroids. Possible adverse effects of such treatment should be carefully considered.