1.Effect of Shin'i-seihai-to on Infantile Stridor.
Kampo Medicine 1994;44(4):517-520
Fifty-five infants aged two or less suffering from stridor were treated with Shin'i-seihai-to (Tsumura's extract preparation). The results were very favorable. The formulation was found to be very effective in 26 infants, effective in 16, and ineffective in three. No statistically significant differences were noted in accompanied sinusitis or concomitant use of other drugs. Management of infantile stridor is often difficult, and the effect of Shin'i-seihai-to merits attention.
2.Changes in Abdominal Diagnosis of Normal Newborn Infants and Babies.
Kampo Medicine 2000;51(1):1-6
Changes of abdominal diagnosis were examined in 28 cases of normal healthy children who received abdominal examinations three or more times within one year after birth. Abdominal diagnosis was done within a week after birth, and thereafter during infants' regular physical examinations. There were 19 cases of Kyoukyoukuman (fullness, tenderness or discomfort of the hypochondrium): neither resistance of the upper abdomen nor Seijouki were evident. There were 17 cases of strain in the rectus abdominas muscle recognized in all age groups (0-12 months of age). Softness of the lower abdomen was identified in 15 cases in all age groups, but the positive coefficient dropped along with age. Only one of the 15 cases occurred in infants in the 7-10 month age range. As a result of softness of the lower abdomen and Seichushin, it appears that Jin (kidney) develops rapidly by one year after birth. In all 21 cases, the abdominal strength was 2.5-3/5 for all ages.
3.Influence of Sensual Similarity of Drug Name on Taking Error
Hiroyasu Sato ; Kohei Fujita ; Yuto Taniguchi ; Hiroko Yahata ; Tomohiro Haruyama ; Yoshihiro Hashimoto ; Shigeki Tanaka ; Hitoshi Komori
Japanese Journal of Drug Informatics 2012;14(1):14-20
Objective: Similarity of drug names is one factor of dispensing incidents. The aim of this study was to survey the relation between sensual similarities of drug names and the occurrence of taking errors for pharmacists who actually prepare medicine.
Methods: A pair of drugs (15 incident pairs and 104 control pairs) was displayed on a computer screen at random. The subject’s task was to determine the sensual similarity of them. Thirteen pharmacists who prepared these pairs and caused their incidents participated in the experiment.
Results: The result showed that the sensual similarity of drug names of incident pairs was found to be highly significant in comparison to one of the control pairs [p=0.026]. However, the similarity in incident pairs is not necessarily high. It was suggested that the similarity of drug name was not the only factor of taking error. Multiple linear regression analyses of the sensual similarity in control pairs were performed, in which 10 variables were reported as quantitative indicators of similarity of drug name and were able to be measured on the internet. The correlation was good [R2=0.828]. However, this regression model was not useful when adjusting to incident pairs. In incident pairs, the similarity value calculated by the regression model was lower than the measured sensual similarity.
Conclusion: The result suggested that measured sensual similarity includes other risk factors of taking error, such as appearance similarity and/or efficacy similarity and/or short distance arrangement. It seemed that the pharmacist’s ability complicated the factor of taking error.
4.A Pharmacoepidemiologic Study on the Relationship between Neuropsychiatric Symptoms and Therapeutic Drugs after Influenza Infection
Toshiharu Fujita ; Yosuke Fujii ; Yoshihiro Watanabe ; Hitoshi Osaka ; Takahito Wada ; Masaaki Mori ; Shumpei Yokota
Japanese Journal of Pharmacoepidemiology 2010;15(2):73-95
Objective: The mechanism underlying the development of neuropsychiatric symptoms such as unconsciousness, abnormal behavior, delirium, hallucinations, and convulsions in influenza has not been thoroughly investigated. The relationship between drug administration and neuropsychiatric symptoms during influenza is also poorly understood. This study is the first pharmacoepidemiologic study focused on investigating the relationship between drug administration and neuropsychiatric symptoms.
Design: Cohort study
Methods: Study subjects were patients under 18 years old who had influenza during the 2006/07 season. We prepared two kinds of questionnaires for doctor and for patient's family, and carried out the survey between January and March, 2007. Using data from 9,389 patients, we analyzed the relationship between neuropsychiatric symptoms, such as delirium, unconsciousness and convulsion, and drug administration of acetaminophen and oseltamivir.
Results: Analysis of the relationship between delirium and drug administration provided hazard ratios of 1.55(p=0.061)for acetaminophen and 1.51(p=0.084)for oseltamivir. These hazard ratios, which were adjusted for risk factors by multivariate analysis of the proportional hazard model, showed an increasing tendency of delirium after administration of each drug. In patients who received oseltamivir, a high incidence of delirium was observed between 6 and 12 hours after onset of fever. Furthermore, delirium was found to develop in a shorter time following oseltamivir use than it did after acetaminophen use. There was no relationship between unconsciousness and acetaminophen administration, as demonstrated by a hazard ratio of 1.06(p=0.839). The incidence of unconsciousness increased significantly with oseltamivir use with a hazard ratio of 1.79(p=0.0389), and unconsciousness was found to occur in a short time after oseltamivir use.
Conclusion: The results obtained from this study suggest that there are increased risks of delirium and unconsciousness with drug administration. Further pharmacoepidemiologic studies for hypothesis testing are required to study the relationship between abnormal behavior and drug administration.
5.Influence of Similarity of the Sheet Appearance in Multiple-Specification Drug on Taking Error
Hiroyasu Sato ; Yusuke Kanetaka ; Kohei Fujita ; Yuto Taniguchi ; Kiyomi Ishida ; Marino Ishio ; Hitoshi Komori
Japanese Journal of Drug Informatics 2016;18(3):186-191
Objective: Similarity in drug appearance is one of the major environmental factors influencing dispensing errors, such as picking the wrong medication (picking error). The purpose of this study is to verify if the index values of appearance similarity calculated objectively for multiple-specification drugs are the factors of picking error.
Methods: Four variables (number of total prescription, deviation of prescriptions between the specifications, sheet size, and color similarity of the sheet surface) were calculated. The number of total prescription and deviation of prescriptions were extracted from the dispensing system. Sheet size and color similarity were calculated, respectively, from the area ratio and by the Histogram Intersection method using the press through package (PTP) sheet image. To evaluate the relationship between the picking error rate and these four variables, univariate and multivariate analyses were performed.
Results: The number of total prescription and the deviation of prescriptions were not significant factors. In contrast, sheet size and color similarity significantly influenced the picking error rates.
Conclusion: Similarity in appearance between multiple-specification drugs is a risk factor of picking error. When the multiple-specification pair has the same sheet size or high color similarity, one needs to be caution of picking error. Further, in the pharmaceutical industry, to reduce the risk of dispensing errors, it is desirable to carry out the devise to enhance the identity of each specification.
6.Survey of the Description of the Risk Minimization Activities in Pharmaceutical Risk Management Plans
Hiroyasu Sato ; Shintaro Hirasawa ; Sayumi Kadono ; Tomohiro Haruyama ; Kohei Fujita ; Yusuke Kanetaka ; Hiroshi Tamura ; Hitoshi Komori
Japanese Journal of Drug Informatics 2017;19(1):32-36
Objective: Currently, the creation of a pharmaceutical risk management plan (RMP) for new drug information is obliged to pharmaceutical companies. The created RMP is published on the Pharmaceuticals and Medical Devices Agency (PMDA) website. RMP is a useful information source to ensure drug safety by healthcare professionals, including pharmacists. “Risk minimization activities” of the RMP are especially important elements for healthcare professionals because they describe measures to minimize risk to patients. We conducted a cross-sectional survey of the description of the contents of “risk minimization activities” in the RMP.
Methods: The RMP of 177 drugs that had been published in February 22, 2016 were investigated.
Results: Total risks enumerated for the study drugs were 1,678. “Routine risk minimization activities” constituted 92.0% of total risks. The most listed item on “routine risk minimization activities” was “attention on the product labeling of the drug package insert” (91.3%). Differences in the expression level on “attention on the product labeling” were observed. On the other hand, the most listed item of “additional risk minimization activities” was “the creation of documents for healthcare professionals” (38.3%) and “implementation of Early Post-marketing Phase Vigilance” (27.1%).
Conclusion: A clear understanding of RMP by healthcare professionals is important. In the RMP, “risk minimization activities” (especially “additional risk minimization activities”) are the most important contents for healthcare professionals, because they include information of documents created by the pharmaceutical company for patient safety. The level of description of the contents of RMP varies between drugs. It is essential that these descriptions be uniform the expression level to be easily and accurately utilized by healthcare professionals.
7.Closed Wedge Distal Femoral Osteotomy with a Polyaxial Locking Plate Designed for the Proximal Tibia: Minimum 5-Year Outcomes
Ryuichi NAKAMURA ; Kenji FUJITA ; Rei OMI ; Kazunari KURODA ; Masaki TAKAHASHI ; Kazumi IKEBUCHI ; Hitoshi NISHIMURA ; Yasuo KATSUKI
The Journal of Korean Knee Society 2017;29(3):232-236
Since distal femoral varus osteotomy (DFO)
Asian Continental Ancestry Group
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Humans
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Japan
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Knee
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Osteoarthritis
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Osteotomy
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Tibia
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Weight-Bearing
8.Role of ¹²³I-BMIPP and serum B-type natriuretic peptide for the evaluation of patients with heart failure.
Shankar Kumar BISWAS ; Masayoshi SARAI ; Hiroshi TOYAMA ; Akira YAMADA ; Hiroto HARIGAYA ; Hiroyuki NARUSE ; Hitoshi HISHIDA ; Yukio OZAKI
Singapore medical journal 2012;53(6):398-402
INTRODUCTIONMyocardial scintigraphy with ¹²³I-15-(p-iodophenyl)-3-methyl pentadecanoic acid (¹²³I-BMIPP) is used to evaluate impaired fatty acid metabolism. B-type natriuretic peptide (BNP), which is secreted by the ventricular myocardium on stretching and/or pressure overload, is a useful cardiac biomarker. This study aimed to evaluate the usefulness of ¹²³I-BMIPP imaging and serum BNP levels in patients with heart failure (HF).
METHODS113 patients with HF were enrolled. There were 68 patients with ischaemic heart disease (IHD) and 22 with overt HF. Cardiac scintigraphy was performed 7 ± 3 days after admission, and heart-to-mediastinum (H/M) count ratios on early and delayed images and washout rates (WR) of ¹²³I-BMIPP were recorded. Serum BNP levels were recorded on the day of ¹²³I-BMIPP imaging. The ejection fraction (EF) was calculated just before cardiac scintigraphy using conventional echocardiography.
RESULTSThe mean BNP level and EF were 282 pg/mL and 47%, respectively, with significant correlation between them. The mean H/M count ratios on early and delayed images were 2.29 and 1.93, respectively, showing significant positive correlations with EF (r = 0.31, p = 0.0006). The WR was significantly correlated with EF (r = -0.36, p < 0.0001) and BNP levels (r = 0.33, p = 0.003), and mean WR was significantly higher in patients with overt HF compared to those without (p < 0.001). Patients with IHD had significantly higher EFs than those with non-IHD (p = 0.03).
CONCLUSIONThe evaluation of impaired myocardial metabolism using ¹²³I-BMIPP scintigraphy and serum BNP levels appears to be useful for the evaluation of severity of HF.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Biomarkers ; metabolism ; Echocardiography ; methods ; Fatty Acids ; metabolism ; Female ; Heart Failure ; blood ; diagnosis ; diagnostic imaging ; Humans ; Iodine Radioisotopes ; Iodobenzenes ; Male ; Middle Aged ; Myocardial Perfusion Imaging ; methods ; Myocardium ; pathology ; Natriuretic Peptide, Brain ; blood ; Time Factors ; Treatment Outcome
9.Association between Lymphovascular Invasion and Recurrence in Patients with pT1N+ or pT2–3N0 Gastric Cancer: a Multi-institutional Dataset Analysis
Keizo FUJITA ; Mitsuro KANDA ; Seiji ITO ; Yoshinari MOCHIZUKI ; Hitoshi TERAMOTO ; Kiyoshi ISHIGURE ; Toshifumi MURAI ; Takahiro ASADA ; Akiharu ISHIYAMA ; Hidenobu MATSUSHITA ; Chie TANAKA ; Daisuke KOBAYASHI ; Michitaka FUJIWARA ; Kenta MUROTANI ; Yasuhiro KODERA
Journal of Gastric Cancer 2020;20(1):41-49
PURPOSE:
Patients with pathological stage T1N+ or T2–3N0 gastric cancer may experience disease recurrence following curative gastrectomy. However, the current Japanese Gastric Cancer Treatment Guidelines do not recommend postoperative adjuvant chemotherapy for such patients. This study aimed to identify the prognostic factors for patients with pT1N+ or pT2–3N0 gastric cancer using a multi-institutional dataset.
MATERIALS AND METHODS:
We retrospectively analyzed the data obtained from 401 patients with pT1N+ or pT2–3N0 gastric cancer who underwent curative gastrectomy at 9 institutions between 2010 and 2014.
RESULTS:
Of the 401 patients assessed, 24 (6.0%) experienced postoperative disease recurrence. Multivariate analysis revealed that age ≥70 years (hazard ratio [HR], 2.62; 95% confidence interval [CI], 1.09–7.23; P=0.030) and lymphatic and/or venous invasion (lymphovascular invasion (LVI): HR, 7.88; 95% CI, 1.66–140.9; P=0.005) were independent prognostic factors for poor recurrence-free survival. There was no significant association between LVI and the site of initial recurrence.
CONCLUSIONS
LVI is an indicator of poor prognosis in patients with pT1N+ or pT2–3N0 gastric cancer.
10.Survey of the Use of Fibrinogen Concentrate during Cardiovascular Surgery in Japan
Akihiko USUI ; Hideyuki SHIMIZU ; Kenji MINATOYA ; Kenji OKADA ; Norihiko SHIIYA ; Noboru MOTOMURA ; Hitoshi YOKOYAMA
Japanese Journal of Cardiovascular Surgery 2023;52(5):353-360
Background: A review committee for unapproved and off-label drugs with high medical needs determined that the indication of fibrinogen concentrate for cardiovascular surgery would be publicly acceptable in 2021. However, the Japanese Society of Cardiovascular Surgery is required the conduct of several surveys demonstrating that fibrinogen concentrate can be used properly in medical settings. A questionnaire concerning the use of fibrinogen concentrate in cardiovascular surgery was one such required survey. Methods: A questionnaire concerning the use of fibrinogen concentrate was conducted in December 2021 at 551 certified training facilities of the Japanese Board of Cardiovascular Surgery, and responses were received from 375 facilities (68%). Results: Fibrinogen concentrate was used in 98 centers (26%). Aortic surgery (thoracic/thoracoabdominal) (50%) and cardiac redo surgery (24%) were eligible common surgeries requiring fibrinogen concentrate, and the intraoperative measurement of fibrinogen levels was performed in 77% of centers. The triggers for the use of fibrinogen concentrate were a fibrinogen level <150 mg/dl in 30%, <100 mg/dl in 20% and massive bleeding tendency in 40%. Of note, only 39 facilities (10%) were able to prepare cryoprecipitate in-hospital, and 34 centers (9%) used it for cardiovascular surgery. One hundred and seven centers (29%) planned to apply for facility accreditation for the use of fibrinogen concentrate, and 40 facilities (10%) answered that they would decide based on the situation. The expected number of annual cases in which fibrinogen concentrate would be used for cardiovascular surgery reached 4,860 cases: <10 cases in 52 centers, 10-19 cases in 50 centers, 20-49 cases in 31 centers, 50-99 cases in 12 centers and ≥100 cases in 2 centers. Conclusion: We conducted a questionnaire on the use of fibrinogen concentrate. Intraoperative fibrinogen level measurement was performed at approximately 80% of institutions, and the annual number of cases likely to use fibrinogen concentrate was predicted to reach about 5,000 cases. However, only 10% of centers used cryoprecipitates prepared in-hospital.