1.Development of an Application for Using the Pharmaceuticals and Medical Devices Agency Side Effect Dataset More Effectively
Hiroshi Sakata ; Yukari Inagaki ; Mizuki Nakazaki ; Fumiko Otsu ; Nobuyuki Goto
Japanese Journal of Drug Informatics 2014;16(2):81-89
Objective: The Pharmaceuticals and Medical Devices Agency (PMDA) discloses reports with accumulated side effect information in comma-separated value (CSV) format. It is difficult to use the information in this type of text file because the amount of data is large and composed of multiple fields. Therefore, we developed an application that presents the data in a way that is easier to read and understand.
Methods: The application can display the whole dataset, or the search results of certain medicines and side effects within the database in Microsoft Access 2013. It exports data from search results into an Excel spreadsheet organized by medicine and side effect.
Results: This application makes it possible to understand statistics contained in the side effect dataset, such as the number of cases, the medicines, and the side effects themselves. Moreover, the application allows the totaled search results for the medicines and the side effects to be graphed. It also makes it possible to understand the sex and age distribution of patients, as well as the days elapsed before developing a side effect.
Conclusions: Recently, the importance of information concerning the safety of medicine has increased. This system could facilitate the effective use of side effect information and the creation of medicine risk management plans in medical institutions.
2.Appearance of Side Effects Related to Non-ionic Iodine Contrast Medium
Hiroaki Watanabe ; Hiroshi Azuma ; Hironao Tanaka ; Syunya Takeno ; Yasutaka Inoue ; Takahiro Inagaki ; Kunihiro Tobisawa ; Takahito Imai
Japanese Journal of Drug Informatics 2012;14(3):94-100
Objective: We investigated the incidence of side effects related to contrast medium employed in our hospital based on monitoring materials to improve the safety of contrast-enhanced examinations. Furthermore, we compared the incidence of side effects between the original product and generic drugs to confirm the safety of each preparation.
Methods: The survey period was from April 2007 until March 2011. Based on the number of patients who underwent contrast-enhanced examinations and that of patients with side effects, we calculated the incidence of side effects in our hospital, and confirmed its annual changes. Subsequently, we again collected the incidence of side effects per each manufacturer’s preparation employed, and confirmed the state of side effects of individual preparations. Furthermore, we evaluated the symptoms as side effects, interval until appearance, and treatment for side effects during the data collection period, as well as the subsequent state, symptoms as side effects, and interval until appearance. The chi square independence test was employed to compare the results among groups. p<0.05 was regarded as significant (paired test).
Results: There were no changes in the annual incidence of side effects. There were also no significant differences in the annual incidence of side effects among the preparations. Furthermore, there were no marked differences in the symptoms, interval until appearance, treatment for side effects, or subsequent state among the preparations.
Conclusion: We investigated the appearance of side effects regarding contrast-enhanced examinations for 4 years. We confirmed that there were no differences in the incidence of side effects among the preparations.
3.A Trial Calculation of the Costs Incurred by the Absences of Agricultural Co-opEmployees in Aichi Prefecture due to Novel Influenza
Hiroshi INAGAKI ; Haruo YAMADA ; Hiromichi MIWA ; Kazuo KONDO ; Yoshitaka FUKUZAWA ; Hironobu KAKUTA
Journal of the Japanese Association of Rural Medicine 2010;58(5):549-557
With the spread of a novel H1N1 strain of influenza A around the world, the World Health Organization declared that the situation had entered the pandemic phase. In Japan, it had a major social impact, causing a great hit to the national economy. And there is every likelihood that the H1N1 influenza is going to break out a lot of people on the staff of the agricultural cooperatives in Aichi Prefecture, seriously affecting the activities of agricultural cooperatives too. Based on the amount of damage from the flu presumed by the Japanese government and various kinds of statistical material, we worked out how much the flu would cost the agricultural co-ops in the prefecture by infecting their employees and involved their family. At an absence rate of 20%, the lowest rate presupposed by the government, our calculation showed that the extra costs would amount to 740 million yen altogether. If the rete of abscense from work was given 40%, the largest estimate by the government, the costs rocketed to highly 1.48 billion yen. A check on the situation of individual co-ops revealed that some of the co-ops would burden an extra cost of well over 100 million yen. From these findings, we concluded that to minimize the effects of the flu appropriate, effective countermeasures have to be taken after sufficient information about the novel influenza virus was collected and analyzed carefully.
4.Change of Oxidative Stress in Cases of Cardiac and Aortic Surgeries
Eiichiro Inagaki ; Sohei Hamanaka ; Hitoshi Minami ; Hisao Masaki ; Atsushi Tabuchi ; Yasuhiko Yunoki ; Hiroshi Kubo ; Takuro Yukawa ; Kazuo Tanemoto
Japanese Journal of Cardiovascular Surgery 2009;38(3):169-174
We measured oxidative stress and antioxidative stress in clinical cases of cardiac and aortic surgery, especially in extracorporeal circulation cases. From June to October 2007, 18 cases who underwent cardiac and aortic surgery with extracorporeal circulation (ECC group) and 8 cases with an infra-renal abdominal aortic aneurysm (AAA group) were studied. We measured reactive oxygen metabolites (d-ROM) in oxidative stress for the operative time, after the operation endpoint, and at one day postoperatively, one, two, and three weeks postoperatively, and one, two, three, and four months postoperatively. Regarding d-ROM, the level in the ECC group was significantly higher than that in the AAA group (p<0.0001). Peak values were observed 3 weeks postoperatively in the ECC group and 2 weeks postoperatively in the AAA group. Although the oxidative stress increased in both groups, the peak value in the ECC group was more marked than that in the AAA group. We concluded that oxidative stress under surgical stress in cardiovascular surgery with extracorporeal circulation was higher than that under surgical stress in cardiovascular surgery for infra-renal abdominal aortic aneurysms.
5.Three Cases of Ascending Aorta-Abdominal Aorta Bypass for Atypical Coarctation with Takayasu's Aortitis
Eiichiro Inagaki ; Sohei Hamanaka ; Hitoshi Minami ; Atsushi Tabuchi ; Yasuhiro Yunoki ; Hiroshi Kubo ; Yuji Kanaoka ; Mitsuaki Matsumoto ; Hisao Masaki ; Kazuo Tanemoto
Japanese Journal of Cardiovascular Surgery 2009;38(4):239-243
We report 3 cases of ascending aorta-abdominal aorta bypass for atypical coarctation with Takayasu's aortitis. We performed an extra-anatomical bypass from the ascending aorta to the terminal abdominal aorta. The graft was arranged to pass through the diaphragm from the pericardium, behind the left lobe of the liver and the stomach, to the front side of the pancreas to the terminal abdominal aorta. Although the graft was exposed in the abdominal cavity in part behind the stomach, it was completely covered with the great omentum thus avoiding direct contact between the graft the abdominal organs. Decrease in the pressure gradient between the ascending aorta and the abdominal aorta was achieved using a large prosthetic graft 14-16 mm in diameter. There are several advantages with this technique. (1) Positional change during surgery can be avoided. (2) Anastomosis can be performed in non-diseased vessels. (3) This bypass graft can be branched off to visceral arteries if necessary. Reduction of the after load on the left ventricle and long-term graft patency by using a large diameter prosthetic graft were anticipated. The postoperative courses of all cases were satisfactory. Case 1 died of another disease 11 years and 11 months postoperatively, but the graft to was still patent.
6.Efficacy of the Erector Spinae Plane Block for Lumbar Spinal Surgery: A Retrospective Study
Hironobu UESHIMA ; Mayumi INAGAKI ; Tomoaki TOYONE ; Hiroshi OTAKE
Asian Spine Journal 2019;13(2):254-257
STUDY DESIGN: A retrospective study. PURPOSE: The first research on the erector spinae plane (ESP) block was published in 2016. To our knowledge, no cohort studies or randomized controlled trials of the ESP block were performed in 2016 and 2017. OVERVIEW OF LITERATURE: This study retrospectively investigated the efficacy of the ESP block in pain management after lumbar spinal surgery. METHODS: Patients who underwent lumbar spinal surgery in 2017 were enrolled in the study. Those who underwent secondary surgery with local anesthesia other than the ESP block were excluded. The primary outcome was the Numerical Rating Scale (NRS) pain score at various time points until the morning of postoperative day 2. The secondary outcomes were the amount of intravenous fentanyl administered during the first 24 hours following the surgery and the number of patients with complaints of complications such as nausea and vomiting until the morning of postoperative day 2. RESULTS: The data of 41 patients undergoing lumbar spinal surgery were retrospectively analyzed. Of these, 23 received only general anesthesia (G group), whereas the other 18 patients received the ESP block in addition to general anesthesia (E group). The NRS pain scores and the amount of fentanyl administered were lower in the G group than in the E group at all measured time points (all data were less than p<0.05). There was no significant difference in the incidence of complications between the two groups (p=0.11). CONCLUSIONS: The ESP block provides effective postoperative analgesic effect for 24 hours in patients undergoing lumbar spinal surgery.
Anesthesia, General
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Anesthesia, Local
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Cohort Studies
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Fentanyl
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Humans
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Incidence
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Nausea
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Pain Management
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Retrospective Studies
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Spinal Nerves
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Vomiting
7.Usefulness of Adalimumab for Treating a Case of Intestinal Behcet's Disease With Trisomy 8 Myelodysplastic Syndrome.
Masamichi KIMURA ; Yoshihisa TSUJI ; Masako IWAI ; Masahiro INAGAKI ; Ali MADIAN ; Takuya YOSHINO ; Minoru MATSUURA ; Hiroshi NAKASE
Intestinal Research 2015;13(2):166-169
Behcet's disease (BD) is a systemic vasculitis, while myelodysplastic syndrome (MDS) is a heterogeneous group of clonal hematologic disorders characterized by ineffective hematopoiesis. Some studies suggest a relationship between MDS and BD, especially intestinal BD, and trisomy 8 seems to play an important role in both diseases. There are several reports on patients with BD comorbid with MDS involving trisomy 8 that frequently have intestinal lesions refractory to conventional medical therapies. Tumor necrosis factor (TNF)-alpha is strongly involved in the pathophysiology of several autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, and BD. In addition, TNF-alpha plays an important role in the pathophysiology of MDS by inhibiting normal hematopoiesis and inducing the programmed cell death of normal total bone marrow cells and normal CD34+ cells. Recent clinical reports demonstrate the favorable effect of TNF-alpha antagonists in patients with refractory intestinal BD and in those with MDS. We present the case of a patient with intestinal BD and MDS involving trisomy 8 who was successfully treated with adalimumab.
Adalimumab
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Arthritis, Rheumatoid
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Autoimmune Diseases
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Behcet Syndrome
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Bone Marrow Cells
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Cell Death
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Hematopoiesis
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Humans
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Inflammatory Bowel Diseases
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Myelodysplastic Syndromes*
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Systemic Vasculitis
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Trisomy*
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Tumor Necrosis Factor-alpha
8.Improvement of Student Presentations Via the Introduction of Presentation Evaluation sheets
Akira NAKASHIMA ; Kazunao KONDO ; Eiichi MIYACHI ; Narushi IIZUKA ; Kazuhisa IKEMOTO ; Satoru ISHIHARA ; Mahito OHKUMA ; Yoko KANEKO ; Fusao KAWAI ; Yu KODANI ; Yui SUGANUMA ; Hiroshi NAGASAKI ; Nobuhiro HARADA ; Tomoaki YOSHIDA ; Hidehito INAGAKI ; Kunihiro TSUCHIDA ; Hisateru YAMAGUCHI
Medical Education 2017;48(5):323-325