Background : As the consequence of the decision at the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) progress, drug safety information reporting system in Japan is being revised. This has led to inevitable increases in the number of safety reports submitted to the industries and in turn, the Ministry of Health and Welfare (MHW). In 1997, the MHW announced they would publicize this acquired information starting in 1999. In the USA, Food and Drug Administration (FDA) has released safety related information to the public, acquired over the years since 1969, though such means in the Web page of MEDWatch using the internet.
Purpose : (1) To review accessibility of individual adverse experience (AE) reports in MEDWatch through internet, (2) to give advise to other possible Japanese users on the use of it and, (3) to give recommendation to the new system being developed in Japan by the MHW and/or other regulatory agency.
Method : Case study started by using personal computer.
Results : (1) The information cannot be accessible only using personal computers. Computer expert assistance and big computer are needed to access the information. (2) Information from more than a million AE cases is accessible. (3) Searches for information can be organized by pharmaceutical name, event term, patient demographics, and others. (4) The detailed information such as the course of the individual case from which drug causality could be assessed is not accessible. (5) The improvement of system should be needed for easy access such as “quick search”. (6) More “user friendly” system is desired to be developed by the MHW and/or other regulatory agency in Japan which enable easy and full access of the information.

　　In this study, to determine the future direction of nursing, we studied the effect of living with a sibling with a brain disorder using two internet search engines: The Japan Medical Abstracts Society website and the National Institute of Informatics site CiNii. A literature search was conducted by setting the publication time as the period between 1983 and 2015, using “brain disorder”, “nursing”, “siblings” and other terms as keywords. Analysis of 26 articles extracted in our literature search revealed that many of the studies were conducted in the fields of sociology and education and were about stress in the primary caregiver or family members of individuals with a brain disorder. On the other hand, studies focusing on the care of individuals with a brain disorder were about self-care, accidental falls, difficulties and negative feelings felt by nurses who supported individuals with a brain disorder, and caregiver satisfaction or burden scales of family members or the primary caregiver. However, none of the studies investigated siblings of individuals with a brain disorder, who live and age together and whose responsibility is different from that of parents or children, thus requiring different informational and emotional support. Taking into account the special features of individuals with a brain disorder and findings in other academic areas, we believe it is important to establish a system to support the siblings of individuals with a brain disorder, in addition to the direct family members and primary caregivers.

A 70-year-old man who had been followed up in our outpatient clinic for mild aortic regurgitation underwent curative surgery for progression of the regurgitation due to a prolapsed right coronary cusp, associated with annular dilatation and aortic root aneurysm formation. The Operation consisted of subvalvular circular annuloplasty to reduce the size of the aortic annulus, adjustable leaflet suspension for the prolapsed right coronary cusp, and modified aortic root remodeling, which replaced the Valsalva sinus of both non and right coronary cusps while sparing the Valsalva sinus of the left coronary cusp. Coronary artery bypass grafting was additionally performed for the 90% stenosis of the proximal right coronary artery segment. The postoperative course was uneventful with no need of blood transfusion. He was discharged from the hospital 10 days postoperatively. This combination of valvuloplasty with valve-sparing aortic root reconstruction procedure can be useful.

A 27-year-old man who presented with worsening dyspnea was transferred to our hospital due to congestive heart failure with multiple organ dysfunction. Echocardiogram showed severe left ventricular systolic dysfunction and a huge thrombus in the left ventricle. An urgent operation was performed to remove the thrombus simultaneously with the placement of bilateral extracorporeal ventricular assist devices. After the operation, despite a rapid improvement in the liver function, renal dysfunction persisted and he remained anuric for nearly a month. We continued maximal circulatory support with biventricular assist device to optimize his end-organ function. His renal function gradually improved, allowing him to be registered as a heart transplant candidate on the 140th postoperative day. On the 146th postoperative day, the patient underwent successful removal of the right ventricular assist device, and the left extracorporeal device was replaced by an implantable device (HeartMate II). He was discharged 78 days after the implantation. We present here a case where adequate support with biventricular assist device enabled a successful bridge to transplantation even in a patient with end-stage heart failure having end-organ dysfunction.

Background : Acute massive pulmonary embolism is a life-threatening disease. It is often treated with thrombolytic therapy, however, the mortality rates are unsatisfactorily high in patients who developed shock and subsequent cardiac arrest. Surgical pulmonary embolectomy is a last resort for patients with hemodynamic instability. We studied the outcomes of our patients who underwent pulmonary embolectomy for acute pulmonary embolism. Methods : Eight patients who underwent pulmonary embolectomy between January 2011 and December 2014 were studied. Our surgical indications were as follows. Patients who experienced cardiac arrest and treated with PCPS, and those in persistent vital shock, with contraindications of thrombolytic therapy, or with right heart floating thrombus. However, patients with ischemic encephalopathy or acute exacerbation of chronic thromboembolic pulmonary hypertension, and those who had already been treated with thrombolytic therapy were excluded. Preoperative ECMO was indicated for those in sustained shock. Pulmonary embolectomy was performed through median sternotomy and with cardiopulmonary bypass. After antegrade cardiac arrest, all clots were removed with forceps under direct vision through incisions in the bilateral main pulmonary arteries. IVC filter (Günther Tulip) was placed through the right atrial appendage. In our early cases, IVC filter (Neuhaus Protect) was placed after chest closure. Anticoagulation was not administered until hemostasis was achieved. Results : Seven patients underwent pulmonary embolectomy for massive pulmonary embolism, and in one patient pulmonary embolectomy was indicated for right heart floating thrombi although the pulmonary embolism was submassive. Three patients underwent cardiopulmonary resuscitation and were treated with ECMO. Other 3 patients in sustained shock vital were electively treated with ECMO. The other patient developed cardiopulmonary arrest shortly after anesthetic induction and intubation, and suffered disturbance of consciousness postoperatively. All patients were successfully weaned from cardiopulmonary bypass and underwent IVC filter placement (5 Neuhaus Protect, and 3 GProtec Tulip). One patient died due to a vascular complication associated with catheter insertion (retroperitoneal hematoma). No patients developed residual pulmonary hypertension. There were postoperative complications including pneumonia in 5 patients, tracheostomy in 2 patients, atrial fibrillation in 3 patients, and pericardial effusion in 1 patient. One patient who suffered disturbance of consciousness died 2.4 months after the surgery. Other patients had not developed any thrombotic and hemorrhagic complications during a median follow-up of 13.1 months. Conclusions : Pulmonary embolectomy is an effective treatment of acute massive pulmonary embolism. We believe that our strategy is useful, consisting of preoperative hemodynamic stability by an institution of ECMO, complete removal of clots by bilateral main pulmonary incisions, and prevention of recurrence by IVC filter placement.

No abstract available.
Japan* ; Sporothrix* ; Sporotrichosis*

No abstract available.
Japan* ; Sporothrix* ; Sporotrichosis*

Objective： Using PMDA's medication side effect database （JADER), the aim of this study is to explore the collective background and characteristics of cases in which adverse events were caused by the total cold medicine.Methods：Latent class analysis is performed on 990 subject cases reported from April 2004 to June 2015. The target group is classified into plural, and each characteristic is clearly indicated. Furthermore, the number of adverse events is counted for each class, and specialization coefficients are calculated. In addition, the signal detection is performed with the same data.Results：The population was divided into three classes. Class 1 was a group which do not have the original disease or medication, 53.7％ of the whole, and it was set as “health group” . Adverse events specialized were immune system diseases. Class 2 was 33.2％, a positive group for self-treatment, it was set as “self-treatment oriented group” . A specialized adverse event was a serious skin disorder. Class 3 was 13.1％, and 90％ of the class was over 60 years old and almost people had primary diseases and medicines, so they were “high age outpatient treatment group” . The main adverse events were lung disease and nervous system disorder. It was possible to relate the characteristic of the group as a background factor.Conclusion：By applying Latent class analysis to the adverse event, it was possible to clarify the relationship between the occurrence of adverse event and its background.This research is applicable to other medicines, and expected to contribute as a new application method of JADER.

OBJECTIVEPeople who live under fragile living conditions may stay overnight in Internet cafés in urban areas. An outbreak of tuberculosis (TB), the routes of which were possibly related to such a facility, has been reported. The purpose of this study was to use a mathematical model to quantify the public health risk of TB infection in such a facility.

METHODSThe reproduction number for airborne infection in an enclosed space (R (A)) was estimated using a Wells-Riley model. First, we estimated R (A) for the TB infection based on the report of the TB outbreak in the Internet café. Second, TB infectious dose, number of days of exposure, and air-exchange rate in the facility were varied to estimate the effect of TB risk settings and environmental factors.

RESULTSWe assumed that TB patients and 59 susceptible subjects stayed for 150 days in a room where the air-exchange rate was five per hour. Using the estimated median R (A) of 44.14, the TB infection rate was 74.6%. This result was similar to the epidemiological report that the TB infection rate among employees in the Internet café was 70%. The median R (A) increased linearly as the number of days of exposure increased. The slope of the change in median R (A) divided by the change in the number of days of exposure increased exponentially as air-exchange rate decreased; thus air ventilation in a facility may be essential to prevent TB infection.

CONCLUSIONSAppropriate air ventilation in facilities such as Internet cafés is needed as part of a TB-control program in metropolitan areas.

OBJECTIVESThe aim of this study is to assess preserved umbilical cords as chemical exposure media to investigatein utero chemical exposure. Furthermore, we aim to apply preserved umbilical cords to retrospective studies of the relationship betweenin utero chemical exposure and neurodevelopment disorders.

METHODSTwo sets of preserved umbilical cord samples were analyzed for exposure to polychlorinated biphenyls (PCBs): one composed of samples from 20 healthy Japanese subjects and the other set included samples from 17 autistic patients and 7 healthy sibling of theirs.

RESULTSThe possibility of external PCBs contamination during storage of preserved umbilical cord samples was found, and due to this problem, the study design should be limited to the comparison between PCBs concentration in preserved cord samples from autistic patients and that in those from their sibling. Total PCBs concentrations in preserved cords from autistic patients and their control siblings were compared and we found no statistically significant difference between them (Wilcoxon signed rank test, p>0.05).

CONCLUSIONSThe association between autism andin utero PCBs exposure was not clarified in this study; however, retrospective studies such as a case-control study of siblings using preserved umbilical cords can be a method of choice for examining the possible relationship betweenin utero chemical exposure and child hood disorders.