During the period of two years from 2001 to 2003, we treated nine cases of takotsubo-type myocardiopathy. In this paper, the clinical characteristics and patients' conditions are described, and the mechanisms leading to dyskinesia of the muscular walls of the heart are discussed. All the cases were female. The mean age was 73 years. Physiological as well as psychological stress was implicated as a major cause of the disease, with onset occurring when some members of their family were suddenly taken ill or when they started quarreling with others. Echocardiograms revealed sigmoid septa in almost half of the nine patients. The prognosis was good. Only one patient had cardiac insufficiency as a sequela, but her condition improved. No one died.Eight patients got over dyskinesia of the left ventricular walls in two weeks. From our experience and studies of literature, we ruled out the possibility of the involvement of circulatory disorder and myocarditis in the onset of the disease. Women of advanced age are apt to have sigmoid septa and left ventricular walls thinning. When the old patient in this condition suffer psychosomatic stress, catecholamines will be released, causing the hypercontraction of the left ventricle, the pressure difference in the chamber, and the collapse of the apical of the heart. We concluded that these physiopathological states may be responsible for the abnormal movements of the muscular walls of the heart peculiar to the disease taken up in this study.

  An inquiry was made into the health of 10 one-time asbestos workers now living in the southern part of Akita Prefecture who had taken screening tests for asbestosis on a regular basis. The purpose of this study was to provide pertinent information and better health support to these people at high risk of developing asbestos-related diseases. The average number of years they served as asbestos workers was 11.1±2.12 years and 29.8±4.64 years had passed sincefirst exposure. All the subjects were found to have had no idea about guarding against exposure to asbestos while at work. Neither had they been told to protect themselves from this fibrous mineral by their employers. What motivated them to take examinations for asbestosis was news reports provided by newspapers and other mass media about pulmonary disorders caused by earlier contact with asbestos fibers. Half of the subjects did not know anything about qualifications for receiving the health card for retired asbestos workers. They expressed apprehensions about their health. One subject said, “I may be taken ill anytime,” another said, “The psychological burden of always taking meticulous care of my health is overwhelming,” and still another said, “There is no way of knowing whether I am suffering from asbestosis because there is no symptom.” The latest statistics showed that the number of officially acknowledged victims of asbestos-related pulmonary diseases is increasing across the nation together with the incidence of mesothelioma. To allay the anxiety of former asbestos workers about their health, this study suggested that as the responsibilities of the medical profession, we should (1) get acquainted with the relief system and related laws, (2) help the patients maintain their quality of life by following up the their problems over a long period of time, and (3) continue research activities and make the results public so as to contribute to the relief of the patients.

We report two cases of farm chemical poisoning which were treated successfully. Two elderly men separately swallowed down paraquat/diquat solutions in an attempt to kill themselves, and resultantly developed pulmonary fibrosis. After steroid therapy, clinical symptoms desappeared, although a slight degree of abnormality remained on chest X-rays. Case 1: a 57-year-old man; the amount of ingestion, 100 ml; hospitalized 2 hours after ingestion; shock, (-); urinary PQ reactoin, (2); serum PQ level, 1.14 ug/ml; pulmonary injury at first examinatoin, (-); pulmonary manifestation of symptoms, at day 3 after hospitalization; minimum Pao₂, 67.6 mmHg. Case 2: a 65-year-old man; the amount of ingestion, one gulp; hospitalized 27 minutes after ingestion ; shock, (-); urinary PQ reactoin, (3+); serum PQ level, 6.6ug/mg; pulmonary injury at first examination, (-); pulmonary manifestation of symptoms, at day 5 after hospitalization; minimum Pao₂, 58.3mmHg. For treatment, gastrointestinal lavage, forced diuresis and direct hemoperfusion were performed in both cases. Steroid pulse therapy was followed by repeated oral administration of large doses of steroid.
Hepatic and renal disorders were transient. Pao₂ was normal when the patients were discharged. The primary reasons we could save their lives are probably that the amount of PQ ingestion was relatively small, hemodialysis was performed repeatedly at early stages, and that large amounts of steroid were used immediately after the onset of pulmonary fibrosis.

We studied 494 patients with lung cancer who had been treated in our hospital from January 1985 through December 1994. Of the total number of cases, 20.4% were stage I; 4.5%, stage II; 12.1%, stage IIIA; 23.8%, stage IIIB; and 34.3%, stage IV. The 5-year-survival rate of patients with non-small cell lung cancer (NSCLC) was 61.0% in stage I, 43.4% in stage II, 21.2% in stage IIIA, 0% in stage IIIB and 0.9% in stage IV. The 3-year-survival rate and median survival time (MST) of patients with small cell lung cancer was 10.3% and 13.7 months in limited disease, and 0% and 4.8 months in extensive disease.
By histologic type, the 5-year-survival rate of patients with NSCLC was 19.7% in squamous cell carcinoma, 19.5% in adenocarcinoma and 5.3% in large cell carcinoma. The 5-year-survival rate of patients who were discovered by health screening was 39.4%; by subjective symptoms, 9.8%; and during the observation of other diseases, 14.7%. The 5-year-survival rate and MST of the patients with NSCLC treated in the Department of Internal Medicine of our hospital (stage III or IV) from 1985 through 1989, and from 1990 through 1994, were 1.9% and 7.4 months in the former period, and 3.7% and 9.9 months in the latter. Approximately 75% of the cases of lung cancer treated in our hospital were stage III or IV disease, and prognosis was very poor. Therefore, prevention and detection in the early stage of lung cancer are important.

During the period of two years from 2001 to 2003, we treated nine cases of takotsubo-type myocardiopathy. In this paper, the clinical characteristics and patients' conditions are described, and the mechanisms leading to dyskinesia of the muscular walls of the heart are discussed. All the cases were female. The mean age was 73 years. Physiological as well as psychological stress was implicated as a major cause of the disease, with onset occurring when some members of their family were suddenly taken ill or when they started quarreling with others. Echocardiograms revealed sigmoid septa in almost half of the nine patients. The prognosis was good. Only one patient had cardiac insufficiency as a sequela, but her condition improved. No one died.Eight patients got over dyskinesia of the left ventricular walls in two weeks. From our experience and studies of literature, we ruled out the possibility of the involvement of circulatory disorder and myocarditis in the onset of the disease. Women of advanced age are apt to have sigmoid septa and left ventricular walls thinning. When the old patient in this condition suffer psychosomatic stress, catecholamines will be released, causing the hypercontraction of the left ventricle, the pressure difference in the chamber, and the collapse of the apical of the heart. We concluded that these physiopathological states may be responsible for the abnormal movements of the muscular walls of the heart peculiar to the disease taken up in this study.
Heart ; Patients ; Dyskinetic syndrome ; Age, NOS ; Heart insufficiency

Between Nov. 1981 and Dec. 1990, seventy-seven patients underwent surgical repair for abdominal aortic aneurysm (56, non-ruptured and 21, ruptured). There were no operative and hospital deaths in the non-ruptured group and 4 deaths (19%) in the ruptured group. To improve operative results by means of decreasing hemorrhagic blood loss and operative time, we have ameliolated some points of the technical procedures as follows. Dissection of the perianeurysmal tissue was limited to only the neck and anterior peritoneal surface of the aneurysm. Taping to keep the aorta and distal iliac artery was not applied and vascular clamps were placed without dissection of the posterior walls of the aorta and distal arteries. Proximal anastomosis of the Y-vascular prostheses were performed by the inclusion technique. The end-to-side method was used in distal anastomosis to the external iliac arteries routing behind the ureter. Even when aneurysmal dilatation involved the common iliac arteries, the orifices of the common iliac arteries were closed by continuous sutures bilaterally. In ruptured cases too, this standard technique was used without application of special means for proximal cross-clamping. Postoperative arteriography or enhanced computed tomography reveald thrombosis and reduction in size of residual aneurysm of the common iliac artery. By these improved surgical techniques, 25 cases (45%) of the 56 non-ruptured group had surgical correction of the abdominal aortic aneurysm without using homologous blood transfusion. Cumulative 5-year survival rate by Kaplan-Meier method of non-ruptured and ruptured group was 87% and 49% respectively.

Four patients with fulminant myocarditis (two males and two females, age 21-67 years old) were examined during 1995-2001. Fulminant myocarditis was diagnosed based on clinical features, abnormal electrocardiographic and echocardiographic findings, and increased serum enzyme levels. In three of four cases, the diagnoses were confirmed histologically in autopsy. All four patients had flu-like symptoms and fever at the start. One patient died suddenly next day. Other three patients went into cardiogenic shock five and seven days after the onset of symptoms and hospitalized, and treated with temporary pacing, steroid pulse therapy, catecholamine (in all three patients) and percutaneous cardiopulmonary support : PCPS (in one patient), but they died within ten days. Electrocardigrams showed ventricular escape rhythm, ST elevation associated with Q wave, and low voltage of the QRS complex. Markedly increased serum enzyme levels, severe metabolic acidosis and disseminated intravascular coagulation were thought to be indicative of poor prognosis. Early recognition of cardiac involvement and using of PCPS without hesitation in an acute phase could improve the outcome of fulminant myocarditis.
Myocarditis ; Clinical ; Therapeutic brand of coal tar ; symptoms <1> ; Serum

A 37-year-old female was admitted to our hospital because of haemoptysis. She had undergone descending thoracic aorta-abdominal aorta bypass grafting 11 years previously. Then the diagnosis was atypical coarctation due to aortitis syndrome. No follow up had been continued. Angiogram and CTscan disclosed a false aneurysm at the anastomotic site of the descending thoracic aorta, which was ruptured into the left lung. An emergency operation was performed. A new extra-anatomical ascending aorta abdominal aorta bypass was constructed using 16mm Dacron prosthesis, and three permanent clamps were employed for thromboexclusion of the descending aorta, previous bypass graft and the ruptured aneurysm. At present, three years after the operation, she is leading normal life with medication of hypotensive drugs. Pathogenesis, surgical approach and long-term postoperative care were discussed.

A19-year-old man was admitted to the hospital because of severe congestive heart failure on 7 April 2000. In the previous year his case had been diagnosed as Churg-Strauss syndrome (allergic granulomatous angiitis, AGA) with bronchial asthma and mononeuritis multiplex. Echocardiography revealed the dilatation of the left ventricle (LVDd 74 mm) and impaired left ventricular systolic function (LVEF 20%). On the 21st hospital day, the irregularity of peripheral branches of left and right coronary arteries was detected by coronary arteriography. Right ventricular endomyocardial biopsy yielded little fibrosis and no infiltration of eosinophil. Although all the laboratory tests showed lower activity of AGA, steroid pulse therapy was tried and the use of steroids was tapered at intervals of two weeks. Left ventricular function was slowly improved (LVDd 60 mm, LVEF 36%). He was discharged on foot on the 71st hospital day.

MHLW released a guideline for Risk Management Plan (RMP) in April 2012, in order to manage the risk of pharmaceutical products from the development stage towards post marketing period. The guideline suggests to determine Safety Specification and to develop Pharmacovigilance Plan (PVP) and Risk Minimization Plan aligned to the ICH E2E guideline. However, in some of the RMPs, which had been published online (as of August 2014), conventional (Special) Drug Use Results Surveys are planned as a “universal” PVP regardless of the impact, severity and characteristics of the risks. Our JPMA taskforce (Data Science Expert Committee) summarized report and published in August 2014. In this report, we explained how to evaluate safety events based on evidence level for safety specification and how to develop PVP. Also, we would like to propose KAIZEN activities for RMP improvement as follows:
1. In order to clarify the research question, rationale and evidence for safety specification should be evaluated carefully.
2. It is essential to be considered in advance how to collect and analyze the safety data for detecting safety specification during clinical development.
3. Safety profiles should be discussed thoroughly on DSUR development among stakeholders in order to clarify safety specification at NDA. Research questions for each different risk and missing information should be established according to PECO, which will flow into appropriate PVP planning.
4. Continuous PDCA cycling is critical for RMP. The first survey or research will bring you next research question (s).
We expect all stakeholders, including clinical development specialists in industry, regulatory authorities, and academia, to have better understating of RMP principle and to manage and implement it more appropriately in a scientific manner.