Objective: The aim of this study was to analyze the factors influencing the addition of clinically significant adverse reactions (CSDR) section in drug package inserts in Japan.
Methods: The summaries of investigation results from August 2011 to July 2014 were evaluated.  The revisions were classified into revisions based only on case reports from Japan ([Revision Y]) and revisions based on other information and/or case reports from Japan ([Revision X]).  The revisions were classified into MedDRA system organ class (SOC).  As index of amount of information from domestic case reports, the number of accumulated cases ([Case A]), cases for which a causal relationship to the product could not be ruled out ([Case B]), and fatal cases ([Case C]) were used.  In each SOC, as index of causal relationship to the product, [Index B/A] ([Case B]/[Case A]) was calculated.  Relationship of [Index B/A] to [Revision X]/all revisions, or to the number of [Case A] in [Revision Y] were evaluated.  Deference of drug lag between [Revision X] and [Revision Y] was evaluated.
Results: Three hundreds twenty-three revisions with respect to the addition of CSDR section were identified.  [Revision Y] was 203 revisions (63%).  The number of [Case A], ([Case B], and ([Case C]) that were required for [Revision X] (120 revisions) were significantly lower than that were required for [Revision Y] (p<0.0001 for all comparisons).  [Index B/A] tended to inversely correlate with [Revision X]/all revisions (r=−0.52, p=0.066), and the number of [Case A] in [Revision Y] (r=−0.61, p=0.025).  Drug lag of [Revision X] was significantly longer than that of [Revision Y] (p<0.001).
Conclusions: In future, it would especially needed to pay attention to adverse reactions with a low [Index B/A] of which revisions relatively depend on other information.

This study sought to determine whether aerobic exercise training affects cognitive functioning among semi-independent (> 75 years) and independent elderly people. Seventy-six semi-independent and independent elderly subjects were divided into the following groups: semi-independent control (n = 16); semi-independent training (n = 13); independent control (n = 22); independent training (n = 25). During the 12-week intervention, subjects in both training groups performed a bench-stepping exercise at the intensity of the lactate threshold. Subjects were assessed at baseline and post-intervention using the Frontal Assessment Battery test (FAB), the Modified Mini-Mental State Exam (3MS), and a bench-stepping test of aerobic capacity. During the intervention, FAB scores improved only in the semi-independent training group (p = .002), while 3MS and MMSE scores improved in both the semi-independent training (p = .032 and p = .004) and independent training groups (p = .001 and p = .013). FAB and 3MS scores were higher in the semi-independent training (p = .001 and p = .002) compared with the semi-independent control group after the intervention. Finally, post-intervention scores for FAB, and 3MS in the semi-independent training group almost reached the baseline levels of the independent control and independent training groups. These results indicate that moderate intensity bench-stepping exercise training can improve cognitive and frontal lobe functioning in semi-independent elderly people, almost to the level exhibited by independent elderly people.

  Our hospital with 723 sickbeds takes care of acute diseases. The volume of documents was enormous, exceeding 3,500 titles each month. Paper work chronically puts too heavy a burden on physicians. Although an electronic system of storing medical records has been employed for years and about a half of documents are now processed electronically, there still remains a lot of paper work requiring hand writing.
  To lighten the work load of physicians, a type of computer software to make it easy to imput and output patients' medical history has become available recently. The features of the software are as follows:
(1) having about 600 formats,
(2) capable of inputting patients' personal information automatically,
(3) capable of retrieving disease names, dates of hospital admission and discharge, surgical procedures, etc. from the cemtra;computer system with electronic cards, and
(4) capable of outputting medical date and printing them.
  By dint of these functional capabilities, it has been made easy to issue the written opinions of physicians regarding the nursing care insurance and the medical certificate for life insurance money.
  With the revision of the schedule of medical service fees in April 2008, some points were given to physicians' desk jobs. Thanks to the new point system, we could assign five clerks to assist physicians with the paper work. They draw up documents and input non-medical data into the computer.
  The deployment of the clerical workers and the introduction of the computer software has shortened the time required for documentation by about 4 days from 11.2 days to 7.2 days. Responding to a questionnaire survey taken 6 months after the start of the new system, eight out of 10 doctors said that the strain on them was eased.

Behcet's disease is generally recognized as a chronic multi-system disease. Approxymately 8% of patients with Behct's disease will have serious vascular compilcations which is called vasculo-Behcet's disease. A male patient of 41 year old was admitted to our clinic, complaining pain of left popliteal fossa and hypesthesia of left lower leg. A popliteal aneurysm was found. Resection of the aneurysm and a saphenous vein graft were successfully performed. Neuropathy disappeared after the surgery. Aneurysms in Behcet's disease mainly appear in major arteries, and rarely in peripheral arteries. Compression neuropathy in the popliteal aneurysm of Behcet's disease has been rarely reported. Early resection of aneurysm before completion of neuropathy is recommended for succsessful outcome.

Anjo Kosei General Hospital is a large-scale hospital having 692 beds and located in the central part of Aichi. When the hospital moved into the present adress in April 2002, we introduced an electronic chart system that was not common in Japan at that time. Hospital management changed dramatically because until then we were using exclusively papers, and had not possessed even an electronic ordering system. It was also true in the field of medical office work. We hereby report the changes in routines after the introduction of the electronic chart system and its usefulness.The characteristics of our medical work system are as follows.(1)Data refrieval function (Data Ware House)(2)Credit control system(3)Receipt imaging functionWe are evaluating the various effects of the system from seven points of view as follows.(1)Basic data of medical care(2)Staff placement and personnel expenses(3)Work accuracy and efficiency(4)Patients service(5)Storage space reduction(6)Paper reduction(7)In-house questionnaire survey
Work ; Hospitals ; chart ; System ; Reduction (chemical)

It has been experienced that Kampo, with its philosophy that every disease is psychosomatic in origin and that herbs affect both the psyche and the soma, sometimes has a dramatic effect on somatoform disorders, though there has been no study examining the effects of Kampo on somatoform disorders. In this preliminary study, the morbidity of somatoform disorders among patients who visited the Keio Kampo Clinic and the patients' psychological well-being were examined.
One hundred patients (17 males and 83 females; mean age [±SD], 39±16) who sought Kampo treatment for the first time at Keio University Hospital participated in this study. A Japanese checklist derived from the somatoform disorders schedule (version 1.1) was used to check the somatoform symptoms. To assess psychological well-being, the subjective well-being inventory (SUBI) was performed. The subjects' clinical records were examined afterwards to rule out symptoms which could be medically explained.
Somatoform patients and medically ill (non-somatoform) patients were 65% and 26% of the total respectively. The somatoform patients showed significantly lower SUBI positive scores than the non-somatoform patients (p=0.042), while SUBI negative scores were significantly higher (p=0.001). Among the somatoform patients, there was a negative correlation between numbers of somatoform symptoms and SUBI positive scores (r=0.267; p=0.032), and a positive correlation between numbers of somatoform symptoms and SUBI negative scores (r=0.337; p=0.006).
Following the SUBI scores through treatment courses may lead to a better understanding of the pathology of somatoform disorders and to more effective use of Kampo.

A survey was carried out on how the To-no District is coping with the need of first aid for patients requiring life-supporting treatment before hospitalization. Although there were cities in this district where statistics on first aid were not available, the survey found that, during the 4-year period from 1994 through 1997, bystander CPR (cardiopulmonary resuscitation) saved 11.2% of the lives of patients with CPA (cardiopulmonary arrest). Incidentally, 11.3% of the population attended CPR courses offered by public institutions. Gifu Prefecture has helicopters for use in rescue work, but the survey found that some cities had not ever sponsored drills using helicopters in life-saving operations. Our findings revealed the indifference of the general public as well as administrators in this district toward emergency care. Public recognition of the importance of the care of suddenly ill or injured patients must be gained. Furthermore, acquisition of skills required for first aid by lay people and technical improvement of these skills in professional rescuers are necessary. The authors think that these are the community educational responsibility of hospitals and other medical institutions.

It is well known that decreased physical performance induces the decreased activity of daily living and increment of mortality rate in elderly subjects. On the other hand, a prolonged heart rate corrected-QT (QTc) interval is associated with an increased risk of cardiac sudden death and cardiac autonomic dysfunction. We investigated the associations between physical performance and QTc interval in elderly subjects. The subjects included 605 elderly persons (274 men and 331 women, age; 71.2±4.7 years) without a history of cardiovascular disease and taking cardioactive drugs. Resting 12-leads electrocardiography was measured after more than 5 minutes of rest. The QTc interval was calculated according to Bazett’s formula. The physical fitness test was performed to determine the physical performance (muscle strength, balance and walking abilities). The subjects were divided into four categories, which were defined as equally quantile distributions of QTc interval. The physical performance levels were significantly lower in the longest QTc interval group compared to the shortest QTc interval group in both men and women (p<0.05, respectively). Moreover, after adjusting for the age, the physical performance levels were significantly lower in the longest QTc interval group compared to the shortest QTc interval group, especially, this relationship was observed in late-stage elderly group (p<0.05, respectively). These results suggest that decreased physical performance levels were also associated with prolonged QTc interval in elderly subjects.

We have treated 12 popliteal aneurysms in ten patients from 1965 to 1989. There were seven men and three women, aged 34 to 78 years (mean, 61.5 years). Two patients had bilateral aneurysms. The chief complaint was pain at rest, claudication, coldness, etc. in eight patients, a mass or induration at the popliteus in two patients, peroneal nerve or vein compression in one patient each. Angiography showed thrombotic obstruction in six legs and distal occlusion in one leg. Ten of aneurysms of eight patients were treated surgically. In two patients, the operation was done on emergency basis. Amputation was not necessary in any case. The operative method was usually excision of the aneurysm. Reconstruction was made with artificial vessels in the first patient who underwent bilateral aneurysm surgery. Auto-saphenous vein were used in other seven patients. All vein grafts were patent at follow-up (mean follow-up period, 4 years and 3 months). Arteriosclerotic changes were histologically observed in all aneurysms. Complications such as thrombotic obstruction and distal occulsion are frequent and leg amputation is necessary in some cases. Arterial reconstruction with an auto-saphenous vein is necessary for popliteal aneurysm.