In hemodialysis patients, muscle cramps in the lower extremities are frequently seen. In order to prevent the occurrence of these cramps, Shakuyakukanzo-to was administered to five patients that frequently suffered from muscle cramps during dialysis. Before receiving dialysis, a dose of 2.5g was given to each of the five patients. The rates of efficacy were: effective for 2 patients, slightly effective for 2 patients and not effective for 1 patient. No severe side effects such as increases in serum potassium levels were observed. The results therefore suggested that Shakuyakukanzo-to is useful in the prevention of muscle cramps during dialysis.

During FY 2004 through 2008, as one of the projects in the first medium term plan, the Pharmaceuticals and Medical Devices Agency(PMDA)had been engaged in the research and establishment of data mining method as an operational support tool to assist staff in charge of post-marketing safety measures, with the goal to implement this tool in April 2009.
This article was written with objective to demonstrate the current operation process of data mining in PMDA.

One of the target points in the PMDA 2nd midterm plan (FY2009-2013) is reinforcement and enhancement of the system for safety evaluation for pharmaceuticals using expanded data sources beyond spontaneous reports of adverse drug reactions (ADRs). To achieve this goal, PMDA started investigation in FY2009 to develop methodology to utilize electronic medical information for secondary purpose of safety evaluation of pharmaceuticals. (MIHARI project- Medical Information for Risk Assessment Initiative)
Data sources targeted in MIHARI project are claims data, diagnosis procedure combination (DPC) data, hospital information system (HIS) data, etc.
Secondary use of electronic medical information for safety evaluation is expected to enable safety evaluation based on quantitative analysis, which has been difficult so far. It will also provide faster and easier way of evaluation compared to collecting primary data from study planned and conducted just for the purpose.
PMDA intends to establish the system to utilize electronic medical information (eg. claim data, DPC data, HIS data) practically for safety evaluation by the end of FY2013. Aiming for this, PMDA is conducting various pilot studies using currently available data in the MIHARI project. Here we report on recent developments of this project.

PMDA started MIHARI project in FY2009 to enhance drug safety assessment by developing ways to utilize electronic medical information as additional data sources to spontaneous adverse drug reaction reports. The project has been established according to PMDA's second midterm plan. In this article, we will introduce latest two studies (pilot studies No. 4 and 5) using data of standardized electronic medical record(EMR) called SS-MIX (standardized structured medical record information exchange) data out of our several pilot studies. SS-MIX is a standard specification published by the Ministry of Health, Labour and Welfare. In these studies, anonymized SS-MIX data were provided by six collaborative hospitals respectively. In pilot study No. 4, we explored approaches for evaluating the impact of regulatory action which instructed relevant manufacturers to revise package inserts of sitagliptin phosphate hydrate (sitagliptin) to call physician's attention. The revision was about reducing dose of sulfonylurea (SU) to avoid serious hypoglycemia when it is prescribed concomitantly with sitagliptin. As indicators of the impact, we evaluated changes in proportion of concomitant use and average SU dose before and after the action and estimated the risk of hypoglycemia in concomitant users compared to SU alone users before and after the action. In conclusion, evaluating impact of the regulatory action using SS-MIX data was technically feasible; however, it was difficult to analyze with adequate accuracy due to limited size of the data. In pilot study No. 5, we examined validity of outcome definitions for hyperthyroidism which were applied to combinations of some data elements of SS-MIX data to identify the patients. Three types of outcome definitions were prepared; 1) definitive diagnosis of hyperthyroidism, 2) prescription of medication for hyperthyroidism, 3) prescription of medication for hyperthyroidism in or after the month in which definitive diagnosis of hyperthyroidism was given. Criteria for case ascertainment were determined according to relevant clinical guidelines. After the cases were ascertained, positive predictives values were calculated. The results suggested that using information on prescription of medication improves validity of definition of outcome. The findings from pilot studies in MIHARI project have been utilized in another project which PMDA is carrying forward now (EMR network project). The findings would be also helpful when we use data from this network. (Jpn J Pharmacoepidemiol 2013；18(1)：23-29)

Since January, 1981 to December, 1990, eight patients (one male, 7 female) of Stanford A type aortic dissection underwent surgical treatments with deep hypothermic circulatory arrest. The average was age 59.6 years (range 50 to 72 years). All of them were diagnosed with UCG and/or CT before operation. Two cases had already been in shock state due to cardiac tamponade. Three cases had aortic insufficiency and one had neurological deficit. After median sternotomy, right atrial-femoral artery bypass was established. Right atrium was incised and coronary sinus was cannulated. Then retrograde coronary infusion of cardioplegic solution was employed at a continuous flow rate of 20ml/kg/hr. The mean rectal temperature was 19.6°C and the mean circulatory arrest time was 35.5min (22-58min). Two of eight cases died, because of DIC followed by necrotizing enteritis at 28th postoperative day, and prolonged shock state before operation. The rest were all survived without any neurological deficits. There were no severe complications related to deep hypothermia. We concluded that deep hypothermic arrest is safe and simple method, allows good inspection of operative field and makes it easier to repair the dissected aorta.

Six (1.2%) of 501 patients sustained phrenic nerve injury during operation for congenital heart disease at our institutions between 1992 and 1998. The diagnosis was confirmed by percutaneous stimulation of the phrenic nerve. All but 1 patient were less than 9 months old, and the average weight was 3.6kg. All 6 patients underwent diaphragmatic plication and were extubated by 7 days after operation. Percutaneous stimulation of the phrenic nerve allowed direct assessment of phrenic nerve function which was difficult to detect by clinical and radiological evidence. This method can be non-invasively used at the bedside to facilitate early and accurate diagnosis of phrenic nerve palsy.

Papua New Guinea (PNG) is one of the Pacific island countries facing a noncommunicable disease (NCD) crisis. Little has been reported about rehabilitation services for them. This study aimed to describe the characteristics of inpatients with the four major NCDs receiving rehabilitation services in PNG: cardiovascular disease (CVD) (divided into cerebrovascular disease and ischaemic heart disease), diabetes, cancer and respiratory disease. We conducted a subanalysis of our previous study. We reviewed the inpatient records of all inpatients (12,241 records, Total group) and those of inpatients receiving rehabilitation services by physical therapy (PT) (350 records, PT group). After extracting the records of patients with NCDs, we investigated the demographic data, diagnostic data and gait function. We calculated the percentages of inpatients’ characteristics and the ratio of the number of inpatients in the PT group to that in the Total group by diagnosis (PT ratio). The final analysis included 442 records in the Total group and 68 records in the PT group. Diagnoses and percentages in the PT group were cerebrovascular disease (65%), diabetes (22%), cancer (9%), respiratory disease (4%) and ischaemic heart disease (0%). The PT ratio was the highest in cerebrovascular disease (0.88), followed by diabetes (0.16) and other diagnosis (≤0.05). The inpatients with cerebrovascular disease and diabetes were more likely to have poor gait function than those with other NCDs. Our findings suggested that the provision of rehabilitation services for inpatients with the four NCDs was limited and biased for specific conditions. For development of rehabilitation services for patients with NCDs in PNG, scaling up the service provision and expanding its scope would be a possible way forward

Objective: Papua New Guinea (PNG) is the largest of the Pacific Island countries that is facing challenges related to the burden of cerebrovascular disease. There are few reports on rehabilitation services for inpatients with cerebrovascular disease, including stroke. This study aimed to examine the provision of rehabilitation services, physical therapy (PT) and service outcomes in PNG. Methods: A sub analysis of our previous retrospective observational study at a single provincial hospital in PNG was conducted in which patient records of all inpatients (Total group, n = 12,241) and those of inpatients receiving rehabilitation services (PT group, n = 350) were reviewed, and the records of inpatients with cerebrovascular disease were extracted for analysis. For descriptive purposes, demographic data, service provision statistics (length of hospital stay and duration and frequency of PT services provided) and gait function were summarized. Results: The final analysis comprised 50 of 12,241 records in the Total group and 34 of 350 records in the PT group. All of these studied patients suffered a stroke. The dominant age in both groups was ≥40 years. The median length of stay in hospital was 9 days in the Total group. The median frequency and duration of PT services were 4 times and 8.5 days, respectively. Of the 34 inpatients in the PT group, 32 (94%) were discharged with poor gait function defined as ‘dependent or no walking function’. Conclusions: The results implied that stroke patients who were discharged with poor gait function and restarted their life in the community would confront significant barriers and challenges in PNG. This first report, to our knowledge, on rehabilitation services for stroke in PNG may provide a reference point for further clinical research.

Insufficient physical function is strongly associated with decreased activity of daily living and health-related quality of life in middle-aged and older women. YOSAKOI Soran is one of the traditional Japanese dances to have naruko (wooden hand clappers) in their hands as they dance and incorporate the phrase from the Soran Bushi in their song. YOSAKOI Soran festivals can be seen being held in various places across the country, proving its growing popularity with residents as a celebration regardless of age or occupation. The purpose of this study was to examine the cross-sectional associations between YOSAKOI Soran and the physical functions of middle-aged and older women. A total of 30 middle-aged and older women practicing YOSAKOI Soran (YOSAKOI group) and 163 middle-aged and older women who had not practiced YOSAKOI Soran (control group) participated in this cross-sectional study. Handgrip strength, 30-second chair stand performance, and flexibility were used to measure physical functions. Handgrip strength was not significantly differed between the YOSAKOI group and the control group (P = 0.79). 30-second chair stand performance and flexibility were significantly higher in the YOSAKOI group than in the control group (both P < 0.05). These results remained significant after adjusting for age and body mass index (both P < 0.05). The present results suggest that practicing YOSAKOI Soran may increase lower extremity function and flexibility in middle-aged and older women.