Background: /Aim: The aim of this study was to compare the therapeutic efficacy of ablation and surgery in solitary hepatocellular carcinoma (HCC) measuring ≤5 cm with a large HCC cohort database. Methods: The study included consecutive 2,067 patients with solitary HCC who were treated with either ablation (n=1,248) or surgery (n=819). Th e patients were divided into three groups based on the tumor size and compared the outcomes of the two therapies using propensity score matching. Results: No significant difference in recurrence-free survival (RFS) or overall survival (OS) was found between surgery and ablation groups for tumors measuring ≤2 cm or >2 cm but ≤3 cm. For tumors measuring >3 cm but ≤5 cm, RFS was significantly better with surgery than with ablation (3.6 and 2.0 years, respectively, P=0.0297). However, no significant difference in OS was found between surgery and ablation in this group (6.7 and 6.0 years, respectively, P=0.668). Conclusion The study suggests that surgery and ablation can be equally used as a treatment for solitary HCC no more than 3 cm in diameter. For HCCs measuring 3-5 cm, the OS was not different between therapies; thus, ablation and less invasive therapy can be considered a treatment option; however, special caution should be taken to prevent recurrence.

Hypertension is one of the most important modifiable risk factors for stroke, and greater than 50% of all stroke events are estimated to be attributable to elevated blood pressure (BP). Randomized trials and meta-analyses have demonstrated that reducing BP is the most effective and generalizable strategy for preventing recurrent stroke. Based on currently available evidence, BP should be reduced to below 140/90 mmHg in all patients during the chronic post-stroke phase and to below 130/80 mmHg when well-tolerated.

Hypertension is one of the most important modifiable risk factors for stroke, and greater than 50% of all stroke events are estimated to be attributable to elevated blood pressure (BP). Randomized trials and meta-analyses have demonstrated that reducing BP is the most effective and generalizable strategy for preventing recurrent stroke. Based on currently available evidence, BP should be reduced to below 140/90 mmHg in all patients during the chronic post-stroke phase and to below 130/80 mmHg when well-tolerated.

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)

We examined the clinical effect of a functional food containing both soy isoflavone and black cohosh extract (test food) on Simplified Menopausal Index (SMI) in a double blind study. Twenty four peri-menopausal women were divided into two groups and four capsules of either the test food or placebo were ingested everyday for eight weeks. The daily intakes of soy isoflavone and black cohosh extract were 50.0 mg and 80.0 mg respectively. As compared with placebo group, the scores of menopausal symptoms such as “stiff neck” and “backache” significantly improved (p<0.05), and the score of “irritation” tended to improve in test food group but not significant statistically. When these results were stratified according to the severity of pretrial menopausal symptoms, the effects of test food were shown to be more effective in mild case group. These results suggest that the functional food containing soy isoflavone and black cohosh extract alleviate menopausal disturbances and improve the quality of life for peri-menopausal women.