Over 40 years, Post-maketing surveillance (PMS) studies have been conducted as a legal obligation in Japan. Though the contribution of these studies to the better use of the drug has been acknowledged, there are criticisms that these PMS studies have been stereotyped and need to be improved. The ICH-E2E guideline entitled as "Pharmcovigilance Planning", agreed in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has been implemented in the concerned countries. The legislation of the guideline in Japan in 2005 seems to have urged drug companies and regulatory agency to review the current PMS practices in contrast with the today's highest scientific standard. We investigated the theoretical and practical aspects of pharmacoepidemiology required when the drug company evaluates safety specification prior to developing the pharmacovigilance plan and designs a PMS study along the lines stipulated in the ICH-E2E guideline. To meet this end, we evaluated the profiles of the drug, summarized "Important identified risks", "Important potential risks" and "Important missing information" to be identified and examined the pharmacovigilance plan suggested by the regulatory agency and that proposed and implemented by the drug company. We examined those aspects for 6 new products selected from 168 drugs newly approved during the period between January 2004 and October 2006. In 5 of 6 cases, we judged that the use of a comparator group would have been appropriate to asses the association between the drug and adverse events of interest. In addition, in one half (3) of 6 cases, it would have been preferable to use the database for the patient registration and/or other types of databases. The issues of relevant legislation and the infrastructure and funding for the investigations needed to develop a desirable study design and conduct a good pharmacoepidemiology study are however beyond a single company's capacity and should be set as a national strategy. The issues of post-marketing safety in the nation is becoming more and more important as the data in the countries outside Japan are being used more often for the processes of marketing authorization application of a new drug and its approval. It is urgent to secure the practice of pharmacoepidemiology to achieve the effective post-approval pharmacovigilance studies.

In August 1995, a committee was inaugurated in our hospital to improve hospital-patient relationship. Under the auspices of the committee, a series of lecture meetings were held with professional consultants and teachers invited. From September to December in that year, the on-the-job training was started and all the staff and part-time workers participated. The second training was carried out exclusively for people in managerial positions and the committee members from January to February in 1996. From March to June the third training was done for all the staff. The fourth and final training was given to the committee members from July to August in 1996. These on-the-job training and meetings resulted in marked improvements in communication between patients and hospital members. Moreover, the reform image of our hospital has been known widely. From now, we should continue our efforts to improve the hospital-patient relationship through various projects.

We have performed mass surveys for colorectal cancer by using an immunological fecal occult blood test (OC Hemodia) since April, 1987. In this report, we evaluated the mass survey protocol, and investigated the upcoming problems and measures.
The total number of examinees for six years until March, 1993 was 172, 474. The persons needed detailed examination amounted to 6, 952 (4.0%) and the persons received the detailed examination, 4, 706 (67.7%). A total of 144 colorectal cancer cases (detection rate: 0.08%, 153 lesions) were discovered, 93 cases (64.6%) were in their early stage. 101 cases (66.0%) of 153 lesions were early cancer, and 71 cases (70.3%) were cured by endoscopic polypectomy.
The detection rate of colorectal cancer was higher in males than females. In particular, the finding rate for males 50 years old and above was extremely high. We strongly recommend that the elderly people should receive a mass survey. Moreover, it is important to offer the opportunity for detailed examination to the persons who don't receive them. That might raise the detection rate.
It was found that detailed examination has left much room for improvement in terms of methodology. Some medical institutions performed only fecal occult blood testing. They are require d to raise the understanding of mass surveys for colorectal cancer. Collaboration with the medical institutions that are capable of detailed examination and care is indispensable to raise the accuracy of examination.
On the basis of the results in 1992, we calculated the diagnostic accuracy of immunological fecal occult blood test. The sensitivity of the one-day-method was 70.8%, the specificity, 97.0%, and the positive predictive value 2.1. The sensitivity of the two-days-method was 86.7%, the specificity, 95. 3%, and the positive predictive value, 2.7, and was better than the one-day-method.
These findings suggest that the carcinomas, negative to the occult blood test, still exist in a high frequency rate. Therefore, we should perform mass surveys by the two-days-method every year, in order to improve the evaluation of the mass survey method for colorectal cancer.

Although evidence of Western therapy for heart failure has been established, evidence of treatment for heart failure with chronic kidney disease (CKD) has still not been established. The efficacy of additional Oriental medicine to standard therapy for heart failure with CKD is unclear. To address this issue, we retrospectively evaluated 20 consecutive heart failure patients with CKD (≧stage 3) who were orally administered goreisan (7.5 g/day) due to insufficient efficacy of standard therapy in our hospital from November 2015 to December 2017. We assessed symptoms, chest X-ray, BNP concentration, serum electrolytes, eGRF, plasma osmolality, and side effects. Goreisan improved heart failure in 11 of 20 patients, did not significantly deteriorate renal function, plasma osmolality, and did not clinically affect electrolytes. In conclusion, the present study suggested that additional use of goreisan to Western standard therapy is safe and useful for heart failure with CKD.

Dry solid matter (rutin content: 51.6 mg/g; quercetin content: 72.2 mg/g) extracted from Tartary buckwheat boiled noodles using 70% methanol as the solvent was found to have α-glucosidase inhibitory activity. As for fractions fractionated by silica gel column chromatography, the fractions rich in quercetin and rutin showed remarkable α-glucosidase inhibitory activity. Tartary buckwheat boiled noodles used as samples in this study contained quercetin produced from rutin by the action of rutinase, suggesting that both rutin and quercetin contained were involved in the α-glucosidase inhibitory activity of the dry solid extract. Changes in postprandial blood glucose levels were compared for boiled noodles made from two types of buckwheat (i.e., Tartary buckwheat and common buckwheat), revealing that blood glucose elevation after eating Tartary buckwheat boiled noodles was suppressed. The blood glucose level 40 minutes after eating Tartary buckwheat boiled noodles was significantly low (p<0.05). It can be concluded that this might be caused by the α-glucosidase inhibitory activity of rutin (270.0 mg) and quercetin (330.5 mg), which correspond to a total amount of 935 mg of rutin equivalents, in the gastrointestinal tract. As a result, the digestion of carbohydrates contained in the samples consumed and their absorption by the intestine might be inhibited, resulting in the suppression of increases in blood glucose levels. The presence of a certain amount of quercetin was considered to be key to the suppression of blood glucose elevation. It is important to control rapid postprandial blood glucose increases to prevent diabetes from developing or becoming serious. This study suggests the potential for Tartary buckwheat boiled noodles to contribute to diabetes prevention.

Although the descriptions of shigyakukachotanto in “Waitaimiyaofang” and tsumyakushigyakukachotanjuto in “Songban Shanghanlun” are quite similar to each other, the specifications of the dosages of crude drugs and the water volume in the books were considerably different. Focused on the specified water volume to decoct these formulas, each reasonable decocting period was estimated, then the decoctions were prepared using hard water that was common in mainland China. The dosages of aconite root were 2­-fold different between these two formulas, but the contents of aconitine-­type diester alkaloids (ADA) in both decoctions were found in the range of 1.2—1.4­-fold. It was suggested that in order to control the efficacy and the safety of aconite, the decocting period was well regulated by the specification of water volume for decocting at this ancient era. Moreover, the dosages of aconite root and glycyrrhiza in bukuryoshigyakuto (BSGT) formula of “Songban Shanghanlun” are equal to those of shigyakuto (SGT) but the specified water volume to begin decocting is as about twice as that of SGT. When prepared using hard water, BSGT resulted to make the contents of ADA lower and those of non-­ester alkaloids higher compared with those of SGT decoction. It was suggested the spe­cific water volume for each formula prescribed in classical Chinese medicine had considerable significance to determine the dosages of chemical ingredients in the decoctions especially in the circumstances using hard water to prepare them.

Prevention, early diagnosis, and early treatment of skeletal-related events (SREs) are important in the treatment of potential or current cases of bone metastasis. In August 2020, our hospital established the bone metastasis team and the bone metastasis board (BMB) started actively engaging in activities aimed at improving the outcome of bone metastasis. We retrospectively examined whether a combined modality therapy started in the diagnosis of bone metastases could prevent the onset of SREs and whether it could prolong survival and improve activities of daily living. The 75 advanced cancer patients who underwent BMB at our hospital from August 1, 2020 to July 31, 2022 were divided into two groups according to when BMB performed before and after SREs for comparative analysis. Numerical Rating Scale improved, however Performance Status did not improve in both groups, and there was no difference in survival between the both groups (15.3 vs. 9.0 months, HR: 0.74, 95%; CI: 0.42–1.29, p=0.29). In conclusion, patients who suffered from SREs from the time of bone metastasis diagnosis were treated early. However, the incidence of SREs after BMB in our hospital was 22.6%, and it is necessary to actively work to prevent SREs in the future.