A 44-year-old man was given a diagnosis of severe ischemic heart disease and Leriche's syndrome. He had critical ischemia in the lower extremities and ischemic gangrene in a toe of the left foot. We planned a one-stage operation for these fatal diseases. To prevent irreversible ischemia of the lower limbs after mobilization of internal thoracic arteries or during extracorporeal circulation, we performed aorto-ilio femoral bypass grafting with extra-peritoneal approach first. Then conventional coronary artery bypass grafting was carried out for three coronary arteries with bilateral internal thoracic arteries (ITAs) and the saphenous vein. The postoperative course was uneventful.

We report three cases of patients with mental illness suffering from symptoms associated with menstruation, which were improved with Kampo treatment. Case1: A 39-year-old female had been in a depressive state after delivery and diagnosed with persistent mood disorder in the Neuropsychiatry Department of Fukushima Medical University (FMU). During treatment for the disorder, she developed premenstrual dysphoric disorder (PMDD) and was immediately hospitalized. After she was introduced to the Obstetrics/Gynecology Department, we treated her with Kampo medicine such as tokakujokito considering the meaning of the pattern (sho), and then she recovered from PMDD. Case2: A 29-year-old female with schizophrenic disorder treated in the Neuropsychiatry Department of FMU was referred to the Obstetrics/Gynecology Department due to PMDD. We administered Kampo medicine such as kamishoyosan, nyosinsan and saikozai when yang pattern was observed, and ninjinto and daikenchuto in yin sho. Then, her condition then gradually improved. Case3: A 37-year-old female diagnosed with borderline personality disorder and attention deficit hyperactivity disorder was hospitalized in the Neuropsychiatry Department of FMU. She was introduced to the Obstetrics/Gynecology department due to dysmenorrhea and PMS. After she was treated with keishibukuryogan and hangekobokuto, her symptoms improved. In conclusion, Kampo treatment appears to be effective for symptoms associated with menstruation in women with mental illness.

Real-world data (RWD), such as a health insurance claim database and electronic medical record database, which records daily medical care information, is one of the most important data sources in pharmacoepidemiological studies. In Japan, a post-marketing database study has been added as a new category of post-marketing surveillance since April 2018. It is expected that the post-marketing database studies will be conducted in the actual risk management plan； however, at this point, few have reached the stage of publishing study results. On the other hand, overseas, many database research results using RWD have already been reported. Although it is necessary to keep in mind that there are differences in the characteristics of the databases (e.g., data contents, structures) and the differences in the medical environment between overseas and Japan, we think that critically reviewing these reports has a reference value for the planning, execution, and interpretation of the results in performing post-marketing database studies in Japan. The purpose of this report is to examine the characteristics and cautions of the database studies through a critical review of published articles of overseas RWD studies and to make recommendations that are useful for conducting post-marketing database studies in Japan. We hope this article will become a help in the planning and implementation of future post-marketing database studies.