Objective: Databases, such as the Medicaid recipient database in the USA and the General Practice Research Database (GPRD) in the UK, take on an important role as resources for balancing the benefits and risks of medicines in Europe and the United States.
Their record sizes are several ten million and a few million each. They are actually used for epidemiological studies. However, in Japan, a database that can be used for such studies is insufficient. We attempted to create a database of pre-marketing clinical trial data for antihypertensive drugs. These data have been managed by a Controller Committee.
(Design : not applicable )
Methods: The database is made from the data and the documents, including electronic and paper media. The creation process was as follows : computerizing documents, item-name identification, defining the integrated database, protocol review, batch processing, and logical/validation checking.
Results: The database has 13 datasets and consists of 56 trials and 12,389 subjects. Overall, 15 trials involved beta-blockers which is the largest drugs as the investigational drug, and 43 trials compared the same group of antihypertensive drugs.
Conclusion: A database that can be used for quantitative evaluation of various hypotheses has been built. It is possible to completely analyze all of the data in this large-scale database to conduct, for example, individual patient data (IPD) meta-analyses.

Objective: To investigate quantitatively the risk factors of hyperkalaemia or increased blood potassium associated with ACE-inhibitor therapy
Design: Nested case-control study
Methods: We used the antihypertensive drug database(72,379 subjects)developed by the RAD-AR Council, Japan and the Institute of Statistical Mathematics based on the post-marketing surveillance(PMS) data of pharmaceutical companies. Of 37,372 subjects taking ACE-inhibitors, the case group was composed of 64 patients who experienced hyperkalaemia or blood potassium increase while taking ACE-inhibitors, and the control group was composed of 1,280 patients(20 patients per case)randomly selected from patients who did not experience hyperkalaemia or blood potassium increase while taking ACE-inhibitors. The relevant factors that can be extracted from the database were the followings: age, WHO classification of hypertension, complications, antihypertensive drugs used before the PMS survey, and concomitant drugs.
Results: Among the subjects taking antihypertensive agents, 65 patients experienced hyperkalaemia orincreased blood potassium, 64(98.5%)of whom were taking ACE-inhibitors. The factors that were significantly different between two groups(p<0.05)by univariate analysis were WHO classification of hypertension(p=0.005), complications of nephritis/nephrosis(p<0.001), other disorder of urinary system(p<0.001), unclear symptom or diagnosis(p=0.005), taking diuretics as antihypertensive drugs before study(p=0.032), and concomitant treatment with diuretics(p=0.004), vasodilators(p<0.001), and antigout agents(p=0.001). Conditional multivariate logistic analysis of these factors yielded adjusted odds ratio of 21.31 for complications of nephritis/nephrosis(p<0.001), 6.83 for other disorder of urinary system(p<0.001), and 2.30 for concomitant therapy with diuretics(p=0.049).
Conclusion: The risk factors of hyperkalaemia or blood potassium increase associated with taking ACE-inhibitors were nephritis/nephrosis, other disorder of urinary system and concomitant therapy with diuretics.

Objective: The mechanism underlying the development of neuropsychiatric symptoms such as unconsciousness, abnormal behavior, delirium, hallucinations, and convulsions in influenza has not been thoroughly investigated. The relationship between drug administration and neuropsychiatric symptoms during influenza is also poorly understood. This study is the first pharmacoepidemiologic study focused on investigating the relationship between drug administration and neuropsychiatric symptoms.
Design: Cohort study
Methods: Study subjects were patients under 18 years old who had influenza during the 2006/07 season. We prepared two kinds of questionnaires for doctor and for patient's family, and carried out the survey between January and March, 2007. Using data from 9,389 patients, we analyzed the relationship between neuropsychiatric symptoms, such as delirium, unconsciousness and convulsion, and drug administration of acetaminophen and oseltamivir.
Results: Analysis of the relationship between delirium and drug administration provided hazard ratios of 1.55(p=0.061)for acetaminophen and 1.51(p=0.084)for oseltamivir. These hazard ratios, which were adjusted for risk factors by multivariate analysis of the proportional hazard model, showed an increasing tendency of delirium after administration of each drug. In patients who received oseltamivir, a high incidence of delirium was observed between 6 and 12 hours after onset of fever. Furthermore, delirium was found to develop in a shorter time following oseltamivir use than it did after acetaminophen use. There was no relationship between unconsciousness and acetaminophen administration, as demonstrated by a hazard ratio of 1.06(p=0.839). The incidence of unconsciousness increased significantly with oseltamivir use with a hazard ratio of 1.79(p=0.0389), and unconsciousness was found to occur in a short time after oseltamivir use.
Conclusion: The results obtained from this study suggest that there are increased risks of delirium and unconsciousness with drug administration. Further pharmacoepidemiologic studies for hypothesis testing are required to study the relationship between abnormal behavior and drug administration.

[Objective]In recent years, communication skills have been recognized as an essential competence for acupuncturists. This study proposes to develop a scale for measuring the medical communication skills of acupuncturists.
[Materials and Methods]A questionnaire of 20 items was used to measure medical communication skills. These items were adopted from a concept analysis conducted in a previous study.
Cronbach's alpha was used to examine the scale's reliability. The scale's validity was examined by correlation analysis and multiple regression analysis comparisons with normal communication skills subscale scores (ENDCOREs, Encode, Decode, Control, Regulate) and a Japanese version of characteristic trait anxiety scores (STAI, State-Trait Anxiety Inventory).
[Results]Factor analysis, using a principal extraction method and promax rotation, was conducted on responses from 443students and therapists. As a result, the original 20 items were reduced to 16, and the following three factors were extracted:I. Acceptance of patients and self-control;II. Appropriate explanation to patients;and III. Understanding of patient's feelings. These three factors had high degrees of internal consistency (Cronbach's alpha =.872 -.892).
The scores of the three factors correlated significantly with the scores of the six factors of ENDCORE, and with the anxiety scores. Although the results of multiple regression analysis showed that each factor of ENDCORE explained the three factors, the anxiety scores did not influence medical communication skills. The scores for the three factors correlated significantly with self-evaluation scores of medical interview skill. In addition, these three factors were affected by the degree of clinical experience.
[Conclusion]These results suggest that this scale may be a reliable instrument for assessing medical communication skills among Japanese acupuncturists.

We describe the use of a C1 laminar screw in combination with a C2 laminar screw as a salvage technique to treat two patients, one with persistent first intersegmental artery and the other with vertebral artery occlusion after cervical spine fracture. The combined use of C1 and C2 laminar screws allows for good fixation of the atlantoaxial joint with a lower risk of vertebral artery injury; therefore, it can be an alternative surgical procedure for patients with congenital or traumatic anomalous vertebral artery.
Arteries ; Atlanto-Axial Joint ; Humans ; Spine ; Vertebral Artery

We herein report a case of 91-year-old woman with antiresorptive agent-related osteonecrosis of the jaw (ARONJ) developed during treatment for osteoporosis with intravenous ibandronate. Although she was treated with several antibiotics and had an incision for the drainage of a pus discharge at a dental clinic for two months after the onset of ARONJ, the discharge persisted. We then added hochuekkito to her treatment, which resulted in a gradual decreased in pus discharge and decrease in wound size and the wound resolved after approximately one month. ARONJ is considered a refractory disease, however, it was successfully treated with hochuekkito in this patient. ARONJ is also a rare condition and to our knowledge, this is considered to be the first case of ARONJ, which has been successfully treated with Kampo medicine.

BACKGROUND: Pneumonia has a high human toll and a substantial economic burden in developed countries like Japan, where the crude mortality rate was 77.7 per 100,000 people in 2017. As this trend is going to continue with increasing number of the elderly multi-morbid population in Japan; monitoring performance over time is a social need to alleviate the disease burden. The study objective was to determine the characteristics of hospital standardized mortality ratios (HSMRs) for pneumonia in Japan from 2010 to 2018 to describe this trend. METHODS: Data of the DPC (Diagnostic Procedures Combination) database were used, which is an administrative claims and discharge summary database for acute care in-patients in Japan. HSMRs were calculated using the actual and expected numbers of in-hospital deaths, the latter of which was calculated using logistic regression model, with a number of explanatory variables, e.g., age, sex, urgency of admission, mode of transportation, patient volume per month in each hospital, A-DROP score, and Charlson comorbidity index (CCI). We constructed two HSMR models: a single-year model, which included hospitals with > 10 in-patients per month and, a 9-year model, which included those hospitals with complete 9-year data. Predictive accuracy of the logistic models was assessed using c-index (area under receiver operating curve). RESULTS: Total 230,372 patients were included for the analysis over the 9-year study period. Calculated HSMRs showed wide variation among hospitals. The proportion of hospitals with HSMR less than 100 increased from 36.4% in 2010 to 60.6% in 2018. Both models showed good predictive ability with a c-statistic of 0.762 for the 9-year model, and no less than 0.717 for the single-year model. CONCLUSION This study denoted that HSMRs of pneumonia can be calculated using DPC data in Japan and revealed significant variations among hospitals with comparable case-mixes. Therefore, HSMR can be used as yet another measure to help improve quality of care over time if other indicators are examined in parallel and to get a clear picture of where hospitals excel and lack.