The spontaneous reporting system for adverse drug reactions(ADRs), through which information is collected on patients who experience ADRs, can lead to hypotheses on causal relationships between drugs and ADRs; however, lack of information on patient characteristics or patients who have not experienced ADRs makes quantitative, relative comparison of risks difficult. From the viewpoint of adapting pharmacoepidemiology to supplement spontaneous reporting of ADRs, RAD-AR Council Japan(RCJ) has been promoting development of a database assembling drug use-results surveillance(DURS) data under the re-examination system for secondary use. RCJ received observational DURS data on antihypertensive drug users from pharmaceutical companies and integrated to develop a database of over 100,000 patients and 19 antihypertensives in 2003. RCJ maintains the database, expanding it to 143,509 patients and 21 antihypertensives in 2007, and also developed a database of antihyperlipidemics with approximately 34,000 patients in 2011. Researchers study these databases through an application and protocol review process stipulated by RCJ, and their results have been presented at conferences and published in articles. This report summarizes DURS data collection and its underpinning regulated systems in terms of data assembly and database maintenance at RCJ. The report also introduces the example for constructing the antihyperlipidemics DURS database and summarizes its patient characteristics. The database is characterized by ADR information and treatment-related laboratory values in addition to patient backgrounds and drug use information. However, it is too small to study rare ADRs and has limited longitudinal observational data. Therefore, RCJ worked to expand the antihypertensives DURS database in 2012 by adding data that include long-term surveillance results. (Jpn J Pharmacoepidemiol 2012; 17(2): 87-97)

Objective: This study aimed to investigate the accuracy and precision of continuous, non-invasive blood pressure obtained using the ClearSight system by comparing it with invasive arterial blood pressure, and to assess the hemodynamic changes using invasive methods and the ClearSight system in patients undergoing cesarean section. Methods: Arterial pressure was measured invasively with an intra-arterial catheter and non-invasively using the ClearSight system during cesarean section in patients with placenta previa or placenta accreta. Blood pressure measurements obtained using these two means were then compared. Results: Total 1,277 blood pressure measurement pairs were collected from 21 patients. Under Bland-Altman analysis, the ClearSight system demonstrated an acceptable accuracy with a bias and standard deviation of 8.8±13.4 mmHg for systolic blood pressure, -6.3±7.1 mmHg for diastolic blood pressure, and -2.7±8.0 mmHg for median blood pressure. Cardiac index levels were significantly elevated during fetal delivery and 5 minutes after placental removal, and systemic vascular resistance index levels were significantly decreased during fetal delivery and 40 minutes after placental removal. Conclusion In patients undergoing cesarean section, the ClearSight system showed excellent accuracy and precision compared to that of the currently used invasive monitoring system.

Objective: To evaluate the efficacy of high-flow nasal cannula oxygen (HFNC) for dyspnea in patients with advanced disease. Methods: A literature search was conducted using MEDLINE, Cochrane Library, EMBASE, and Ichu-shi Web. Inclusion criteria were: 1) randomized controlled trials evaluating the effect of HFNC on dyspnea; 2) aged 18 years or older with advanced disease with hypoxemia; 3) control group was conventional oxygen therapy or noninvasive positive pressure ventilation. Exclusion criteria were: 1) patients in intensive care unit, 2) weaning from ventilator. Results: Six studies (4 from database searches, and 2 from hand searches) were included. In the 2 studies evaluating short-term intervention, one showed HFNC was more efficacious, and the other conventional oxygen was more efficacious. In the 2 studies evaluating long-term interventions: one showed HFNC was more efficacious, and the other showed no significant difference. In the 2 studies evaluating the intervention during exercise, one showed HFNC was more efficacious, and the other showed no significant difference. Conclusion: HFNC may be effective for dyspnea in patients with advanced disease associated with hypoxemia.