2.Results of a Post-marketing Surveillance Study on a Switch OTC Product and Information Providing for Appropriate Use
Yoshio Wada ; Yoshitaka Mori ; Reiko Iwabuchi ; Noriko Inoue ; Satoshi Takita ; Kazuya Omura ; Tsunenobu Uda
Japanese Journal of Drug Informatics 2011;12(4):168-172
Objective: To investigate frequency of adverse drug reactions (ADR) on HIGURD ®
, a switch OTC product of azelastine hydrochloride, in a three-year post-marketing surveillance study.
Methods: We conducted two surveys in this study a solicited survey with a questionnaire and a survey of spontaneous ADR reports.
Results: A total of 183 cases with 293 ADRs were reported in the solicited survey on 3,453 consumers and a total of 29 cases with 37 ADRs were reported from spontaneous sources. No serious ADRs were reported. Most frequently reported ADRs were somnolence, thirst, malaise, and dysgeusia, all of which are common on azelastine hydrochloride. This study indicated that HIGURD ®
is well tolerated.
Conclusion: This study suggested that efficacy and safety of HIGURD ®
depend on how much consumers understand the contents of “Precautions for Use” section of package insert. It is considered to be effective for safety assurance in an early post-marketing phase that pharmacists inform consumers about appropriate use of HIGURD ®
and ask for the occurrence of ADRs.
3.Decrease in the prevalence of smoking among Japanese adolescents and its possible causes: periodic nationwide cross-sectional surveys.
Yoneatsu OSAKI ; Takeo TANIHATA ; Takashi OHIDA ; Hideyuki KANDA ; Yoshitaka KANEITA ; Masumi MINOWA ; Kenji SUZUKI ; Kiyoshi WADA ; Kenji HAYASHI
Environmental Health and Preventive Medicine 2008;13(4):219-226
OBJECTIVESTo assess trends in smoking prevalence among Japanese adolescents and to analyze possible causal factors for the decrease in smoking prevalence observed in a 2004 survey.
METHODSNationwide cross-sectional surveys were conducted in 1996, 2000 and 2004. Survey schools, both junior and senior high schools, considered to be representative of the whole of Japan were sampled randomly. Enrolled students were asked to complete a self-reporting anonymous questionnaire on smoking behavior. The questionnaires were collected from 115,814 students in 1996, 106,297 in 2000, and 102,451 in 2004. School principals were asked about the policy of their respective school on smoking restrictions.
RESULTSCigarette smoking prevalence (lifetime, current, and daily smoking) in 2004, based on the completed questionnaires, had decreased relative to previous years in both sexes and in all school grades. The most important trends were: a decrease in smoking prevalence among the fathers and older brothers of the students; an increase in the proportion of students who did not have friends; a decrease in the proportion of current smokers who usually bought cigarettes in stores decreased in 2004, in particular for the oldest boys. An association was found between a lower smoking rate at a school and a smoke-free school policy.
CONCLUSIONSJapan has experienced a decrease in the prevalence of smoking among adolescents. A decrease in smoking prevalence among the fathers and older brothers, limitations to minors' access to tobacco, an increase in the proportion of students without friends, and a school policy restricting smoking may have contributed to this decreasing trend.
4.Onigiri Esophagography as a Screening Test for Esophageal Motility Disorders
Shohei HAMADA ; Eikichi IHARA ; Kazumasa MUTA ; Masafumi WADA ; Yoshitaka HATA ; Hiroko IKEDA ; Yoshimasa TANAKA ; Haruei OGINO ; Takatoshi CHINEN ; Yoshihiro OGAWA
Journal of Neurogastroenterology and Motility 2022;28(1):43-52
Background/Aims:
No screening test for esophageal motility disorder (EMD) has been established, the objective of this study is to examine the potential usefulness of our newly developed “Onigiri esophagography” combined with an obstruction level (OL) classification system in screening for EMD.
Methods:
A total of 102 patients with suspected EMDs who underwent both high-resolution manometry (HRM) and Onigiri esophagography between April 2017 and January 2019 were examined. The EMD diagnosis was performed based on the Chicago classification version 3.0 by HRM. Onigiri esophagography was performed using a liquid medium (barium sulfate) followed by a solid medium, which consisted of an Onigiri (a Japanese rice ball) with barium powder. The extent of medium obstruction was assessed by the OL classification, which was defined in a stepwise fashion from OL0 (no obstruction) to OL4 (severe obstruction).
Results:
The patients with OL0 (32.3%), OL1 (50.0%), OL2 (88.0%), OL3 (100.0%), and OL4 (100.0%) were diagnosed EMDs by HRM. The area under the curve, as determined by a receiver operating characteristic analysis, for the OL classification was 0.86. Using the cutoff value of OL1, the sensitivity and specificity were 87.3% and 61.3%, respectively, while using a cutoff value of OL2, the sensitivity and specificity were 73.2% and 90.3%, respectively.
Conclusion
In conclusion, Onigiri esophagography combined with the OL classification system can be used as a screening test for EMDs with a cutoff value of OL1.