1.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.
2.Acupuncture Therapy for Hypertension (I)
Terukazu UCHIDA ; Hideo FUJIWARA ; Toshiaki IMOTO ; Shigeki OKADA ; Keiko NAKAYAMA ; Hiromasa INOUE ; Noriko MAEDA ; Shinya ABE ; Sei FURUTANI ; Yoshitomo SHIOAKI ; Naohide KOBAYASHI ; Futomi KOSAKA
Journal of the Japan Society of Acupuncture and Moxibustion 1982;32(1):54-58
Introduction
Essential hypertension is one of the leading causes of hypertension; responsible for more than 90% of such cases. Diet cure or drug treatment are usually prescribed for this disease. We drew notice to the antihypertensive effects of acupuncture.
Method
Subjects were healthy persons as well as patients complainig of simple essential hypertension. According to the WHO method, they were divided into three groups, e. g. normal, limitaneus, hypertensive. In situ needles were inserted in the antihypertensive points of both auricular sides for one week.
Effect
This treatment gave immediate results in 70% of the limitaneus and hypertensive groups. There was no observable effect for the balance. A number of these subjects were obese; a factor to be considered.
Evaluation
This method is very uncomplex and takes but minimal amount of time to treat patients.
3.Risk factor for occlusion of central venous access port system in colon cancer patients
Hisakazu Nishimori ; Noriko Kouge ; Hitomi Nishimoto ; Yuko Tsuyumu ; Yukie Matsushima ; Megumi Kuyama ; Megumi Fukutake ; Yoshiko Inoue ; Momoe Fujita ; Taizo Hirata ; Katsuyuki Hotta ; Masahiro Tabata
Palliative Care Research 2013;8(1):135-141
Purpose: It is critical to reduce complications associated with the central venous access port (CV-port) system for patients who were treated with chemotherapy or palliative care. Methods: From October 2006 to December 2011, 68 colon cancer patients who were treated with outpatient chemotherapy via a CV-port in the Center for Clinical Oncology, Okayama University Hospital, were analyzed retrospectively. Results: CV-port related complications occurred in 20 (29.4%) patients. No blood could be aspirated in 15 patients when treated via a CV-port. Among the patients with no blood aspiration from their CV-port, ten cases had no complications other than failure of blood aspiration, and anticancer agents have been successfully administered. However, the other five patients had their CV-port system replaced due to complications. Subclavian and left side insertions were the risk factors for catheter occlusion or inability to aspirate blood. Conclusion: Medical staffs should be aware that approximately one-third of the cases with no blood aspiration potentially have troubles with their CV-ports that need to be replaced.