1.Evaluation of Factors Influencing Addition of Clinically Significant Adverse Reactions Section in Drug Package Inserts
Yukiya Suzuki ; Tatsuo Kishi ; Mitsuhiro Nakamura ; Hiroaki Yamada
Japanese Journal of Drug Informatics 2017;19(1):17-23
Objective: The aim of this study was to analyze the factors influencing the addition of clinically significant adverse reactions (CSDR) section in drug package inserts in Japan.
Methods: The summaries of investigation results from August 2011 to July 2014 were evaluated. The revisions were classified into revisions based only on case reports from Japan ([Revision Y]) and revisions based on other information and/or case reports from Japan ([Revision X]). The revisions were classified into MedDRA system organ class (SOC). As index of amount of information from domestic case reports, the number of accumulated cases ([Case A]), cases for which a causal relationship to the product could not be ruled out ([Case B]), and fatal cases ([Case C]) were used. In each SOC, as index of causal relationship to the product, [Index B/A] ([Case B]/[Case A]) was calculated. Relationship of [Index B/A] to [Revision X]/all revisions, or to the number of [Case A] in [Revision Y] were evaluated. Deference of drug lag between [Revision X] and [Revision Y] was evaluated.
Results: Three hundreds twenty-three revisions with respect to the addition of CSDR section were identified. [Revision Y] was 203 revisions (63%). The number of [Case A], ([Case B], and ([Case C]) that were required for [Revision X] (120 revisions) were significantly lower than that were required for [Revision Y] (p<0.0001 for all comparisons). [Index B/A] tended to inversely correlate with [Revision X]/all revisions (r=−0.52, p=0.066), and the number of [Case A] in [Revision Y] (r=−0.61, p=0.025). Drug lag of [Revision X] was significantly longer than that of [Revision Y] (p<0.001).
Conclusions: In future, it would especially needed to pay attention to adverse reactions with a low [Index B/A] of which revisions relatively depend on other information.
2.A Case Report of Obturator Foramen Bypass for Infected Vascular Prosthesis.
Norihiko KAMADA ; Tatsuo SATOU ; Tomoyuki YAMADA ; Minoru AOSHIMA
Japanese Journal of Cardiovascular Surgery 1993;22(2):127-130
A 76-year-old man underwent the aorto-femoral bypass with prosthetic graft at other hospital. Prosthetic graft infection with abcess at inguinal wound occurred 4 months later. A obturator foramen bypass was performed and the infected graft and the inguinal vessels were removed. The obturator foramen bypass is useful extra-antomical bypass.
4.HOME BASED EXERCISE EFFECTS ON COGNITION IN THE SEMI-INDEPENDENT ELDERLY
FUKI NAKAYAMA ; TAKURO TOBINA ; MAKOTO AYABE ; YUKIKO DOI ; YUKARI MORI ; TATSUO YAMADA ; AKIRA KIYONAGA ; HIROAKI TANAKA
Japanese Journal of Physical Fitness and Sports Medicine 2011;60(4):379-386
This study sought to determine whether aerobic exercise training affects cognitive functioning among semi-independent (> 75 years) and independent elderly people. Seventy-six semi-independent and independent elderly subjects were divided into the following groups: semi-independent control (n = 16); semi-independent training (n = 13); independent control (n = 22); independent training (n = 25). During the 12-week intervention, subjects in both training groups performed a bench-stepping exercise at the intensity of the lactate threshold. Subjects were assessed at baseline and post-intervention using the Frontal Assessment Battery test (FAB), the Modified Mini-Mental State Exam (3MS), and a bench-stepping test of aerobic capacity. During the intervention, FAB scores improved only in the semi-independent training group (p = .002), while 3MS and MMSE scores improved in both the semi-independent training (p = .032 and p = .004) and independent training groups (p = .001 and p = .013). FAB and 3MS scores were higher in the semi-independent training (p = .001 and p = .002) compared with the semi-independent control group after the intervention. Finally, post-intervention scores for FAB, and 3MS in the semi-independent training group almost reached the baseline levels of the independent control and independent training groups. These results indicate that moderate intensity bench-stepping exercise training can improve cognitive and frontal lobe functioning in semi-independent elderly people, almost to the level exhibited by independent elderly people.
5.Implementation of TB/HIV collaboration program in Phnom Penh, Cambodia
Yoko Tsurugi ; Khun Kim Eam ; Mao Tan Eang ; Ritei Uehara ; Yosikazu Nakamura ; Kuniko Murakami ; Tatsuo Sugiyama ; Norio Yamada ; Nobukatsu Ishikawa
Journal of International Health 2011;26(4):323-330
Background
The national tuberculosis (TB) control program established Phnom Penh as a pilot area for TB and human immunodeficiency virus (HIV) infection collaborative activities because of the high prevalence of HIV among patients with TB.
Process
In 2005, we provided transportation fees so that patients could travel to an operational district referral hospital for HIV counseling and testing by dispatched counselors. However, only around 10.3 patients with TB (range 0-21) per month in all 4 operational districts made use of this service. In 2006, we modified the program by providing HIV counseling and testing by four trained TB/HIV coordinators in TB wards. Thereafter, in-depth, individual, semi-structured interviews were conducted with the TB staff (not the coordinators) of 18 health facilities from April through November 2006 to identify problems in the current TB/HIV collaborative activities in Phnom Penh and to investigate ways for further improving the program.
Results
TB staff members encouraged their patients to undergo an HIV test under directly observed treatment, short course. Some TB staff lacked confidence to discuss HIV issues because they lacked sufficient HIV/ acquired immunodeficiency disease syndrome (AIDS) knowledge. Furthermore, there was no formal referral structure between TB and HIV services or sharing of information on the treatment of patients co-infected with TB/HIV with the antiretroviral treatment clinic.
Conclusions
We started the program to enable TB patients to receive HIV counseling and testing at the same venue as they received TB treatment. However, problems such as low confidence among TB staff in discussing HIV/AIDS and weak collaboration between TB and HIV services were identified. We found that training of TB staff, development of Information, Education and Communication (IEC) materials, regular meetings among stakeholders, and encouragement for the TB/HIV coordinators to supervise all TB/HIV activities in their operational districts were needed to improve the program.