1.Studies on the Amount of Exposure to Pesticides and Blood Levels of Organophosphorus Pesticides of Farmers Engaging in Joint Control Works over Apple Orchards
Saburo USUTANI ; Kunitaka NISHIYAMA ; Ikuo SATO ; Kimio MATSUURA ; Yukimasa SAWADA
Journal of the Japanese Association of Rural Medicine 1978;27(1):79-88
The concentration of pesticide that was inspired by speed sprayer (SS) operatorsin spraying a low toxic organophosphorus pesticide (800-fold to 1000-fold dilutions of wettable agent) were measured by the impinger-one respirator-per man measuring system. The mean ± standard error was 0.01116 ± 0.00191 mg/m3.
The operators were made to perform the spraying task every day, and the organophosphorus pesticide concentration in the serum was gas-chromatographically measured before and after the task on each day. The maximum concentration after daily task was 0.032μg/2ml in an operator, and 0.061μg/2ml in anassistant. The concentration was already trace or undetectable in many of them the following morning. No apparent tendency for the pesticide to be accumulated was observed even in the operators after spraying the pesticide for 2 consecutivedays.
The 24-hour urine was collected from each subject to measure the outputof PNMC (p-nitro-m-crezol). The output tended to be greater in the assistants than in the operators. This finding may be attributed to the fact that the assistants are trasiently exposed to high concentrations of the pesticide in powder form.
2.International Collaborative Study of the Effectiveness of Computer-Based Educational Materials for Clinical-Skills Training: Report of a Study at Kochi Medical School
Yukio KURIHARA ; Katsushi ODA ; Shu KURAMOTO ; Hiromi SEO ; Kimio MATSUURA ; Yoichiro MIKI ; Teruaki WATABE ; Mutsuo NOBUSAKI ; A. Karim QAYUMI
Medical Education 2003;34(3):199-206
The abundant computer-based materials for medical education developed in Europe and North America have found limited use in Japan. To remedy this situation, the usefulness of such educational materials for Japanese students should be clearly presented, because issues of language and cost are involved. For detailed evaluation of educational material, collaboration with the developing institution is necessary. Kochi Medical School participated in an international collaborative study proposed by the University of British Columbia to evaluate computer-based educational materials. The study evaluated computer-based educational materials for clinical-skills training (CyberPatient) developed at the University of British Columbia. Fourteen medical educational institutions from six countries participated in the study. Kochi Medical School's portion of the study was successfully performed in December 2001. However, we found four problems related to this collaborative study: dealing with foreign languages in educational materials, establishing rapid communication, flexibly coping with sudden changes in study design, and guaranteeing the coherence of the study design among collaborating institutions.
3.Phase 2 single-arm study on the safety of maintenance niraparib in Japanese patients with platinum-sensitive relapsed ovarian cancer
Kazuhiro TAKEHARA ; Takashi MATSUMOTO ; Junzo HAMANISHI ; Kosei HASEGAWA ; Motoki MATSUURA ; Kiyonori MIURA ; Shoji NAGAO ; Hidekatsu NAKAI ; Naotake TANAKA ; Hideki TOKUNAGA ; Kimio USHIJIMA ; Hidemichi WATARI ; Yoshihito YOKOYAMA ; Yoichi KASE ; Shuuji SUMINO ; Ajit SURI ; Hiroaki ITAMOCHI ; Nobuhiro TAKESHIMA
Journal of Gynecologic Oncology 2021;32(2):e21-
Objective:
The primary objective of this study was to evaluate the safety of niraparib 300 mg/day in Japanese patients with platinum-sensitive, relapsed ovarian cancer in a maintenance setting.
Methods:
Phase 2, multicenter, open-label, single-arm study enrolled Japanese patients with platinum-sensitive, relapsed ovarian cancer who had received ≥2 platinum-based regimens.The primary endpoint (incidence of grade 3 or 4 thrombocytopenia-related events within 30 days after initial niraparib administration) was justified by the incidences of a global pivotal phase 3 study and its post-hoc safety analysis on thrombocytopenia, the major hematological adverse event of niraparib. The overall safety analysis examined other treatment-emergent adverse events (TEAEs).
Results:
Enrolled patients (n=19) had a median (min, max) body weight of 53.9 (40.8–79.1) kg; all but one patient weighed <77 kg. Most (94.7%) patients initially received niraparib 300 mg/day but this decreased in subsequent cycles (mean±standard deviation dose intensity, 191.6±65.7 mg/day). In total, 6/19 (31.6%) patients experienced grade 3 or 4 thrombocytopenia-related events within 30 days of initial niraparib administration.Other common TEAEs included nausea, and decreased platelet or neutrophil counts. No progression-free or overall survival events occurred; only 1 of 4 response-evaluable patients had a post-baseline tumor assessment (stable disease).
Conclusion
The incidence of grade 3 or 4 thrombocytopenia-related events in Japanese ovarian cancer patients was similar to that in the corresponding non-Japanese study. Overall, the safety profile was acceptable and consistent with the known safety profile and previous experience with niraparib.