2.Development of a Novel Database That Rapidly Provides Valuable Information Efficiently Aimed at Improving the Safety of the Simple Suspension Method
Masahiro Watanabe ; Tatsuya Tai ; Shigeko Tsuji ; Hiroaki Tanaka ; Takahiro Motoki ; Kazunori Yamaguchi ; Kenta Sumiyoshi ; Takato Nozaki ; Masato Kaji ; Masato Asakura ; Shinji Kosaka ; Hitoshi Houchi
Japanese Journal of Drug Informatics 2015;17(2):69-76
Objective: Many patients in Kagawa University Hospital are administered medicines prepared by the simple suspension method. Pharmacists in charge of these patients receive inquiries from doctors and nurses regarding the suitability of medicines for the simple suspension method. Answering these inquiries is complicated and time-consuming as multiple data sources need to be searched. In order to simplify these complicated procedures, we herein attempted to develop a novel database to provide valuable information that could contribute to the safe performance of the simple suspension method, and evaluated its usefulness.
Method: The specifications of the database were determined by analyzing previously answered inquiries. To evaluate the usefulness of the database, we used test prescriptions and compared the amount of time required to gather information using the database and the conventional method, i.e., using books alone. We also analyzed previous prescriptions with the database in order to determine what kinds of problems could be detected.
Results: The investigation of previous prescriptions indicated that some medicines needed to be examined not only for their suitability for the simple suspension method, but also their incompatibility. Therefore, we added a feature regarding the incompatibility of medicines to the database. The time required to gather the information needed to answer the test prescription was shorter with our database than with the conventional method. Furthermore, the database improved the detection of medicines that require particular attention for their properties including incompatibility. An analysis of previous prescriptions using our database indicated the possibility of incompatibility in half of the previous prescriptions examined.
Conclusion: Our database could rapidly provide information related to the simple suspension method, including the incompatibility of medicines.
3.Urinary bisphenol-A concentration in infertile Japanese women and its association with endometriosis: A cross-sectional study.
Hiroaki ITOH ; Motoki IWASAKI ; Tomoyuki HANAOKA ; Hiroshi SASAKI ; Tadao TANAKA ; Shoichiro TSUGANE
Environmental Health and Preventive Medicine 2007;12(6):258-264
OBJECTIVESBisphenol A (BPA), a raw material commonly used in the manufacture of resins such as polycarbonate and epoxy, is a possible xenoestrogen that is hypothesized to disrupt the human endocrine system. Humans are widely exposed to BPA. We investigated the urinary concentration of BPA in infertile Japanese women and its possible association with endometriosis.
MATERIALS AND METHODSWe recruited 166 women (aged 20-45) who had complained of infertility and visited a university hospital in Tokyo. The subjects were interviewed and their urine samples were obtained prior to a laparoscopic diagnosis of endometriosis between January 2000 and December 2001. Urinary total BPA concentration in 140 eligible urine samples was then measured using enzymatic deconjugation of glucuronide and sulfate and high-performance liquid chromatography isotope-dilution tandem mass spectrometry.
RESULTSMedian (25th-75th percentile) unadjusted and creatinine-adjusted urinary BPA concentrations were 1.6 (0.69-2.8) μg/L and 0.80 (0.45-1.3) μg/g creatinine. No significant monotonic association of endometriosis with urinary BPA concentration was observed. Median urinary BPA concentration in women with stage 0-1 endometriosis (0.74 μg/g creatinine) did not significantly differ from that in those with stage II-IV endometriosis (0.93 μg/g creatinine) (p for difference=0.24).
CONCLUSIONSThis study, based on a larger number of samples than those in previous studies in Japan and using the most reliable analytical method currently available, showed that urinary concentrations of BPA in women who consulted a physician for infertility were not higher than those in other populations. Moreover, no association between urinary BPA concentration and endometriosis was found in this cross-sectional study.
4.Objective Criteria for Judging Walking Independence in a Convalescent Rehabilitation Ward for Hemiparetic Stroke:A Study Using Decision Tree Analysis
Takashi HOSHINO ; Kazuyo OGUCHI ; Masanori ITO ; Sae OGASAWARA ; Motoki TANAKA ; Haruka MATSUDA
The Japanese Journal of Rehabilitation Medicine 2022;():22005-
Objective:This study aimed to clarify the objective criteria for assessing walking independence using cane in patients with stroke in the convalescent rehabilitation ward.Methods:Participants were in-patients with hemiparetic stroke who could walk with a cane, and they were categorized into the independent (ID) and supervised (SV) walking groups. Stroke impairment assessment set-motor for lower extremity (SIAS-LE), trunk control test (TCT), Berg balance scale (BBS), 10-m walking speed (m/s), and functional independence measure-cognitive (FIM-C) were assessed. ID and SV used the scores at the time of independent walking and at the discharge time, respectively. Additionally, falls after independence were investigated. Statistical analysis was performed using univariate analysis and decision tree analysis.Results:In total, 148 patients (ID:n=101, 68±13 years, SV:n=47, 79±12) were included. Significant differences were observed in walking speed, TCT score, BBS score, and FIM-C score between the groups. Moreover, walking speed, FIM-C score, and BBS score were selected in the decision tree analysis in this order and divided into five groups namely:1) walking speed ≥ 0.42 and FIM-C ≥ 22 (percentage of independent patients 97%/percentage of fallers 5%), 2.) walking speed ≥ 0.42, FIM-C<22, and BBS ≥ 50 (100%/0%), 3.) walking speed ≥ 0.42, FIM-C<22, and BBS<50 (52%/8%), 4.) walking speed<0.42, and BBS ≥ 28 (49%/28%), and 5) walking speed<0.42 and BBS<28 (0%/0%). The overall percentage of fallers was 8.9%, with group 4 having the highest number of fallers.Conclusion:Walking speed, FIM-C, and BBS, in decreasing order, were involved in walking independence. Patients with low walking speed were more likely to fall. Therefore, careful assessment of walking independence is particularly required.
5.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.
6.Objective Criteria for Judging Walking Independence in a Convalescent Rehabilitation Ward for Hemiparetic Stroke:A Study Using Decision Tree Analysis
Takashi HOSHINO ; Kazuyo OGUCHI ; Masanori ITO ; Sae OGASAWARA ; Motoki TANAKA ; Haruka MATSUDA
The Japanese Journal of Rehabilitation Medicine 2022;59(8):836-846
Objective:This study aimed to clarify the objective criteria for assessing walking independence using cane in patients with stroke in the convalescent rehabilitation ward.Methods:Participants were in-patients with hemiparetic stroke who could walk with a cane, and they were categorized into the independent (ID) and supervised (SV) walking groups. Stroke impairment assessment set-motor for lower extremity (SIAS-LE), trunk control test (TCT), Berg balance scale (BBS), 10-m walking speed (m/s), and functional independence measure-cognitive (FIM-C) were assessed. ID and SV used the scores at the time of independent walking and at the discharge time, respectively. Additionally, falls after independence were investigated. Statistical analysis was performed using univariate analysis and decision tree analysis.Results:In total, 148 patients (ID:n=101, 68±13 years, SV:n=47, 79±12) were included. Significant differences were observed in walking speed, TCT score, BBS score, and FIM-C score between the groups. Moreover, walking speed, FIM-C score, and BBS score were selected in the decision tree analysis in this order and divided into five groups namely:1) walking speed ≥ 0.42 and FIM-C ≥ 22 (percentage of independent patients 97%/percentage of fallers 5%), 2.) walking speed ≥ 0.42, FIM-C<22, and BBS ≥ 50 (100%/0%), 3.) walking speed ≥ 0.42, FIM-C<22, and BBS<50 (52%/8%), 4.) walking speed<0.42, and BBS ≥ 28 (49%/28%), and 5) walking speed<0.42 and BBS<28 (0%/0%). The overall percentage of fallers was 8.9%, with group 4 having the highest number of fallers.Conclusion:Walking speed, FIM-C, and BBS, in decreasing order, were involved in walking independence. Patients with low walking speed were more likely to fall. Therefore, careful assessment of walking independence is particularly required.