1.Determination of Adequate Analgesic Dose of Oxycodone Injection in Opioid-switching from Transdermal Fentanyl in Patients with Cancer-related Pain
Manabu Tatokoro ; Keita Watanabe ; Kumiko Matsushita ; Toru Miyazaki ; Satoshi Miyake
Palliative Care Research 2017;12(1):301-305
Opioid-switching (OS) is usually performed with conversion methods based on the equianalgesic dose table. However, the conversion ratios might lead to significant differences in clinical practice. No clear guideline exists for safe, effective switching from transdermal fentanyl (TF) to oxycodone injection (OXJ). We retrospectively investigated the adequate analgesia dose of OXJ in OS from TF by comparing with the equianalgesic calculated dose based on the conversion ratio of 1.0 : 41.7 between TF and OXJ. Patients with a pain scale score of 0 were assigned to the “NRS/VRS=0” group (n=4), and the remaining patients were assigned to the “NRS/VRS>0” group (n=27). During a 4-year period, 31 of 49 patients with cancer-related pain who underwent OS from TF to OXJ were investigated. All patients in the NRS/VRS=0 group (4/4, 100%) and most in the NRS/VRS>0 group (23/27, 85%) achieved adequate analgesia. Among the 27 patients with adequate analgesia, the median effective OXJ dose was 28% (interquartile range, 21-47) of the equianalgesic calculated dose in the well-controlled group and 103% (interquartile range, 71-164) in the poor analgesia group. Strong drowsiness developed in two patients the day after OS, and the OXJ dose was decreased. Our findings suggest that in patients without pain, it might be necessary to reduce the OXJ dose to approximately 30% of the equianalgesic calculated dose for safe OS from TF. Pain intensity and drowsiness due to an opioid overdose should be carefully monitored and may require dose adjustment.
2.Evaluating a Palliative Medicine Education Program for Undergraduate Medical Students at a Regional Hospice
Manabu Tatokoro ; Kumiko Matsushita ; Keita Watanabe ; Eriko Yamanaka ; Toru Miyazaki ; Mihoko Takahashi
Palliative Care Research 2017;12(2):911-917
Background: There is increasing demand for clinical clerkships in palliative medicine, though conventional medical education has focused only on providing students with sufficient medical knowledge and skills. In Japan, there is no standard program for palliative medicine in undergraduate medical education. Our hospice, in cooperation with a clinical clerkship for palliative medicine launched by Tokyo Medical and Dental University, has developed its own comprehensive bedside learning curriculum. Aim: This study aimed to evaluate the efficacy of the program. Methods: The curriculum involves not only experience in hospice care, ward rounds, and interviews with terminally ill patients, it also provides each medical student with educational sessions moderated by certified hospice nurses and pharmacists. We conducted a self-administered five-point scale questionnaire (with a higher score indicating higher satisfaction) to assess students’ satisfaction and understanding of the program. We also conducted a questionnaire on basic palliative medicine knowledge before and after the program. Results: Twenty students took part in the program. Ratios of scores of 4 or 5 for satisfaction and understanding of the program were 100% and 95%, respectively. Mean rates of correct answers on the pre-program and post-program test were 51% and 85%, respectively; showing a marked increase and emphasizing the educational significance of our curriculum. Students evidently benefit from the experience of bedside learning, and 95% reported having recommended the program to their juniors. Conclusion: These outcomes suggest the program is effective toward developing a standard education program in palliative medicine.
3.Using PMDA Drug Adverse Event Report Database, Study on Collective Background of Adverse Events Caused by the Total Cold Medicine : Classification of Onset Cases Using Latent Class Analysis
Shoko KAMIYA ; Michiko WATANABE ; Keita YAMAUCHI
Japanese Journal of Pharmacoepidemiology 2018;23(2):75-87
Objective: Using PMDA's medication side effect database (JADER), the aim of this study is to explore the collective background and characteristics of cases in which adverse events were caused by the total cold medicine.Methods:Latent class analysis is performed on 990 subject cases reported from April 2004 to June 2015. The target group is classified into plural, and each characteristic is clearly indicated. Furthermore, the number of adverse events is counted for each class, and specialization coefficients are calculated. In addition, the signal detection is performed with the same data.Results:The population was divided into three classes. Class 1 was a group which do not have the original disease or medication, 53.7% of the whole, and it was set as “health group” . Adverse events specialized were immune system diseases. Class 2 was 33.2%, a positive group for self-treatment, it was set as “self-treatment oriented group” . A specialized adverse event was a serious skin disorder. Class 3 was 13.1%, and 90% of the class was over 60 years old and almost people had primary diseases and medicines, so they were “high age outpatient treatment group” . The main adverse events were lung disease and nervous system disorder. It was possible to relate the characteristic of the group as a background factor.Conclusion:By applying Latent class analysis to the adverse event, it was possible to clarify the relationship between the occurrence of adverse event and its background.This research is applicable to other medicines, and expected to contribute as a new application method of JADER.
4.The novel latex agglutination turbidimetric immunoassay system for simultaneous measurements of calprotectin and hemoglobin in feces
Sakiko HIRAOKA ; Shiho TAKASHIMA ; Toshihiro INOKUCHI ; Asuka NAKARAI ; Masahiro TAKAHARA ; Keita HARADA ; Yasuhiro SEKI ; Katsunori WATANABE ; Jun KATO ; Hiroyuki OKADA
Intestinal Research 2019;17(2):202-209
BACKGROUND/AIMS: Fecal calprotectin (Fcal) as well as the fecal immunochemical test (FIT) are useful biomarkers for detecting activity and mucosal healing in inflammatory bowel diseases. Here, we report the performance of simultaneous measurements of Fcal and FIT for ulcerative colitis (UC) patients using the newly-developed latex agglutination turbidimetric immunoassay (LATIA) system. METHODS: Fcal and hemoglobin were measured by the LATIA system in 152 UC patients who underwent colonoscopy. Fcal was also quantified with a conventional enzyme-linked immunosorbent assay (ELISA). Fecal markers were evaluated in conjunction with the mucosal status of UC, which was assessed via the Mayo endoscopic subscore (MES) classification. RESULTS: The LATIA system could quantify calprotectin and hemoglobin simultaneously with the same fecal samples within 10 minutes. The values of the Fcal-LATIA closely correlated with those of the Fcal-ELISA (Spearman rank correlation coefficient, r=0.84; P<0.0001). The values of Fcal for each assay and the FIT all significantly correlated with the MESs (Spearman rank correlation coefficient, Fcal-LATIA: r=0.58, Fcal-ELISA: r=0.55, and FIT: r=0.72). The mucosal healing predictability (determined by an MES of 0 alone) of the Fcal-LATIA, Fcal-ELISA, and FIT-LATIA with the cutoffs determined by receiver operating characteristic curve analysis was 0.79, 0.78, and 0.92 for sensitivity, respectively, and 0.78, 0.69, and 0.73 for specificity, respectively. CONCLUSIONS: The performance of the novel Fcal-LATIA was equivalent to that of the conventional Fcal assay. Simultaneous measurements with FITs would promote the clinical relevance of fecal biomarkers in UC.
Agglutination
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Biomarkers
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Classification
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Colitis, Ulcerative
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Colonoscopy
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Enzyme-Linked Immunosorbent Assay
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Feces
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Humans
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Immunoassay
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Inflammatory Bowel Diseases
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Latex
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Leukocyte L1 Antigen Complex
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ROC Curve
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Sensitivity and Specificity
5.Therapeutic Endoscopic Treatment Plus Maintenance Dimethyl Sulfoxide Therapy Prolongs Recurrence-Free Time in Patients With Hunner Type Interstitial Cystitis: A Pilot Study
Atsushi OTSUKA ; Takahisa SUZUKI ; Yuto MATSUSHITA ; Hiromitsu WATANABE ; Keita TAMURA ; Daisuke MOTOYAMA ; Toshiki ITO ; Takayuki SUGIYAMA ; Hideaki MIYAKE
International Neurourology Journal 2019;23(4):327-333
PURPOSE: To evaluate whether hydrodistention with fulguration of Hunner lesions (HD/FUL) plus maintenance dimethyl sulfoxide (DMSO) therapy prolongs the recurrence-free time in patients with Hunner type interstitial cystitis (IC).METHODS: The study enrolled patients with Hunner type IC who required repeat HD/FUL due to recurrence of IC symptoms after the first HD/FUL at our institution. All patients received a second HD/FUL plus maintenance DMSO therapy. The maintenance DMSO therapy was performed every 2 weeks for a total of 8 instillations, and then once every 4 weeks thereafter. The recurrencefree time from HD/FUL to therapeutic failure was estimated using the Kaplan-Meier method. The recurrence-free time between the first HD/FUL and second HD/FUL plus maintenance DMSO therapy was statistically compared using the log-rank test.RESULTS: A total of 21 patients (mean age, 66.3±10.8 years) with Hunner type IC were evaluated. The recurrence-free time for the second HD/FUL plus maintenance DMSO therapy was significantly longer than that for the first HD/FUL (P<0.0001). The median recurrence-free time for the first HD/FUL was 10.1 months, while that for the second HD/FUL plus maintenance DMSO therapy has yet to be reached. The recurrence-free rate for the first HD/FUL was 81.0% at 6 months, 38.1% at 1 year, 9.5% at 2 years, and 4.8% at 3 years. In contrast, the rate for the second HD/FUL plus maintenance DMSO therapy was 100% at 6 months, 94.7% at 1 year, 82.6% at 2 years, and 82.6% at 3 years. There were no significant differences in efficacy between the first and second HD/FUL.CONCLUSIONS: HD/FUL plus maintenance DMSO therapy clearly prolongs the recurrence-free time compared with HD/FUL alone in Hunner type IC.
Cystitis, Interstitial
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Dimethyl Sulfoxide
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Humans
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Methods
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Pilot Projects
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Recurrence
6.Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection
Shunji WATANABE ; Naoki MORIMOTO ; Kouichi MIURA ; Toshimitsu MUROHISA ; Toshiyuki TAHARA ; Takashi SATO ; Shigeo TANO ; Yukimura FUKAYA ; Hidekazu KURATA ; Yukishige OKAMURA ; Norikatsu NUMAO ; Keita UEHARA ; Kozue MURAYAMA ; Katsuyuki NAKAZAWA ; Hitoshi SUGAYA ; Hiroaki YOSHIZUMI ; Makoto IIJIMA ; Mamiko TSUKUI ; Takuya HIROSAWA ; Yoshinari TAKAOKA ; Hiroaki NOMOTO ; Hiroshi MAEDA ; Rie GOKA ; Norio ISODA ; Hironori YAMAMOTO
Journal of Rural Medicine 2020;15(4):139-145
Objective: Combination therapy with glecaprevir and pibrentasvir (G/P) has been shown to provide a sustained virologic response (SVR) rate of >97% in patients with chronic hepatitis C virus (HCV) infection in the first published real-world Japanese data. However, a recently published study showed that the treatment was often discontinued in patients ≥75 years old, resulting in low SVR in intention-to-treat (ITT) analysis. Thus, our aim was to evaluate real-world data for G/P therapy in patients ≥75 years of age, the population density of which is high in “rural” regions.Patients and Methods: We conducted a multicenter study to assess the efficacy and safety of G/P therapy for chronic HCV infection, in the North Kanto area in Japan.Results: Of the 308 patients enrolled, 294 (95.5%) completed the treatment according to the protocol. In ITT and per-protocol analyses, the overall SVR12 rate was 97.1% and 99.7%, respectively. The old-aged patients group consisted of 59 participants, 56 of whom (94.9%) completed the scheduled protocol. Although old-aged patients tended to have non-SVR factors such as liver cirrhosis, history of HCC, and prior DAA therapies, the SVR12 rates in old-aged patients were 98.3% and 100% in the ITT and PP analyses, respectively. Of 308 patients enrolled, adverse events were observed in 74 patients (24.0%), with grade ≥3 events in 8 patients (2.6%). There was no significant difference in any grade and grade ≥3 adverse events between the old-aged group and the rest of the study participants. Only one patient discontinued the treatment because of adverse events.Conclusion: G/P therapy is effective and safe for old-aged patients.