1.Comparison of Efficacy and Safety of Original Ritodrine Injection and Its Generic Formulation
Shuichi Aoyagi ; Mayuko Suzuki ; Yosuke Suto ; Mikio Uesugi ; Hiromi Otomo ; Yasuko Saito ; Hiromi Kobayashi ; Hajime Okamoto ; Jiro Tsuruta
Japanese Journal of Drug Informatics 2017;18(4):284-288
Objective: In Japan, the healthcare authority encourages physicians to prescribe generic drugs in order to reduce the copayments by the patients for pharmaceutical expenses and to improve the financial status of the national medical insurance system. In accordance with this governmental policy, we have been actively involved in switching original to generic formulations. Thus, Utemerine® 50 mg injection was replaced with Ritodrine hydrochloride 50 mg intravenous injection produced by Nichiiko. There have been some reports on adverse events caused by the generic formulations of Ritodrine hydrochloride. Factors contributing to these adverse effects may include different additives and/or vehicles and the exemption of demonstrating some conditions for approval, including clinical trials. Therefore, in order to assess the efficacy and safety of a generic formulation of Ritodrine hydrochloride injection formulation compared with the original formulation and to decide on its continued use, we carried out a retrospective cohort study.
Methods: We carried out a retrospective cohort study in order to assess the efficacy and safety of a generic formulation of Ritodrine hydrochloride injection formulation compared with the original formulation.
Results: There were no significant differences in the length of hospital stay, rate of emergency transport to other institutions, gestational week of delivery, rate of stillbirth, rate of abortion, or incidence of adverse events between the two formulations.
Conclusion: Our results may contribute to the safe and secure use of the generic formulations of Ritodrine hydrochloride in the current situation of the increasing use of generic drugs in health care. Although there are some limitations in our study, the results suggest that there are no particular problems with the continued use of Ritodrine hydrochloride 50 mg intravenous injection produced by Nichiiko.
2.Gastric Xanthomas and Fundic Gland Polyps as Endoscopic Risk Indicators of Gastric Cancer
Kentaro YAMASHITA ; Ryo SUZUKI ; Toshiyuki KUBO ; Kei ONODERA ; Tomoya IIDA ; Mayuko SAITO ; Yoshiaki ARIMURA ; Takao ENDO ; Masanori NOJIMA ; Hiroshi NAKASE
Gut and Liver 2019;13(4):409-414
BACKGROUND/AIMS: Fundic gland polyps (FGPs), hyperplastic polyps (HPs), and xanthomas (XTs) are common benign gastric lesions that can be diagnosed by endoscopic appearance alone in most cases. The aim of this study was to evaluate associations between gastric cancer and these benign lesions. METHODS: Two expert endoscopists reviewed a series of gastroscopy images. FGPs, HPs, and XTs were diagnosed by endoscopic appearance, whereas all gastric cancers were confirmed pathologically. RESULTS: Of the 1,227 patients reviewed, 114 (9.3%) had a concurrent or past history of gastric cancer. The overall prevalences of FGPs, HPs and XTs were 9.4%, 6.3% and 14.2%, respectively. HPs and XTs coexisted in 1.6% of patients, whereas other combinations were rarer. XTs were observed in 39.3% and 11.5% of patients with and without gastric cancer, respectively (p<0.001). In contrast, no gastric cancer patients had FGPs, whereas 10.4% of patients without cancer had FGPs (p<0.001). The prevalence of HPs was similar between the two groups (8.8% and 6.0% of patients with and without cancer, respectively, p=0.29). Multivariate and Mantel-Haenszel analyses demonstrated that XTs were positively associated and FGPs were negatively associated with gastric cancer. CONCLUSIONS: XTs and FGPs might be useful as endoscopic risk indicators for monitoring gastric cancer.
Gastroscopy
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Humans
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Polyps
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Prevalence
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Stomach Neoplasms
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Xanthomatosis
3.Autologous Blood Donation for Patients With Low-Lying Placenta
Heisuke HIROWATARI ; Shigeru TODA ; Mai FUJIKURA ; Keita KURODA ; Mayuko BANDO ; Komei KATAYAMA ; Maya HANATANI ; Takuto NAKAMURA ; Aya SOBAJIMA ; Hiromi FUJIKI ; Akiko FUKATSU ; Takayasu SUGANUMA ; Takahiro SUZUKI
Journal of the Japanese Association of Rural Medicine 2021;70(4):354-359
This study was undertaken to elucidate the usefulness and problems of autologous blooddonation for the patients with low-lying placenta. Seventy-eight women with low-lying placentawho gave birth in our institution were retrospectively analyzed. Autologous blood donation wasperformed in 58 patients (74%). The median volume of donated blood was 300 mL. Patients withor without autologous blood donation showed no significant difference in the distance betweenthe edge of the placenta and the internal os of the uterus. Median blood loss due to intrapartumhemorrhage was 1183 mL. All 7 patients with blood loss of more than 2000 mL had donatedautologous blood. The donated blood was transfused in 9 of the 58 patients (16%) who underwentautologous blood donation. No patients underwent allogenic blood transfusion. Althoughautologous blood donation was expected to be useful for avoiding allogenic blood transfusion inthese patients with low-lying placenta, the high discard rate suggests the need for a strategy toselect those patients at high risk for blood loss requiring transfusion.
4.Development of a Patient Registry System for Specialized Palliative Care Quality Assessment Using Patient-reported Outcomes: A Multicenter Pilot Study
Hideyuki HIRAYAMA ; Eriko SATOMI ; Yoshiyuki KIZAWA ; Mayuko MIYAZAKI ; Keita TAGAMI ; Ryuichi SEKINE ; Kozue SUZUKI ; Nobuyuki YOTANI ; Koji SUGANO ; Hirofumi ABO ; Meidai SAKASHITA ; Kazuki SATO ; Sari NAKAGAWA ; Yoko NAKAZAWA ; Jun HAMANO ; Mitsunori MIYASHITA
Palliative Care Research 2022;17(4):171-180
Objective: This study aimed to investigate the feasibility of a patient registry system for assessing PCT (palliative care team) by PRO (Patient-reported outcome) in Japan. Methods: We operated a patient registry system with electronic data collection at eight hospitals in 2021 in Japan. We consecutively included newly referred patients for a month and followed up with them for a month. IPOS or ESAS obtained as PRO at the start of the intervention, three days later, and every week after. The primary endpoint was the response rate to the symptom rating scale by patients and providers. Results: 318 patients were enrolled. The patient response rate was 59.1% at intervention and 37.0% after intervention, and the medical provider response rate was 98.4% at intervention and 70.3% after intervention. Interviews with PCT members indicated that participants required support to input PRO responses required support and paper questionnaire was better and that managing the survey date and overall management was burdensome. Discussion: Although only about half of the patients were able to respond to the PRO, this was the same level as in previous studies. The system and its operation method have many problems. We found that improvements such as reducing items and making the patient interviews paper-based are necessary to expand the system nationwide.
5.Integration of publicly available case-based data for real-time coronavirus disease 2019 risk assessment, Japan
Kota Ninomiya ; Mariko Kanamori ; Naomi Ikeda ; Kazuaki Jindai ; Yura K Ko ; Kanako Otani ; Yuki Furuse ; Hiroki Akaba ; Reiko Miyahara ; Mayuko Saito ; Motoi Suzuki ; Hitoshi Oshitani
Western Pacific Surveillance and Response 2022;13(1):43-48
In response to the outbreak of coronavirus disease 2019 (COVID-19) in Japan, a national COVID-19 cluster taskforce (comprising governmental and nongovernmental experts) was established to support the country’s Ministry of Health, Labour and Welfare in conducting daily risk assessment. The assessment was carried out using established infectious disease surveillance systems; however, in the initial stages of the pandemic these were not sufficient for real-time risk assessment owing to limited accessibility, delay in data entry and inadequate case information. Also, local governments were publishing anonymized data on confirmed COVID-19 cases on their official websites as daily press releases. We developed a unique database for nationwide real-time risk assessment that included these case lists from local government websites and integrated all case data into a standardized format. The database was updated daily and checked systematically to ensure comprehensiveness and quality. Between 15 January 2020 and 15 June 2021, 776 459 cases were logged in the database, allowing for analysis of real-time risk from the pandemic. This semi-automated database was used in daily risk assessments, and to evaluate and update control measures to prevent community transmission of COVID-19 in Japan. The data were reported almost every week to the Japanese Government Advisory Panel on COVID-19 for public health responses.