1.Identification and International Comparison of Drugs Contraindicated for Pregnant Women in the Package Inserts
Takamasa SAKAI ; Yuri SATO ; Shiro HATAKEYAMA ; Daisuke KIKUCHI ; Masami TSUCHIYA ; Yuki KONDO ; Izumi SATO ; Yuko OKADA ; Taku OBARA
Japanese Journal of Drug Informatics 2024;25(4):211-219
Objective: The package inserts are official clinical decision-making documents that provide pharmacological treatment information. However, it has been noted that package inserts on perinatal drug usage differ greatly from expert opinions. This study identified Japanese package insert drugs that are contraindicated for pregnant women and compared them to foreign risk categories.Methods: The survey included 19,022 drugs on the drug pricing list as of April 2022, with package inserts available on the Pharmaceuticals and Medical Devices Agency website. We retrieved the package inserts with the word “pregnant” in the “Contraindications” section and reviewed the descriptions to exclude those that satisfied the exclusion criteria. We also checked the foreign risk categories of contraindicated ingredients for pregnant women. This study used the Australian Therapeutic Goods Administration’s categorization for prescribing medicines in pregnancy (the TGA classification).Results: Of the 19,022 medicines studied, 4,111 (21.6%) were contraindicated for pregnant women. Conversely, 19 (5.1%) ingredients categorized under the relatively safe TGA classifications A, B1, and B2 were also contraindicated for pregnant Japanese women.Conclusion: This study revealed that Japanese package inserts contraindicate over 20% of drugs for pregnant women. On the other hand, some forbidden ingredients did not match the foreign risk categories. Therefore, healthcare professionals should be aware of the limitations of Japanese package inserts concerning pregnant women and make careful decisions based on both package inserts and additional drug information.
2.A Rapid Reporting System for Third-Generation Cephalosporin-Resistant Bacteria in Blood Culture Tests at Our Hospital and Its Clinical Utility
Yuki NAGATA ; Mikiyasu SAKAI ; Hiroko KOMAI ; Toshitaka WATARIGUCHI ; Kouichi TANAKA ; Yuri KIMURA ; Osamu MATSUKUBO ; Yui SUGIYAMA ; Misaki MATSUMOTO ; Rino ASAI ; Atsushi KAWABATA
Journal of the Japanese Association of Rural Medicine 2024;72(5):367-373
Early detection of third-generation cephalosporin-resistant bacteria in blood culture tests influences the choice of antimicrobial agents. We report on our hospital’s system for early reporting of third-generation cephalosporin-resistant bacteria and its utility. The hospital operates a 24-h simple cefpodoxime (CPDX) testing system, where the content of a sample container with a positive blood culture result is smeared on a CA Sheep Blood Agar/VCM Chocolate EX II fractionation medium, and an antibiotic susceptibility test (AST) disk (Sensi-Disk CPDX) is placed at the center of the medium and incubated. The presence or absence of third-generation cephalosporin-resistant bacteria is estimated from the diameter of the growth inhibition zone. The physician in charge of AST makes comments on the chart based on the simple CPDX test results. The sensitivity of the simple CPDX test for detecting third-generation cephalosporin-resistant bacteria, based on AST results, was 95.5%. Among patients with failed antimicrobial therapy, the rate of switching antimicrobials before the AST results were known was 57.9% in cases where there were comments made by the physicians in charge of AST, compared with 42.9% in cases without comments. These results suggest that the simple CPDX test enables early and accurate detection of third-generation cephalosporin-resistant bacteria, facilitating early switching of antimicrobial agents through collaboration with physicians in charge of AST.
3.Patient-specific mechanical analysis of pedicle screw insertion in simulated osteoporotic spinal bone models derived from medical images
Norihiro NISHIDA ; Hidenori SUZUKI ; Hanvey TETSU ; Yuki MORISHITA ; Yogesh KUMARAN ; Fei JIANG ; Masahiro FUNABA ; Kazuhiro FUJIMOTO ; Yusuke ICHIHARA ; Takashi SAKAI ; Junji OHGI
Asian Spine Journal 2024;18(5):621-629
Methods:
Male and female patients with computed tomography data were selected. Dimensions of the first thoracic (T1), fourth lumbar (L4), and fifth lumbar (L5) vertebrae were measured, and bone models consisting of the cancellous and cortical bones made from polyurethane foam were created. PS with diameters of 4.5 mm, 5.5 mm, and 6.5 mm were used. T1 PS were 25 mm long, and L4 and L5 PS were 40 mm long. The bone models were secured with cement, and the MIT was measured using a calibrated torque wrench. After MIT testing, the PS head was attached to the machine’s crosshead. POS was then calculated at a crosshead speed of 5 mm/min until failure.
Results:
The L4 and L5 were notably larger in female bone models, whereas the T1 vertebra was larger in male bone models. Consequently, the MIT and POS for L4 and L5 were higher in female bone models across all PS diameters than in male bone models. Conversely, the MIT for T1 was higher in male bone models across all PS; however, no significant differences were observed in the POS values for T1 between sexes.
Conclusions
The mechanical properties of the proposed bone models can vary based on the vertebral structure and size. For accurate 3D surgical and mechanical simulations in the creation of custom-made medical devices, bone models must be constructed from patientspecific medical images.
4.The Prevalence and Characteristics of Symptomatic Uncomplicated Diverticular Disease Among Asian Patients With Unexplained Abdominal Symptoms
Tsumugi JONO ; Yuki KASAI ; Takaomi KESSOKU ; Tomoki OGATA ; Kosuke TANAKA ; Tsutomu YOSHIHARA ; Noboru MISAWA ; Shingo KATO ; Takuma HIGURASHI ; Kunihiro HOSONO ; Masato YONEDA ; Kosuke SEITA ; Takayuki KATO ; Eiji SAKAI ; Takeo KURIHASHI ; Machiko NAKATOGAWA ; Shunsuke OYAMADA ; Seiji FUTAGAMI ; Kok-Ann GWEE ; Atsushi NAKAJIMA
Journal of Neurogastroenterology and Motility 2024;30(1):87-96
Background/Aims:
The precise incidence of symptomatic uncomplicated diverticular disease (SUDD) and its effects on the quality of life (QOL) remain unclear, particularly in Asian patients with right-sided SUDD. We assess the prevalence of SUDD and its impact on QOL in a real-world population.
Methods:
Five institutional cohorts of patients who received outpatient treatment for unexplained abdominal symptoms from January 15, 2020 to March 31, 2022, were included. All patients underwent colonoscopy. SUDD was defined as the presence of recurrent abdominal symptoms, particularly pain in the lower right or left quadrant lasting > 24 hours in patients with diverticulosis at the site of pain. The 36-item short-form health survey was used to assess QOL.
Results:
Diverticula were identified in 108 of 361 patients. Among these 108 patients, 31% had SUDD, which was right-sided in 39% of cases.Of the 50 patients with right-sided diverticula, 36% had SUDD, as did 15 of 35 patients with left-sided diverticula (43%). Among the 33 patients with SUDD, diverticula were right-sided, left-sided, and bilateral in 39%, 45%, and 15% of patients, respectively. Diarrhea was more frequent in the SUDD group than in the non-SUDD group. Patients with SUDD had significantly lower physical, mental, and role/social component scores than those without SUDD.
Conclusions
It is important to recognize that patients with SUDD account for as high as 31% of outpatients with unexplained abdominal symptoms; these patients have diarrhea and a low QOL. The presence of right-sided SUDD was characteristic of Asian patients.
5.Proof-of-concept study of the caninized anti-canine programmed death 1antibody in dogs with advanced non-oral malignant melanoma solid tumors
Masaya IGASE ; Sakuya INANAGA ; Shoma NISHIBORI ; Kazuhito ITAMOTO ; Hiroshi SUNAHARA ; Yuki NEMOTO ; Kenji TANI ; Hiro HORIKIRIZONO ; Munekazu NAKAICHI ; Kenji BABA ; Satoshi KAMBAYASHI ; Masaru OKUDA ; Yusuke SAKAI ; Masashi SAKURAI ; Masahiro KATO ; Toshihiro TSUKUI ; Takuya MIZUNO
Journal of Veterinary Science 2024;25(1):e15-
Background:
The anti-programmed death 1 (PD-1) antibody has led to durable clinical responses in a wide variety of human tumors. We have previously developed the caninized anti-canine PD-1 antibody (ca-4F12-E6) and evaluated its therapeutic properties in dogs with advance-staged oral malignant melanoma (OMM), however, their therapeutic effects on other types of canine tumors remain unclear.
Objective:
The present clinical study was carried out to evaluate the safety profile and clinical efficacy of ca-4F12-E6 in dogs with advanced solid tumors except for OMM.
Methods:
Thirty-eight dogs with non-OMM solid tumors were enrolled prospectively and treated with ca-4F12-E6 at 3 mg/kg every 2 weeks of each 10-week treatment cycle. Adverse events (AEs) and treatment efficacy were graded based on the criteria established by the Veterinary Cooperative Oncology Group.
Results:
One dog was withdrawn, and thirty-seven dogs were evaluated for the safety and efficacy of ca-4F12-E6. Treatment-related AEs of any grade occurred in 13 out of 37 cases (35.1%).Two dogs with sterile nodular panniculitis and one with myasthenia gravis and hypothyroidism were suspected of immune-related AEs. In 30 out of 37 dogs that had target tumor lesions, the overall response and clinical benefit rates were 6.9% and 27.6%, respectively. The median progression-free survival and overall survival time were 70 days and 215 days, respectively.
Conclusions
The present study demonstrated that ca-4F12-E6 was well-tolerated in nonOMM dogs, with a small number of cases showing objective responses. This provides evidence supporting large-scale clinical trials of anti-PD-1 antibody therapy in dogs.
6.Assessing the utility of osteoporosis self-assessment tool for Asians in patients undergoing hip surgery
Keisuke UEMURA ; Kazuma TAKASHIMA ; Ryo HIGUCHI ; Sotaro KONO ; Hirokazu MAE ; Makoto IWASA ; Hirohito ABE ; Yuki MAEDA ; Takayuki KYO ; Takashi IMAGAMA ; Wataru ANDO ; Takashi SAKAI ; Seiji OKADA ; Hidetoshi HAMADA
Osteoporosis and Sarcopenia 2024;10(1):16-21
Objectives:
Diagnosis and treatment of osteoporosis are instrumental in obtaining good outcomes of hip surgery.Measuring bone mineral density (BMD) using dual-energy X-ray absorptiometry (DXA) is the gold standard for diagnosing osteoporosis. However, due to limited access to DXA, there is a need for a screening tool to identify patients at a higher risk of osteoporosis. We analyzed the potential utility of the Osteoporosis Self-assessment Tool for Asians (OSTA) as a screening tool for osteoporosis.
Methods:
A total of 1378 female patients who underwent hip surgery at 8 institutions were analyzed. For each patient, the BMD of the proximal femoral region was measured by DXA (DXA-BMD), and the correlation with OSTA score (as a continuous variable) was assessed. Receiver operating characteristic (ROC) curve analysis was performed to assess the ability of OSTA score to predict osteoporosis. Lastly, the OSTA score was truncated to yield an integer (OSTA index) to clarify the percentage of patients with osteoporosis for each index.
Results:
DXA-BMD showed a strong correlation with OSTA (r = 0.683; P < 0.001). On ROC curve analysis, the optimal OSTA score cut-off value of − 5.4 was associated with 73.8% sensitivity and 80.9% specificity for diagnosis of osteoporosis (area under the curve: 0.842). A decrease in the OSTA index by 1 unit was associated with a 7.3% increase in the probability of osteoporosis.
Conclusions
OSTA is a potentially useful tool for screening osteoporosis in patients undergoing hip surgery. Our findings may help identify high-risk patients who require further investigation using DXA.
7.6. Postgraduate Training and CME : Nijiiro Doctors Initiative
Eriko YOSHIDA ; Yusuke KANAKUBO ; Nozomi KUBOTA ; Yuki SAKAI ; Hiromitsu YAMASHITA
Medical Education 2023;54(1):35-40
Nijiiro Doctors offered a six-month LGBTQ healthcare training course for physicians in their third year of post-graduate studies or above, with the goal of implementing practice at their institutions. In addition to lectures, the course included dialogues with LGBTQ individuals, role-plays in which the LGBTQ individuals played the role of mock patients and reviews in small groups in each session.
8.Screening for Distress and Its Impact on Palliative Care Referral at a General Medical Center: Retrospective Cohort Study
Reika IKI ; Emiko SAITO ; Nobuko WADA ; Hirohito TAKATA ; Mariko SHINOMIYA ; Masatoshi SHIMADA ; Masako TANAKA ; Chinami YOSHIZUMI ; Hiroaki SAKAI ; Yuki KATAOKA
Palliative Care Research 2021;16(1):93-98
Purpose: Distress screening is mandated by Ministry of Health, Labor and Welfare of Japan, however there is few data available on its effect in actual practice. We examined the impact of distress screening on palliative care referral at Hyogo Prefectural Amagasaki General Medical Center in Japan. Materials and Methods: We implemented distress screening on cancer patients who were given chemotherapy from February 2018. Patients were referred to the palliative care team when the physicians judged the need on the basis of the screening results or when the patients themselves wanted to receive the palliative care service. We examined the number of the patients referred to the palliative care team, then we researched the changes of the number after implementation of the screening, using the regression discontinuity analysis. Results: The distress screening didn’t increase the number of the patients who were referred to the palliative care team: the estimated difference of the number was 3.32 (95% confidence interval: −3.19〜9.82). Conclusion: We implemented distress screening at our hospital but it didn’t increase palliative care referral. Only a few studies have examined how routine screening impacts clinical outcomes. We expect our study helps to research the effectiveness of screening in each healthcare facility.
9.Ongoing rubella epidemic in Osaka, Japan, in 2018–2019
Daiki Kanbayashi ; Takako Kurata ; Hideyuki Kubo ; Seiji Yamamoto ; Kazutaka Egawa ; Yuki Hirai ; Kazuma Okada ; Ryo Ikemori ; Takahiro Yumisashi ; Akira Yamamoto ; Hideki Yoshida ; Takanori Hirayama ; Kazuyoshi Ikuta ; Kazushi Motomura ; Atsushi Kaida
Western Pacific Surveillance and Response 2020;11(2):48-50
Abstract
A large rubella epidemic is currently ongoing since 2018 in Osaka, Japan. The detected rubella viruses were classified into genotypes 1E lineage 2 and 2B lineage 1. These strains may have been imported from endemic countries, and these viruses spread within the susceptible population.
10.Predictive Value of Localized Stenosis of the Main Pancreatic Duct for Early Detection of Pancreatic Cancer
Yoshihide KANNO ; Shinsuke KOSHITA ; Takahisa OGAWA ; Hiroaki KUSUNOSE ; Kaori MASU ; Toshitaka SAKAI ; Keisuke YONAMINE ; Yujiro KAWAKAMI ; Yuki FUJII ; Kazuaki MIYAMOTO ; Toji MURABAYASHI ; Fumisato KOZAKAI ; Jun HORAGUCHI ; Yutaka NODA ; Masaya OIKAWA ; Takaho OKADA ; Kei ITO
Clinical Endoscopy 2019;52(6):588-597
BACKGROUND/AIMS: In this study, we aimed to evaluate the predictive value of localized stenosis of the main pancreatic duct (MPD) for early detection of pancreatic cancer.METHODS: Among 689 patients who underwent endoscopic retrograde pancreatography from January 2008 to September 2018, 19 patients with MPD findings were enrolled. These patients showed findings for indicating suspicious pancreatic cancer at an early stage (FiCE); FiCE was defined as a single, localized stenosis in the MPD without a detectable mass (using any other imaging methods) and without other pancreatic diseases, such as definite chronic pancreatitis, intraductal papillary mucinous neoplasm, and autoimmune pancreatitis. Final diagnoses were established by examining resected specimens or through follow-up examinations after an interval of >5 years.RESULTS: Among 19 patients with FiCE, 11 underwent surgical resection and 8 were evaluated after a >5-year observation period. The final diagnosis of the MPD stenosis was judged to be pancreatic cancer in 9 patients (47%), including 3 with intraepithelial cancer, and to be a non-neoplastic change in 10. The sensitivity, specificity, and accuracy of preoperative pancreatic juice cytology were 75%, 100%, and 88%, respectively.CONCLUSIONS: The predictive value of FiCE for pancreatic cancer prevalence was 47%. Histological confirmation with pancreatic juice cytology is necessary before surgical resection.
Cholangiopancreatography, Endoscopic Retrograde
;
Constriction, Pathologic
;
Diagnosis
;
Follow-Up Studies
;
Humans
;
Mucins
;
Pancreatic Diseases
;
Pancreatic Ducts
;
Pancreatic Juice
;
Pancreatic Neoplasms
;
Pancreatitis
;
Pancreatitis, Chronic
;
Prevalence
;
Sensitivity and Specificity


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