KEIO JOURNAL OF MEDICINE最新文献

Community Pharmacists' Attitudes and Experiences Regarding the Promotion of Vaccinations in Japan. 日本社区药师对推广疫苗接种的态度与经验。

IF 0.8

KEIO JOURNAL OF MEDICINE Pub Date : 2026-09-25 Epub Date: 2026-02-13 DOI: 10.2302/kjm.2025-0007-OA

Hiroki Iwata, Taiki Kirihara, Noriko Kobayashi, Yuki Nakamura, Tomoko Koike, Katsunori Yamaura

{"title":"Community Pharmacists' Attitudes and Experiences Regarding the Promotion of Vaccinations in Japan.","authors":"Hiroki Iwata, Taiki Kirihara, Noriko Kobayashi, Yuki Nakamura, Tomoko Koike, Katsunori Yamaura","doi":"10.2302/kjm.2025-0007-OA","DOIUrl":"10.2302/kjm.2025-0007-OA","url":null,"abstract":"Japan has the lowest vaccine confidence worldwide. Although community pharmacists are expected to support public health, it remains unclear whether Japanese community pharmacists-who cannot administer vaccines-engage in vaccine consultation and promotion. This cross-sectional study used a paper-based, self-administered, anonymous questionnaire distributed to randomly selected community pharmacists in Japan to investigate their attitudes and experiences regarding vaccination, exploring issues related to the prevalence of the vaccine-related roles of community pharmacists. One thousand pharmacies were chosen, and the valid response rate was 44.6%. While 86.5% of respondents had experience with vaccine consultation, only 59.2% had experience with vaccine promotion. The rate of vaccine promotion was significantly higher among community pharmacists who recognized Japan's low vaccine confidence and held positive attitudes toward vaccine promotion (P < 0.001). Most respondents (76.9%) desired training to expand pharmacists' roles in vaccination. Additionally, 62.1% supported pharmacist-administered vaccines, though many were concerned about technical skills (83.3%) and potential anaphylaxis (63.6%). These findings suggest that promoting awareness of vaccine hesitancy and strengthening attitudes toward vaccine promotion could increase the number of community pharmacists involved in such activities. Japanese pharmacists may also need appropriate vaccine administration knowledge and skills to prepare for potential future responsibilities in vaccine administration.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":"55-62"},"PeriodicalIF":0.8,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146203231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Identifying High-Cost RSV Hospitalizations at a Secondary Hospital in Japan. 确定日本二级医院RSV住院的高成本。

IF 0.8

KEIO JOURNAL OF MEDICINE Pub Date : 2026-09-25 Epub Date: 2026-01-23 DOI: 10.2302/kjm.2025-0020-LE

Tomomi Matsuda, Yoshiko Seki, Masayuki Akashi, Kazushige Ikeda

{"title":"Identifying High-Cost RSV Hospitalizations at a Secondary Hospital in Japan.","authors":"Tomomi Matsuda, Yoshiko Seki, Masayuki Akashi, Kazushige Ikeda","doi":"10.2302/kjm.2025-0020-LE","DOIUrl":"10.2302/kjm.2025-0020-LE","url":null,"abstract":"Respiratory syncytial virus (RSV) is a leading cause of hospitalization in infants and young children worldwide. Although most RSV hospitalizations occur at secondary hospitals, information on RSV-related healthcare costs in these settings is limited. A retrospective analysis of RSV-related hospitalizations was conducted at Saitama City Hospital, a secondary hospital, between April 2018 and May 2024. Patients with laboratory-confirmed RSV infection were included. The study period was divided into three phases based on revisions of the national medical reimbursement schedule. Hospitalization costs were calculated, and high-cost outliers were identified using the interquartile range (IQR) method. A total of 345 patients were hospitalized for RSV, with a marked reduction in Phase II admissions corresponding to the early COVID-19 pandemic. Median hospitalization costs per episode increased in all three phases, from JPY 318,930 to JPY 393,930. Eighteen admissions were identified as cost outliers and classified into three subgroups: (1) children with airway or neurologic disorders, often older than 24 months; (2) otherwise healthy infants under 12 months; and (3) children eligible for palivizumab who contracted RSV before or after the recommended prophylaxis period. Our findings emphasize the existence of high-cost RSV cases outside the currently recognized high-risk groups, including older children with chronic airway disease and healthy young infants. Clinical burden and healthcare costs may be reduced by refining prophylaxis strategies and early intervention in Japan.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":"51-54"},"PeriodicalIF":0.8,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146047262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Imaging Characteristics, Clinical Presentation, and Prognosis of Spinal Cord Infarction. 脊髓梗死的影像学特征、临床表现及预后。

IF 0.8

KEIO JOURNAL OF MEDICINE Pub Date : 2026-09-09 DOI: 10.2302/kjm.2026-0007-OA

Yasuhiro Kamata, Narihito Nagoshi, Yoshikane Izawa, Toshiki Okubo, Masahiro Ozaki, Satoshi Suzuki, Kazuki Takeda, Takahito Iga, Kentaro Shimizu, Morio Matsumoto, Masaya Nakamura, Kota Watanabe

{"title":"Imaging Characteristics, Clinical Presentation, and Prognosis of Spinal Cord Infarction.","authors":"Yasuhiro Kamata, Narihito Nagoshi, Yoshikane Izawa, Toshiki Okubo, Masahiro Ozaki, Satoshi Suzuki, Kazuki Takeda, Takahito Iga, Kentaro Shimizu, Morio Matsumoto, Masaya Nakamura, Kota Watanabe","doi":"10.2302/kjm.2026-0007-OA","DOIUrl":"https://doi.org/10.2302/kjm.2026-0007-OA","url":null,"abstract":"Spinal cord infarction is a rare neurological disorder, and its clinical features, imaging findings, and prognostic factors remain incompletely understood. This retrospective cohort study aimed to comprehensively evaluate the clinical presentation, magnetic resonance imaging (MRI) characteristics, and functional prognosis of patients with spinal cord infarction. We analyzed 19 patients diagnosed with spinal cord infarction at multiple institutions in Japan between 2012 and 2022. Clinically, infarctions were classified into anterior spinal artery (ASA) syndrome (n =12), Brown-Séquard syndrome (n =5), and transverse infarction (n =2). A favorable prognosis, defined as independent ambulation at discharge, was observed in six patients, five of whom presented with Brown-Séquard syndrome, indicating a significant association between this phenotype and better functional outcomes. In contrast, ASA syndrome and transverse infarction were more frequently associated with poor prognosis. All patients demonstrated hyperintensity at the infarcted site on T2-weighted MRI during follow-up. Among eight patients who underwent diffusion-weighted imaging (DWI) within two days of symptom onset, five showed early hyperintensity, suggesting the usefulness of DWI for early diagnosis. The etiology of infarction, including iatrogenic and non-iatrogenic causes, was not significantly related to neurological outcome. These findings suggest that early DWI may facilitate prompt diagnosis of spinal cord infarction and that the infarction pattern, rather than etiology, is an important determinant of functional prognosis.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148921161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Clinical Course and Prognostic Factors of C5 Palsy after Cervical Spine Surgery. 颈椎术后C5型麻痹的临床病程及预后因素分析。

IF 0.8

KEIO JOURNAL OF MEDICINE Pub Date : 2026-09-09 DOI: 10.2302/kjm.2026-0006-OA

Kentaro Ago, Narihito Nagoshi, Junichi Yamane, Tatsuya Yamamoto, Hitoshi Kono, Yoshiomi Kobayashi, Reo Shibata, Takahiro Kitagawa, Norihiro Isogai, Haruki Funao, Soraya Nishimura, Shuhei Ito, Takeshi Ikegami, Takahito Iga, Toshiki Okubo, Kazuki Takeda, Masahiro Ozaki, Satoshi Suzuki, Morio Matsumoto, Masaya Nakamura, Kota Watanabe

{"title":"Clinical Course and Prognostic Factors of C5 Palsy after Cervical Spine Surgery.","authors":"Kentaro Ago, Narihito Nagoshi, Junichi Yamane, Tatsuya Yamamoto, Hitoshi Kono, Yoshiomi Kobayashi, Reo Shibata, Takahiro Kitagawa, Norihiro Isogai, Haruki Funao, Soraya Nishimura, Shuhei Ito, Takeshi Ikegami, Takahito Iga, Toshiki Okubo, Kazuki Takeda, Masahiro Ozaki, Satoshi Suzuki, Morio Matsumoto, Masaya Nakamura, Kota Watanabe","doi":"10.2302/kjm.2026-0006-OA","DOIUrl":"https://doi.org/10.2302/kjm.2026-0006-OA","url":null,"abstract":"This retrospective multicenter cohort study investigated recovery trajectories and prognostic factors after postoperative C5 palsy (C5P) following cervical spine surgery. Sixty-three patients from 11 institutions who developed new-onset or worsened deltoid and/or biceps weakness within two months postoperatively were analyzed. Full recovery, defined as return to or beyond the preoperative manual muscle testing (MMT) grade, was achieved in 50 patients (79.4%), whereas 13 patients (20.6%) showed incomplete recovery. Multivariate logistic regression demonstrated that higher preoperative MMT grade and higher MMT grade at the onset of C5P were independently associated with a lower risk of incomplete recovery. Kaplan-Meier analysis further showed that patients with higher preoperative or postoperative MMT grades experienced significantly faster motor recovery. Subgroup analysis stratified by preoperative motor status and postoperative palsy severity suggested that preoperative motor function may be associated with greater recovery potential after postoperative C5P. However, this interpretation should be made cautiously because some subgroups included only a small number of patients. These findings indicate that both preoperative motor function and motor severity at palsy onset are clinically relevant indicators of recovery. Careful preoperative neurological assessment and early postoperative evaluation may help guide prognostic counseling, rehabilitation planning, and postoperative management for patients who develop postoperative C5P.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148921244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Diverse Gatekeeper Role of a Hospital General Medicine Physician: A Case of a Pathologist with Recurrent Fever. 医院全科医师的不同看门人角色：一位反复发烧的病理学家病例。

IF 0.8

KEIO JOURNAL OF MEDICINE Pub Date : 2026-08-11 DOI: 10.2302/kjm.2026-0003-CR

Seitaro Fujishima, Junko Kuramoto, Kimiko Ubukata

{"title":"Diverse Gatekeeper Role of a Hospital General Medicine Physician: A Case of a Pathologist with Recurrent Fever.","authors":"Seitaro Fujishima, Junko Kuramoto, Kimiko Ubukata","doi":"10.2302/kjm.2026-0003-CR","DOIUrl":"10.2302/kjm.2026-0003-CR","url":null,"abstract":"In Japan, general medicine (GM) has been recognized as a unique specialty addressing the needs of an aging society with complex comorbidities. GM physicians act as essential \"gatekeepers,\" managing initial evaluations for diverse conditions and facilitating collaboration among various medical departments. This case study presents the critical nature of this role when clinical suspicion encounters diagnostic limitations. A young pathologist presented with recurrent fever. She expressed concern regarding possible occupational exposure during an autopsy and pathological specimen preparation performed months earlier on a deceased patient with an undetermined infection. Although the autopsy revealed widespread necrotizing granulomatous lesions associated with yeast-like fungi, the hospital's central laboratory was unable to identify the species. The GM physician used a professional network to consult an infectious disease specialist, who subsequently engaged a fungal expert. The pathogen was identified as Histoplasma capsulatum via PCR sequencing. However, the patient's subsequent test for histoplasma antibodies was negative, and a causal relationship between the recurrent fever and potential histoplasma exposure could not be established. Histoplasmosis is extremely rare in Japan and is typically associated with international travel. However, the deceased patient in this case had no recent history of overseas travel. Because laboratory assays for this high-risk fungus are not currently covered by the Japanese health insurance, such cases may remain undiagnosed. This report demonstrates that a general physician's ability to establish and coordinate specialist networks is crucial for resolving complex diagnostic challenges and ensuring the safety of healthcare workers.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2026-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148727445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Elucidation of Cefmetazole Binding to Human Serum Albumin In Vitro and Prediction of Unbound Cefmetazole Concentrations in Clinical Patients. 头孢美唑体外与人血清白蛋白结合的研究及临床患者未结合头孢美唑浓度的预测。

IF 0.8

KEIO JOURNAL OF MEDICINE Pub Date : 2026-08-11 DOI: 10.2302/kjm.2026-0001-OA

Ryusei Hara, Yuta Yokoyama, Takaya Namiki, Keishi Yamasaki, Aya Jibiki, Yuma Nonomiya, Yurika Mizoguti, Sayo Suzuki, Tomonori Nakamura

{"title":"Elucidation of Cefmetazole Binding to Human Serum Albumin In Vitro and Prediction of Unbound Cefmetazole Concentrations in Clinical Patients.","authors":"Ryusei Hara, Yuta Yokoyama, Takaya Namiki, Keishi Yamasaki, Aya Jibiki, Yuma Nonomiya, Yurika Mizoguti, Sayo Suzuki, Tomonori Nakamura","doi":"10.2302/kjm.2026-0001-OA","DOIUrl":"10.2302/kjm.2026-0001-OA","url":null,"abstract":"Cefmetazole (CMZ), a cephamycin, has a protein-binding rate of approximately 85%. The unbound concentration is microbiologically active and may vary greatly depending on variations in human serum albumin (HSA) concentration. However, the binding parameters and sites of HSA have not been clarified, and the predicted unbound concentrations using these parameters have not been evaluated. This study aimed to clarify these binding characteristics and evaluate unbound CMZ concentrations predicted using the calculated binding parameters. Total and unbound CMZ concentrations in the HSA solutions were measured at several HSA concentrations (10 g/L, 25 g/L, and 40 g/L) and total CMZ concentrations (10, 60, and 150 mg/L). A Scatchard plot was constructed. To identify specific binding sites, competitive binding assays were performed using the site markers warfarin, dansylsarcosine, bicalutamide, and bilirubin. Unbound CMZ concentrations were predicted using binding parameters from total CMZ and albumin concentrations in 37 patients. The association constant (K) for CMZ to HSA was determined to be 6.59 × 103 M-1, with number of binding sites (n) of 1.08. The binding rate decreased as the CMZ concentration increased or the HSA concentration decreased. Competitive binding assays revealed that CMZ binds to Subdomain IB on HSA. A strong correlation (r=0.907) was observed between predicted and measured unbound CMZ concentrations. This study successfully defined the binding parameters and specific binding sites of CMZ on HSA, and unbound CMZ concentrations were accurately predicted from the total CMZ concentrations in clinical patients using these binding parameters.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2026-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148723724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Impact of COVID-19-Related Social Restrictions on Vitamin D Levels in Japanese Newborns and Infants: A Retrospective Cohort Study. 新冠肺炎相关社会限制对日本新生儿和婴儿维生素D水平的影响：一项回顾性队列研究

IF 0.8

KEIO JOURNAL OF MEDICINE Pub Date : 2026-07-25 DOI: 10.2302/kjm.2025-0024-OA

Yoshiko Seki, Kaori Hara-Isono, Kazumi Morisawa, Mariko Hida, Kazushige Ikeda

{"title":"Impact of COVID-19-Related Social Restrictions on Vitamin D Levels in Japanese Newborns and Infants: A Retrospective Cohort Study.","authors":"Yoshiko Seki, Kaori Hara-Isono, Kazumi Morisawa, Mariko Hida, Kazushige Ikeda","doi":"10.2302/kjm.2025-0024-OA","DOIUrl":"https://doi.org/10.2302/kjm.2025-0024-OA","url":null,"abstract":"This study evaluated the impact of the COVID-19 pandemic on vitamin D status in Japanese newborns and early infants by comparing serum 25-hydroxyvitamin D (25(OH)D) concentrations between pandemic and non-pandemic periods. A total of 805 newborns aged ≤4 days and 366 infants aged 29-42 days were included. Nearest-neighbor matching was performed to adjust for key confounders, including season, body mass index, and formula intake. No significant differences in serum 25(OH)D levels were observed between the overall pandemic and non-pandemic periods in either age group after matching. In the ≤4-day-old group, median [IQR] 25(OH)D concentrations were 15.2 [11.9-18.9] ng/mL and 14.9 [12.1-18.9] ng/mL in the pandemic and non-pandemic groups, respectively (P = 0.79). In the 1-month-old group, corresponding values were 12.2 [6.8-17.2] ng/mL and 12.6 [6.2-17.9] ng/mL (P = 0.70). When the analysis in the 1-month-old group was restricted to the strict restriction period corresponding to the state of emergency, serum 25(OH)D levels were significantly lower before matching (P = 0.005), but the difference was no longer significant after matching (P = 0.12). Across all analyses, markers of bone metabolism, including calcium, phosphorus, alkaline phosphatase, and intact parathyroid hormone, showed no clinically meaningful differences.In addition, vitamin D insufficiency (<20 ng/mL) was highly prevalent in both age groups, regardless of the pandemic period. These findings suggest that COVID-19-related restrictions had a limited impact on vitamin D status in Japanese newborns and early infants, although potential effects during periods of strict social restrictions cannot be excluded.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2026-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148621836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Night-to-night Variability of Overnight Pulse Oximetry in Children with Underlying Medical Conditions. 有潜在疾病的儿童夜间脉搏氧饱和度的夜间变异性

IF 0.8

KEIO JOURNAL OF MEDICINE Pub Date : 2026-07-15 DOI: 10.2302/kjm.2025-0021-OA

Saori Oguri, Hisato Kobayashi, Goro Koinuma

{"title":"Night-to-night Variability of Overnight Pulse Oximetry in Children with Underlying Medical Conditions.","authors":"Saori Oguri, Hisato Kobayashi, Goro Koinuma","doi":"10.2302/kjm.2025-0021-OA","DOIUrl":"https://doi.org/10.2302/kjm.2025-0021-OA","url":null,"abstract":"Children with underlying medical conditions, such as neuromuscular diseases, craniofacial malformations, or chromosomal abnormalities, are at increased risk of obstructive sleep apnea (OSA). Although polysomnography remains the diagnostic gold standard for OSA, its feasibility in children is limited. Overnight pulse oximetry is a widely used screening tool, but its diagnostic accuracy may be compromised by first-night effects and night-to-night variability, particularly in children with neurodevelopmental or craniofacial disorders. Therefore, we evaluated night-to-night agreement of pulse oximetry indices in children with underlying medical conditions using correlation and Bland-Altman analysis. We retrospectively analyzed thirty-two children with underlying medical conditions under 15 years of age (median age 3 years) who underwent two consecutive nights of overnight pulse oximetry to evaluate night-to-night agreement of oximetry indices. Oxygen desaturation indices (ODI3, ODI4) and desaturation times <90% (DT90) and <95% (DT95) were evaluated. Correlations between nights were moderate to high (ODI3: r =0.71; DT90: r =0.72), but Bland-Altman analysis revealed wide 95% limits of agreement for ODI3 (-7.06 to +8.14 events/h), comparable to the diagnostic threshold of 7/h, leading to diagnostic reclassification in 25% of cases. Despite moderate to strong correlations, Bland-Altman analysis demonstrated clinically meaningful variability near diagnostic thresholds. In children with underlying conditions, a single-night oximetry study may under- or over-diagnose OSA. While two-night assessments should remain the standard, we propose a stepwise diagnostic algorithm in which a markedly elevated first-night ODI3 (≥15/h) may justify immediate intervention, whereas further evaluation is warranted in cases suspected to represent mild-to-moderate disease.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2026-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148457273","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of Non-sedating and Sedating Histamine H₁-receptor Antagonist Premedication for Preventing Subcutaneous Daratumumab-associated Infusion-related Reactions: A Multicenter Retrospective Observational Study. 非镇静组胺h1受体拮抗剂与镇静组胺h1受体拮抗剂预防daratumumab皮下注射相关反应的比较：一项多中心回顾性观察研究

IF 0.8

KEIO JOURNAL OF MEDICINE Pub Date : 2026-07-14 DOI: 10.2302/kjm.2025-0019-OA

Mayu Yakumaru-Suzukawa, Tohru Aomori, Norifumi Suzuki, Tatsuya Hayama, Yukiyoshi Fujita, Hiromu Tanigawa, Yuki Ozawa, Naoya Suehiro, Akihiro Uchiike, Manami Amagasa, Yohei Suzuki, Hiroomi Sakurai, Keisuke Kiyomiya, Haruki Ishikawa, Hitoshi Kawazoe, Hisakazu Ohtani

{"title":"Comparison of Non-sedating and Sedating Histamine H1-receptor Antagonist Premedication for Preventing Subcutaneous Daratumumab-associated Infusion-related Reactions: A Multicenter Retrospective Observational Study.","authors":"Mayu Yakumaru-Suzukawa, Tohru Aomori, Norifumi Suzuki, Tatsuya Hayama, Yukiyoshi Fujita, Hiromu Tanigawa, Yuki Ozawa, Naoya Suehiro, Akihiro Uchiike, Manami Amagasa, Yohei Suzuki, Hiroomi Sakurai, Keisuke Kiyomiya, Haruki Ishikawa, Hitoshi Kawazoe, Hisakazu Ohtani","doi":"10.2302/kjm.2025-0019-OA","DOIUrl":"https://doi.org/10.2302/kjm.2025-0019-OA","url":null,"abstract":"Sedating antihistamines (sAH) are widely used as premedication to prevent infusion-related reactions (IRRs). Subcutaneous daratumumab (DARA-SC) is administered in a shorter time than its intravenous form. Therefore, sedation caused by sAH after DARA-SC administration may also pose a concern. We investigated the efficacy and safety of sAH and non-sedating antihistamines (nsAH) premedication. This multicenter, retrospective, observational study was conducted from six hospitals in Japan. Data from the electronic medical records of consecutive patients with multiple myeloma who received DARA-SC injection between 19 May 2021 and 31 December 2022 was analyzed. The incidence of IRR and drowsiness was investigated as efficacy and safety endpoints, respectively. Differences in incidence between patients treated with nsAH and those treated with sAH were compared. Thirty-one patients in the nsAH group and 130 patients in the sAH group were evaluated. All patients in the nsAH group were treated with levocetirizine, while patients in the sAH group were treated with dexchlorpheniramine or diphenhydramine. The incidence of IRRs was 0% (0/31) in the nsAH group and 1.5% (2/130) in the sAH group. The incidence of drowsiness was 6.5% (2/31) in the nsAH group and 7.7% (10/130) in the sAH group. These differences were not statistically significant. This study showed that levocetirizine is not obviously inferior in efficacy and safety relative to sAH in preventing IRRs and drowsiness. Therefore, levocetirizine can be considered as a substitute for patients for whom the use of sAH is not acceptable.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2026-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148457248","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of Clinical Development of Digital Therapeutics among Japan, the Unites States, and Germany. 日本、美国和德国数字治疗临床发展的比较。

IF 0.8

KEIO JOURNAL OF MEDICINE Pub Date : 2026-06-25 Epub Date: 2025-11-21 DOI: 10.2302/kjm.2025-0006-OA

Toshiyoshi Tominaga, Tomonobu Hasegawa, Eiji Harada

{"title":"Comparison of Clinical Development of Digital Therapeutics among Japan, the Unites States, and Germany.","authors":"Toshiyoshi Tominaga, Tomonobu Hasegawa, Eiji Harada","doi":"10.2302/kjm.2025-0006-OA","DOIUrl":"10.2302/kjm.2025-0006-OA","url":null,"abstract":"Digital therapeutics (DTx) have demonstrated promising potential as a novel therapeutic approach, with their clinical development gaining momentum. Comparison of DTx development between Japan, a relative newcomer, and Germany and the U.S., known for favorable circumstances, is a topic of interest. DTx developed in Japan as of November 2023 were identified on the Pharmaceuticals and Medical Devices Agency (PMDA) website and in the literature. Similar DTx available in the U.S. and Germany were identified in the databases maintained by the U.S. Food and Drug Administration (USFDA) and Federal Institute for Drugs and Medical Devices (BfArM). Data on their clinical trials and regulatory status were obtained from these databases and their respective national clinical trial registries. The data obtained were compared and analyzed. By November 2023, Japan had developed DTx, encompassing 11 therapeutic areas. Seven DTx had reached or completed the confirmatory study stage, whereas five DTx were in the exploratory phase. Twenty DTx in the therapeutic areas were selected from the U.S. and Germany. A total of 27 DTx were reviewed regarding the designs of confirmatory studies and regulatory actions taken. Trial designs demonstrated more similarities than differences across the countries and therapeutic areas. Placebo trial design-associated difficulties were conspicuous. Although regulatory actions to place DTx in the market differed across countries, they effectively ensured the efficacy and safety of DTx that were suitable for marketing considering the most current science. The regulatory measures in the three countries seem to have positively impacted DTx development.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":"21-28"},"PeriodicalIF":0.8,"publicationDate":"2026-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145596914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0