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Article: A 1-Year Survey of Zoster-Associated Pain after Amenamevir Treatment.

Kawashima, Makoto / Miyachi, Yoshiki

2022 Volume 12, Issue 5, Page(s) 1239–1252

Abstract: Introduction: Amenamevir is a new anti-varicella-zoster virus drug that inhibits the helicase-primase complex involved in viral replication. Amenamevir has the same effect as valaciclovir on acute pain and skin eruption, but no studies have examined the ...

Abstract	Introduction: Amenamevir is a new anti-varicella-zoster virus drug that inhibits the helicase-primase complex involved in viral replication. Amenamevir has the same effect as valaciclovir on acute pain and skin eruption, but no studies have examined the presence of long-term zoster-associated pain (ZAP) or postherpetic neuralgia (PHN) after amenamevir treatment. Methods: A total of 785 herpes zoster patients treated with amenamevir were followed up for 12 months. Patients recorded their pain status on a questionnaire once a month. Results: The proportion of patients with pain was 20.8% at 90 days, 8.0% at 180 days, 3.8% at 270 days, and 2.7% at 360 days after treatment. The median residual pain duration was 48 days. ZAP resolution rate slowed between 90 and 120 days, suggesting that the main feature of ZAP is a shift from nociceptive pain to neuropathic pain. Older age and more severe skin symptoms at the first visit were associated with a higher risk of developing PHN. Median ZAP duration was high for the head, face, and upper back and chest. Regarding the nature of pain, sudden pain attacks that felt like electric shocks, sensation of numbness, burning sensation, and cold/heat pain tended to remain as PHN. Conclusions: Although conclusions must remain tentative without further comparative studies, amenamevir seems to have a similar effect on PHN as conventional nucleoside analogs, despite having a different action mechanism. Clinical trial registration: UMIN000035938.
Language	English
Publishing date	2022-05-02
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2680284-3
ISSN	2190-9172 ; 2193-8210
ISSN (online)	2190-9172
ISSN	2193-8210
DOI	10.1007/s13555-022-00727-9
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Article ; Online: Rhododendrol, a reductive metabolite of raspberry ketone, suppresses the differentiation of 3T3‑L1 cells into adipocytes.

Uramaru, Naoto / Kawashima, Azusa / Osabe, Makoto / Higuchi, Toshiyuki

Molecular medicine reports

2023 Volume 27, Issue 2

Abstract: Obesity is a serious medical condition worldwide, and a major risk factor for type 2 diabetes, metabolic syndrome, cancer and cardiovascular disease. In addition to changes in dietary habits and physical activity, consuming supplements to maintain good ... ...

Abstract	Obesity is a serious medical condition worldwide, and a major risk factor for type 2 diabetes, metabolic syndrome, cancer and cardiovascular disease. In addition to changes in dietary habits and physical activity, consuming supplements to maintain good health and prevent obesity is important in modern society. Raspberry ketone (RK) is a natural phenolic ketone found in the European red raspberry (
MeSH term(s)	Animals ; Humans ; Mice ; 3T3-L1 Cells ; Adipocytes/cytology ; Adipocytes/metabolism ; Adipogenesis/drug effects ; Butanols/pharmacology ; CCAAT-Enhancer-Binding Protein-alpha/metabolism ; Obesity/prevention & control ; PPAR gamma/genetics ; PPAR gamma/metabolism ; Anti-Obesity Agents/pharmacology
Chemical Substances	Butanols ; CCAAT-Enhancer-Binding Protein-alpha ; PPAR gamma ; raspberry ketone (7QY1MH15BG) ; rhododendrol (12QWN45UL0) ; Anti-Obesity Agents
Language	English
Publishing date	2023-01-12
Publishing country	Greece
Document type	Journal Article
ZDB-ID	2469505-1
ISSN	1791-3004 ; 1791-2997
ISSN (online)	1791-3004
ISSN	1791-2997
DOI	10.3892/mmr.2023.12938
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Article ; Online: The effectiveness of S-LEC™ solar control film L in laminated glass for reducing the burning sensation caused by near-infrared radiation.

Shinohara, Koji / Nomachi, Akira / Kawashima, Makoto

Journal of cosmetic dermatology

2023 Volume 22, Issue 12, Page(s) 3500–3504

Abstract: Objectives: The aim of this study was to examine the potential for S-LEC™ Solar Control Film L, a heat insulating interlayer film for laminated glass developed by Sekisui Chemical Co., Ltd., to reduce the burning sensation caused by near infrared (NIR) ... ...

Abstract	Objectives: The aim of this study was to examine the potential for S-LEC™ Solar Control Film L, a heat insulating interlayer film for laminated glass developed by Sekisui Chemical Co., Ltd., to reduce the burning sensation caused by near infrared (NIR) radiation. Methods: A crossover study was performed in 49 male and female subjects, using three different combinations of laminated glass with interlayer films. Subjects placed their right hand under each glass in an NIR irradiation device. The dorsal side of the right hand was irradiated with NIR for 30 s and the onset and degree of a burning sensation was measured. Results: Laminated glass with S-LEC™ Solar Control Film L reduced the burning sensation caused by NIR and delayed the onset of the sensation, compared with the control glasses. Conclusion: The use of S-LEC™ Solar Control Film L in the laminated glass of vehicles may improve passenger comfort and prevent skin disorders such as photoaging caused by prolonged exposure to NIR.
MeSH term(s)	Male ; Humans ; Female ; Cross-Over Studies ; Sunlight ; Infrared Rays ; Sensation
Language	English
Publishing date	2023-09-04
Publishing country	England
Document type	Journal Article
ZDB-ID	2280551-5
ISSN	1473-2165 ; 1473-2130
ISSN (online)	1473-2165
ISSN	1473-2130
DOI	10.1111/jocd.15876
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Article: Nemolizumab Improves Patient-Reported Symptoms of Atopic Dermatitis with Pruritus: Post Hoc Analysis of a Japanese Phase III Randomized Controlled Trial.

Kabashima, Kenji / Matsumura, Takayo / Komazaki, Hiroshi / Kawashima, Makoto

Dermatology and therapy

2023 Volume 13, Issue 4, Page(s) 997–1011

Abstract: Introduction: Atopic dermatitis (AD), with its signs and symptoms of pruritus, dryness, and erythema, severely reduces the quality of life (QOL) of affected patients. We investigated the impact of nemolizumab 60 mg on QOL in Japanese patients aged ≥ 13 ... ...

Abstract	Introduction: Atopic dermatitis (AD), with its signs and symptoms of pruritus, dryness, and erythema, severely reduces the quality of life (QOL) of affected patients. We investigated the impact of nemolizumab 60 mg on QOL in Japanese patients aged ≥ 13 years with AD and inadequately controlled moderate-to-severe pruritus, using data derived from patient-reported outcome (PRO) measures. Methods: PROs were the Insomnia Severity Index (ISI), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), and Work Productivity and Activity Impairment: Atopic Dermatitis questionnaire (WPAI-AD). Correlations between PRO scores and symptom severity, assessed by the pruritus visual analog scale (VAS) and the Eczema Area and Severity Index (EASI), were explored. Results: The mean percent change (standard error) from baseline in the pruritus VAS and EASI scores at week 16 was, respectively, -45.6% (2.7) and -46.0% (3.2) in the nemolizumab group, and -24.1% (3.7) and -33.2% (4.9) in the placebo group. By week 16, significantly more patients in the nemolizumab group versus the placebo group had an ISI score of 0 for difficulty falling asleep (41.6% versus 13.1%, nominal p < 0.01) or difficulty staying asleep (45.4% versus 10.9%; nominal p < 0.01). Similarly, more nemolizumab- than placebo-treated patients had a DLQI score of 0 for interference with shopping, or home/garden activities (45.2% versus 18.6%, nominal p < 0.01), and 0 days per week of nighttime sleep disturbance (50.8% versus 16.9%, nominal p < 0.01) or bleeding skin (43.4% versus 7.5%, nominal p < 0.01) measured by POEM at week 16. Based on WPAI-AD scores, long-term administration of nemolizumab also improved the ability to conduct work activities. Conclusions: Subcutaneous administration of nemolizumab ameliorated pruritus and skin signs, and thereby produced improvement in patient QOL across multiple PRO measures, including sleep, interpersonal relationships, and the ability to conduct social or work activities. Clinical trial registration: JapicCTI-173740 (registered 20 October 2017).
Language	English
Publishing date	2023-03-11
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2680284-3
ISSN	2190-9172 ; 2193-8210
ISSN (online)	2190-9172
ISSN	2193-8210
DOI	10.1007/s13555-023-00901-7
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Article ; Online: Polyarteritis nodosa with splenic rupture and multiple cerebral infarctions.

Norimatsu, Yuta / Saku, Aiko / Kawashima, Hirotoshi / Minagawa, Takuya / Itano, Osamu / Shiga, Takashi / Hayashi, Yuichiro / Hirose, Koichi / Sugaya, Makoto

The Journal of dermatology

2024

Language	English
Publishing date	2024-02-27
Publishing country	England
Document type	Letter
ZDB-ID	800103-0
ISSN	1346-8138 ; 0385-2407
ISSN (online)	1346-8138
ISSN	0385-2407
DOI	10.1111/1346-8138.17162
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Article ; Online: Clinically meaningful improvements in cutaneous lesions and quality of life measures in patients with atopic dermatitis with greater pruritus reductions after treatment with 60 mg nemolizumab subcutaneously every 4 weeks: subgroup analysis from a phase 3, randomized, controlled trial.

Kabashima, Kenji / Matsumura, Takayo / Hayakawa, Yoshiteru / Kawashima, Makoto

The Journal of dermatological treatment

2022 Volume 34, Issue 1, Page(s) 2177096

Abstract: Background: Data from the Japanese phase 3 Nemolizumab-JP01 study (JapicCTI-173740) found that nemolizumab in combination with topical treatments reduced pruritus associated with atopic dermatitis inadequately controlled with current therapies.: ... ...

Abstract	Background: Data from the Japanese phase 3 Nemolizumab-JP01 study (JapicCTI-173740) found that nemolizumab in combination with topical treatments reduced pruritus associated with atopic dermatitis inadequately controlled with current therapies. Methods: This Results: Pruritus VAS responders (≥50% improvement from baseline to week 16) showed greater improvements from baseline in these additional endpoints as early as week 1, compared with non-responders. Responders also had EASI improvement, and more than 80% achieved an ISI score ≤7, or had improvement in the DLQI or POEM. The percent change from baseline in VAS and EASI scores at week 16 was in favor of nemolizumab in all subgroups based on baseline characteristics. No specific factor affecting treatment response to nemolizumab was identified. Conclusions: In this
MeSH term(s)	Humans ; Dermatitis, Atopic/complications ; Dermatitis, Atopic/drug therapy ; Dermatitis, Atopic/diagnosis ; Quality of Life ; Pruritus/drug therapy ; Pruritus/etiology ; Eczema ; Severity of Illness Index ; Treatment Outcome ; Double-Blind Method
Chemical Substances	nemolizumab (GN465U8B72)
Language	English
Publishing date	2022-12-29
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase III ; Journal Article
ZDB-ID	1036299-x
ISSN	1471-1753 ; 0954-6634
ISSN (online)	1471-1753
ISSN	0954-6634
DOI	10.1080/09546634.2023.2177096
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Zs.A 2627: Show issues

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Article: Single-Dose, Patient-Initiated Amenamevir Therapy for Recurrent Genital Herpes: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study.

Kawashima, Makoto / Imafuku, Shinichi / Fujio, Kosuke / Komazaki, Hiroshi

Open forum infectious diseases

2022 Volume 9, Issue 10, Page(s) ofac494

Abstract: Background: Amenamevir is a helicase-primase inhibitor with novel mechanisms of antiherpetic action. A patient-initiated single-dose regimen showed clinical efficacy for genital herpes in a phase 2 study.: Methods: In this phase 3 study, adult ... ...

Abstract	Background: Amenamevir is a helicase-primase inhibitor with novel mechanisms of antiherpetic action. A patient-initiated single-dose regimen showed clinical efficacy for genital herpes in a phase 2 study. Methods: In this phase 3 study, adult immunocompetent patients with recurrent genital herpes and able to accurately recognize prodromal symptoms were randomly assigned to administer amenamevir 1200 mg or placebo as a patient-initiated therapy within 6 hours after onset of prodromal symptoms. The primary efficacy endpoint was time to healing of all genital herpes lesions. Results: In the modified intention-to-treat population, which excluded patients with aborted lesions (amenamevir, n = 89; placebo, n = 97), the median time to all lesion healing was 4.0 days for amenamevir versus 5.1 days for placebo (hazard ratio, 1.60 [95% confidence interval, 1.19-2.15]; Conclusions: Patient-initiated single-dose amenamevir reduced the time to all lesion healing of recurrent genital herpes versus placebo, with no safety concerns, suggesting it could be an effective treatment option for patients with recurrent genital herpes.
Language	English
Publishing date	2022-09-22
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofac494
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Article ; Online: Integrated anatomical practice combining cadaver dissection and matched cadaver CT data processing and analysis.

Kawashima, Tomokazu / Sakai, Makoto / Hiramatsu, Keita / Sato, Fumi

Surgical and radiologic anatomy : SRA

2022 Volume 44, Issue 3, Page(s) 335–343

Abstract: Purpose: With the increasing significance of diagnostic imaging in clinical practice, long-term anatomical education and training is required to ensure that students can reliably distinguish anatomical structures and interpret images. To improve ... ...

Abstract	Purpose: With the increasing significance of diagnostic imaging in clinical practice, long-term anatomical education and training is required to ensure that students can reliably distinguish anatomical structures and interpret images. To improve students' motivation and prospects for learning imaging anatomy, we developed an integrated anatomical practice program combining cadaveric dissection with cadaver CT data processing and analysis during undergraduate students' dissection courses. Methods: Workstations imported with post-mortem CT data of dissected cadavers and various forms of clinical CT/MRI data were set in the dissection room. Medical students had free access to the imaging data during cadaver dissection, and they were challenged to process and analyze the data for submission of voluntary imaging reports on their topics of interest. Finally, we surveyed the integrated anatomical education of 481 medical students. Results: The positive response rate to the integrated anatomical practice was 74.9%, and 79.4% of the students answered that this form of practice offered a suitable introduction to anatomical imaging. The usefulness of this approach in understanding the 2- to 3D arrangement of the human body and enhancing interest in anatomy was also confirmed. The submission rate of voluntary imaging reports also increased annually and is currently 97.4%. Conclusion: Our integrated anatomical practice only allowed students to actively browse CT images and facilitated imaging processing and analysis of their region of interest. This practice may improve students' long-term ability to analyze images and deepen their understanding. A competitive imaging contest may help improve students' motivation when they begin learning imaging anatomy.
MeSH term(s)	Anatomy/education ; Cadaver ; Curriculum ; Dissection/education ; Education, Medical, Undergraduate/methods ; Educational Measurement/methods ; Humans ; Students, Medical ; Surveys and Questionnaires ; Tomography, X-Ray Computed/methods
Language	English
Publishing date	2022-01-25
Publishing country	Germany
Document type	Journal Article
ZDB-ID	632839-8
ISSN	1279-8517 ; 0930-312X ; 0930-1038
ISSN (online)	1279-8517
ISSN	0930-312X ; 0930-1038
DOI	10.1007/s00276-022-02890-2
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Zs.A 1456: Show issues

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Article ; Online: Moral distress among critical care nurses: A cross-cultural comparison.

Ashida, Kaoru / Kawashima, Tetsuharu / Kawakami, Aki / Tanaka, Makoto

Nursing ethics

2022 Volume 29, Issue 6, Page(s) 1341–1352

Abstract: Background: Although, moral distress presents a serious problem among critical care nurses in many countries, limited research has been conducted on it. A validated scale has been developed to evaluate moral distress and has enabled cross-cultural ... ...

Abstract	Background: Although, moral distress presents a serious problem among critical care nurses in many countries, limited research has been conducted on it. A validated scale has been developed to evaluate moral distress and has enabled cross-cultural comparison for seeking its root causes. Research aims: This study aimed to (1) clarify the current status of moral distress among nurses who worked in critical care areas in Japan, (2) compare the moral distress levels among nurses in Japan with previously reported results from the United States (US), and (3) explore the factors associated with moral distress. Research design: A nationwide cross-sectional study was conducted. Participants and research context: We conducted a self-administered questionnaire survey using the Measure of Moral Distress-Healthcare Professionals (MMD-HP) among critical care nurses who were randomly selected from hospitals across Japan. The mean differences between the two countries were compared using a Student's t-test with summary statistics. The factors associated with higher levels of moral distress were examined using a multiple regression analysis. Ethical considerations: The study was approved by the Ethics Committee of the Tokyo Medical and Dental University (approval nos. M2018-214 and M2019-045). Results: We obtained 955 valid responses from 94 facilities. In Japan, the items with the highest moral distress scores were those related to aggressive/inappropriate treatment. The total MMD-HP score was significantly higher in Japanese nurses compared to US nurses (122.8 ± 70.8 vs 112.3 ± 73.2). Some factors, such as leadership experience, were associated with higher moral distress. Discussion: The top root causes of moral distress were similar to potentially inappropriate treatments in both countries. Conclusion: This study revealed the factors associated with higher moral distress and its characteristics in each country. These results can be used for reducing moral distress in the future.
MeSH term(s)	Attitude of Health Personnel ; Critical Care ; Cross-Cultural Comparison ; Cross-Sectional Studies ; Humans ; Morals ; Nurses ; Stress, Psychological/complications ; Surveys and Questionnaires
Language	English
Publishing date	2022-05-18
Publishing country	England
Document type	Journal Article
ZDB-ID	1200467-4
ISSN	1477-0989 ; 0969-7330
ISSN (online)	1477-0989
ISSN	0969-7330
DOI	10.1177/09697330221085773
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Zs.A 4041: Show issues

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Article ; Online: A phase 3, randomized, double-blind, placebo-controlled study evaluating a single, patient-initiated dose of amenamevir for recurrent herpes labialis.

Kawashima, Makoto / Watanabe, Daisuke / Fujio, Kosuke / Komazaki, Hiroshi

The Journal of dermatology

2022 Volume 50, Issue 3, Page(s) 311–318

Abstract: Amenamevir (ASP2151), a novel, non-nucleoside analog, antiviral drug, inhibits the enzyme activities of helicase and primase, which are essential for replication of herpes viral genomic DNA. In this phase 3, randomized, double-blind, placebo-controlled, ... ...

Abstract	Amenamevir (ASP2151), a novel, non-nucleoside analog, antiviral drug, inhibits the enzyme activities of helicase and primase, which are essential for replication of herpes viral genomic DNA. In this phase 3, randomized, double-blind, placebo-controlled, multicenter study, the authors investigated the efficacy and safety of a single patient-initiated dose of amenamevir to treat recurrent herpes labialis. Adult immunocompetent patients with recurrent herpes labialis who had the experience and ability to recognize prodromal symptoms were randomly assigned to administer amenamevir 1200 mg or placebo as a patient-initiated therapy within 6 hours after onset of prodromal symptoms. The primary efficacy end point was time to healing of all herpes labialis lesions in the modified intention-to-treat population. Secondary efficacy end points were time to crusting of all herpes labialis lesions, time to resolution of pain accompanying herpes labialis, proportion of patients with aborted lesions, and time to resolution of subjective symptoms accompanying herpes labialis. The modified intention-to-treat population, which excluded patients with aborted lesions, comprised 298 patients who self-initiated amenamevir and 307 who took placebo. Amenamevir demonstrated superiority over placebo for the primary end point; the median time to all lesion healing was 5.1 days for amenamevir versus 5.5 days for placebo (hazard ratio, 1.24; 95% confidence interval, 1.06-1.46; p = 0.0085). Time to crusting of all lesions was significantly shorter with amenamevir versus placebo (p = 0.0065); there were no significant between-group differences in other secondary outcomes. Treatment-emergent adverse events in both groups were generally mild in severity; there were two moderate events that were judged unrelated to study treatment, and no severe or serious events. In summary, a single patient-initiated dose of amenamevir 1200 mg taken within 6 hours of prodromal symptom onset significantly shortened the time to all lesion healing of recurrent herpes labialis compared with placebo, with no clinically important safety concerns.
MeSH term(s)	Adult ; Humans ; Herpes Labialis/drug therapy ; Herpes Labialis/chemically induced ; Prodromal Symptoms ; Neoplasm Recurrence, Local/drug therapy ; Antiviral Agents/adverse effects ; Double-Blind Method ; Recurrence
Chemical Substances	ASP2151 ; Antiviral Agents
Language	English
Publishing date	2022-11-09
Publishing country	England
Document type	Randomized Controlled Trial ; Multicenter Study ; Clinical Trial, Phase III ; Journal Article
ZDB-ID	800103-0
ISSN	1346-8138 ; 0385-2407
ISSN (online)	1346-8138
ISSN	0385-2407
DOI	10.1111/1346-8138.16608
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