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Report of the 6th Annual Meeting of the Toukai & Hokuriku Region of the JSCPT 联委会第六届东海北陆地区年会报告
Q4 Medicine Pub Date : 2022-11-30 DOI: 10.3999/jscpt.53.6_269
T. Yamauchi
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引用次数: 0
Report of the 6th Annual Meeting of the Kyushu & Okinawa Region of the JSCPT JSCPT九州冲绳地区第六届年会报告
Q4 Medicine Pub Date : 2022-11-30 DOI: 10.3999/jscpt.53.6_275
M. Kuroiwa, F. Kaneko, A. Nishi
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引用次数: 0
Comparison of Regulations and Status of Promoting Drug Development and Authorization of Pediatric Indications among Japan, the United States and the United Kingdom 日本、美国和英国促进药物开发和儿科适应症授权的法规和现状比较
Q4 Medicine Pub Date : 2022-11-30 DOI: 10.3999/jscpt.53.6_225
Mizuki Suwa, S. Miyake, H. Urushihara
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引用次数: 1
Public Awareness of Industrial Use of Research Data Generated from Provided Biological Samples: Consideration from the Results of the Questionnaire Survey 从提供的生物样本中产生的研究数据的工业使用的公众意识:从问卷调查结果的考虑
Q4 Medicine Pub Date : 2022-11-30 DOI: 10.3999/jscpt.53.6_235
Ayako Kamisato, Kazuyo Arisawa
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引用次数: 0
Study Protocol for a Randomized Double-blind Placebo-controlled Phase 2 Clinical Trial to Assess Anti-inflammatory Effect of Colchicine (DRC3633) in Mild to Moderately Severe COVID‒19 Patients (DRC-06C) 评估秋水仙碱(DRC3633)对轻至中重度COVID-19患者(DRC-06C)抗炎作用的随机双盲安慰剂对照2期临床试验研究方案
Q4 Medicine Pub Date : 2022-11-30 DOI: 10.3999/jscpt.53.6_199
T. Kinjo, Yumi Ikehara, T. Misumi, Kouji Yamamoto, K. Murotani, T. Ogura, Toshio Miyata, Shin‐ichiro Ueda
Introduction: Given that coronavirus disease 2019(COVID-19)aggravation is associated with an excessive host immune response, complementary anti-inflammatory treatment is recommended in severe disease. Although dexamethasone is a widely used anti-inflammatory agent in COVID-19 patients with respiratory failure, its use in patients with mild COVID-19 not receiving oxygen could have harmful effects. Colchicine, an anti-inflammatory drug, blocks the upstream immune response by inhibiting NALP3 inflammasome activation. This study aimed to assess the efficacy and safety of low-dose colchicine(DRC 3633)in mild COVID-19. Method(s): This study is a prospective, multicenter, placebo-controlled, double-blind randomized, phase 2 clinical trial patients with moderate COVID-19 admitted at nine hospitals in Japan (jRCT2071200078). The primary endpoint is area under the curve(AUC)for the amount of change of serum hypersensitive C-reactive protein(hs-CRP)from baseline to 1, 2, and 4 weeks after initiating investigational drug. Study participants will be randomly assigned to the colchicine or placebo group at a 1:1 ratio. On day 1, patients in the colchicine group will receive 1 mg of colchicine, followed by 0.5 mg of colchicine after 2 h barring gastrointestinal complications. From day 2 to 28, 0.5 mg of colchicine will be administered once daily. Discussion(s): An appropriate anti-inflammatory strategy is critical to improve the outcome of severe COVID-19 patients. This study will assess the efficacy of low-dose colchicine not only by the AUC of the amount of change in serum hs-CRP from baseline to several time points, but also by evaluating whether the result of the primary endpoint is consistent with other relevant biomarkers and clinical parameters measured as secondary endpoints. Copyright © 2022 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT)
简介:鉴于2019冠状病毒病(新冠肺炎)的加重与宿主过度免疫反应有关,建议对严重疾病进行补充抗炎治疗。尽管地塞米松是新冠肺炎呼吸衰竭患者中广泛使用的抗炎药,但在轻度新冠肺炎患者中使用它可能会产生有害影响。秋水仙碱是一种抗炎药,通过抑制NALP3炎症小体的激活来阻断上游免疫反应。本研究旨在评估低剂量秋水仙碱(DRC 3633)治疗轻度新冠肺炎的疗效和安全性。方法:本研究是一项前瞻性、多中心、安慰剂对照、双盲随机、2期临床试验,患者为日本9家医院收治的中度新冠肺炎(jRCT2071200078)。主要终点是从基线到试验药物开始后1、2和4周血清超敏C反应蛋白(hs-CRP)变化量的曲线下面积(AUC)。研究参与者将按1:1的比例随机分配到秋水仙碱组或安慰剂组。在第1天,秋水仙碱组的患者将接受1 mg秋水仙碱,然后在2小时后接受0.5 mg秋水仙素,除非出现胃肠道并发症。从第2天至第28天,每天给药一次0.5mg秋水仙碱。讨论:适当的抗炎策略对于改善重症新冠肺炎患者的预后至关重要。本研究将评估低剂量秋水仙碱的疗效,不仅通过从基线到几个时间点的血清hs-CRP变化量的AUC,还通过评估主要终点的结果是否与作为次要终点测量的其他相关生物标志物和临床参数一致。版权所有©2022日本临床药理学和治疗学学会(JSCPT)
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引用次数: 0
Novel Gene Therapies Technology for Spinal Cord Injury (SCI) Therapy: Efficient Direct Lineage Reprogramming 脊髓损伤(SCI)治疗的新基因治疗技术:有效的直接谱系重编程
Q4 Medicine Pub Date : 2022-10-03 DOI: 10.33597/jcpt-03-id1028
Chunggoo Kim, Hyun Soo Shim, Yujung Chang, Hyeonjoo Im, Junsang Yoo
What is known and objectives: Spinal Cord Injury (SCI) is defined for the last few decades as patients getting wheelchair bound and under medication for a lifetime [1]. Medical battery for SCI is very limited which often results in heightened frustration for the caregivers who land up with no solid solution to the condition. However, in recent times due to the huge volume of research, neuroscience has progressed massively through GT offering better insight and high hopes of neural regeneration and functional rehabilitation [2]. As GT technology becomes more popular as an emerging therapeutic method, many studies using a manufactured virus (AAV, retro, adeno, lenti) are opening up promising research avenues [3-5]. In this review, we dealt with Direct Lineage Reprogramming (DLR) technology for a novel GT method for SCI patients.
已知情况和目标:在过去的几十年里,脊髓损伤(SCI)被定义为患者被轮椅束缚并终生接受药物治疗[1]。对于脊髓损伤的医疗电池是非常有限的,这通常会导致护理人员在没有坚实的解决方案的情况下感到非常沮丧。然而,近年来由于大量的研究,神经科学通过GT取得了巨大的进展,为神经再生和功能康复提供了更好的见解和更高的希望[2]。随着GT技术作为一种新兴的治疗方法越来越受欢迎,许多使用人造病毒(AAV、retro、adeno、lenti)的研究正在开辟有前途的研究途径[3-5]。在这篇综述中,我们讨论了直接谱系重编程(Direct Lineage Reprogramming, DLR)技术作为一种治疗SCI患者的新型GT方法。
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引用次数: 1
Patient and Public Involvement Online in National Whole-genome Sequencing Project in Japan 患者和公众在线参与日本国家全基因组测序项目
Q4 Medicine Pub Date : 2022-09-30 DOI: 10.3999/jscpt.53.5_169
H. Nakada, Megumu Yokono, A. Nagai
The Japanese government developed a national-level whole genome sequencing project in December 2020, which is expected to promote precision medical care for cancer and rare disease patients. Since this is a nationwide project, there is a need for implementing patient and public involvement (PPI). Considering the current COVID-19 pandemic, we conducted online PPI to formulate the contents of the project's informed consent form (ICF) for participation. This online PPI aimed at gaining insights from cancer patients and their family members regarding the ICF. A one-day seminar was conducted online in September 2021, which included three lectures related to the national project, followed by discussion among the attendees divided into two groups based on their age and types of cancer. We had eight attendees who were cancer patients and/or their family members. They discussed the ICF's contents based on the draft developed by the project's research team. Online PPI has its merits and drawbacks. It allows for easier participation and is beneficial for patients who are unable to physically attend either because of their medical condition or geographical location. For the researcher also, it becomes easier to recruit a diverse variety of people who wish to join the PPI activities. In contrast, at times, participants find it difficult to use online devices. Moreover, the attendees may not feel comfortable with the online discussions owing to the lack of nonverbal expression and interactions when compared with personal interaction. For promoting PPIs in the future, we recommend considering the following three crucial aspects:practicing online PPI in a variety of situations, constructing a framework that enables PPI quickly, and promoting diversity in the attendees participating in such PPI activities. Copyright:©2022 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT)
日本政府于2020年12月开发了一个国家级全基因组测序项目,预计将促进癌症和罕见病患者的精准医疗。由于这是一个全国性的项目,因此有必要实施患者和公众参与(PPI)。考虑到当前新冠肺炎疫情,我们进行了在线PPI,以制定项目知情同意书(ICF)的内容供参与。这一在线PPI旨在从癌症患者及其家属那里获得有关ICF的见解。2021年9月,在线举办了为期一天的研讨会,其中包括三场与国家项目相关的讲座,随后与会者根据年龄和癌症类型分为两组进行了讨论。我们有八位与会者,他们是癌症患者和/或他们的家人。他们根据项目研究小组制定的草案讨论了ICF的内容。在线PPI有其优点和缺点。它允许更容易的参与,并且对那些由于医疗条件或地理位置而无法亲自就诊的患者有益。对于研究人员来说,招募各种各样希望加入PPI活动的人也变得更容易了。相比之下,参与者有时会发现很难使用在线设备。此外,与个人互动相比,由于缺乏非语言表达和互动,与会者可能对在线讨论感到不舒服。为了在未来推广PPI,我们建议考虑以下三个关键方面:在各种情况下练习在线PPI,构建一个快速实现PPI的框架,以及促进参与此类PPI活动的参与者的多样性。版权所有:©2022日本临床药理学和治疗学学会(JSCPT)
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引用次数: 0
Report of the 6th Annual Meeting of the Chugoku & Shikoku Region of the JSCPT 联委会中国四国地区第六届年会报告
Q4 Medicine Pub Date : 2022-09-30 DOI: 10.3999/jscpt.53.5_189
Shinji Kosaka
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引用次数: 0
Report of the 5th Annual Meeting of the Hokkaido & Tohoku Region of the JSCPT JSPT北海道和东北地区第五届年会报告
Q4 Medicine Pub Date : 2022-09-30 DOI: 10.3999/jscpt.53.5_193
Yoshikazu Tasaki
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引用次数: 0
Current and Issues Status of Ethics Review of Multi-center Research Projects: From the Viewpoint of the Secretariat of the Central Ethics Review Committee 多中心科研项目伦理审查的现状与问题——以中央伦理审查委员会秘书处为视角
Q4 Medicine Pub Date : 2022-09-30 DOI: 10.3999/jscpt.53.5_177
Ryota Kitao, Takuya Watanabe, Shinji Kosugi
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引用次数: 0
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JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
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