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Current state and issues related to cell therapy under the Act on the Safety of Regenerative Medicine 再生医学安全法案下细胞治疗的现状和相关问题
Pub Date : 2018-07-01 DOI: 10.1016/j.pmu.2018.04.003
Morikuni Tobita

In May the 2013, Regenerative Medicine Promotion Act was enacted in order to promote regenerative medicine in Japan. Based on this Act, in November 2014, the Act on the Safety of Regenerative Medicine, which ensured the safety of regenerative medicine, was put into effect. The Act on the Safety of Regenerative Medicine was intended to promote the swift and safe provision and promulgation of regenerative medicine, and it applies to both clinical research and private practice that utilizes regenerative medicine.

In this review, an overview of the Act on the Safety of Regenerative Medicine is introduced, and the current state of this act and future issues are discussed.

2013年5月,日本颁布了《再生医学促进法》,以促进再生医学的发展。在此基础上,2014年11月,确保再生医学安全的《再生医学安全法》开始实施。《再生医学安全法》旨在促进再生医学的快速和安全的提供和颁布,它适用于利用再生医学的临床研究和私人实践。本文介绍了再生医学安全法案的概况,并对该法案的现状和未来的问题进行了讨论。
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引用次数: 2
DNA methylation analysis of cancer-related genes from cell-free DNA of patients with cancer 癌症患者游离DNA中癌症相关基因的DNA甲基化分析
Pub Date : 2017-07-01 DOI: 10.1016/j.pmu.2017.04.002
Yukie Saeki , Minako Abe , Fumika Kono , Akane Nakazato , Yoshimori Ishihara , Hiroyuki Abe

DNA methylation is a very important mechanism for regulating gene expression in normal development and cell differentiation. However, DNA methylation, when acting on the promoter region of a tumor suppressor gene, suppresses transcription and is one of the major epigenetic modifications involved in the development and progression of many cancers (Wajed et al., 2001; Morris and Chan 2015). In our laboratory, we have carried out methylation analysis of 14 different tumor suppressor genes in cell-free DNA from the peripheral blood of over 1400 cancer patients, and have detected more than a total of 1900 methylations. We performed an analysis of DNA methylations of 14 different tumor suppressor genes, by type of cancer, stage of cancer, function of tumor suppressor genes, and their correlation to genetic mutations.

DNA甲基化是调控正常发育和细胞分化过程中基因表达的重要机制。然而,当DNA甲基化作用于肿瘤抑制基因的启动子区域时,会抑制转录,并且是许多癌症发生和进展中涉及的主要表观遗传修饰之一(Wajed等人,2001;Morris and Chan 2015)。在我们的实验室中,我们对1400多名癌症患者外周血的游离DNA中14种不同的肿瘤抑制基因进行了甲基化分析,共检测到1900多个甲基化。我们根据癌症类型、癌症分期、肿瘤抑制基因的功能及其与基因突变的相关性,对14种不同肿瘤抑制基因的DNA甲基化进行了分析。
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引用次数: 1
Efficacy and safety of a compound supplement containing glucosamine, chondroitin, and five bioactive ingredients in volunteers with knee joint pain 含有葡萄糖胺、软骨素和五种生物活性成分的复合补充剂在膝关节疼痛志愿者中的疗效和安全性
Pub Date : 2017-07-01 DOI: 10.1016/j.pmu.2016.10.001
Takeshi Katayoshi , Masakatsu Kageyama , Riyo Kobashi , Junko Minakuchi , Naoko Suzuki , Tsuyoshi Takara , Tomofumi Negishi , Seika Kamohara , Kentaro Naito

Purpose

This study was designed to evaluate the efficacy and safety of a compound supplement containing glucosamine (GS), chondroitin sulfate (CS), and five bioactive ingredients for improvement of knee osteoarthritis (OA).

Methods

Sixteen volunteers aged ≥40 years with knee pain and without ambulant treatment participated in a 6-week randomized, double-blind, placebo-controlled study. They were assigned to the dietary supplement or placebo groups (n = 8, respectively) and ingested six capsules twice daily. The OA symptoms of each subject were determined in pre- and post-treatment periods using a visual analog scale for pain (VAS pain) and four Japanese Knee Osteoarthritis Measure (JKOM) subscales (“joint stiffness,” “daily living,” “social activities,” and “general health condition”). For safety and biomarker assessments, blood and urine samples were tested.

Results

In the treatment group, the subjective symptoms of VAS pain and three JKOM subscale scores except for “social activities” were significantly improved compared to pre-treatment. Among them, the pattern of change in “joint stiffness” and total JKOM scores showed a significant difference between groups (p = 0.008 and 0.041, respectively). The serum level of interleukin-6, a systemic inflammation biomarker, was significantly decreased in the treatment group after 6 weeks (p = 0.019), whereas the level remained stable in the placebo group (p = 0.690). Diagnostic urine and hematological parameters revealed no serious adverse differences following dietary supplementation over the 6-week study.

Conclusion

These findings suggest that the compound supplementation of functional food ingredients has potential as an adjunctive and safe therapy for knee OA.

目的评价含葡萄糖胺(GS)、硫酸软骨素(CS)和5种生物活性成分的复合制剂对膝关节骨性关节炎(OA)的疗效和安全性。方法16名年龄≥40岁、膝关节疼痛且未进行门诊治疗的志愿者参加了一项为期6周的随机、双盲、安慰剂对照研究。他们被分配到膳食补充剂组或安慰剂组(n = 8),每天服用两次6粒胶囊。使用视觉模拟疼痛量表(VAS疼痛)和四个日本膝关节骨性关节炎量表(JKOM)亚量表(“关节僵硬”、“日常生活”、“社会活动”和“一般健康状况”)在治疗前和治疗后确定每位受试者的OA症状。为了安全性和生物标志物评估,对血液和尿液样本进行了测试。结果治疗组VAS疼痛主观症状及除“社交活动”外的三个JKOM分量量表得分均较治疗前显著改善。其中,“关节刚度”变化规律和JKOM总评分组间差异有统计学意义(p分别为0.008和0.041)。6周后,治疗组的血清白细胞介素-6(一种全身炎症生物标志物)水平显著降低(p = 0.019),而安慰剂组的水平保持稳定(p = 0.690)。诊断尿液和血液学参数显示,在6周的研究中,膳食补充后没有严重的不良差异。结论功能性食品成分的复合补充有可能作为一种安全的辅助治疗膝关节OA。
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引用次数: 2
A case of advanced ovarian cancer effectively treated with a combination of multi-peptide dendritic cell immunotherapy, surgery, and chemotherapy 多肽树突状细胞免疫疗法、手术和化疗联合治疗晚期卵巢癌1例
Pub Date : 2017-07-01 DOI: 10.1016/j.pmu.2017.04.003
Amane Sasada, Minako Abe, Hiroyuki Abe
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引用次数: 0
Clinical study of the efficacy of a yeast containing S-adenosyl methionine on knee osteoarthritis 含s -腺苷蛋氨酸酵母治疗膝关节骨关节炎的临床研究
Pub Date : 2017-07-01 DOI: 10.1016/j.pmu.2017.05.002
Yukio Mitsui , Maki Satou , Shinichi Shimizu , Hiroshi Mitsui , Hirohiko Matsumoto
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引用次数: 0
Oral administration of freeze-dried powders of honey bee larvae inhibits the development of atopic dermatitis-like skin lesions in NC/Nga mice 口服蜜蜂幼虫冻干粉可抑制NC/Nga小鼠特应性皮炎样皮肤病变的发展
Pub Date : 2017-07-01 DOI: 10.1016/j.pmu.2017.05.001
Masakatsu Kageyama , Guoqing Xing , Kejuan Li , Zhenya Zhang , Akihiko Sugiyama

Purpose

This study was designed to evaluate the suppressive effect of the oral administration of the freeze-dried honey bee larvae powder on atopic dermatitis (AD)-like skin lesions in NC/Nga mice.

Methods

The effects of freeze-dried honey bee larvae powder on AD-like skin lesions in mice were studied by evaluating the condition of the skin macroscopically and histopathologically, ear swelling degree, serum levels of total IgE, interleukin-4 (IL-4) and interferon-γ (IFN-γ), and level of IL-18 and IL-12 in skin lesions.

Results

NC/Nga mice fed the freeze-dried honey bee larvae powder-supplemented diet showed a decrease in dermatitis scores of the dorsal skin, ear thickness, skin hypertrophy, inflammatory cell infiltration in the skin, serum total IgE, IL-4, and IFN-γ levels, and IL-18 and IL-12 levels in skin lesions. These results suggest that the freeze-dried powder of honey bee larvae inhibits the development of AD-like skin lesions in NC/Nga mice by suppressing both T-helper (Th) 1 and Th 2 cell responses.

Conclusions

Our results indicate that oral administration of the freeze-dried honey bee larvae powder could provide an adjunctive therapy for the management of AD.

目的观察冻干蜜蜂幼虫粉口服对NC/Nga小鼠特应性皮炎样皮损的抑制作用。方法通过观察冻干蜜蜂幼虫粉对小鼠ad样皮损的宏观及病理变化、耳肿胀程度、血清总IgE、白细胞介素-4 (IL-4)、干扰素-γ (IFN-γ)水平及皮损组织中IL-18、IL-12水平的影响,探讨冻干蜜蜂幼虫粉对ad样皮损的治疗作用。结果冻干蜜蜂幼虫粉添加饲料后,snc /Nga小鼠背侧皮肤皮炎评分、耳部皮肤厚度、皮肤肥大、皮肤炎症细胞浸润、血清总IgE、IL-4、IFN-γ水平以及皮损处IL-18、IL-12水平均明显降低。这些结果表明,蜜蜂幼虫冻干粉通过抑制辅助性t (Th) 1和Th 2细胞的反应来抑制NC/Nga小鼠ad样皮肤病变的发展。结论冻干蜜蜂幼虫粉口服治疗AD是一种辅助治疗方法。
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引用次数: 3
Diagnosis and treatment in the era of precision medicine – Precision medicine and tailor-made medicine 精准医疗时代的诊疗——精准医疗和量身定制医疗
Pub Date : 2017-07-01 DOI: 10.1016/j.pmu.2017.03.002
Masayoshi Nagata, Shigeo Horie

Recently, precision medicine has gained attention in several fields of medical society. Today's medical consensus revolves around Evidence-Based Medicine (EBM) built on the results of many randomized controlled trials. Ever since the advent of EBM, guidelines based on EBM have provided a basis for clinical decision-making. Treatments based on these guidelines largely improved the prognosis of a certain ailment. However, these guidelines can only provide the best fit based on the statistics. Treatments based on the statistics leave behind many un- or less-responsive patients. Herein, we explain in detail the concept of “precision medicine” launched by the Obama administration in the U.S., its difference from personalized medicine, how it started to take shape, and the benefits it is expected to bring to our society.

近年来,精准医学已经引起了医学界多个领域的关注。今天的医学共识围绕着基于许多随机对照试验结果的循证医学(EBM)。自循证医学出现以来,基于循证医学的指南为临床决策提供了依据。基于这些指导方针的治疗在很大程度上改善了某种疾病的预后。然而,这些指导方针只能提供基于统计数据的最佳匹配。基于统计数据的治疗留下了许多无反应或反应较差的患者。本文将详细阐述美国奥巴马政府提出的“精准医疗”概念,它与个性化医疗的区别,它是如何形成的,以及它有望给我们社会带来的好处。
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引用次数: 1
Chlorogenic acid modulates hypoxia response of Hep3B cells 绿原酸调节Hep3B细胞的缺氧反应
Pub Date : 2017-07-01 DOI: 10.1016/j.pmu.2017.03.001
Ferbian Milas Siswanto, Ami Oguro, Susumu Imaoka

Coffee is the most widely consumed beverage around the world, and it contains many compounds that have beneficial effects on human health. Chlorogenic acid (CGA), the most abundant polyphenol in coffee, has been reported to inhibit cancer cell growth and has a beneficial effect on ameliorating aging-related diseases. We found that CGA decreased HIF-1α levels in human hepatoma cell line Hep3B under hypoxic conditions (O2 = 1%) in a dose-dependent manner, thereby decreasing the expression of its downstream targets EPO and VEGF. However, similar effects were not found in the presence of 100 μM 2,2′-dipyridyl. Further studies showed that the lysosomal protease inhibitor NH4Cl inhibited the decrease in HIF-1α levels, whereas the proteasome inhibitor MG132 did not, indicating that CGA requires lysosomal protease to affect the hypoxia response.

咖啡是世界上消费最广泛的饮料,它含有许多对人体健康有益的化合物。咖啡中最丰富的多酚——绿原酸(CGA)已被报道能抑制癌细胞生长,并对改善与衰老有关的疾病有有益作用。我们发现,在缺氧条件下(O2 = 1%), CGA以剂量依赖的方式降低人肝癌细胞系Hep3B中HIF-1α的水平,从而降低其下游靶点EPO和VEGF的表达。然而,在100 μM 2,2 ' -二吡啶存在时,没有发现类似的效果。进一步的研究表明,溶酶体蛋白酶抑制剂NH4Cl抑制HIF-1α水平的下降,而蛋白酶体抑制剂MG132则没有,表明CGA需要溶酶体蛋白酶来影响缺氧反应。
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引用次数: 13
Gap in perception regarding recovery between patients and nurses in recovery-stage rehabilitation ward 康复期康复病房患者与护士对康复认知的差异
Pub Date : 2017-07-01 DOI: 10.1016/j.pmu.2017.04.001
Masumi Kumada , Miki Matsunami
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引用次数: 0
Detection of aberrant DNA methylation of tumor suppressor genes in circulating tumor cells from a pancreatic cancer patient 胰腺癌患者循环肿瘤细胞中肿瘤抑制基因DNA甲基化异常的检测
Pub Date : 2017-07-01 DOI: 10.1016/j.pmu.2017.04.004
Hiroaki Kawasaki , Hiroyuki Abe
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引用次数: 0
期刊
Personalized Medicine Universe
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