Venetoclax plus low-dose cytarabine in patients with newly diagnosed acute myeloid leukemia ineligible for intensive chemotherapy: an expanded access study in Japan

Background: In a Phase 3 international clinical trial (VIALE-C), venetoclax plus low-dose cytarabine improved the response rate and overall survival versus placebo plus low-dose cytarabine in patients with newly diagnosed acute myeloid leukemia who were ineligible for intensive chemotherapy. After the enrollment period of VIALE-C ended, we conducted an expanded access study to provide preapproval access to venetoclax in combination with low-dose cytarabine in Japan. Methods: Previously, untreated patients with acute myeloid leukemia who were ineligible for intensive chemotherapy were enrolled according to the VIALE-C criteria. Patients received venetoclax (600 mg, Days 1–28, 4-day ramp-up in Cycle 1) in 28-day cycles and low-dose cytarabine (20 mg/m2, Days 1–10). All patients took tumor lysis syndrome prophylactic agents and hydration. Safety endpoints were assessed. Results: Fourteen patients were enrolled in this study. The median age was 77.5 years (range = 61–84), with 78.6% over 75 years old. The most common grade ≥ 3 treatment-emergent adverse event was neutropenia (57.1%). Febrile neutropenia was the most frequent serious adverse event (21.4%). One patient developed treatment-related acute kidney injury, leading to discontinuation of treatment. Two patients died because of cardiac failure and disease progression that were judged not related to study treatment. No patients developed tumor lysis syndrome. Conclusions: The safety outcomes were similar to those in VIALE-C without new safety signals and were well managed with standard medical care. In clinical practice, more patients with severe background disease are expected, in comparison with in VIALE-C, suggesting that it is important to carefully manage and prevent adverse events

地球地図・グローバル樹木被覆率データの高精度化に関する研究

Dataset 1. Fold-changes of gene expression in roots of 6 week-old Arabidopsis plants. The fold-changes are log2 values. In the column header the upper line/condition is compared to the lower line/condition. Significant up-regulation is indicated by red background color. Significant down-regulation is indicated by green background-color. The residual insignificant and below-threshold values are masked by black background color. Dataset 2. Fold-changes of gene expression in 6 day-old Arabidopsis whole seedlings. The fold-changes are log2 values. In the column header the upper line/condition is compared to the lower line/condition. Significant up-regulation is indicated by red background color. Significant down-regulation is indicated by green background-color. The residual insignificant and below-threshold values are masked by black background color. Dataset 3. Juxtaposition of the fold-changes of gene expression in roots of 6-day-old Arabidopsis seedlings and 6-week-old Arabidopsis roots. The fold-changes are log2 values. In the column header the upper line/condition is compared to the lower line/condition. Significant up-regulation is indicated by red background color. Significant down-regulation is indicated by green background-color. The residual insignificant and below-threshold values are masked by black background color. Dataset 4. Juxtaposition of the fold-changes of gene expression in roots of 6-day-old Arabidopsis seedlings and 6-week-old Arabidopsis roots. The fold-changes are log2 values. In the column header the upper line/condition is compared to the lower line/condition. Significant up-regulation is indicated by red background color. Significant down-regulation is indicated by green background-color. The residual insignificant and below-threshold values are masked by black background color. The genes were filtered so that only genes are present in this table which were found regulated at least in one comparison in whole seedlings and in one comparison in roots. Dataset 5: Genes that are regulated in an iron-dependent manner across 10 studies with a total of 14 comparisons. Up-regulated genes are represented by the value 1 and a red background color. Down-regulated genes are represented by the value -1 and a green background color. Genes with no significant regulation or with regulation below the threshold of the respective study are represented by the value 0 and black background color. The column titled ‘ABS’ shows the number of comparisons in which the gene was found regulated. The column titled ‘SUM’ shows the overall sum of the given values (-1 for down-regulation, +1 for up-regulation, ±0 for no regulation) of all comparisons. The genes with the highest sum are regarded as most stably up-regulated upon iron deficiency. The genes with the lowest sum are regarded as most stably down-regulated upon iron deficiency. The column titled ‘RAT’ contains the result of division of the absolute value of ‘SUM’ by ‘ABS’ and is supposed to provide a threshold for the Supplemental Dataset 6, along with ‘SUM’. (XLSX 4180 kb

人生100年時代に活かすフォーカシング : 沖縄ワークショップでの取り組み

本稿の目的は、人生100年時代にむけたフォーカシングの活用例として、沖縄で実施したワークショップの実践を報告することである。先進国では2007年産まれの2人に1人が100歳を超えて生きる「人生100年時代」が到来すると予測されている（Gratton & Scott, 2016/2016）。また、それに伴い、これまで主流であった教育→仕事→引退といった3ステージの生き方を変えていく必要があり、選択肢が増えたことによって人生のステージが多様化する（Gratton & Scott, 2016/2016 ）。このような多様化した時代に、われわれはどのように生き抜いていけばよいのだろうか。その手がかかりとして筆者らはフォーカシングを取り上げ、人生100年時代に関するワークショップを開催した。参加者は、11名（男性2名、女性9名）であり、年齢層は40歳代～ 70歳代であった。ワークショップは2日間開催し、ワークショップの効果を検討するためにFMS-18（森川ら，2014 ）を実施した。途中参加者を除く10名を対象として分析したところ、ワークショップ前と2日目終了後の間において、注意態度のみ有意差が認められた（（t 9）=, p＜.05）。今回のワークショップ内容が、“感じる体験” を中心に構成していたことが影響しており、注意態度は少なくとも身についたと考えることができる。また、参加者の年代によって、人生100年時代の捉え方が異なる可能性がうかがわれたため、各年代に沿ったワークの考案も視野に入れていく必要性が考えられた

Crossing with Animals : An existential exercise emerging from the Theory of Experiencing

自分の生きざまを動物に喩えて、その動物は何をしているのかなどと形容しながらペアで話し合うワークを考案し、それを「アニクロ」(Crossing with Animals)と命名した。本論では、その理論背景として実存哲学、メタファー論やジェンドリン哲学を含む体験過程理論について論じたあと、その実践を３つの側面から検討した。それらは、アニクロ初体験者に対するアンケート結果について、産業メンタルヘルス研修でのアニクロの応用について、そしてゲシュタルトセラピーにおけるアニクロの実践についてである。アニクロは多用な実践が可能であるが、その基本原理はフォーカシングであり、本論は最後に、アニクロを通してみたフォーカシングの基礎理論を考察した。This paper introduces and discusses an exercise where one expresses one\u27s own sense of living as an animal and dialogues with a partner on how the animal exists. The paper terms this exercise "crossing with animals." First, the theory of experiencing, a theory that includes aspects of existential philosophy, metaphor theory, and the philosophy of Eugene Gendlin, is discussed as a theoretical basis of crossing with animals. Then the practice of crossing with animals is discussed from three aspects : (1) the results of a questionnaire administered to those who were new to the exercise ; (2) the use of crossing with animals in corporate mental health training ; and (3) the use of crossing with animals in Gestalt therapy. Although crossing with animals can be practiced in diverse populations, it is a form of Focusing, and the paper concludes with a theoretical discussion of Focusing principles in relation to the practice of crossing with animals

頭頸部領域および食道領域の各種症状に対する食道運動機能の関与について : High Resolution Manometry を用いた検討

頭頸部領域および食道領域における各種症状に対する食道運動機能の関与を検討した.2007年9月から2012年6月までに,咽喉頭異常感などの頭頸部領域の症状および嚥下困難感,胸痛,胸やけなどの食道領域に関連した症状を主訴に,当科を受診した261例(男性138例,女性123例,平均年齢56.8±17.1才)を対象とし,健康関連QOL(Health Related Quality of Life: HRQL)の測定と食道内圧検査を施行した.健康関連QOLの検討では,咽喉頭違和感,嚥下困難感,胸やけ等の各症状を訴えた患者で,身体的QOL,精神的QOL を表すPCS(physical component summary)あるいはMCS(mental component summary)が低下し,健常者と比較して有意にQOLの低下を認めた.食道内圧検査による食道運動機能異常は,全対象患者中62.0%に認めた.各症状別に食道運動機能障害の内訳を見ると,咽喉頭違和感ではIEM(ineffective esophageal motility)(31.8%),嚥下困難感は食道アカラシア(56.6%),喉のつかえ感は食道アカラシア(35.5%),胸やけはIEM(39.4%),胸痛は食道アカラシア(50.0%),噫気はIEM(50.0%)を最も多く認めた.咽喉頭違和感,嚥下困難感,喉のつかえ感,胸やけ,胸痛などの頭頚部および食道症状を有するものの,器質的疾患を認めない患者のQOLは障害されており,その病態の一つとして食道運動機能異常の存在を念頭に置き,診療にあたることが重要である.There are many cases of patients presenting at the hospital complaining of dysphagia or chest pain. At that time organic diseases are not always detected in these patients;previously several studies showed esophageal motility dysfunction was one of the important factors in the development of these symptoms. However, there have been few reports investigating the relationship between esophageal motility dysfunction and these symptoms. Between September 2007 and June 2012, 216 patients (138 men,123 women;mean age 56.8±17.1 years old) were admitted complaining of the following symptoms:dysphagia, globus sensation, or heart burn and non-cardiac chest pain,but without any organic diseases related symptoms. They all underwent high-resolution esophageal manometry (HRM) and completed a questionnaire regarding their health-related quality of life (HRQOL). The aim of this study was to evaluate the relationship between these symptoms and esophageal motility dysfunction and QOL. In our series, 62% of patients with non-obstructive dysphagia, globus sensation, heartburn and unexplained (non-cardiac) chest pain have an esophageal motility disorder (Achalasia 31.5%, IEM 26.4%, Diffuse esophageal spasm 4.6%;nutcracker esophagus 2.8% and Impaired ECJ relaxation 0.5%). SF-8 score of PCS(Physical Component Summary) in all of the symptoms were significantly lower in comparison with the matched healthy control. SF-8 score of MCS(Mental Component Summary) with globus sensation and esophageal dysphagia were significantly lower in comparison with the matched healthy control. The patients complaining of several symptoms located in the pharynx or esophagus have impaired quality of life and esophageal motility dysfunctions.It is important to consider these issues while examining these patients

Longitudinal Change of Forearm-Hand Inertia Value and Shoulder Musculature Using Dual X-ray Absorptiometry in Youth Japanese Baseball Players: Implications for Elbow Injury

It is important to understand the timing of the maximum increase of forearm-hand inertia value and lean body mass (LBM) of the shoulder girdle musculature when elbow injury frequently occurs. This study aimed to clarify the discrepancies of those in youth baseball players. Forty-three male baseball players (8- to 14-years-old) participated in this study. The forearm-hand inertia value and LBM of the shoulder girdle musculature were calculated using dual-energy X-ray absorptiometry (DXA). A cubic spline fit was applied to the annual increase forearm-hand inertia value and LBM of the shoulder girdle musculature for each chronological age and years from peak height velocity (PHV) age. As a result of cubic splines fitting, the peak timing for forearm-hand inertia value and LBM of the shoulder girdle musculature was 12.42 and 12.75 years in chronological age, −0.66 and −0.11 years in PHV age. Therefore, the peak timing of forearm-hand inertia value was about 4 months earlier in chronological age and half a year earlier in PHV age than LBM of the shoulder girdle musculature. Acquiring sufficient shoulder girdle musculature during the period when the growth of the shoulder girdle musculature cannot catch up with forearm-hand inertial value is necessary to reduce the elbow load while throwing

Pain Relief after Extracorporeal Shock Wave Therapy for Patellar Tendinopathy: An Ultrasound Evaluation of Morphology and Blood Flow

We aimed to investigate the changes caused by focused extracorporeal shock wave pain therapy (f-ESWT) in patients with patellar tendinopathy by means of ultrasound imaging. We included 18 knees from 11 college athletes with patellar tendinopathy. We assessed the tendon thickness and blood flow of the patellar tendon using ultrasound imaging, rest pain using NRS and tenderness using a pressure pain gauge. We recorded four measurements: immediately before f-ESWT (PRE①) and after f-ESWT (POST①) and two weeks after the first irradiation before f-ESWT (PRE②) and after f-ESWT (POST②). Only the resting pain in both the first and second irradiations showed a significant difference immediately before and after the treatment. In terms of pain changes after two weeks later, we observed significant differences in the resting pain between PRE① and PRE② and also in the resting pain, tenderness and blood flow area between PRE① and POST②. No significant difference was seen in the tendon thickness. We concluded that pain in the patellar tendon at rest decreased before and after irradiation, suggesting that f-ESWT may have influenced the nociceptive structures and had an analgesic effect