地域包括支援センター保健師のコンピテンシーリストの開発と決定因子

愛知県立大学2017年

Serious adverse events and compensation in registration trials : a review of data from a Japanese university hospital

Background: Clinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices. The contribution of support staff, such as the clinical research coordinator (CRC) and administrative officers, in registration trials is now widely recognized. Attending to serious adverse events is an important duty of the CRC and investigators alike, and managing these complications and compensation constitutes a key responsibility. We retrospectively examined the frequency of serious adverse events and compensation events reported from 2007 through 2011 at Tokushima University Hospital, an academic hospital in rural Japan. We present herein the results of our analysis. Results: Over the five-year period, 284 subjects participating in 106 registration trials experienced a total of 43 serious adverse events, and eight compensation events were documented. Among the serious adverse events, 35 (81.4%) were considered not related to the investigational drug, and 17 (39.5%) resulted in withdrawal of the study drug. Patients with malignant diseases experienced serious adverse events significantly more frequently compared to those with non-malignant diseases (28.3% versus 8.2%, respectively; P < 0.01). Conclusions: The CRC should be vigilant for serious adverse events in oncology clinical trials due to the generally higher frequency of these complications in subjects with malignancy. However, on an individual basis, the CRC may be seldom involved in the process for compensating serious adverse events. Therefore, the CRC’s ability to share such experiences may serve as an opportunity for educating clinical trial support staff at the study site as well as those at other sites. However, further study is warranted to determine the role of the clinical trial support staff in optimizing methods for managing adverse events requiring compensation in registration trials

ロートを用いた客観的な簡易とろみ評価方法の開発

Some patients with dysphagia are prone to aspiration of low-viscosity liquids. Thickened liquids are often used in attempts to prevent aspiration. The patients should be given thickened liquids with suitable thickness, and the thickness should be constant at all time. While rotational and cone-and-plate viscometers are used for the evaluation of thickened liquids, they are high-precision and expensive equipment. To control the thickness of liquids, a simple and objective evaluation method is thus necessary. We developed a method to evaluate thickened liquids using funnels, and verified the appropriateness of this method. We measured the outflow times of five thickened liquids through funnels. One of the thickened liquids was a commercially available nutritional supplement, another was made with a thickening agent that contained guar gum, and all others were made with a thickening agent that contained xanthan gum. Four funnels with different stem sizes were tested. We found that the outflow time of thickened liquids through a funnel depended on their viscosities at a shear rate between 10 and 50 s–1, when the average inner diameter of the stem was in the range of 5.3–9.0 mm, and the volume of the liquid poured into the funnel was 30 mL. The correlation coefficient between the value of the sensory evaluation and the outflow time of the funnel with an average stem ID of 5.3 mm was 0.946. Therefore, this method may be useful in hospital and nursing home kitchens for evaluating thickened liquids

世界遺産宮島の森林を教材にした小中大学連携 : 宮島ロープウエー駅舎付近の植生回復を例に

Itsukushima (Miyajima) Island is a UNESCO World Heritage site in Japan. The site consists of Itsukushima Shinto Shrine and a natural forest in Mt. Misen. In 1962, a pack of Japanese macaque (Macaca fuscata) from Shodoshima Island of Kagawa Prefecture, Shikoku, was introduced for a tourism resource near Shishiiwa Terminal by Miyajima Ropeway Company. After the introduction, the forest area was decayed because of use by the macaques as well as gathering by Japanese sika deer approaching the macaques for feeding. Recently, the macaques were moved to Okazaki Monkey Center in Aichi Prefecture to protect the forest area. In 2016, the heritage site was in the twentieth anniversary of the opening and over 4 million tourists have visited every year; on the other hand, depopulation and aging are progressing in the island. In 2014, a plan was started to restore the original vegetation of the forest near the terminal and to prevent debris flows. The plan was also used as a teaching material in association with environmental education for Miyajima Elementary and Junior High Schools (Miyajima Combined School), one of the UNESCO Associated Schools, in collaboration with Miyajima Natural Botanical Garden of Hiroshima University. Seedlings from many species collected from the natural forest were used and cultivated through the educational program. The program would be continued at least 10 years to foster love of nature as well as hometown of the younger generation to weaken the depopulation trend

Systemic and Ocular Determinants of Choroidal Structures on Optical Coherence Tomography of Eyes with Diabetes and Diabetic Retinopathy

Knowledgeof the choroidal structures in eyes with diabetes and diabetic retinopathy (DR) should provide information on the pathogenesis of DR. A prospective study was performed to determine the systemic and ocular factors that affect the choroidal structures in eyes with diabetes. Two-hundred consecutive diabetic subjects consisted of 160 treatment-naïve patients with different stages of DR and 40 patients with proliferative DR with prior panretinal photocoagulation (PRP). All underwent blood and urine tests and enhanced depth imaging optical coherence tomography (EDI-OCT). The cross-sectional EDI-OCT images of the subfoveal choroid were binarized to measure the total choroidal area (TCA), luminal area, and stromal area. Multivariate regression analyses were performed to determine the systemic and ocular factors that were significantly correlated with the choroidal structures. The subfoveal choroidal thickness, TCA, luminal area, and stromal area were larger at more advanced stage of DR, and smaller in eyes with PRP than those without (P < 0.001). The TCA and stromal area were significantly and positively correlated with the degree of albuminuria (P = 0.034, P = 0.025, respectively). The choroidal lumen and stroma may increase as the stages of DR progress and decrease after PRP. Albuminuria may be associated with the choroidal stromal edema

ISR-DEPENDENT METABOLIC REGULATION

The eukaryotic translation initiation factor 2α (eIF2α) phosphorylation‐dependent integrated stress response (ISR), a component of the unfolded protein response, has long been known to regulate intermediary metabolism, but the details are poorly worked out. We report that profiling of mRNAs of transgenic mice harboring a ligand‐activated skeletal muscle–specific derivative of the eIF2α protein kinase R‐like ER kinase revealed the expected up‐regulation of genes involved in amino acid biosynthesis and transport but also uncovered the induced expression and secretion of a myokine, fibroblast growth factor 21 (FGF21), that stimulates energy consumption and prevents obesity. The link between the ISR and FGF21 expression was further reinforced by the identification of a small‐molecule ISR activator that promoted Fgf21 expression in cell‐based screens and by implication of the ISR‐inducible activating transcription factor 4 in the process. Our findings establish that eIF2α phosphorylation regulates not only cell‐autonomous proteostasis and amino acid metabolism, but also affects non‐cell‐autonomous metabolic regulation by induced expression of a potent myokine.—Miyake, M., Nomura, A., Ogura, A., Takehana, K., Kitahara, Y., Takahara, K., Tsugawa, K., Miyamoto, C., Miura, N., Sato, R., Kurahashi, K., Harding, H. P., Oyadomari, M., Ron, D., Oyadomari, S. Skeletal muscle‐specific eukaryotic translation initiation factor 2α phosphorylation controls amino acid metabolism and fibroblast growth factor 21‐mediated non‐cell‐autonomous energy metabolism

Checklist of vascular plants of Kui Block Field, Mihara City, Hiroshima Prefecture, Japan

広島県三原市久井町に位置する久井岩海は国の天然記念物に指定されている。今回，久井岩海の天然記念物調査に際し，維管束植物（シダ植物，裸子植物，被子植物）のフロラの見直しを行う機会を得た。本稿では，標本および文献にもとづいて久井岩海および周辺地域の維管束植物フロラをまとめた。その結果，維管束植物合計415種（ヒカゲノカズラ植物1種と狭義シダ植物36種，裸子植物6種，被子植物372種。ただし，種以下の下位分類群や雑種は種として数えた）が生育していることが確認された。Kui Block Field, Mihara City, Hiroshima Prefecture, SW Japan is designated as a national natural monument. In this study, a checklist of the vascular plants recorded from Kui Block Field is provided, based on previous publications, herbarium specimens and our recent investigations. 415 species of vascular plants are recorded, consisting of 1 species of lycopods, 36 species of pteridophytes, 6 species of gymnosperms, and 372 species of angiosperms

Exercise on the Structure and Circulation of Choroid

Aims To determine the effects of dynamic exercise on the circulation and the luminal and stromal areas of the choroid in normal eyes. Methods This was a prospective interventional study of 38 eyes of 38 normal subjects enrolled by invitation. The systolic and diastolic blood pressures, heart rate, intraocularpressure, mean ocular perfusion pressure (MOPP), choroidal blood velocity, and enhanced depth imaging optical coherence tomographic (EDI-OCT) images were recorded before, and immediately after mild dynamic exercise. The same measurements were recorded after 10 min of rest. The choroidal blood velocity was measured bylaser speckle flowgraphy, and the mean blur rate was used for the evaluations. The horizontal EDI-OCT images of the subfoveal choroid were converted to binary images. The central choroidal thickness (CCT), total cross sectional choroidal area, luminal areas, stromal areas, and the ratio of luminal area to total choroidal area (L/C ratio) were determined from these images. Results The systolic and diastolic blood pressures, heart rate, MOPP, and the mean blur rate were significantly increased immediately after the exercise and significantly decreased 10 minutes after the exercise. There wereno significant changes in the mean CCT, the mean total choroidal area, the mean luminal and stromal areas, and the mean L/C ratio after the exercise. Conclusions Our results suggest that a rest period is needed before measurements of blood flow velocity but not necessary for the EDI-OCT imaging to determine the choroidal thickness and area