Therapeutic Research
Volume 38, Issue 3, 2017
Volumes & issues:
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Information:日本循環器学会 第27回プレスセミナー
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Information:日本抗加齢医学会エデュケーショナルセミナーアンチエイジング医学最先端!2016
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Topics:日本医療研究開発機構(AMED)再生医療臨床研究促進基盤整備事業
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Topics:第7回慶應義塾生命科学シンポジウム 食と医科学フォーラム 食・運動・ごきげんでアンチエイジング
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Series:呼吸ケア・フロントランナー
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慢性期までカバーするRST 活動の実際/RSTのオーガナイザーとして病棟スタッフをサポートする/人工呼吸器の専門家としての立場からRSTに提案する/早期離床を目指した早期リハ介入を提案する/認知機能を評価した上での作業療法を提案する/医療職とは異なる視点から退院後を見据えてサポートする
38巻3号(2017);View Description Hide Description
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Symposium:第49回埼玉不整脈ペーシング研究会
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- 一般演題
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総説
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GERD 診療におけるPatient Reported Outcome の意義―パターナリズムからの脱却―
38巻3号(2017);View Description Hide Description
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原著
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高リン血症を呈する血液透析患者における炭酸ランタンの長期安全性および有効性の検討―特定使用成績調査の6 年次中間報告―
38巻3号(2017);View Description Hide Description背景:炭酸ランタンの血液透析患者を対象とした特定使用成績調査の中間成績はすでに報告しているが,わが国ではリン吸着薬に関してより長期の安全性データが重要であると考えられているため,さらに追跡観察を行えるよう,その計画を一部変更した。方法:高リン血症を呈する血液透析患者を対象として,当初5 年間の観察を目的として3267例を登録した。本剤を承認用法・用量に従い投与し,重点調査項目である消化器系有害事象の発現状況,二次性副甲状腺機能亢進症および骨への影響,低カルシウム血症の有無あるいは血清リン濃度,血清補正カルシウム濃度の変化などを記録した。また5 年間の観察を完了した症例では,さらに3 年間の追跡観察を行うことに同意が得られた145 施設において,追跡観察を行うこととした。結果:今回の中間報告は,2016 年8 月30 日までに調査票が収集・固定されたものを解析対象とした。5 年以上の観察例1209 例を含む3074例の解析対象例のうち,732 例(23.81%)に1196 件の副作用が認められた。主なものは悪心203 件(6.60%),二次性副甲状腺機能亢進症 168件(5.47%),嘔吐114 件(3.71%),低カルシウム血症71 件(2.31%),便秘60 件(1.95%)であり,前回の中間解析結果と特に差はなかった。有効性に関しては,最終観察時の血清リン濃度が管理目標値内にあったものは59.5%(1830 例/3074 例)であった。結論:重点調査項目である消化器系副作用の発現状況,あるいは骨関連副作用の発現頻度は前回の中間報告と同様であり,また血清リン濃度低下作用も長期にわたり維持されており,承認時までの成績を確認するものであった。 -
SGLT2 阻害薬の積極的な使い方―当院におけるDPP‒4 阻害薬またはメトホルミンからの切替え,および腎機能低下例への投与経験から―
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アナグリプチン投与による脂質代謝,過酸化脂質の改善効果
38巻3号(2017);View Description Hide DescriptionBackground:Dipeptidyl peptidase 4(DPP‒4)inhibitors are widely used as antihyperglycemic agents for type 2 diabetes mellitus(T2DM). Recently, increasing attention has been focused on the pleiotropic actions of DPP‒4 inhibitors. Object:The aim of the present study was to examine whether anagliptin, as the DPP‒4 inhibitor, could ameliorate features of hyperlipidemia, inflammation and oxidative stress as well as in the hyperglycemia. Method:We performed observational study in 21 patients with T2DM treated with anagliptin for more than 6 months. The lipid and diabetic profiles obtained in this study were compared between before or after administration. Furthermore, as the inflammatory marker, serum amyloid A protein which exist in the hole serum and the LDL‒binding fraction(LDL‒SAA), and oxidized low‒density lipoprotein(ox‒LDL)were assessed in this study. Results:Anagliptin administration improved fasting blood sugar, HbA1c, microalbuminuria, LDL‒cholesterol, triglyceride and serum amyloid A protein in both of hole serum and LDL fraction. The reduction of LDL‒SAA after anagliptin administration correlated with triglyceride levels. Conclusion:These findings demonstrate that anagliptin as an anti‒hyperglycemic agents improvement not only in HbA1c but also in the high sensitive inflammatory marker such as SAA and LDL‒SAA and oxidative marker in ox‒LDL through the anti‒lipidemic action. -
日本人健康成人女性および白人健康成人女性を対象にしたスピラマイシン単回経口投与時の忍容性と薬物動態を検討したオープンラベル試験(TDU14412 試験)
38巻3号(2017);View Description Hide DescriptionBackground and Objective:The macrolide spiramycin, in addition to providing an antibiotic spectrum typical of the macrolides, is also effective against Toxoplasma gondii. Outside Japan, spiramycin has been used to prevent vertical transmission of toxoplasmosis during pregnancy for more than 30 years. In Japan, however, no antibiotics have yet been approved to treat toxoplasmosis in pregnant women. This study evaluated the safety, tolerability, and pharmacokinetics of spiramycin following single‒dose oral administration in healthy Japanese and Caucasian women. The study was designed to support extrapolation to Japanese patients of previously published efficacy and safety data from Caucasian patients. Methods:This was a single‒center, open‒label study of a single dose of spiramycin (3 million international units;MIU), administered orally to healthy adult female Japanese and Caucasian subjects. Safety, tolerability and pharmacokinetic parameters including maximum plasma concentration(Cmax), time to Cmax (tmax), terminal elimination half‒life(t1/2z), area under the plasma concentration‒time curve(AUC)and AUC from 0 to last quantifiable concentration(AUClast)as primary parameters were assessed. Results:Twenty subjects(10 Japanese;10 Caucasian)were enrolled in this study. No treatment‒emergent adverse events were reported. Very few abnormal laboratory values that were predefined in the protocol were identified in either group, and spiramycin was well tolerated in both groups. Mean spiramycin exposure including Cmax, AUC and AUClast was slightly higher in the Japanese than in the Caucasian women, but individual exposure in the Caucasians was within the range of observed exposure in the Japanese. Conclusions:Spiramycin administered orally at a dose of 3 MIU was safe and well‒tolerated in healthy female Japanese and Caucasian subjects. The pharmacokinetic results indicated no clinically meaningful differences in the pharmacokinetic profile of spiramycin between the Japanese and Caucasian women. These results suggest that the clinically recommended dosage for pregnant Caucasian women can be adopted for the treatment of toxoplasmosis in pregnant Japanese women. -
生理学的薬物動態モデルによるビスホスホネート製剤の経口吸収プロファイルの比較検討
38巻3号(2017);View Description Hide DescriptionBackground:Absorption of bisphosphonates(BPs)from the gastrointestinal tract is inhibited by forming a complex combined with multivalent cation in intake foods. Food intake other than water should be avoided for a certain period of time after oral administration of BPs to prevent the reduction of absorption. The prescribed fasting intervals vary among BPs. Object:The absorption profiles were compared among BPs by using a newly developed physiologically based pharmacokinetic (PBPK)model in order to investigate the relationship between fasting intervals and absorption profiles. Method:Alendronate(ALN), Risedronate(RIS), Minodronate (MIN)and Ibandronate(IBN)were compared in this analysis. Physiochemical properties and pharmacokinetic profiles were adopted either from the observed values in the publication or computational predicted values. Results:Serum or plasma BP concentration agreed well between the observation and the model prediction by setting paracellular pathways. Highest BP absorption was predicted in jejunum followed by duodenum and upper ileum. They were hardly absorbed in stomach, lower ileum, caecum, and ascending colon. Time to absorb more than 95% of total absorption of ALN, RIS, MIN and IBN was predicted to be about 3.5 hours. Conclusion:PBPK models for ALN, RIS, MIN and IBN were successfully developed. These models predicted absorption profiles including absorption sites and time to absorb as well as the similarity among all the BPs. It was predicted that 1 h fasting time was needed to maximize absorption. In fact, higher exposure were observed in 1 h fasting than 0.5 fasting.
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CASE REPORT
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ルストロンボパグ投与後に観血的治療を行った高度血小板減少症合併肝硬変の3 例
38巻3号(2017);View Description Hide DescriptionThrombocytopenia is a common feature in chronic liver disease and responsible for bleeding tendency. The low platelet number has been considered to be a risk for bleeding after invasive treatment. Here we describe three cirrhotic patients accompanied by severe thrombocytopenia(≦5.0×104/μL). They intended to receive invasive treatment, such as radiofrequency ablation and transarterial chemoembolization for hepatocellular carcinoma and endoscopic injection sclerotherapy for esophageal varices. Lusutrombopag, a small molecule thrombopoietin receptor agonist, was administrated orally for 5 or 7 days before the invasive treatment. Subsequently, a satisfactory increase in the platelet number was observed to varying degrees in all patients and the treatment was successfully performed. Lusutrombopag appears to be a beneficial drug for the patients with severe thrombocytopenia who schedule invasive treatment.
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Information
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