診療と新薬 2016；53（11）：971-979

【総説】T細胞と表皮細胞からみた乾癬の病態

佐藤伸一

東京大学大学院医学系研究科皮膚科学

Shinryo to Shinyaku （Med Cons New-Remed）2016；53（11）：971-979

生物学的製剤の登場によって，乾癬の治療は飛躍的に進歩し，その病態についても理解がさらに深まった。乾癬の病態については，従来はT 細胞を軸に理解されていたが，表皮細胞を軸とする病態モデルも最近の知見より提唱されている。本稿では，T細胞軸と表皮細胞軸という二つの病態モデルを提示することによって，TNF-α 阻害薬とIL-17 阻害薬の臨床効果とその副作用の相違について考えてみたい。

診療と新薬 2016；53（11）：971-979

【総説】T細胞と表皮細胞からみた乾癬の病態

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診療と新薬 2016；53（11）：981-1001

タクロリムス錠「トーワ」製造販売後調査（関節リウマチ）の結果

Shinryo to Shinyaku （Med Cons New-Remed）2016；53（11）：981-1001

The Results of Post-marketing Surveys of TACROLIMUS TABLETS

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診療と新薬 2016；53（11）：1002-1012

パンクレリパーゼ製剤（リパクレオンⓇ）の特定使用成績調査〔慢性膵炎および膵切除等による膵外分泌機能不全患者における長期使用に関する調査〕

岡卓志 1），浅野陽子 1），三木崇生 1），黒瀬由喜 2），永濱忍 2），須賀哲也 2），上崎利昭 2），加藤淳 1）

1）マイランEPD合同会社，2）EAファーマ株式会社

Shinryo to Shinyaku （Med Cons New-Remed）2016；53（11）：1002-1012

Survey of Specified Drug Use of Pancrelipase Formuration (Lipacreon Ⓡ) ─ Investigation of Long-Term Administration in Patients with Exocrine Pancreatic Insufficiency due to Chronic Pancreatitis and/or Pancreatic Surgery ─

Takashi OKA, et al.

Mylan EPD G. K.

目的：慢性膵炎および膵切除等による膵外分泌機能不全患者におけるパンクレリパーゼ製剤（リパクレオンⓇ：以下，本剤）長期使用による安全性および有効性を市販後使用実態下で調査することである。
方法：患者は中央登録方式にて登録した。本調査の調査期間は52 週間とした。安全性については，調査期間中に発現した有害事象（adverse events：AEs）を，MedDRA/Jにより評価した。有効性については，臨床症状，栄養指標および生活の質（quality of life：QOL）の投与開始前からの変化量で評価した。
結果：2011年8月から2013年7月までに全国136施設から579例の症例登録があり，2014年7月までに562例の調査票を収集した。安全性解析対象症例（553例）における，本剤に起因する副作用は，36例（6.5％）で，主な症状は，消化器症状であった。そのうち，重篤な副作用は，4例（5件）であった。有効性に関しては，臨床症状（脂肪便，下痢，便の悪臭等），栄養指標（体重，血清総蛋白，アルブミン，総コレステロール等）およびQOLの有意な改善を認めた。
結論：本剤の長期投与は，慢性膵炎および膵切除等による膵外分泌機能不全患者に対して，安全かつ有効であることが示唆された。

キーワード：パンクレリパーゼ製剤（リパクレオンⓇ），膵外分泌機能不全，慢性膵炎，膵切除，生活の質，膵酵素補完療法

診療と新薬 2016；53（11）：1002-1012

パンクレリパーゼ製剤（リパクレオンⓇ）の特定使用成績調査〔慢性膵炎および膵切除等による膵外分泌機能不全患者における長期使用に関する調査〕

岡卓志 1），浅野陽子 1），三木崇生 1），黒瀬由喜 2），永濱忍 2），須賀哲也 2），上崎利昭 2），加藤淳 1）

1）マイランEPD合同会社，2）EAファーマ株式会社

Shinryo to Shinyaku （Med Cons New-Remed）2016；53（11）：1002-1012

Survey of Specified Drug Use of Pancrelipase Formuration (Lipacreon Ⓡ) ─ Investigation of Long-Term Administration in Patients with Exocrine Pancreatic Insufficiency due to Chronic Pancreatitis and/or Pancreatic Surgery ─

Takashi OKA, et al.

Mylan EPD G. K.

Objectives: The objective of this survey was to investigate the long-term safety and efficacy of pancrelipase (LipaCreonⓇ) in patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) and/or pancreatic surgery (PS) in postmarketing use.
Methods: Patients were enrolled via a central registration method. In this survey, the observation period per patient was 52 weeks. Adverse events (AEs) were evaluated according to the MedDRA/J. Efficacy data collected during the survey period included induced clinical symptomatology, nutritional
parameters and quality of life (QOL) in order to identify any improvement due to LipaCreonⓇ treatment compared with baseline at the start of this survey.
Results: Patients were registered from 136 institutions nationwide from August 2011 through July 2014. Our investigation of safety data in 553 patients indicated that adverse drug reactions (ADRs) caused by LipaCreonⓇ treatment were reported in 36 patients (6.5%) with the most common being gastrointestinal events. In only 4 patients (5 events), serious ADRs (SADRs) were observed. Our investigation of efficacy data indicated that there were statistically significant improvements in clinical symptomatology (steatorrhea, diarrhea, foul stool odour, etc.) nutritional laboratory parameters (body weight, serum total protein, albumin, total cholesterol, etc.) and the QOL status of patients.
Conclusion: The results of the present survey suggest that the long-term LipaCreonⓇ treatment is safe and effective in patients with EPI due to CP and/or SP, etc.

Key words: exocrine pancreatic insufficiency, chronic pancreatitis, pancreatic surgery, quality of life, pancreatic enzyme replacement therapy

診療と新薬 2016；53（11）：1002-1012

パンクレリパーゼ製剤（リパクレオンⓇ）の特定使用成績調査〔慢性膵炎および膵切除等による膵外分泌機能不全患者における長期使用に関する調査〕

Shinryo to Shinyaku （Med Cons New-Remed）2016；53（11）：1002-1012

Survey of Specified Drug Use of Pancrelipase Formuration (Lipacreon Ⓡ) ─ Investigation of Long-Term Administration in Patients with Exocrine Pancreatic Insufficiency due to Chronic Pancreatitis and/or Pancreatic Surgery ─

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診療と新薬 2016；53（11）：1013-1017

たるみとほうれい線に対する美容液の改善効果

Shinryo to Shinyaku （Med Cons New-Remed）2016；53（11）：1013-1017

The Remedial Effect of Sagging Skin and Nasolabial Fold by Cosmetic Essence

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診療と新薬 2016；53（11）：1018-1027

電動3D音波洗顔ブラシの使用による毛穴状態の改善効果

Shinryo to Shinyaku （Med Cons New-Remed）2016；53（11）：1018-1027

The Improvement Effect of The State of the Pores with Using Electric 3D sonic Face Brush

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診療と新薬 2016；53（11）：1028-1036

Shinryo to Shinyaku （Med Cons New-Remed）2016；53（11）：1028-1036

Hair Restoration Efficacy of Supplements Containing Banana Extract, Parthenolide Derived from Feverfew, and Soy Isoflavone in Healthy Japanese ― A Randomized, Double-blind, Placebo-controlled Study ―

Masatomo NAJIMA 1），Akinobu MIYATA 2），Katsuhisa KINOSHITA 3），Asako HORIKAWA 3），Kenji KUNISHIGE 3）

1）JACTA (Japan Clinical Trial Association)，2）Nihonbashi M's Clinic，3）Kitanotatsujin Corporation

Objective: The objective of this research was to investigate the effectiveness of daily ingestion of a capsule, which contains banana extract, parthenolide derived from Feverfew, and soy isoflavone on hair growth.
Methods: A randomized, placebo-controlled, double-blind study was conducted. To evaluate, the thickness of the hair, the level of sebum around the pore, 6 indexes to score the condition of the scalp (inflammation, rash, amount of dandruff, pore-clogging, sebum
capacity and dryness) and the physician’s assessments of the change in scalp coverage were
measured.
Results: From all of 83 applicants, 43 were eliminated according to the Hamilton’s index of thinning hair (for males), or according to the modified Ludwig Type (for females). Among 40 subjects, 4 were withdrawn due to illness or business, and the remaining 36 subjects completed the study (MO = 16: M ; 8, F ; 8, Placebo = 20: M ; 11, F ; 9). After 12 weeks ingestion, the study showed significant improvement in“ the level of sebum around the pore”,“ the condition of the scalp, including amount of dandruff, pore-clogging, and sebum capacity”, and “the physician’s assessments of scalp coverage”. The result of selfassessment also showed the significant improvement in many items related to hair loss. No adverse effects were observed after the ingestion of the test product.
Conclusion: We found out that, compared with Placebo, the ingestion of the supplement containing banana extract (cycloeucalenone), parthenolide derived from Feverfew, and soy isoflavone for 12 weeks contributed to hair restoration, which is achieved by the improvement of scalp conditions such as pore-clogging, dandruff, and/or itching, and by reducing hair loss. In addition, no safety-related matters occurred during the 12-week test period.

Key words: banana, Feverfew, parthenolide, soy isoflavone, hair growth, hair loss, hair follicles, scalp condition

Shinryo to Shinyaku （Med Cons New-Remed）2016；53（11）：1028-1036

Hair Restoration Efficacy of Supplements Containing Banana Extract, Parthenolide Derived from Feverfew, and Soy Isoflavone in Healthy Japanese ― A Randomized, Double-blind, Placebo-controlled Study ―

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診療と新薬 2016；53（11）：1037-1045

Shinryo to Shinyaku （Med Cons New-Remed）2016；53（11）：1037-1045

Improvement in Immune Function By Supplement Contained Β-Glucans ― A Randomized, Double-Blind, Placebo-Controlled Study ―

Masatomo NAJIMA 1），Mitsuhiko MUNEKATA 2），Hiroyuki SASAKI 3)

1）JACTA (Japan Clinical Trial Association)，2）OZ Clinic，3）LINKS Inc.

Objectives: The objective of this research was to investigate the effectiveness of daily ingestion of Reishi tablet, which contains β -glucans, on the immunological vigor of human.
Methods: In this randomized, placebo-controlled, double-blind trial, 27 people were subjected. The SIV score (combination of the number of T cells, naive T cells, CD8+CD28+ T cells, B cells and NK cells, and ratios of CD4/CD8 T cell and naive/memory T cell) and blood pressure were measured as its primary outcomes.
Results: 6 subjects were withdrawn due to personal reasons and the remaining 21 subjects completed the study. Significant differences of T lymphocyte, T cells, CD8+CD28+ T cells and the systolic blood pressure were observed between test and placebo samples after 12 weeks of ingestion.
Conclusion: We found out that the ingestion of the processed food of Reishi (Ganoderma lucidum ) containing β-glucans for 12 weeks contributed to improving the immunological vigor of human and the systolic blood pressure. In addition, no safety-related matter occurred during the 12-week test period.

Key words: Reishi, Ganoderma lucidum , β -glucan, immunological vigor, immune, SBP

Shinryo to Shinyaku （Med Cons New-Remed）2016；53（11）：1037-1045

Improvement in Immune Function By Supplement Contained Β-Glucans ― A Randomized, Double-Blind, Placebo-Controlled Study ―

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