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医学と薬学 79/10 2022年10月号

出版社: 自然科学社
発行日: 2022-09-27
分野: 薬学  >  雑誌
ISSN: 03893898
雑誌名:
特集: 動脈硬化性疾患についての最新の話題
電子書籍版: 2022-09-27 (第1版第1刷)
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目次

  • 特集 動脈硬化性疾患についての最新の話題
       ―「動脈硬化性疾患予防ガイドライン2022年版」を踏まえて

    序文
    動脈硬化性疾患の包括的リスク評価
    動脈硬化性疾患予防のための生活習慣指導
    動脈硬化性疾患予防ガイドラインの概要
    動脈硬化症予防のための脂質管理
     ―薬物療法
    家族性高コレステロール血症に対する包括的リスク管理
    脂質異常症に対する新規薬剤の開発状況

    臨床試験
     トルバプタンOD錠15mg「トーワ」の日本人健康成人男性における生物学的同等性試験
     エスシタロプラムOD錠10mg「トーワ」の日本人健康成人男性における生物学的同等性試験

    薬理・薬剤
     独自の形状を有するエスシタロプラム錠「ニプロ」の品質評価
     各種病原ウイルス(SARS-CoV-2等)に対する医薬品類および雑貨品の有効性判定

    研究
     コナヒョウヒダニ抽出物投与によるマウス喘息モデルの有用性
     Investigation into Performance of 2 -μm Diameter Microfiber Cloth
      in Removing Feline Enteric Coronavirus(FECoV)

    Diagnosis
     唾液検体に対する銀増幅イムノクロマトグラフィーを用いた
      SARS-CoV-2抗原検出システムの臨床性能評価
     COVID-19確定患者における肺炎球菌の重複感染に関する研究
      ―尿中肺炎球菌抗原キット「クイックチェイサー®肺炎球菌II」の有用性―
     ルミパルス®L2400を用いたメトトレキサート定量試薬
      「ルミパルスプレスト®メトトレキサート」の基礎性能評価

    Cosmetic
    「シズカホワイトバーム」の使用が加齢肌に及ぼす影響
      ―抗シワ,洗浄,美白 ―ヒト臨床試験―

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【特集 動脈硬化性疾患についての最新の話題 - 「動脈硬化性疾患予防ガイドライン2022年版」を踏まえて】

P.1256 掲載の参考文献
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2) Abifadel M, Varret M, Rabes JP, et al : Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet 34 : 154-156, 2003.
3) Benjannet S, Hamelin J, Chretien M, et al : Lossand gain-of-function PCSK9 variants : cleavage specificity, dominant negative effects, and low density lipoprotein receptor (LDLR) degradation. J Biol Chem 287 : 33745-33755, 2012.
4) Do RQ, Vogel RA, Schwartz GG : PCSK9 Inhibitors : potential in cardiovascular therapeutics. Curr Cardiol Rep 15 : 345, 2013.
5) Robinson JG, Farnier M, Krempf M, et al : Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med 372 : 1489-1499, 2015.
6) Sabatine MS, Giugliano RP, Wiviott SD, et al : Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med 372 : 1500-1509, 2015.
7) Ray KK, Landmesser U, Leiter LA, et al : Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol. N Engl J Med 376 : 1430-1440, 2017.
8) Hovingh GK, Lepor NE, Kallend D, et al : Inclisiran Durably Lowers Low-Density Lipoprotein Cholesterol and Proprotein Convertase Subtilisin/Kexin Type 9 Expression in Homozygous Familial Hypercholesterolemia : The ORION-2 Pilot Study. Circulation 141 : 1829-1831, 2020.
9) Henney NC, Banach M, Penson PE : RNA Silencing in the Management of Dyslipidemias. Curr Atheroscler Rep 23 : 69, 2021.
10) Yamamoto T, Harada-Shiba M, Nakatani M, et al : Cholesterol-lowering Action of BNA-based Antisense Oligonucleotides Targeting PCSK9 in Atherogenic Diet-induced Hypercholesterolemic Mice. Mol Ther Nucleic Acids 1 : e22, 2012.
11) Wada F, Yamamoto T, Kobayashi T, et al : Drug discovery and development scheme for liver-targeting bridged nucleic acid antisense oligonucleotides. Mol Ther Nucleic Acids 26 : 957-969, 2021.
12) Dewey FE, Gusarova V, Dunbar RL, et al : Genetic and Pharmacologic Inactivation of ANGPTL3 and Cardiovascular Disease. N Engl J Med 377 : 211-221, 2017.
13) Harada-Shiba M, Ali S, Gipe DA, et al : A randomized study investigating the safety, tolerability, and pharmacokinetics of evinacumab, an ANGPTL3 inhibitor, in healthy Japanese and Caucasian subjects. Atherosclerosis 314 : 33-40, 2020
14) Raal FJ, Rosenson RS, Reeskamp LF, et al : Evinacumab for Homozygous Familial Hypercholesterolemia. N Engl J Med 383 : 711-720, 2020.
15) Graham MJ, Lee RG, Brandt TA, et al : Cardiovascular and Metabolic Effects of ANGPTL3 Antisense Oligonucleotides. N Engl J Med 377 : 222-232, 2017.
16) Viney NJ, van Capelleveen JC, Geary RS, et al : Antisense oligonucleotides targeting apolipoprotein (a) in people with raised lipoprotein (a) : two randomised, double-blind, placebo-controlled, dose-ranging trials. Lancet 388 : 2239-2253, 2016.
17) Koren MJ, Moriarty PM, Baum SJ, et al : Preclinical development and phase 1 trial of a novel siRNA targeting lipoprotein (a). Nat Med 28 : 96-103, 2022.

【臨床試験】

P.1318 掲載の参考文献
1) サムスカOD錠7.5mg, サムスカOD錠15mg, サムスカOD錠30mg, サムスカ顆粒1%の医薬品インタビューフォーム (2021年7月改訂〔第22版〕) (大塚製薬株式会社).
2) サムスカOD錠7.5mg, サムスカOD錠15mg, サムスカOD錠30mg, サムスカ顆粒1%の医薬品添付文書 (2021年6月改訂〔第3版〕) (大塚製薬株式会社).
3) 後発医薬品の生物学的同等性試験ガイドライン (平成9年12月22日医薬審 第487号〔平成13年5月31日医薬審発 第786号, 平成18年11月24日 薬食審査発 第1124004号, 平成24年2月29 日薬食審査発0229 第10号にて一部改正〕).
4) 「後発医薬品の生物学的同等性試験ガイドライン等の改正 (案) 」に関する御意見の募集について (平成31年2月28日医薬品審査管理課).
5) 奥田豊 : RACTAB(R) 技術を活用したOD錠の製剤設計. 薬剤学 71 (1) : 21, 2011.
6) 医薬品の臨床試験の実施の基準に関する省令 (平成9年3月27日厚生省令第28号〔平成15年6月12日厚生労働省令第106号, 平成16年12月21日厚生労働省令第172号, 平成18年3月31日厚生労働省令第72号, 平成20年2月29日厚生労働省令第24号, 平成24年12月28日厚生労働省令第161号, 平成28年1月22日厚生労働省令第9号にて一部改正〕).
P.1335 掲載の参考文献
1) レクサプロ錠10mg, レクサプロ錠20mgの医薬品添付文書 (2018年11月改訂〔第8版〕) (持田製薬株式会社).
2) 後発医薬品の生物学的同等性試験ガイドライン (平成9年12月22日医薬審第487号 (平成13年5月31日医薬審発第786号, 平成18年11月24日 薬食審査発第1124004号, 平成24年2月29日 薬食審査発0229 第10号にて一部改正).
3) 奥田豊 : RACTAB(R) 技術を活用したOD錠の製剤設計. 薬剤学 71 (1) : 21, 2011.
4) 医薬品の臨床試験の実施の基準に関する省令 (平成9年3月27日厚生省令第28号), 医薬品の臨床試験の実施の基準に関する省令の一部を改正する省令 (平成15年6月12日厚生労働省令第106号, 平成16年12月21日厚生労働省令第172号, 平成18年3月31日厚生労働省令第72号, 平成20年2月29日厚生労働省令第24号, 平成28年1月22日厚生労働省令第9号), 薬事法施行規則等の一部を改正する省令 (平成24年12月28日厚生労働省令第161号).

【薬理・薬剤】

P.1349 掲載の参考文献
1) 医薬品インタビューフォーム レクサプロ(R) 錠10mg, レクサプロ(R) 錠20mg. 2021年1月改訂 (第11版)
2) 安定性試験実施方法のガイドライン (平成3年2月15日薬審第43号)
3) 錠剤・カプセル剤の無包装状態での安定性情報 (改訂5版, 医薬ジャーナル社)
4) 第十八改正日本薬局方 (令和3年6月7日厚生労働省告示第220号)
5) 後発医薬品の生物学的同等性試験ガイドライン (平成9年12月22日付け医薬審第487号一部改正令和2年3月19日付薬生薬審発0319 第1号)
6) 含量が異なる経口固形製剤の生物学的同等性試験ガイドライン (平成12年2月14日医薬審第64号 一部改正令和2年3月19日薬生薬審発0319 第1号)
P.1358 掲載の参考文献
1) 厚生労働省・経済産業省・消費者庁 新型コロナウイルスの消毒・除菌方法について https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/syoudoku_00001.html [参照2022年8月26日]
2) Nomura T, Nazmul T, Sakaguchi T, et al : Ethanol susceptibility of SARS-CoV-2 and other enveloped viruses. Biocont Sci 26 (3) : 177-180, 2021.
3) 日本感染症学会 ノロウイルス感染症 https://www.kansensho.or.jp/ref/d50.html [参照2022年8月26日]
4) Ueda K, Kawabata R, Sakaguchi T, et al : Inactivation of pathogenic viruses by plant-derived tannins : strong effects of extracts from persimmon (Diospyros kaki) on a board range of viruses. PLoS One 8 (1) : e55343, 2013.
5) Noma K, Kiyotani K, Kouchi H, et al : Endogenous protease-dependent replication of human influenza viruses in two MDCK cell lines. Arch Virol 143 (10) : 1893-1909, 1998.
6) Coyne CB, Oberste MS, Pallansh MA : Enteroviruses : Polioviruses, Coxsackieviruses, Echoviruses, and Newer Enteroviruses. Fields Virology 7th, vol 1 (ed. by Howley PM, Knipe DM), p.87, Wolters Kluwer, Philadelphia 2021.
7) Ohmine T, Narai S, Sakaguchi T, et al : Eligibility of feline calicivirus for a surrogate of human norovirus in comparison with murine norovirus, poliovirus and coxsackievirus. Biocont Sci 23 (3) : 145-149, 2018.
8) イギリス保健省Emerging infections : how and why they arise. https://www.gov.uk/government/publications/emerging-infections-characteristics-epidemiology-and-global-distribution/emerging-infections-howand-why-they-arise [参照2022年8月26日]

【研究】

P.1366 掲載の参考文献
1) 川上裕子, 川上敏明 : マスト細胞活性化とアレルギー疾患. 生化学 92 (4) : 517-526, 2020.
2) 中島裕史 : 喘息モデルマウス. アレルギー 59 (11) : 1539-1545, 2010.
3) 萩野敏, 榎本雅夫, 和田光雄 : アレルギー性鼻炎と住環境ダニ抗原量. 耳鼻臨床 95 (1) : 45-50, 2002.
4) Kato G, Takahashi K, Tashiro H, et al : β2 adrenergic agonist attenuates house dust mite-induced allergic airway inflammation through dendritic cells. BMC Immunology 15 : 39, 2014.
5) Tashiro H, Takahashi K, Hayashi S, et al : Interleukin-33 from Monocytes Recruited to the Lung Contributes to House Dust Mite-Induced Airway Inflammation in a Mouse Model. PLoS One 11 (6) : 2016.
6) Tashiro H, Takahashi K, Sadamatsu H, et al : Saturated Fatty Acid Increases Lung Macrophages and Augments House Dust Mite-Induced Airway Inflammation in Mice Fed with High-Fat Diet. Inflammation 40 (3) : 1072-1086, 2017.
7) Ishii T, Niikura Y, Kurata K, et al : Time-dependent distinct roles of Toll-like receptor 4 in a house dust mite-induced asthma mouse model. Scand J Immunology 87 (3) : e12641, 2018.
8) 稲垣直樹 : 最近のアレルギー研究の進歩. 日薬理誌 131 : 22-27, 2008.
9) 井上博雅 : II. 病因と病態 2. 気道炎症と気道リモデリングの分子病態. 日本内科学会雑誌 98 (12) : 3006-3012, 2009.
10) 斎藤博久 : 特集I マスト細胞を軸としたアレルギー・感染・炎症 気道リモデリングとマスト細胞. 炎症と免疫 14 (5) : 586-591, 2006.
11) 斎藤博久 : 医学と医療の最前線 マイクロアレイ法による新しいアレルギー炎症性疾患診断マーカー. 日本内科学会雑誌 96 (6) : 140-145, 2007.
12) 斎藤博久 : 喘息における組織リモデリング : マスト細胞の役割を中心に. 日薬理誌 134 : 64-67, 2009.
P.1376 掲載の参考文献
1) Hatakeyama T, Matsuda K, Osawa M, Sagehashi N, Kumagai M : Change in cleanliness over time following introduction of microfiber cloth for wipe cleaning of medical instruments. J Jpn Assoc Clin Engineer Technologists 56 : 100-103, 2016. (In Japanese)
2) Hatakeyama T, Matsuda K, Osawa M, Sagehashi N, Kumagai M : Study on usefulness of Toraysee(R) for CE. J Jpn Assoc Clin Engineer Technologists 53 : 67-71, 2015. (In Japanese)
3) Nakamura K, Tojo K, Sato E, Kunimi M, et al : An investigation of cleaning cloths. The Japanese Journal of Medical Instrumentation 82 (2) : 600-601, 2012. (In Japanese)
4) Matsumoto Y, Takahashi K, and Urano H. Removal of bacterial cells adhering to surface by using a wiping cloth. J Antibact Antifung Agents 43 : 3-7, 2015. (In Japanese)
5) Muto M, et al : Investigation of disinfecting effect of wiping with a cleaning cloth (Toraysee for CE). J Jpn Assoc Clin Engineer Technologists 51-262, 2014. (In Japanese)
6) Tojo K, Nakamura K, Sato E, Hayami S, Fujii M, Miyaji K : Effectiveness of microfiber cleaning cloth used for medical equipment. Ther Res 34 : 399-407, 2013. (In Japanese)
7) National Institute of Technology and Evaluation. Investigative committee on efficacy assessment on alternative disinfection methods for the SARSCoV-2 virus, Efficacy assessment on alternative disinfection methods for the SARS-CoV-2 virus (Final Report), 2020 June. (In Japanese) https://www.nite.go.jp/data/000111315.pdf [Accessed 8 Aug 2021]
8) Satoshi Fukuzaki : Features and medical applications of microfiber cloth for cleaning equipment. Journal of Antibacterial and Antifungal Agents. ISSN 2187-431X. (In Japanese)
9) Satoshi Fukuzaki : Features and Medical Applications of Microfiber Cloth for Cleaning Instruments with Wipes. Ther Res 40 (11) : 2019.
10) Amauchi M, Soman K, Hirata A, Fushimi R, Okamoto N, Takahashi R, et al : Study of wiping, transferring and oozing of three kinds of wipes (materials) by evaluating ATP. J Healthcare-assoc Infect 9 : 42-51, 2016. (In Japanese)
11) Tojo K, Nojima Y, Sagehashi N, Nakamura K, Sato M, Fujii M, et al. Evaluation of virus removal efficiency with a microfiber cleaning cloth. Ther Res 35 : 827-836, 2014. (In Japanese)
12) Tojo K, Fujii M, Nakamura K, Sato M, Nojima Y, Sagehashi N, Evaluation of virus removal efficiency with a microfiber cleaning cloth. Jpn J Med Instrument 87 : 40-46, 2017. (In Japanese)
13) Japan Ministry of Health, Labour and Welfare. Special Web Page of Ministry of Health, Labour and Welfare/Ministry of Economy, Trade and Industry/Consumer Affairs Agency : On disinfection/elimination methods for the SARS-CoV-2 virus. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/syoudoku_00001.html [Accessed 1 May 2022]
14) Japan Hygiene Products Industry Association. Methodology for testing the disinfection performance of wet wipes (enacted on April 1, 2013)
15) Sato M, Tojo K, Nakamura K, Kunimi M, et al : Investigation into wiping up blood with Toraysee microfiber material cleaning cloth. J Jpn Assoc Clin Engineer Technologists 51 : 254, 2014.
16) CDC Sterilization in Healthcare Facilities, Nov. 2018

【Diagnosis】

P.1385 掲載の参考文献
1) World Health Organisation : Coronavirus disease (COVID-19) Weekly Epidemiological Update and Weekly Operational Update. https://www.who.int/publications/m/item/weeklyepidemiological-update-on-covid-19 [accessed 19 August 2022]
2) 厚生労働省 健康局 結核感染症課 : 新型コロナウイルス感染症の現在の状況と厚生労働省の対応について (令和4年7月15日版) https://www.mhlw.go.jp/stf/newpage_26818.html
3) 厚生労働省 病原体検査の指針検討委員会 : 新型コロナウイルス感染症 (COVID-19) 病原体検査の指針 (第5.1版. 2022年3月17日)
4) 廣津伸夫, 菊地直子, 深谷千佳, 他 : 銀増幅イムノクロマトグラフィーを用いた高感度SARS-CoV-2抗原検出システムの臨床評価. 医学と薬学 78 (7) : 873-879, 2021.
5) 国立感染症研究所 : 病原体検出マニュアル 2019-nCoV (Ver.2.9.1, 2020年3月19日)
6) Joseph Ojonugwa Shaibu, Chika K Onwuamah, Ayorinde Babatunde James, et al : Full length genomic sanger sequencing and phylogenetic analysis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Nigeria. PloS one 16 (1) : 2021. e0243271. doi : 10.1371/journal.pone.0243271.
7) World Health Organisation : Target product profiles for priority diagnostics to support response to the COVID-19 pandemic v.1.0 2020 September.
8) Min-Chul Kim, Chunguang Cui, Kyeong-Ryeol Shin, et al : Duration of Culturable SARS-CoV-2 in Hospitalized Patients with Covid-19. The New England journal of medicine 18 : 384 (7) : 671-673, 2021. doi : 10.1056/NEJMc2027040.
9) Dalia Raich-Regue, Jordana Munoz-Basagoiti, Daniel Perez-Zsolt, et al : Performance of SARSCoV-2 Antigen-Detecting Rapid Diagnostic Tests for Omicron and Other Variants of Concern. Frontiers in microbiology 13 : 810576, 2022. doi : 10.3389/fmicb.2022.810576.
10) Justin Hardick, Nicholas Gallagher, Jaiprasath Sachithanandham, et al : Evaluation of Four Point of Care (POC) Antigen Assays for the Detection of the SARS-CoV-2 Variant Omicron. Microbiology spectrum 10 (3) : e0102522, 2022. doi : 10.1128/spectrum.01025-22.
P.1395 掲載の参考文献
1) Qun Li, et al : Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med 382 : 1199-207, 2020.
2) 厚生労働省 診療の手引き検討委員会 : 新型コロナウイルス感染症 (COVID-19) 診療の手引き (第7.2版, 2022年5月9日)
3) David M Morens, Jeffery K Taubenberger, Anthony S Faucil : Predominant role of bacterial pneumonia as a cause of death in pandemic influenza : implications for pandemic influenza preparedness. J Infect Dis 198 : 962-970, 2008.
4) Bradley J Langford, Miranda So, Sumit Raybardhan, et al : Bacterial co-infection and secondary infection in patients with COVID-19 : a living rapid review and meta-analysis. Clin Microbiol Infect 26 : 1622-1629, 2020.
5) Pontus Hedberg, Niclas Johansson, Anders Ternhag, et al : Bacterial co-infections in community-acquired pneumonia caused by SARS-CoV-2, influenza virus and respiratory syncytial virus. BMC Infect Dis 22 : 108, 2022.
6) Anahita Rouze, Ignacio Martin-Loeches, Pedro Povoa, et al : Early Bacterial Identification among Intubated Patients with COVID-19 or Influenza Pneumonia : A European Multicenter Comparative Clinical Trial. Am J Respir Crit Care Med 204 : 546-556, 2021.
7) Tetsuya Tsukamoto, Noriko Nakajima, Aki Sakurai, et al : Lung Pathology of Mutually Exclusive Co-infection with SARS-CoV-2 and Streptococcus pneumoniae. Emerg Infect Dis 27 : 919-923, 2021.
8) 日本呼吸器学会 : 成人肺炎診療ガイドライン 2017
P.1406 掲載の参考文献
1) メソトレキセート点滴静注液200mg/1000 mg 添付文書.
2) Treon SP, Chabner BA : Concepts in use of highdose methotrexate therapy. Clinical chemistry 42 : 1322-1329, 1996.
3) Howard SC, McCormick J, Ching-Hon Pui, et al : Preventing and managing toxicities of high-dose methotrexate. The oncologist 21 : 1471-1482, 2016.
4) Nishizono I, Iida S, N Suzuki N, et al : Rapid and Sensitive Chemiluminescent Enzyme Immunoassay for Measuring Tumor Markers. Clin Chem 37 : 1639-1644, 1991.
5) Clinical and Laboratory Standards Institute. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures ; Approved Guideline-Second Edition. CLSI Document EP17-A2.
6) 中村裕美, 名執由起, 小林葉子, 他 : メトトレキサートの測定試薬2法の性能評価. 医学検査 65 (3) : 290-297, 2016.
7) ルミパルスプレスト メトトレキサート 添付文書.
8) ナノピアeTDMメトトレキサート 添付文書.

【Cosmetic】

P.1418 掲載の参考文献
1) 高橋康之 : 2. 健やかな肌をつくるための保湿化粧品. 日本皮膚科学会雑誌 132 (6) : 1449-1455, 2022.
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3) 酒井裕二 : 理想的な洗顔料の開発. 日本化粧品技術者会誌 33 (2) : 109-118, 1999.
4) 南野美紀 : 化粧品の種類と使い方-スキンケア化粧品-. 日本香粧品学会誌 42 (2) 109-124. 2018.
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