日本臨牀　70/増刊号6　医薬品副作用学(第2版)

I 副作用総論

P.11 掲載の参考文献

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7) 過去5年間の副作用報告の公表状況. 平成22年8月4日, 平成22年度第1回厚生労働省薬事・食品衛生審議会医薬品等安全対策部会資料2-1-2.

 

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6) Hung SI, et al : Genetic susceptibility to carbamazepine-induced cutaneous adverse drug reactions. Pharmacogenet Genomics 16:297-306, 2006.

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8) Kaniwa, et al : HLA-B locus in Japanese patient with anti-epileptics and allopurinol-related Stevens-Johnson syndrome and toxic epidermal necrolysis. Pharmacogenomics J 9:1617-1622, 2008.

 

9) Ozeki T, et al : Genome-wide association study identifies HLA-A*3101 allele as a genetic risk factor for carbamazepine-induced cutaneous adverse drug reactions in Japanese population. Hum Mol Genet 20:1034-1041, 2011.

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10) Hung SI, et al : HLA-B*5801 allele as a genetic marker for severe cutaneous adverse reactions caused by allopurinol. Proc Natl Acad Sci USA 102:4134-4139, 2005.

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P.23 掲載の参考文献

1) 澤田純一, 斎藤嘉朗 : ゲノム情報に基づいた副作用予測. 日本臨牀 65(増刊号8):16-21, 2007.

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2) 斎藤嘉朗ほか : 薬剤副作用に関する遺伝子解析. 日本臨牀 68(増刊号8):263-268, 2010.

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3) Chung WH, et al : Genetic predisposition of life-threatening antiepileptic-induced skin reactions. Expert Opin Drug Saf 9:15-21, 2010.

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4) Wei CY, et al : A Recent Update of Pharmacogenomics in Drug-Induced Severe Skin Reactions. Drug Metab Pharmacokinet 27:132-141, 2012.

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5) Chung WH, et al : Medical genetics : a marker for Stevens-Johnson syndrome. Nature 428:486, 2004.

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6) Wei CY, et al : Direct interaction between HLA-B and carbamazepine activates T cells in patients with Stevens-Johnson syndrome. J Allergy Clin Immunol 129:1562-1569, 2012.

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7) Chen P, et al : Carbamazepine-induced toxic effects and HLA-B*1502 screening in Taiwan. N Engl J Med 364:1126-1133, 2011.

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8) Lucena MI, et al : Susceptibility to amoxicillin-clavulanate-induced liver injury is influenced by mul-tiple HLA class I and II alleles. Gastroenterology 141:338-347, 2011.

 

9) Lucena MI, et al : Glutathione S-transferase m1 and t1 null genotypes increase susceptibility to idiosyncratic drug-induced liver injury. Hepatology 48:588-596, 2008.

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10) Niemi M, et al : Organic anion transporting polypeptide 1B1 : a genetically polymorphic transporter of major importance for hepatic drug uptake. Pharmacol Rev 63:157-181, 2011.

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11) Kurose K, et al : Population differences in major functional polymorphisms of pharmacokinetics/pharmacodynamics-related genes in Eastern Asians and Europeans : Implications in the clinical trials for novel drug development. Drug Metab Pharmacokinet 27:9-54, 2012.

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12) Saito Y, et al : CYP2C8 haplotype structures and their influence on pharmacokinetics of paclitaxel in a Japanese population. Pharmacogenet Genomics 17:461-471, 2007.

 

P.28 掲載の参考文献

1) 重篤副作用疾患別対応マニュアル第1集(平成19年), 第2集(平成20年), 第3集(平成21年), 第4 集(平成22年), 第5集(平成23年), 重篤副作用疾患別対応マニュアル総合索引(平成23年), 発行(財)日本医薬品情報センター(JAPIC), 発行協力 日本病院薬剤師会.

 

2) Clinical Nephrotoxins-Renal Injury from Drugs and Chemicals(ed by De Broe ME, Porter GA), Third ed, Springer, 2008.

 

3) 臨床医のための腎毒性物質のすべて(De Broe ME, Porter GA編), 杉崎徹三監訳, シュプリンガー・ジャパン, 2008.

 

P.35 掲載の参考文献

1) 医薬品・医療機器等安全性情報 医療機関報告のお願い[http://www.info.pmda.go.jp/info/houkoku.html].

 

2) 医薬品製造販売指針2010, じほう, 2010.

 

P.44 掲載の参考文献

1) 藤井俊志 : 12医薬品情報業務の実際. 医薬品情報学(小清水敏昌編著), p158-172, 朝倉書店, 1998.

 

2) 高橋春男 : 3章市販後調査と情報. 医薬品情報学第3版(山崎幹夫監), p24-36, 東京大学出版会, 2005.

 

3) 医薬品等の副作用の重篤度分類基準について, 薬安第80号(厚生省薬務局安全課課長通知), 1992.

 

4) National Cancer Institute-Common Toxicity Criteria(NCI-CTC Version 2.0, April 30, 1999)～日本語訳JCOG版-第2版～(日本臨床腫瘍研究グループ), 初版1999年4月, 第1回改訂2001年9月.

 

5) 有害事象共通用語規準v4.0 日本語訳JCOG版-2010年9月11日 Common Terminology Criteria for Adverse Events v4.0(CTCAE)-May 28, 2009(v4.03 : Jun. 14, 2010). [http://www.jcog.jp/doctor/tool/CTCAEv4J-20100911.pdf]

 

P.50 掲載の参考文献

1) 「医療用医薬品添付文書の見直し等に関する研究班」報告. [http://www1.mhlw.go.jp/houdou/0805/65.html]

 

2) 適正使用情報提供状況確認等事業最終報告書. [http://www.info.pmda.go.jp/kyoten-iyaku/file/tekisei-report-final.pdf]

 

3) 重篤副作用疾患別対応マニュアル. [http://www.info.pmda.go.jp/juutoku/juutoku-index.html]

 

4) 患者向医薬品ガイド. [http://www.info.pmda.go.jp/guide-iyaku/guide-iyaku.html]

 

P.59 掲載の参考文献

1) 健康被害救済制度のホームページ. [http://www.pmda.go.jp/kenkouhigai.html]

 

2) 医薬品副作用被害救済制度の請求書類. [http://www.pmda.go.jp/kenkouhigai/fukusayo-dl/index.html]

 

3) 独立行政法人医薬品医療機器総合機構 : 平成23事業年度業務報告. [http://www.pmda.go.jp/guide/outline/report.html]

 

4) 副作用救済給付の決定に関する情報. [http://www.pmda.go.jp/kenkouhigai/help/information.html]

 

5) 宮崎生子, 桂栄美 : 医薬品副作用被害救済制度について. 成人病と生活習慣病 36:1405-1412, 2006.

 

6) 厚生労働省医薬食品局 : 医薬品副作用被害救済制度・生物由来製品感染等被害救済制度について. 医薬品・医療機器等安全性情報 No.273(2010年10月).

 

7) 原田紗世子ほか : 医薬品副作用被害救済制度において支給された健康被害の薬効分類別分析(第2報). 第21回日本医療薬学会年会講演要旨集, p303, 神戸, 2011.

 

8) 荒川千佳ほか : 「医薬品副作用被害救済制度」に請求された一般用医薬品による健康被害の事例の分析. 第129年会日本薬学会要旨集3, p276, 京都, 2009.

 

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II 副作用概論

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III 副作用各論 - 重大な副作用 -

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IV 特論

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3) タルセバ(R)錠 特定使用成績調査(全例調査)3000例最終解析結果のご報告, 中外製薬株式会社.

 

4) 山口研成ほか :「アービタックス(R)(一般名 : セツキシマブ)の使用成績調査(全例調査)の最終成績」(ASCO GI 2011).

 

5) ベクティビックス(R)点滴静注100mg 市販直後調査 結果のお知らせ, 武田薬品工業株式会社.

 

6) スーテント(R)カプセル12.5mg 特定使用成績調査中間報告書, ファイザー株式会社.

 

7) ネクサバール(R)錠200mg 特定使用成績調査中間報告書(根治切除不能又は転移性の腎細胞癌), バイエル薬品株式会社.

 

8) 向井陽美ほか : Lung disorders and interstitial pneumonia associated with Bortezomib(Velcade) ther-apy in Japan. 第72回日本血液学会総会, 2010.

 

9) アフィニトール(R)錠特定使用成績調査における間質性肺疾患の有害事象についての集計結果(2011年7月15日までの集積症例より).

 

10) トーリセル(R)点滴静注液25mg適正使用ガイド, ファイザー株式会社.

 

11) ハーセプチン(R)注射用150 使用成績調査集計結果, 中外製薬株式会社.

 

12) アバスチン(R)点滴静注用100mg/4mL, 400mg/16mL, 特定使用成績調査集計結果, 中外製薬株式会社.

 

13) ベルケイド注射用3mg中間集計結果<500例サイクルデータを用いた集計結果>, ヤンセンファーマ株式会社.

 

P.770 掲載の参考文献

1) 塩崎佳友ほか : QT延長症候群原因医薬品の追跡調査とスクリーニングソフトウェアの作成. 札幌医学雑誌 79:13-19, 2011.

 

2) 齊藤嘉津彦, 宮本篤 : 抗がん剤の副作用とその対策-白血球減少と感染. 薬局 57(3):33-40, 2006.

 

3) 片倉道啓ほか : 薬剤識別コードおよび調剤総数の筆記照合による調剤過誤防止対策の効果. 医療薬学 34(11):997-1003, 2008.

Medical*Online

4) 北澤式文ほか :「医薬品の安全使用のための業務手順書」作成マニュアル, 平成18年度厚生労働科学研究「医薬品等の安全管理体制の確立に関する研究」(平成19年3月). [www.mhlw.go.jp/topics/bukyoku/isei/i-anzen/hourei/dl/070330-1a.pdf]

 

5) 厚生労働省医政局長通知「医薬品の販売名の類似性等による医療事故防止対策の強化・徹底について(注意喚起)」(平成20年12月4日付医政発1204001号). [www.info.pmda.go.jp/iryoujiko/file/20081204.pdf]

 

6) (社)日本病院薬剤師会薬剤業務委員会「ハイリスク薬の薬剤管理指導に関する業務ガイドライン(Ver.2)」(平成22年10月30日改訂). [http://www.jshp.or.jp/cont/10/1104.pdf]

 

7) 松山賢治, 阿南節子(監) : ハイリスク治療薬2012, じほう, 2012.

 

8) 荒木博陽(監) : ハイリスク薬チェックシート, じほう, 2011.

 

9) 荒木博陽(編) : ナースのためのハイリスク薬, 照林社, 2011.

 

10) 松原和夫ほか : 薬剤師の病棟勤務時間が長いほど薬剤が関連するインシデント発生数は少ない-国立大学病院における調査. 薬学雑誌 131(4):635-641, 2011.

 

11) 厚生労働省医政局長通知「医療スタッフの協働・連携によるチーム医療の推進について」(平成22年4月30日付医政発0430第1号). [http://www.jshp.or.jp/cont/10/1021-2.pdf]

 

12) 厚生労働省医政局長通知(医政発0430第1号)「医療スタッフの協働・連携によるチーム医療の推進について」日本病院薬剤師会による解釈と具体例(Ver.1)(平成22年10月21日). [http://www.jshp.or.jp/cont/10/1021-1.pdf]

 

P.776 掲載の参考文献

1) 日本医薬情報センター : 重篤副作用疾患別対応マニュアル第1集-第5集, 2007-2011.

 

2) 日本病院薬剤師会(編) : 重大な副作用回避のための服薬指導情報集[1]-[4], じほう, 1997-2001.

 

3) 日本病院薬剤師会(編) : 注射薬の重大な副作用回避のための情報集, じほう, 2006.

 

4) 山崎幹夫(監) : 医薬品適正使用と医薬品情報. 医薬品情報学第3版, p1-5, 東京大学出版会, 2005.

 

5) 濱敏弘 : 外来患者を対象とした服薬指導. チームで進めるがん外来化学療法(藤原弘監), p26-33, 日経メディカル出版, 2009.

 

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