WHO必須医薬品モデルリストに見る血漿分画製剤の位置付けの歴史的変遷と現状
「はじめに」 血漿分画製剤は, 人の血液中の血漿タンパク質という限られた資源を分離, 精製して作り出される医薬品である. 血漿という1つの原材料を利用して, 重症熱傷や大量出血等の重篤な疾病から, 血友病を始めとする様々な希少疾病に至るまで, 幅広い種類の血漿分画製剤が生み出される. この血漿分画製剤は, 1941年に開発されたアルブミン以来, 70年以上の歴史を持つ1). その一方で, 血漿分画製剤は, 数多ある医薬品の中でも議論の多い(controversial)ものの1つである. 非加熱の血液凝固因子製剤によって多くの血友病患者がHIVに感染した事件2), またフィブリノゲン製剤や血液凝...
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| Published in | YAKUGAKU ZASSHI Vol. 134; no. 2; pp. 237 - 247 |
|---|---|
| Main Authors | , |
| Format | Journal Article |
| Language | Japanese |
| Published |
公益社団法人 日本薬学会
01.02.2014
日本薬学会 |
| Online Access | Get full text |
| ISSN | 0031-6903 1347-5231 |
| DOI | 10.1248/yakushi.12-00282 |
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| Abstract | 「はじめに」 血漿分画製剤は, 人の血液中の血漿タンパク質という限られた資源を分離, 精製して作り出される医薬品である. 血漿という1つの原材料を利用して, 重症熱傷や大量出血等の重篤な疾病から, 血友病を始めとする様々な希少疾病に至るまで, 幅広い種類の血漿分画製剤が生み出される. この血漿分画製剤は, 1941年に開発されたアルブミン以来, 70年以上の歴史を持つ1). その一方で, 血漿分画製剤は, 数多ある医薬品の中でも議論の多い(controversial)ものの1つである. 非加熱の血液凝固因子製剤によって多くの血友病患者がHIVに感染した事件2), またフィブリノゲン製剤や血液凝固第IX因子製剤によるHCVへの感染の問題3)など, 血漿分画製剤は, 日本における薬害の原因として大きな社会的問題となった. 血漿分画製剤が議論を呼ぶのは, 有限な人の血液を由来にする医薬品であるということ, そして, その使用による病原体伝播の可能性が完全には否定できないという2つの特性を持つからであろう. |
|---|---|
| AbstractList | 「はじめに」 血漿分画製剤は, 人の血液中の血漿タンパク質という限られた資源を分離, 精製して作り出される医薬品である. 血漿という1つの原材料を利用して, 重症熱傷や大量出血等の重篤な疾病から, 血友病を始めとする様々な希少疾病に至るまで, 幅広い種類の血漿分画製剤が生み出される. この血漿分画製剤は, 1941年に開発されたアルブミン以来, 70年以上の歴史を持つ1). その一方で, 血漿分画製剤は, 数多ある医薬品の中でも議論の多い(controversial)ものの1つである. 非加熱の血液凝固因子製剤によって多くの血友病患者がHIVに感染した事件2), またフィブリノゲン製剤や血液凝固第IX因子製剤によるHCVへの感染の問題3)など, 血漿分画製剤は, 日本における薬害の原因として大きな社会的問題となった. 血漿分画製剤が議論を呼ぶのは, 有限な人の血液を由来にする医薬品であるということ, そして, その使用による病原体伝播の可能性が完全には否定できないという2つの特性を持つからであろう. |
| Author | 津谷, 喜一郎 坂上, 裕一郎 |
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| DOI | 10.1248/yakushi.12-00282 |
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Ther., 32, 99-105 (2004). 35) World Health Organization, “WHO guidelines on good manufacturing practices for blood establishments,” WHO Technical Report Series No. 961, 2011, pp. 148-214. 13) World Health Organization, “The selection and use of essential medicines: Report of the WHO Expert Committee, 2002 (including the 12th Model List of Essential Medicines),” WHO Technical Report Series No. 914, 2003, pp. 13-14. 33) World Health Organization, “The use of essential drugs: Report of a WHO Expert Committee,” WHO Technical Report Series No. 685, 1983, p. 24. 24) World Health Organization, “The use of essential drugs: Ninth report of the WHO Expert Committee (including the revised Model List of Essential Drugs),” WHO Technical Report Series No. 895, 2000, p. 47. 51) Burnouf T., Vox Sang., 100, 68-83 (2011). 21) Laing R., Waning B., Gray A., Ford N., ‘t Hoen E., Lancet, 361, 1723-1729 (2003). 36) World Health Organization, “Twenty-eighth World Health Assembly: Utilization and supply of human blood and blood products,” 1975. 17) World Health Organization, “WHO Model List of Essential Medicines.”: 〈http://www.who.int/medicines/publications/essentialmedicines/EMLsChanges1977_2011.xls〉, cited 30 October, 2012. 14) Tsutani K., J. Jpn. Med. Assoc., 134, 1522-1523 (2005). 23) Cochrane Injuries Group Albumin Reviewers, BMJ, 317, 235-240 (1998). 25) The SAFE Study Investigators, N. Engl. J. Med., 350, 2247-2256 (2004). 8) Blood and Blood Products Division, Ministry of Health, Labour and Welfare. “Ketsuekijigyo hokoku,” 2012, p. 37: 〈http://www.mhlw.go.jp/new-info/kobetu/iyaku/kenketsugo/2s/index.html〉, cited 18 July, 2013. 26) Flood P., Wills P., Lawler P., Ryan G., Richard K. A., “Review of Australia's Plasma Fractionation Arrangements,” Chap. 2, Commonwealth of Australia, Canberra, 2006, pp. 39-52. 11) World Health Organization, “Recommendations for the production, control and regulation of human plasma for fractionation,” WHO Technical Report Series No. 941, 2007, pp. 245-246. 22) World Health Organization, “The use of essential drugs: Fourth report of the WHO Expert Committee,” WHO Technical Report Series No. 796, 1990, p. 47. 7) Hetzl E., “Production of Plasma Proteins for Therapeutic Use,” Chap. 32, ed. by Bertolini J., Goss N., Curling J., John Wiley & Sons, Inc., Hoboken, 2013, pp. 437-448. 18) World Health Organization, “The selection of essential drugs: Report of a WHO Expert Committee,” WHO Technical Report Series No. 615, 1977, p. 27. 2) Mitsubishi Tanabe Pharma Corporation, “HIV Jiken ni kansuru saishu hokokusho,” 2007: 〈http://www.mt-pharma.co.jp/shared/show.php?url=/release/nr/mpc/2007/hiv.html〉, cited 2 August, 2013. 4) Yasuda J., “Ketsuekiseizai,” 2nd ed, Kindaishuppan, Tokyo, 1986, pp. 1-20. 10) Blood Products Research Organization, “Ketsuekiseizai kiko dayori,” No. 103, 2008, pp. 4-5: 〈http://www.bpro.or.jp/newsletter/pdf/103.pdf〉, cited 27 July, 2013. 29) World Health Organization, “The selection and use of essential medicines: Report of the WHO Expert Committee, 2005 (including the 14th Model List of Essential Medicines),” WHO Technical Report Series No. 933, 2006, pp. 15-16. 31) World Health Organization. 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Ser., 4, 329-331 (2009). 12) Price H., Genereux M., Sinclair C., “Production of Plasma Proteins for Therapeutic Use,” Chap 14, ed. by Bertolini J., Goss N., Curling J., John Wiley & Sons, Inc., Hoboken, 2013, pp. 207-216. 49) World Federation of Hemophilia, “Contract Fractionation,” 3rd ed., WFH, Montreal, 2008, pp. 1-12. 19) World Health Organization, “The selection of essential drugs: Second report of the WHO Expert Committee,” WHO Technical Report Series No. 641, 1979, p. 18. 42) Watanabe H., “Seibutsugakuteki seizai kijun kaisetsu,” Jiho Inc., Tokyo, 2007. 38) World Federation of Hemophilia, “Report on the Annual Global Survey 2009,” WFH, Montreal, 2011, p. 7. 39) Burnouf T., Pharmaceuticals Policy and Law, 7, 209-218 (2005, 2006). 34) World Health Organization, “Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products,” WHO Technical Report Series No. 924, 2004, pp. 150-224. 27) World Health Organization, “The selection and use of essential medicines: Report of the WHO Expert Committee, 2003 (including the 13th Model List of Essential Medicines),” WHO Technical Report Series No. 920, 2004, pp. 24-27. 3) Ministry of Health, Labour and Welfare, “Yakugai kanen no kensho oyobi saihatsu boshi ni kansuru kenkyu: saishu hokoku,” 2010: 〈http://www.mhlw.go.jp/shingi/2010/03/s0300-1.html〉, cited 30 October, 2012. 37) World Health Organization, “Sixty-third World Health Assembly: Availability, safety and quality of blood products,” 2010, pp. 1-4. 5) World Health Organization, “Requirements for the collection, processing and quality control of blood, blood components and plasma derivatives,” WHO Technical Report Series No. 840, 1994, pp. 39-41. 52) Cheraghali A. M., Abolghasemi H., Biologicals, 38, 81-86 (2010). 20) World Health Organization, “The use of essential drugs: Report of a WHO Expert Committee,” WHO Technical Report Series No. 685, 1983, p. 41. 9) Ito K., “Ketsuekiseizai, Chap. 5, Kesshobunkakuseizai,” Kyoritsu Shuppan Co., Ltd., Tokyo, 1999, pp. 81-102. 16) World Health Organization, “Essential Medicines.”: 〈http://www.who.int/medicines/services/essmedicines_def/en/〉, cited 30 October, 2012. 44) Blood and Blood Products Division, Ministry of Health, Labour and Welfare. “Ketsuekijigyo hokoku,” 2012, p. 7: 〈http://www.mhlw.go.jp/new-info/kobetu/iyaku/kenketsugo/2s/index.html〉, cited 1 August, 2013. 40) Plasma Protein Therapeutic Association, “Unique by nature: the special case of plasma protein therapeutics.”: 〈http://www.pptaglobal.org/publication/brochures.aspx〉, cited 30 October, 2012. 48) Farrugia A., Cassar J., Blood Transfus., 11, 183-192 (2013). 28) World Health Organization, “The selection and use of essential medicines: Report of the WHO Expert Committee, 2005 (including the 14th Model List of Essential Medicines),” WHO Technical Report Series No. 933, 2006, pp. 41-42. 43) Ministry of Health, Labour and Welfare, “Anzenna ketsuekiseizai no anteikyokyu no kakuhoto ni kansuru horitsu.”: 〈http://www.mhlw.go.jp/new-info/kobetu/iyaku/kenketsugo/3.html〉, cited 1 August, 2013. |
| References_xml | – reference: 3) Ministry of Health, Labour and Welfare, “Yakugai kanen no kensho oyobi saihatsu boshi ni kansuru kenkyu: saishu hokoku,” 2010: 〈http://www.mhlw.go.jp/shingi/2010/03/s0300-1.html〉, cited 30 October, 2012. – reference: 51) Burnouf T., Vox Sang., 100, 68-83 (2011). – reference: 17) World Health Organization, “WHO Model List of Essential Medicines.”: 〈http://www.who.int/medicines/publications/essentialmedicines/EMLsChanges1977_2011.xls〉, cited 30 October, 2012. – reference: 29) World Health Organization, “The selection and use of essential medicines: Report of the WHO Expert Committee, 2005 (including the 14th Model List of Essential Medicines),” WHO Technical Report Series No. 933, 2006, pp. 15-16. – reference: 21) Laing R., Waning B., Gray A., Ford N., ‘t Hoen E., Lancet, 361, 1723-1729 (2003). – reference: 25) The SAFE Study Investigators, N. Engl. J. Med., 350, 2247-2256 (2004). – reference: 48) Farrugia A., Cassar J., Blood Transfus., 11, 183-192 (2013). – reference: 44) Blood and Blood Products Division, Ministry of Health, Labour and Welfare. “Ketsuekijigyo hokoku,” 2012, p. 7: 〈http://www.mhlw.go.jp/new-info/kobetu/iyaku/kenketsugo/2s/index.html〉, cited 1 August, 2013. – reference: 49) World Federation of Hemophilia, “Contract Fractionation,” 3rd ed., WFH, Montreal, 2008, pp. 1-12. – reference: 6) Blood and Blood Products Division, Ministry of Health, Labour and Welfare. “Ketsuekijigyo hokoku,” 2006, p. 4: 〈http://www.mhlw.go.jp/new-info/kobetu/iyaku/kenketsugo/2d/dl/1b.pdf〉, cited 30 October, 2012. – reference: 40) Plasma Protein Therapeutic Association, “Unique by nature: the special case of plasma protein therapeutics.”: 〈http://www.pptaglobal.org/publication/brochures.aspx〉, cited 30 October, 2012. – reference: 38) World Federation of Hemophilia, “Report on the Annual Global Survey 2009,” WFH, Montreal, 2011, p. 7. – reference: 11) World Health Organization, “Recommendations for the production, control and regulation of human plasma for fractionation,” WHO Technical Report Series No. 941, 2007, pp. 245-246. – reference: 2) Mitsubishi Tanabe Pharma Corporation, “HIV Jiken ni kansuru saishu hokokusho,” 2007: 〈http://www.mt-pharma.co.jp/shared/show.php?url=/release/nr/mpc/2007/hiv.html〉, cited 2 August, 2013. – reference: 10) Blood Products Research Organization, “Ketsuekiseizai kiko dayori,” No. 103, 2008, pp. 4-5: 〈http://www.bpro.or.jp/newsletter/pdf/103.pdf〉, cited 27 July, 2013. – reference: 23) Cochrane Injuries Group Albumin Reviewers, BMJ, 317, 235-240 (1998). – reference: 12) Price H., Genereux M., Sinclair C., “Production of Plasma Proteins for Therapeutic Use,” Chap 14, ed. by Bertolini J., Goss N., Curling J., John Wiley & Sons, Inc., Hoboken, 2013, pp. 207-216. – reference: 32) World Health Organization, Comments to support the “Application for the re-instatement of Polyvalent Human Immunoglobulin in the WHO Model List of Essential Medicines.”: 〈http://archives.who.int/eml/expcom/expcom15/Late/WHO_EML_IVIG.pdf〉, cited 30 October, 2012. – reference: 43) Ministry of Health, Labour and Welfare, “Anzenna ketsuekiseizai no anteikyokyu no kakuhoto ni kansuru horitsu.”: 〈http://www.mhlw.go.jp/new-info/kobetu/iyaku/kenketsugo/3.html〉, cited 1 August, 2013. – reference: 15) Tsutani K., Jpn. Pharmacol. Ther., 32, 99-105 (2004). – reference: 7) Hetzl E., “Production of Plasma Proteins for Therapeutic Use,” Chap. 32, ed. by Bertolini J., Goss N., Curling J., John Wiley & Sons, Inc., Hoboken, 2013, pp. 437-448. – reference: 8) Blood and Blood Products Division, Ministry of Health, Labour and Welfare. “Ketsuekijigyo hokoku,” 2012, p. 37: 〈http://www.mhlw.go.jp/new-info/kobetu/iyaku/kenketsugo/2s/index.html〉, cited 18 July, 2013. – reference: 41) Tsutani K., Jpn. Pharmacol. Ther., 32, 123-134 (2004). – reference: 16) World Health Organization, “Essential Medicines.”: 〈http://www.who.int/medicines/services/essmedicines_def/en/〉, cited 30 October, 2012. – reference: 50) Ayob Y., ISBT Sci. Ser., 4, 329-331 (2009). – reference: 42) Watanabe H., “Seibutsugakuteki seizai kijun kaisetsu,” Jiho Inc., Tokyo, 2007. – reference: 37) World Health Organization, “Sixty-third World Health Assembly: Availability, safety and quality of blood products,” 2010, pp. 1-4. – reference: 20) World Health Organization, “The use of essential drugs: Report of a WHO Expert Committee,” WHO Technical Report Series No. 685, 1983, p. 41. – reference: 39) Burnouf T., Pharmaceuticals Policy and Law, 7, 209-218 (2005, 2006). – reference: 19) World Health Organization, “The selection of essential drugs: Second report of the WHO Expert Committee,” WHO Technical Report Series No. 641, 1979, p. 18. – reference: 31) World Health Organization. The selection and use of essential medicines: Report of the WHO Expert Committee, 2009 (including the 16th Model List of Essential Medicines and the 2nd WHO Model List of Essential Medicines for Children), WHO Technical Report Series No. 958, 2009, p. 88. – reference: 52) Cheraghali A. M., Abolghasemi H., Biologicals, 38, 81-86 (2010). – reference: 36) World Health Organization, “Twenty-eighth World Health Assembly: Utilization and supply of human blood and blood products,” 1975. – reference: 22) World Health Organization, “The use of essential drugs: Fourth report of the WHO Expert Committee,” WHO Technical Report Series No. 796, 1990, p. 47. – reference: 33) World Health Organization, “The use of essential drugs: Report of a WHO Expert Committee,” WHO Technical Report Series No. 685, 1983, p. 24. – reference: 35) World Health Organization, “WHO guidelines on good manufacturing practices for blood establishments,” WHO Technical Report Series No. 961, 2011, pp. 148-214. – reference: 9) Ito K., “Ketsuekiseizai, Chap. 5, Kesshobunkakuseizai,” Kyoritsu Shuppan Co., Ltd., Tokyo, 1999, pp. 81-102. – reference: 26) Flood P., Wills P., Lawler P., Ryan G., Richard K. A., “Review of Australia's Plasma Fractionation Arrangements,” Chap. 2, Commonwealth of Australia, Canberra, 2006, pp. 39-52. – reference: 47) Blood and Blood Products Division, Ministry of Health, Labour and Welfare. “Kesshobunkakuseizai no kyokyu no arikata ni kansuru kentokai saishu hokokusho,” 2012, pp. 4-5: 〈http://www.mhlw.go.jp/stf/shingi/2r98520000024c45-att/2r98520000024c8i.pdf〉, cited August 3, 2013. – reference: 30) World Health Organization, “The selection and use of essential medicines: Report of the WHO Expert Committee, 2007 (including the 15th Model List of Essential Medicines),” WHO Technical Report Series No. 946, 2007, pp. 52-54. – reference: 13) World Health Organization, “The selection and use of essential medicines: Report of the WHO Expert Committee, 2002 (including the 12th Model List of Essential Medicines),” WHO Technical Report Series No. 914, 2003, pp. 13-14. – reference: 45) Japan Red Cross Society, Mitsubishi Tanabe Pharma Corporation, Press Release, May 8 2012: 〈http://www.jrc.or.jp/vcms_lf/ketsueki120508.pdf〉, Japanese Red Cross Society Web, cited June 20, 2013. – reference: 18) World Health Organization, “The selection of essential drugs: Report of a WHO Expert Committee,” WHO Technical Report Series No. 615, 1977, p. 27. – reference: 1) Creager A. N. H., Stud. Hist. Phil. Biol. Biomed. Sci., 30, 377-405 (1999). – reference: 14) Tsutani K., J. Jpn. Med. 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| Snippet | 「はじめに」 血漿分画製剤は, 人の血液中の血漿タンパク質という限られた資源を分離, 精製して作り出される医薬品である. 血漿という1つの原材料を利用して, 重症熱傷や大量出血等の重篤な疾病から, 血友病を始めとする様々な希少疾病に至るまで, 幅広い種類の血漿分画製剤が生み出される. この血漿分画製剤は,... |
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| StartPage | 237 |
| Title | WHO必須医薬品モデルリストに見る血漿分画製剤の位置付けの歴史的変遷と現状 |
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