JP2019089796A - 下痢を治療するための製品及び方法 - Google Patents
下痢を治療するための製品及び方法 Download PDFInfo
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- JP2019089796A JP2019089796A JP2019009896A JP2019009896A JP2019089796A JP 2019089796 A JP2019089796 A JP 2019089796A JP 2019009896 A JP2019009896 A JP 2019009896A JP 2019009896 A JP2019009896 A JP 2019009896A JP 2019089796 A JP2019089796 A JP 2019089796A
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- Prior art keywords
- receptor antagonist
- diarrhea
- patient
- pharmaceutical composition
- cetirizine
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Abstract
Description
本願は、2013年3月14日に出願の“PRODUCT AND METHOD FOR TREATING DIARRHEA”と題された米国仮特許出願第61/782608号の利益を請求するものであり、この文献の全内容は、本願に相反する部分を除き、参照により本願において援用される。
(16)用語「下痢」は、大便の流動性又は頻度の上昇を意味する。
(43)
(45)65歳の患者1が慢性下痢に関係した体重減少及び体液喪失により1週間を超えて入院した。患者は1日20〜40回排便し、生命に関わる重度の下痢をおこしていた。患者を1日1回、20mgのファモチジン及び10mgのセチリジンで治療した。症状は48時間以内に治まり、排便回数は95%減少し、患者は退院した。患者は治療に反応し、現在、排便は1日1回、時折2回ではあるが、下痢はない。
(47)26〜80歳の7人の患者を、1日の排便回数が3〜18回の軽度〜重度の下痢について治療した。
(56)中等度の下痢を訴え、それ以上の診断はついていない81歳の患者の排便回数は1日4〜6回であり、活動レベル及び生活様式に支障をきたしていた。患者を1日1回、20mgのファモチジン及び10mgのセチリジンで治療した。治療は成功し、排便回数は70%減少して1日1〜2回(多くは1回)となり、症状が消散したことから再度の結腸内視鏡検査はキャンセルされた。
(58)結腸癌及び中等度〜重度の下痢を抱え、化学療法剤からの脱条件づけ状態にある64歳の患者の排便回数は1日5〜10回であった。患者を1日1回、20mgのファモチジン及び10mgのセチリジンで治療した。治療は成功し、排便回数は80%減少して1日1〜2回となり、固さは正常となり、副作用はなかった。
(60)35〜64歳の3人の患者を、潰瘍性大腸炎又はクローン病に関係している重度の下痢について治療した。
(65)セリアック病の57歳の患者1は軽度〜中等度の下痢をおこし、1日の排便回数は2〜4回であった。1日1回の20mgのファモチジン及び10mgのセチリジンでの治療では改善が見られなかった。副作用はなかった。
(68)研究母集団の年齢は18〜80歳であり、治療に同意した診療所の外来患者集団及び医療センターの外来患者から選ばれた慢性で説明のつかない下痢をおこしている患者である。全身性若しくは皮膚肥満細胞症の病歴を有する患者、下痢の原因が特定可能(IBS−D又は慢性特発性下痢以外)、例えばセリアック病、炎症性腸疾患、乳糖不耐症の患者又は妊娠中の患者は除外した。研究はIRB承認後に開始された。
(79)研究母集団の年齢は21〜70歳であり、患者は慢性下痢と診断され、治療に同意している。H1受容体アンタゴニスト又はH2受容体アンタゴニストに対して敏感である又はアレルギーがある、腎機能障害を抱えている又は腎不全の病歴がある、炎症性腸疾患(クローン病又は潰瘍性大腸炎)と診断されている、結腸が公知の活動性感染症にかかっている(例えば、クロストリジウム・ディフィシル(Clostridium difficile)、ジアルディア属の鞭毛虫、サルモネラ(Salmonella))、生検により顕微鏡的大腸炎(膠原性又はリンパ球性大腸炎)にかかっていると判明している、あるいは研究中に他の止瀉薬の使用を中断できないならば、患者を除外した。また、妊娠している若しくは授乳中の女性であるならば又は患者がアタザナビル、イトラコナゾール若しくはケトコナゾールを服用しているならば、患者を除外した。研究はIRB承認後に開始された。
(85)Schiller LR, “Secretory Diarrhea” Current Gastroenterology Reports (1999) 1:389-397.
(86)Schiller, LR, Hogan RB, Morawski, SG, Santa Ana, CA, Bern MJ, Nogaard, RP, Bo-Linn, GW, Fordtran JS, “Studies of the Prevalence and Significance of Radiolabeled Rice Acid Malabsorption in a Group of Patients with Idiopathic Chronic Diarrhea” Gastroenterology (1997) 92:151-160.
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〔1〕患者において下痢を治療する方法であって、H1受容体アンタゴニスト及びH2受容体アンタゴニストを前記患者に投与する工程を含み、好ましくは前記患者が肥満細胞性腸炎に罹患していないことを特徴とする、方法。
〔2〕患者において下痢を治療する方法であって、H1受容体アンタゴニスト及びH2受容体アンタゴニストを前記患者に投与する工程を含み、前記H1受容体アンタゴニストがセチリジンを含み、前記H2受容体アンタゴニストがファモチジンを含むことを特徴とする、方法。
〔3〕患者において下痢を治療する方法であって、H1受容体アンタゴニスト及びH2受容体アンタゴニストを患者に投与する工程を含み、前記H2受容体アンタゴニストがラニチジンではないことを特徴とする、方法。
〔4〕下痢に罹患している患者を治療する薬物を調製するための、H1受容体アンタゴニスト及びH2受容体アンタゴニストの使用であって、好ましくは前記患者が肥満細胞性腸炎に罹患していないことを特徴とする、使用。
〔5〕下痢に罹患している患者を治療する薬物を調製するための、H1受容体アンタゴニスト及びH2受容体アンタゴニストの使用であって、前記H1受容体アンタゴニストがセチリジンを含み、前記H2受容体アンタゴニストがファモチジンを含むことを特徴とする、使用。
〔6〕下痢に罹患している患者を治療する薬物を調製するための、H1受容体アンタゴニスト及びH2受容体アンタゴニストの使用であって、前記H2受容体アンタゴニストがラニチジンではないことを特徴とする、使用。
〔7〕前記H1受容体アンタゴニストが、第2世代H1受容体アンタゴニストを含む、先行する態様のいずれかに記載の方法又は使用。
〔8〕前記H1受容体アンタゴニストが、セチリジン、レボセチリジン又はこれらの混合物を含む、先行する態様のいずれかに記載の方法又は使用。
〔9〕前記H2受容体アンタゴニストが、ファモチジン、ラニチジン又はこれらの混合物を含む、先行する態様のいずれかに記載の方法又は使用。
〔10〕前記H1受容体アンタゴニスト及び前記H2受容体アンタゴニストを、同時に投与する、先行する態様のいずれかに記載の方法又は使用。
〔11〕前記H1受容体アンタゴニスト及び前記H2受容体アンタゴニストを、1日1回、少なくとも2日間にわたって投与する、先行する態様のいずれかに記載の方法又は使用。
〔12〕前記H1受容体アンタゴニスト及び前記H2受容体アンタゴニストを、1日1回、少なくとも7日間にわたって投与する、先行する態様のいずれかに記載の方法又は使用。
〔13〕前記患者が、慢性下痢に罹患している、先行する態様のいずれかに記載の方法又は使用。
〔14〕前記患者が、IBS−Dに罹患している、先行する態様のいずれかに記載の方法又は使用。
〔15〕前記患者が、急性下痢に罹患している、先行する態様のいずれかに記載の方法又は使用。
〔16〕セチリジンを5〜20mgの量で投与する、先行する態様のいずれかに記載の方法又は使用。
〔17〕ファモチジンを10〜40mgの量で投与する、先行する態様のいずれかに記載の方法又は使用。
〔18〕ファモチジン及びセチリジンを単位剤形として一緒に投与する、先行する態様のいずれかに記載の方法又は使用。
〔19〕前記H2受容体アンタゴニストが、ファモチジンを含む、先行する態様のいずれかに記載の方法又は使用。
〔20〕下痢を治療するための医薬組成物であって、
H1受容体アンタゴニストと、
H2受容体アンタゴニストとを含み、
前記H2受容体アンタゴニストがラニチジンではなく、
前記医薬組成物が経口剤形であることを特徴とする、医薬組成物。
〔21〕下痢を治療するための医薬組成物であって、
H1受容体アンタゴニストと、
H2受容体アンタゴニストとを含み、
前記H1受容体アンタゴニストがジフェンヒドラミンではないことを特徴とする、医薬組成物。
〔22〕患者において下痢を治療するための医薬組成物であって、H1受容体アンタゴニストと、H2受容体アンタゴニストとを含み、好ましくは患者が肥満細胞性腸炎に罹患していないことを特徴とする、医薬組成物。
〔23〕前記H1受容体アンタゴニストが、第2世代H1受容体アンタゴニストを含む、先行する態様のいずれかに記載の医薬組成物。
〔24〕前記H1受容体アンタゴニストが、セチリジン、レボセチリジン又はこれらの混合物を含む、先行する態様のいずれかに記載の医薬組成物。
〔25〕前記H2受容体アンタゴニストが、ファモチジンを含む、先行する態様のいずれかに記載の医薬組成物。
〔26〕前記H1受容体アンタゴニストが、セチリジンを含み、前記H2受容体アンタゴニストがファモチジンを含む、先行する態様のいずれかに記載の医薬組成物。
〔27〕前記経口剤形が、単位剤形を含む、先行する態様のいずれかに記載の医薬組成物。
〔28〕前記経口剤形が、少なくとも1つの錠剤又はカプセルを含む、先行する態様のいずれかに記載の医薬組成物。
〔29〕前記経口剤形が、ナトリウム、及び、グルコース又はグルコース含有サッカリドをさらに含む、先行する態様のいずれかに記載の医薬組成物。
〔30〕前記経口剤形が、経口補水溶液をさらに含む、先行する態様のいずれかに記載の医薬組成物。
〔31〕前記経口剤形が、複数の単位剤形を含む、先行する態様のいずれかに記載の医薬組成物。
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Claims (31)
- 患者において下痢を治療する方法であって、H1受容体アンタゴニスト及びH2受容体アンタゴニストを前記患者に投与する工程を含み、好ましくは前記患者が肥満細胞性腸炎に罹患していないことを特徴とする、方法。
- 患者において下痢を治療する方法であって、H1受容体アンタゴニスト及びH2受容体アンタゴニストを前記患者に投与する工程を含み、前記H1受容体アンタゴニストがセチリジンを含み、前記H2受容体アンタゴニストがファモチジンを含むことを特徴とする、方法。
- 患者において下痢を治療する方法であって、H1受容体アンタゴニスト及びH2受容体アンタゴニストを患者に投与する工程を含み、前記H2受容体アンタゴニストがラニチジンではないことを特徴とする、方法。
- 下痢に罹患している患者を治療する薬物を調製するための、H1受容体アンタゴニスト及びH2受容体アンタゴニストの使用であって、好ましくは前記患者が肥満細胞性腸炎に罹患していないことを特徴とする、使用。
- 下痢に罹患している患者を治療する薬物を調製するための、H1受容体アンタゴニスト及びH2受容体アンタゴニストの使用であって、前記H1受容体アンタゴニストがセチリジンを含み、前記H2受容体アンタゴニストがファモチジンを含むことを特徴とする、使用。
- 下痢に罹患している患者を治療する薬物を調製するための、H1受容体アンタゴニスト及びH2受容体アンタゴニストの使用であって、前記H2受容体アンタゴニストがラニチジンではないことを特徴とする、使用。
- 前記H1受容体アンタゴニストが、第2世代H1受容体アンタゴニストを含む、先行する請求項のいずれかに記載の方法又は使用。
- 前記H1受容体アンタゴニストが、セチリジン、レボセチリジン又はこれらの混合物を含む、先行する請求項のいずれかに記載の方法又は使用。
- 前記H2受容体アンタゴニストが、ファモチジン、ラニチジン又はこれらの混合物を含む、先行する請求項のいずれかに記載の方法又は使用。
- 前記H1受容体アンタゴニスト及び前記H2受容体アンタゴニストを、同時に投与する、先行する請求項のいずれかに記載の方法又は使用。
- 前記H1受容体アンタゴニスト及び前記H2受容体アンタゴニストを、1日1回、少なくとも2日間にわたって投与する、先行する請求項のいずれかに記載の方法又は使用。
- 前記H1受容体アンタゴニスト及び前記H2受容体アンタゴニストを、1日1回、少なくとも7日間にわたって投与する、先行する請求項のいずれかに記載の方法又は使用。
- 前記患者が、慢性下痢に罹患している、先行する請求項のいずれかに記載の方法又は使用。
- 前記患者が、IBS−Dに罹患している、先行する請求項のいずれかに記載の方法又は使用。
- 前記患者が、急性下痢に罹患している、先行する請求項のいずれかに記載の方法又は使用。
- セチリジンを5〜20mgの量で投与する、先行する請求項のいずれかに記載の方法又は使用。
- ファモチジンを10〜40mgの量で投与する、先行する請求項のいずれかに記載の方法又は使用。
- ファモチジン及びセチリジンを単位剤形として一緒に投与する、先行する請求項のいずれかに記載の方法又は使用。
- 前記H2受容体アンタゴニストが、ファモチジンを含む、先行する請求項のいずれかに記載の方法又は使用。
- 下痢を治療するための医薬組成物であって、
H1受容体アンタゴニストと、
H2受容体アンタゴニストとを含み、
前記H2受容体アンタゴニストがラニチジンではなく、
前記医薬組成物が経口剤形であることを特徴とする、医薬組成物。 - 下痢を治療するための医薬組成物であって、
H1受容体アンタゴニストと、
H2受容体アンタゴニストとを含み、
前記H1受容体アンタゴニストがジフェンヒドラミンではないことを特徴とする、医薬組成物。 - 患者において下痢を治療するための医薬組成物であって、H1受容体アンタゴニストと、H2受容体アンタゴニストとを含み、好ましくは患者が肥満細胞性腸炎に罹患していないことを特徴とする、医薬組成物。
- 前記H1受容体アンタゴニストが、第2世代H1受容体アンタゴニストを含む、先行する請求項のいずれかに記載の医薬組成物。
- 前記H1受容体アンタゴニストが、セチリジン、レボセチリジン又はこれらの混合物を含む、先行する請求項のいずれかに記載の医薬組成物。
- 前記H2受容体アンタゴニストが、ファモチジンを含む、先行する請求項のいずれかに記載の医薬組成物。
- 前記H1受容体アンタゴニストが、セチリジンを含み、前記H2受容体アンタゴニストがファモチジンを含む、先行する請求項のいずれかに記載の医薬組成物。
- 前記経口剤形が、単位剤形を含む、先行する請求項のいずれかに記載の医薬組成物。
- 前記経口剤形が、少なくとも1つの錠剤又はカプセルを含む、先行する請求項のいずれかに記載の医薬組成物。
- 前記経口剤形が、ナトリウム、及び、グルコース又はグルコース含有サッカリドをさらに含む、先行する請求項のいずれかに記載の医薬組成物。
- 前記経口剤形が、経口補水溶液をさらに含む、先行する請求項のいずれかに記載の医薬組成物。
- 前記経口剤形が、複数の単位剤形を含む、先行する請求項のいずれかに記載の医薬組成物。
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