JP2015500702A - 腸管前処置のための方法 - Google Patents
腸管前処置のための方法 Download PDFInfo
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- JP2015500702A JP2015500702A JP2014546138A JP2014546138A JP2015500702A JP 2015500702 A JP2015500702 A JP 2015500702A JP 2014546138 A JP2014546138 A JP 2014546138A JP 2014546138 A JP2014546138 A JP 2014546138A JP 2015500702 A JP2015500702 A JP 2015500702A
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- gastrointestinal tract
- taste
- pretreatment composition
- acid
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Abstract
Description
本出願は、米国仮出願第61/568,131号(2011年12月7日出願)に対する優先権を主張し、その仮出願全体が本参照により本出願に組み込まれるものである。
本発明は、診断の、外科的な、または治療の処置の前に患者の胃腸管を洗浄するための方法に関する。特に、本発明は、胃腸管前処理組成物を快い味にする。
(T1−T2)/T1*100%
No.2: Nulytely製剤で、風味パック添加あり pH8.0
No.3: Nulytely製剤で、レモネード粉末及びレモン抽出物添加あり pH4.8
11人の被験者それぞれが試料2オンスを受け取り、それを試飲した。試料No.1から開始し、次いで残りの試料No.2から3と続けた。
データシートは11人の被験者全員から回収された。塩味に対する平均評価が計算された。表2及び図1を参照。
前処理溶液の塩味は、ミラクルベリーの使用後、著しく減少した。
スクリーニング大腸内視鏡検査を受ける予定の患者が、本研究の対象として考慮される。患者は、以前に大腸内視鏡検査を受けたことがあっても良く、またはなくても良い。味覚にいかなる異常または機能不全がある患者は、本研究からは除外される。同様に、結腸、小腸または胃の手術を受けたことのある患者もまた、患者が本製剤に耐える能力を変更しうるため、除外基準に含まれる。口渇症、口内乾燥症などと診断されている患者は、本研究から除外される。大腸内視鏡検査を実施するための指示は、特定の診断上の病訴に対して出されているべきではなく、むしろスクリーニングまたは監視の目的のために出されているべきである。特定の胃腸に関する病訴を有する患者は、本研究からは除外される。
例えばCoumadin Plavixなどの血液希釈剤を服用している患者は、大腸内視鏡検査の少なくとも1週間前に、指示を出している医療提供者(例えば、医師)に投薬を中止することの認可を得るために連絡を取らなければいけない。
処置の直後に、結腸粘膜の可視化の質を評価するように設計された調査票を、外来患者用内視鏡検査ユニットの担当の消化器科医に完成させるようお願いすることにより、結腸洗浄の質が評価される。内視鏡での可視性は、結腸内の気泡量、及び結腸前処理の適切性が評価される。内視鏡医は、患者に腸前処理の詳細について質問しないよう指示される。
本研究の結果は、胃腸管製剤をミラクルベリー錠剤とともに服用した患者は、製剤を単独で服用した患者に比べて、腸前処理の要件をより良く満たしたことを示すだろう。これらの結果は、胃腸管製剤溶液をミラクルベリー錠剤とともに服用した患者は、製剤を単独で服用した患者に比べて、大腸内視鏡検査がより上手く行ったことも示すだろう。
胃腸管前処理溶液をミラクルベリー錠剤とともに服用した患者は、胃腸管前処理溶液を単独で服用した患者に比べて、前処理期間中に著しく大きい容積の流動体(例えば、前者が平均3.9から4リットル、後者は平均3リットル)を摂取したと報告するだろう。この2つの前処理方法の総合的な許容度もまた、異なるだろう。
内視鏡検査を実施した内視鏡医は、胃腸管製剤溶液をミラクルベリー錠剤とともに服用した患者と製剤を単独で服用した患者との間には、結腸粘膜の可視化の質に違いがあると報告するだろう。結腸粘膜の質は、胃腸管製剤溶液をミラクルベリー錠剤とともに服用した患者群の方が、製剤を単独で服用した患者群よりも著しく高くなるだろう。内視鏡医は、胃腸管製剤溶液をミラクルベリー錠剤とともに服用した患者の方が、製剤を単独で服用した患者と比べて、結腸粘膜の可視化がより明瞭だったと報告するだろう。彼らはまた、後者の群よりも前者の群からの患者の方が、患者の結腸領域に管腔内の気泡が少なく、また結腸から流動体及び糞便を吸引し粘膜を掃除するために結腸を洗うのに費やした時間が短かったとも報告するだろう。胃腸管製剤溶液をミラクルベリー錠剤とともに服用した患者では、製剤を単独で服用した者よりも、完了した大腸内視鏡検査の成功率が高く、また大腸内視鏡検査を完了するのに要する時間も短いだろう。
・ 温度範囲: 0−80℃、32−176°F
・ 分解能: 0.01 pH、温度分解能は0.1℃/F
・ 精度: +/− 0.02 pH、温度精度は+/− 2%
・ 較正: デジタル式微調整機能付きデジタル式自動較正(1点)
・ 電極: 交換式ガラス製センサー及び対照チューブ電極
・ 外被: IP−67防水性(浸水可、水に浮く)
・ 電源: 1.5Vボタン型電池x3
・ 寸法: 18.5x3.4x3.4cm
・ 重量: 96.4g (3.4oz)
試飲実験当日、各試料のpHが実験開始の5分前に再び測定された。一晩前の試料調整時からpHに変化はなかった。溶液は一晩の保管後、沈殿物を含有していなかった。
No.2 試飲試料 pH 7.0
No.3 試飲試料 pH 6.0
No.4 試飲試料 pH 5.0
No.5 試飲試料 pH 4.0
No.6 試飲試料 pH 3.0
ミラクルベリーなし
4人の被験者それぞれが試料2オンスを受け取り、それを試飲した。上記の最も塩基性の溶液(試料No.1、pH8)から開始し、次いで残りの溶液No.2から6と続けた。試料は、甘味、塩味、及び総合的な嗜好性に関して被験者によって評価された。各被験者が自身の対照標準として機能した。
4人の被験者は次いで、The Great Green Miracle Fruit Farm Ltd.により生産されたMiracle Frooties錠剤(1回分あたり600mg)を1つ与えられた。Miracle Frooties錠剤は以下のものを含有した。乾燥ミラクルフルーツ果肉、ジャガイモデンプン、微結晶セルロース、二塩基性リン酸カルシウム、及びステアリン酸マグネシウム。
製剤溶液の総合的な嗜好性は、酸性環境下でのミラクルベリー錠剤の使用後、大いに向上した。ミラクルベリーありの場合、pH5の溶液が最も快い味がする製剤溶液と認められた。
No.2: Nulytely製剤で、風味パック添加あり pH8.0
No.3: Nulytely製剤で、レモネード粉末及びレモン抽出物添加あり pH4.8
No.4: Nulytely製剤で、レモネード粉末、並びにレモン及びオレンジ抽出物添加あり pH4.8
11人の被験者それぞれが試料2オンスを受け取り、それを試飲した。試料No.1から開始し、次いで残りの溶液No.2から4と続けた。
データシートは11人の被験者全員から回収された。各試飲試料に対する2つのカテゴリー(甘味、及び総合的な嗜好性)各々における、11人の被験者からの平均評価が計算された。表5及び図7を参照。
製剤溶液の総合的な嗜好性及び甘味は、酸性環境下(例えば、本実験ではpH4.8)でのミラクルベリー錠剤の使用後、大いに向上した。
Claims (33)
- 患者の胃腸管を洗浄するための方法であって、
塩味を有する胃腸管前処理組成物のpHを測定し、且つ必要な場合に前記pHを約3〜約6.4の範囲になるように調節する工程と、
前記患者に味修正物質を提供する工程と、
前記胃腸管前処理組成物を前記患者に経口投与する工程と
を有し、前記胃腸管前処理組成物の塩味が、前記味修正物質が提供されなかった場合の胃腸管前処理組成物の塩味と比較して、少なくとも約20%軽減される、方法。 - 請求項1記載の方法において、前記胃腸管が腸であり、及び前記胃腸管前処理組成物が腸前処理溶液である、方法。
- 請求項2記載の方法において、前記腸が結腸である、方法。
- 請求項1記載の方法において、前記患者に対して診察の、治療の、及び/または外科的な処置を実施する前に、前記胃腸管は洗浄されるものである、方法。
- 請求項1記載の方法において、前記胃腸管は内視鏡検査の前に洗浄されるものである、方法。
- 請求項5記載の方法において、前記内視鏡検査が、大腸内視鏡検査またはS状結腸鏡検査である、方法。
- 請求項1記載の方法において、バリウム注腸検査、カプセル内視鏡検査、結腸手術、または胃腸管手術の前に、前記胃腸管は洗浄されるものである、方法。
- 請求項1記載の方法において、前記味修正物質が酸味修正剤である、方法。
- 請求項8記載の方法において、前記酸味修正剤がミラクリンである、方法。
- 請求項9記載の方法において、ミラクリンが、ミラクルフルーツ、ミラクルフルーツ果肉、ミラクルフルーツ果粒、ミラクルベリー、ミラクルベリー抽出物、ミラクルフルーツ錠剤、ミラクルベリー錠剤、または遺伝子改変生物により産生されたミラクリンを有するものである、方法。
- 請求項1記載の方法において、前記味修正物質が、ソーマチン、モネリン、マビンリン、ブラゼイン、ペンタジン、クルクリン、ネオクリン、ミラクリン、及びそれらの混合物から成る群から選択されるものである、方法。
- 請求項1記載の方法において、前記味修正物質が、カプセル剤、錠剤、丸薬、粒剤、散剤、小丸剤、固体混合物、溶液、分散体、乳剤、ペースト剤、エキス剤、または天然源からの単離物の形態で提供される、方法。
- 請求項1記載の方法において、前記味修正物質が、前記胃腸管前処理組成物が投与される約1分〜約1時間前に前記患者に提供される、方法。
- 請求項13記載の方法において、前記味修正物質が、前記胃腸管前処理組成物が投与される約5分〜約30分前に提供される、方法。
- 請求項14記載の方法において、前記味修正物質が、前記胃腸管前処理組成物が投与される約10分〜約15分前に提供される、方法。
- 請求項1記載の方法において、前記胃腸管前処理組成物の前記塩味が、少なくとも30%軽減される、方法。
- 請求項16記載の方法において、前記胃腸管前処理組成物の前記塩味が、少なくとも50%軽減される、方法。
- 請求項17記載の方法において、前記胃腸管前処理組成物の前記塩味が、少なくとも70%軽減される、方法。
- 請求項1記載の方法において、前記胃腸管前処理組成物のpHを測定する工程が、前記患者に味修正物質を提供する工程の前または後に実施される、方法。
- 請求項1記載の方法において、前記pHが約4〜約6.4の範囲にわたるものである、方法。
- 請求項1記載の方法において、前記pHが約4.8である、方法。
- 請求項1記載の方法において、前記胃腸管前処理組成物のpHが、少なくとも無機酸または有機酸によって調節される、方法。
- 請求項22記載の方法において、前記酸が、クエン酸、酢酸、アスコルビン酸、リン酸、リンゴ酸、コハク酸、ギ酸、フマル酸、マレイン酸、またはそれらの混合物から成る群から選択される、方法。
- 請求項1記載の方法において、前記胃腸管前処理組成物のpHが、水酸化アンモニウム、炭酸ナトリウム、炭酸カリウム、重炭酸ナトリウム、二酸化炭素、及びそれらの混合物の群から選択される化合物によって調節される、方法。
- 請求項1記載の方法において、前記胃腸管前処理組成物が、カリウム塩、ナトリウム塩、カルシウム塩、アンモニウム塩、またはそれらの混合物を有するものである、方法。
- 請求項1記載の方法において、前記胃腸管前処理組成物が、少なくとも1つのリン酸ナトリウムを有するものである、方法。
- 請求項1記載の方法において、前記胃腸管前処理組成物が、塩化ナトリウム、塩化カリウム、及び重炭酸ナトリウム(炭酸水素ナトリウム)、硫酸ナトリウム、またはそれらの混合物を有するものである、方法。
- 請求項1記載の方法において、前記胃腸管前処理組成物が、少なくとも1つのアルカリ金属塩、及び/または少なくとも1つのアルカリ土類金属塩を有するものである、方法。
- 請求項28記載の方法において、前記アルカリ金属がナトリムまたはカリウムである、方法。
- 請求項28記載の方法において、前記アルカリ土類金属がマグネシウムまたはカルシウムである、方法。
- 請求項1記載の方法において、前記胃腸管前処理組成物が溶液であり、且つ前記胃腸管前処理組成物の容積が約0.1リットル〜約5リットルの範囲にわたるものである、方法。
- 請求項31記載の方法において、前記胃腸管前処理組成物の容積が、約1リットル〜約4リットルの範囲にわたるものである、方法。
- 請求項1記載の方法において、前記胃腸管前処理組成物がポリエチレングリコール(PEG)を有するものである、方法。
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