JP2021506980A - エーラス・ダンロス症候群の治療用組成物および治療法 - Google Patents
エーラス・ダンロス症候群の治療用組成物および治療法 Download PDFInfo
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Abstract
Description
この出願は、その開示全体が本明細書に参照により組み込まれる2017年12月21日に出願がなされた米国仮特許出願第62/608,687号の優先権の利益を主張するものである。
この実施例によれば、hEDSと診断された女性を、フェノール食塩水緩衝液(a phenylated saline buffer)中に4TCID50の用量の麻疹ウイルス(Attenuvax(登録商標)、ニュージャージー州、ホワイトハウスステーション、Merck & Co.)、0.008mgのヒスタミン(ワシントン州、スポーカン、Hollister Stier Allergy)、Sigma−Aldrich(Millipore−Sigmaとしても知られている)製の0.002mgの牛由来コラーゲンおよび0.003mgの免疫グロブリン(GamaSTAN(商標)、ノースカロライナ州、リサーチトライアングルパーク、Talecris Biotherapeutics, Inc.)を含む組成物の1滴(0.05ml)の毎日4回の舌下投与により治療した。
この実施例によれば、タイプ3エーラス・ダンロス症候群と診断された約8年間症候群を患った異なる女性患者を、フェノール食塩水緩衝液(a phenylated saline buffer)中に4TCID50の用量の麻疹ウイルス(Attenuvax(登録商標)、ニュージャージー州、ホワイトハウスステーション、Merck & Co.)、0.008mgのヒスタミン(ワシントン州、スポーカン、Hollister Stier Allergy)、Sigma−Aldrich(Millipore−Sigmaとしても知られている)製の0.002mgの牛由来コラーゲンおよび0.003mgの免疫グロブリン(GamaSTAN(商標)、ノースカロライナ州、リサーチトライアングルパーク、Talecris Biotherapeutics, Inc.)を含む組成物の1滴(0.05ml)の毎日4回の舌下投与により治療した。
この実施例によれば、タイプ3エーラス・ダンロス症候群と診断された症候群を患った中年男性患者を、フェノール食塩水緩衝液(a phenylated saline buffer)中に4TCID50の用量の麻疹ウイルス(Attenuvax(登録商標)、ニュージャージー州、ホワイトハウスステーション、Merck & Co.)、0.008mgのヒスタミン(ワシントン州、スポーカン、Hollister Stier Allergy)、Sigma−Aldrich(Millipore−Sigmaとしても知られている)製の0.002mgの牛由来コラーゲンおよび0.003mgの免疫グロブリン(GamaSTAN(商標)、ノースカロライナ州、リサーチトライアングルパーク、Talecris Biotherapeutics, Inc.)を含む組成物の1滴(0.05ml)の舌下投与により治療した。患者は、痛みの軽減、疲労の軽減および生活の質の向上を報告した。
この実施例によれば、幼年時代以来関節過可動性を有する61歳の女性を治療した。彼女は、遺伝評価によるEDSタイプに関して分類されていないが、現在の専門語ではhEDSを患っているとして分類されるであろう。彼女は、彼女が1週間あたり6日働く小さな販売店のオーナーである。治療を開始する時点で、彼女は、痛み、疲労、関節痛、および彼女の長い就業日を乗り切る困難を訴えた。
hEDS(タイプ3EDS)と診断された27歳の男性は、脆弱性、疼痛および関節脱臼を訴え、眠るのが困難であり、「物忘れ」を患っていると報告した。患者はまた、彼の状態の症候が彼の雇用の維持を困難にしていると報告した。
この実施例によれば、高アーチ型口蓋、関節過可動性、関節痛/脱臼、痣ができやすい異常な皮膚、異常な瘢痕、創傷治癒の遅れ、皮膚伸張および皮膚線条および近視を示した21歳の女性患者は、hEDSと診断され、6/9のブライトンスコアを示した。彼女はまた、軟らかい/もち肌の皮膚、痣のできやすさ、体位性起立性頻拍症候群(POTS)の症候および筋痛を示した。
この実施例によれば、17歳の女性患者は、膝と肩の脱臼の初期症候、慢性疲労および病気(単核球症、連鎖球菌性咽頭炎など)、瘢痕と痣のできやすさ、腺の腫れおよび物忘れを示した。彼女はまた、8/9のブライトンスコアを示し、身体検査は、慢性疲労、全身性疼痛、温/冷に反応性の高い紫がかったもち肌の皮膚を示した。患者はまた、不快であり、泣き、パニック発作などの情緒的障害、および鬱病、握手、疼痛、および全身の刺痛、関節脱臼、過敏性腸症候群、酸逆流、吐き気、疲労、眩暈、嚥下困難、発疹、ドライアイ症候群および口腔内潰瘍を有することを示した。
この実施例によれば、hEDS、cEDSおよび他のEDS変形と診断された患者は、コントロール群と、彼らがリン酸食塩水緩衝液(a phenylated saline buffer)中に4TCID50の用量の麻疹ウイルス(Attenuvax(登録商標)、ニュージャージー州、ホワイトハウスステーション、Merck & Co.)、0.008mgのヒスタミン(ワシントン州、スポーカン、Hollister Stier Allergy)およびSigma−Aldrich(Millipore−Sigmaとしても知られている)製の0.002mgの牛由来コラーゲンを含む3成分組成物の1滴(0.05ml)の毎日4回の舌下投与により治療されたプロトコルに従って治療された治療群とに分けられる。
Claims (13)
- エーラス・ダンロス症候群を患う患者のエーラス・ダンロス症候群症候の治療法であって、前記患者に麻疹ウイルス、ヒスタミンおよびコラーゲンを含む有効量の組成物を投与する工程を含む方法。
- 前記エーラス・ダンロス症候群が、過可動型EDS(hEDS)および古典型EDS(cEDS)の群から選択される、請求項1に記載の方法。
- 前記エーラス・ダンロス症候群が、過可動型EDS(hEDS)である、請求項1に記載の方法。
- 前記エーラス・ダンロス症候群の症候が、疼痛、疲労、関節可動域、嘔吐および生活の質の低下からなる群から選択される1つ以上の症候である、請求項1に記載の方法。
- 前記組成物が、0.4TCID50から400TCID50の、より好ましくは1TCID50から10TCID50の、そして最も好ましくは4TCID50の用量で麻疹ウイルスを含む、方法。
- 前記組成物が、0.001mgから0.1mgの、より好ましくは0.01mgから0.05mgの、そして最も好ましくは0.008mgの用量でヒスタミンを含む、方法。
- 前記ヒスタミンが、水溶性ヒスタミン塩である、請求項1に記載の方法。
- 前記ヒスタミンが、リン酸ヒスタミンである、請求項1に記載の方法。
- 前記組成物が、0.0001mgから0.1mgの、より好ましくは0.001mgから0.01mgの、そして最も好ましくは0.002mgの用量でコラーゲンを含む、方法。
- 前記組成物が、さらに免疫グロブリンを含む、請求項1に記載の方法。
- 前記組成物が、0.0001mgから0.3mgの、より好ましくは0.001mgから0.03mgの、そして最も好ましくは0.003mgの用量で免疫グロブリンを含む、請求項10に記載の方法。
- 前記免疫グロブリンが、ヒト免疫グロブリンである、請求項10に記載の方法。
- 前記免疫グロブリンが、IgGである、請求項10に記載の方法。
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