TW201424729A - 用於治療創傷後壓力症候群之方法 - Google Patents
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- TW201424729A TW201424729A TW102134108A TW102134108A TW201424729A TW 201424729 A TW201424729 A TW 201424729A TW 102134108 A TW102134108 A TW 102134108A TW 102134108 A TW102134108 A TW 102134108A TW 201424729 A TW201424729 A TW 201424729A
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Abstract
本發明之實施態樣一般而言係有關用於治療人類之創傷後壓力症候群之方法及補充劑。
Description
本發明之實施態樣一般而言係有關用於治療創傷後壓力症候群之方法及補充劑。
創傷後壓力症候群(PTSD)係一嚴重焦慮症,其可在暴露於任何造成心理創傷之事件後發展出。此事件可涉及對自己或別人之死亡威脅,其通常壓倒該個人之應付能力。作為心理創傷之影響,相較於更常見之急性壓力反應,PTSD較不頻繁且更持久。PTSD之診斷症狀包含經由回閃或惡夢重複經歷該原始創傷、閃避與該創傷相關之刺激以及增加之喚起性-諸如難以入睡或難以保持睡眠、憤怒及高警覺性(hypervigilance)。
創傷後壓力症候群被歸類為一種焦慮症,其特徵是暴露於一心理創傷之事件後(有時數個月後)所發展出的與焦慮相關之厭惡的經歷、行為及生理反應。其特徵持續超過30天,此與短期的急性壓力疾患有所區別。此等持續性創傷後壓力症狀對生活功能之一或多個重要領域造成顯
著之破壞。
雖然大部分的人(50-90%)於一生中遭遇創傷,僅約8%發展成完全的PTSD。易於罹患PTSD被認為是源於生物素質、早期童年發展之經歷及創傷嚴重性之交互作用。
多種藥物在減少PTSD症狀已顯示有附加的益處,然而目前對PTSD並沒有明確的藥物治療。陽性症狀(重複經歷、高警覺性、增加之喚起性)一般而言相較於陰性症狀(閃避、退卻)對藥物有較佳之反應,以及任何藥物試驗建議維持至少6-8週。
已被用於症狀管理之藥物類別包括:SSRIs(選擇性血清素再攝取抑制劑,諸如西酞普蘭(citalopram)、依他普崙(escitalopram)、氟西汀(fluoxetine)、氟伏沙明(fluvoxamine)、吡咯希定(paroxetine)及舍曲林(sertraline));抗憂鬱劑(諸如安非他酮(bupropion)、文拉法辛(venlafaxine)、舍曲林(sertraline)、氟西汀(fluoxetine)、奈法唑酮(nefazodone)、雜環及帕羅西汀(paroxetine));甲型腎上腺受體拮抗劑(諸如哌唑嗪(prazosin)及可樂定(clonidine));抗痙攣劑、情緒穩定劑、抗侵略劑(anti-aggression agents)(諸如卡巴氮平(carbamazepine)、唑吡坦(zolpidem)、拉莫三嗪(lamotrigine)、偉伯益酸(valproic acid)及丁螺環酮(buspirone));抗精神病藥物;非典型抗憂鬱劑(諸如奈法唑酮(nefazodone)及曲唑酮(trazodone));乙種腎上腺阻斷劑;苯二氮平類藥物;糖皮質素;雜環/三環抗憂鬱劑(諸如阿米替林(amitriptyline)及伊米胺
(imipramine));以及單胺氧化酶抑製劑(MAOIs)。已被用於症狀預防之藥物類別包含:甲型腎上腺受體拮抗劑;乙種腎上腺阻斷劑;及糖皮質素。
已觀察到睡眠開始之低生長激素曲線與PTSD之睡眠問題之間有一直接相關性。(參見van Liempt,Decreased nocturnal growth hormone secretion and sleep fragmentation in combat-related posttraumatic stress disorder;potential predictors of impaired memory consolidation,Psychoneuroendocrinology(2011)36,1361-1369)。
提供一用於治療創傷後壓力症候群之營養補充劑係所欲的。
在此所描述的是有關營養補充劑及使用該補充劑之方法。該營養補充劑包含一胺基酸促泌素(secretagogue)組成物,其當口服服用能刺激該腦下垂體釋放hGH。
一些實施態樣包含一口服營養補充劑,其包含L-精胺酸、氧代-脯胺酸及L-離胺酸。
本揭露內容之一特定實施態樣係有關於一口服營養補充劑,其包含l-離胺酸、l-精胺酸、氧代-脯胺酸及半胱胺酸或麩胺醯胺酸之一者等胺基酸。該等胺基酸可以其無毒鹽類、其有效錯合物、其穩定螯合物、其活性酯類、其功能性衍生物及其等之混合物被傳遞,其於增加一般民眾之hGH位準係有效的。
另一特定之態樣係關於一口服營養補充劑,其基本上係由下列所組成:l-離胺酸HCl、l-精胺酸HCl、氧代-脯胺酸、N-乙醯-l-半胱胺酸、l-麩胺醯胺酸及荊芥(schizonepeta)(地上部分)粉末。
其他態樣係有關於治療人類之創傷後壓力症候群之方法,其包括口服施予該所揭露之營養補充劑於患有創傷後壓力症候群之人類。
圖1顯示持續使用該補充劑,隨時間之入睡時間的線性回歸分析:以及圖2顯示持續使用該補充劑,隨時間之睡眠中清醒的時間。
本發明係關於一供人類使用之營養補充劑。本發明係針對一營養補充劑及使用該補充劑之方法。該營養補充劑係一胺基酸促泌素組成物,其當以口服服用可治療一或多種創傷後壓力症候群(PTSD)之症狀。本發明之補充劑作為一膳食補充劑,其藉由協助身體自己的能力,以安全且有效之方式治療PTSD,其同時是平價的。
本揭露內容之一特定態樣係關於一口服營養補充劑,其包含l-離胺酸、l-精胺酸、氧代-脯胺酸,以及半胱胺酸或麩胺醯胺酸二者之一。該補充劑可額外包含半胱胺酸及麩胺醯胺酸兩者,及/或荊芥粉末。在特定之態樣中,
一功能性劑量包含一位準在0.1-6mmol之間之該l-精胺酸及0.1-8mmol之間之該氧代-脯胺酸,及/或含量在0.1-12mmol之間之該l-離胺酸。該半胱胺酸及/或麩胺醯胺酸可以位準0.001-6mmol之間被包含。在特定之態樣中,一功能性劑量包含一位準在2.5-4.5mmol之該l-精胺酸及4-6mmol之間之該氧代-脯胺酸,及/或含量在7-9mmol之間之該l-離胺酸。該半胱胺酸及/或麩胺醯胺酸可以位準0.001-0.5mmol之間被包含。該半胱胺酸可以是n-乙醯基L-半胱胺酸以及該麩胺醯胺酸可為l-麩胺醯胺酸。該等胺基酸可被以下列形式投遞:其無毒性鹽類、其有效錯合物、其穩定螯合物、其活性酯類、其功能性衍生物及其等之混合物,其係有效於增加一般民眾之hGH位準。該營養補充劑可以2.9克之量存在。該營養補充劑可以是任何可接受及已知之口服製劑,諸如粉末、錠劑、膠囊、液體或薄片(wafer)形式。
另一特定之態樣係關於一口服營養補充劑,其基本上係由下列所組成:l-離胺酸HCl、l-精胺酸HCl、氧代-脯胺酸、N-乙醯-l-半胱胺酸、l-麩胺醯胺酸及荊芥(地上部分)粉末。在特定之態樣中,一功能性劑量包含一位準在0.1-6mmol之間之該l-精胺酸HCl及0.1-8mmol之間之該氧代-脯胺酸,及/或含量在0.1-12mmol之間之該l-離胺酸HCL。該n-乙醯基L-半胱胺酸及/或l-麩胺醯胺酸可以0.001-6mmol之間之位準被包含。在另一特定之態樣中,一功能性劑量包含一位準在2.5-4.5mmol之間之該l-精胺酸HCl及4-6mmol之間之該氧代-脯胺酸,及/或含量在7-9
mmol之間之該l-離胺酸HCL。該n-乙醯基L-半胱胺酸及/或l-麩胺醯胺酸可以0.001-0.5mmol之間之位準被包含。該營養補充劑可以是任何可接受的及已知之口服製劑,諸如粉末、錠劑、膠囊、液體或薄片形式。
其他態樣係有關於增加人類之人類生長激素之方法,其包含口服施予該所揭露之營養補充劑於一健康人類。在此所用之「健康人類」,其意指無關年齡沒有任何hGH之生理缺陷的人類。本發明之特定態樣係關於口服施予該所揭露之營養補充劑於一至少30歲之人類。該營養補充劑可以每日自一至三次施予,或者,可以隔日施予,或可以一週一次施予。於特定態樣中,該營養補充劑可空腹施予。
依照「基本上由...組成」及「基本上以...組成」之語句,該第三態樣之該營養補充劑基本上係受限於該等前述之成分,且不包含任何意圖添加營養成分(如維他命、礦物質等)之額外活性成分,但可包含非意圖添加營養成分之額外成分,諸如意圖滿足一非營養性之目的(如著色劑、填充劑、調味劑、用於維持該結構型式之成分等)。
本發明之該營養補充劑之每一成分可依照一熟習此藝者已知之任何方法製備。或者,每一成分可從一完整製備之市售來源所獲得。
本發明之該營養補充劑可為任何合適之口服施予型式,其包含但不限於:一咀嚼劑型式、一液體型式、一噴霧型式、一膠囊型式、一栓劑型式、可溶性薄片及一粉末型式。
無關該營養補充劑之結構型式,該營養補充劑之該等成分可均質地或非均質地分布於該營養補充劑中。
本發明之該營養補充劑可定期攝入,諸如每天或每週攝入一根據個人所需求之劑量;例如,該營養補充劑係根據該個人之需求以該結構單元(片劑、錠劑、膠囊、液體劑量等)之倍數(1x、2x等)被定期服用。例如,相較於一從事經常性劇烈運動之年輕人,一生活主要久坐的老年人可能需要較高之每日劑量。或者,本發明之該營養補充劑可根據個人所需劑量,以視需要攝入。醫學或營養諮詢可有利於達成根據該個人需求之一理想的或最佳的劑量。
該等胺基酸之種類的組合、質量及特定製劑係被選擇以達協同性平衡的,且其量係足夠以達到所欲之生理效果,即,PTSD症狀之治療。該等胺基酸之不合適之組合可能係無效的。該等胺基酸組份當它們之幾個結合在一起時,在此意義上係具協同性的,其能協同地治療一或多種PTSD之症狀。該組合物亦是經選擇來減少或抑制該等胺基酸之間的化學性組合或反應。
一雙盲研究,其涉及15位健康受試者[10位男性、5位女性;平均年齡=33±7歲]。每一受試者完成一基線之愛普渥斯嗜睡度量表(Epworth Sleepiness Scale)自我報告問卷以及一平時睡眠習慣之標準化的檢測。所有受試者
皆被視為有在正常範圍內之平均睡眠參數。
該等受試者接著被提供三週之新穎的SeroVital補充劑(每劑量2.9g,其為下列之混合劑:l-離胺酸HCl、l-精胺酸HCl、氧代-脯胺酸、N-乙醯-l-半胱胺酸、l-麩胺醯胺酸及荊芥(地上部分)粉末)。該新穎的SeroVital混合劑先前已顯示於健康男性或女性志願者中,在使用單一劑量120分鐘後能使血清中人類生長激素hGH之位準增加八倍(等同於682%)。由於夜間hGH之起始係與睡眠效率直接相關,我們調查研究了三週之睡眠模式,其間伴隨持續使用該補充劑,該補充劑係於每晚在晚餐後兩小時、就寢前空腹服用。於每一試驗日,受試者報告1)就寢時間;2)最終醒來之時間;3)估計之入睡所需時間;4)睡眠中醒來之時間/清醒時間之長度。以日為單位將估計之入睡所需時間及睡眠中清醒之時間長度的數據彙整藉以評估睡眠效率。每天每一量測值係以該等受試者之平均值(±S.D.)對上該研究之該段時間所繪製,以及一線性回歸表係用以評估隨著時間之整體趨勢。該分析包含了所有可用數據。
線性回歸分析顯示估計之入睡所需時間(圖1)及睡眠中清醒之時間(圖2)伴隨著於該研究之該段時間持續使用該補充劑,兩者皆傾向於隨著時間減少。入睡所需時間每日減少了-0.24分鐘之平均斜率,而睡眠中清醒之時間每日減少了-0.26分鐘之平均斜率。整體而言,伴隨規律之夜間使用該新穎之SeroVital補充劑(當依指示於晚餐後兩小時、就寢前空腹服用),藉由入睡所需時間及睡眠中清醒
之時間兩者之量測,其兩者經過三週具有經量化之平均減少約每日0.25分鐘之該等結果顯示一趨勢朝向較佳之睡眠效率。
透過門診診所及退伍軍人事務醫療中心(Veteran Affairs Medical Centers)招募患有PTSD之退伍軍人。創傷控制組(TC;沒有PTSD之退伍軍人)及健康控制組(HC;從未被部屬之服務成員或平民)。控制組與PTSD群組係經年齡、發展疾病之年數(TC)及發展之區域(TC)配對。所有參與者係經精神病篩選。其PTSD之診斷係經由臨床醫生管理的PTSD量表(Clinician Administered PTSD Scale(CAPS))確認,以及病人得到評量分數超過50且除了情緒及焦慮症之外無精神病係被包含。該等TC組當符合PTSD之標準(經歷、見證或面對涉及自己或他人實際或死亡威脅或嚴重外傷之事件),但具有低於18之CAPS分數者係被包含。所有參與者係醫學上健康之個體且於過去六個月並無精神藥物之使用及酒精依賴或藥物依賴。所有控制組受試者皆無精神病史且無睡眠之抱怨。
連續兩晚之睡眠登記係於睡眠實驗室中執行。取得之睡眠記錄包含EMG之雙極衍生、垂直及水平眼球運動之EOG、EEG及ECG。
於第二個晚上入睡前三小時給予一項15字任務以評估陳述性記憶之鞏固。十五個中性一個音節的字以視
覺呈現於一電腦螢幕並重複三次。跟隨每一呈現之後是一自由的立即回想,並於隔天早上清醒後30-45分鐘被評估。
睡眠數據係以30秒之時期,由一有經驗的睡眠技術人員分析,該技術人員對於PTSD診斷係被蒙蔽的。針對前半夜晚之第2期睡眠(Stage 2 sleep)、慢波睡眠(slow wave sleep)或快速眼動睡眠(rapid eye movement sleep)的自主覺醒次數係被測定。總睡眠時間亦被測定。
雖然本發明之實施態樣作為說明目的已在此被描述,諸多修飾及改變對於那些熟習此藝者將是顯而易見的。因此,所附之申請專利範圍旨在涵蓋所有落在本發明之真正的精神及範圍內所有之這些修飾及改變。
Claims (23)
- 一種治療人類之創傷後壓力症候群之方法,其包含:提供一口服營養補充劑,其包含:L-精胺酸;氧代-脯胺酸;及L-離胺酸;及對一展現一或多種創傷後壓力症候群之症狀的人類口服施予該營養補充劑。
- 如請求項1之方法,其中該l-精胺酸係以每一份介於0.1-6mmol間之位準被包含。
- 如請求項1之方法,其中該氧代-脯胺酸係以每一份介於0.1-8mmol間之位準被包含。
- 如請求項1之方法,其中該l-離胺酸係以每一份介於0.1-12mmol間之位準被包含。
- 如請求項1之方法,其中該等胺基酸可以下列形式被投遞:其無毒性鹽類、其有效錯合物、其穩定螯合物、其活性酯類、其功能性衍生物及其等之混合物,其係有效於增加一般民眾之hGH位準。
- 如請求項1之方法,其中該營養補充劑係以2.9克之量存在。
- 如請求項1之方法,其中該營養補充劑係呈粉劑、錠劑、膠囊、液體或薄片之型式。
- 如請求項1之方法,其中該營養補充劑係每天自一至三 次施予。
- 如請求項1之方法,其中該營養補充劑係一週一次施予。
- 如請求項1之方法,其中該營養補充劑係於空腹施予。
- 如請求項1之方法,其中對一健康人類口服施予該營養補充劑包含對一女性口服施予該營養補充劑。
- 如請求項1之方法,其中對一展現一或多種創傷後壓力症候群之症狀的人類口服施予該營養補充劑包含口服施予該營養補充劑至一展現一或多種下列症狀的人類:經由回閃或惡夢重複經歷該原始創傷、閃避與該創傷相關之刺激、增加之喚起性、難以入睡或難以保持睡眠、憤怒或高警覺性(hypervigilance)。
- 一種治療人類之創傷後壓力症候群之方法,其包含:提供一口服營養補充劑,其包含:L-精胺酸HCl;氧代-脯胺酸;L-離胺酸HCl;以及n-乙醯-l-半胱胺酸、l-麩胺醯胺酸或兩者;其中該l-精胺酸係以每一份介於0.1-6mmol間之位準被包含,該氧代-脯胺酸係以每一份介於0.1-8mmol間之位準被包含,以及該l-離胺酸係以每一份介於0.1-12mmol間之位準被包含;以及對一展現一或多種創傷後壓力症候群之症狀的人類口服施予該營養補充劑。
- 如請求項13之方法,其中該N-乙醯-L-半胱胺酸係以每 一份介於0.001-6mmol間之位準被包含。
- 如請求項13之方法,其中該營養補充劑係以2.9克之量存在。
- 如請求項13之方法,其中該營養補充劑係呈粉劑、錠劑、膠囊、液體或薄片之型式。
- 如請求項13之方法,其中該營養補充劑係每天自一至三次施予。
- 如請求項13之方法,其中該營養補充劑係一週一次施予。
- 如請求項13之方法,其中該營養補充劑係於空腹施予。
- 如請求項13之方法,其進一步包含L-麩胺醯胺酸。
- 如請求項13之方法,其進一步包含荊芥(schizonepeta)(地上部分)粉末。
- 如請求項13之方法,其中對一健康人類口服施予該營養補充劑包含對一女性口服施予該營養補充劑。
- 如請求項13之方法,其中對一展現一或多種創傷後壓力症候群之症狀的人類口服施予該營養補充劑包含口服施予該營養補充劑至一展現一或多種下列症狀的人類:經由回閃或惡夢重複經歷該原始創傷、閃避與該創傷相關之刺激、增加之喚起性、難以入睡或難以保持睡眠、憤怒或高警覺性。
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