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TW201615219A - 呼吸系統疾病用藥臨床新應用 - Google Patents

呼吸系統疾病用藥臨床新應用 Download PDF

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TW201615219A
TW201615219A TW104134944A TW104134944A TW201615219A TW 201615219 A TW201615219 A TW 201615219A TW 104134944 A TW104134944 A TW 104134944A TW 104134944 A TW104134944 A TW 104134944A TW 201615219 A TW201615219 A TW 201615219A
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陳丘泓
莊秀美
蕭乃文
梁瑞岳
筱彤 陳
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朗齊生物醫學股份有限公司
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Abstract

本發明提供多種呼吸系統疾病用藥的新臨床之應用。該多種呼吸系統疾病用藥皆是經過衛生署通過核准上市的呼吸系統疾病用藥。本發明提供多種呼吸系統疾病用藥有效的抑制不同類型的癌細胞。

Description

呼吸系統疾病用藥臨床新應用
本發明係為多種呼吸系統疾病用藥的新適應症之應用，尤其該多種藥物為通過臨床實驗且具有抑制多種癌症之用途。
癌症長期高居全球死因之首，且罹患癌症人數更是逐年攀升，因此治療癌症儼然成為重要的課題。癌症的治療可區分為手術治療、放射線治療、化學治療及標靶治療。
一般來說，癌症藥物治療無論是化學治療或標靶治療，目的多是讓癌細胞無法複製、分裂，來阻斷腫瘤的蔓延擴張。在臨床治療選擇上，通常會結合一到數種化療藥物以及標靶治療，希望能藉由不同機制來殺死癌細胞以提高治療效果，但事實上，還是常遇到患者對於治療藥物的反應不佳。進一步，許多癌細胞相繼產生抗藥性，使藥物的使用成效大幅降低，最終導致癌症治療失敗。
呼吸系統疾病(Respiratory Diseases)。是指局限於呼吸系統的疾病。從生理上分為兩類：阻塞性肺病和限制性肺疾病。 從解剖學上可分為：上呼吸道疾病、下呼吸道疾病、肺間質疾病和血管性肺病。其中，阻塞性肺病(Obstructive lung diseases)包含：支氣管炎(Bronchitis)、小支氣管炎(Bronchiolitis)、肺氣腫(Emphysema)、哮喘(Asthma)、慢性阻塞性肺病[Chronic obstructive pulmonary disease(COPD)]、支氣管擴張(Bronchiectasis)、棉塵症(Byssinosis)。而限制性肺疾病(Restrictive lung diseases)包含：肺纖維化(Fibrosis)、結節病(Sarcoidosis)、胸腔積液(Pleural effusion)、過敏性肺炎(Hypersensitivity pneumonitis)、石棉肺(Asbestosis)、胸膜炎(Pleurisy)。感染性肺病(Infectious lung diseases)包含：上呼吸道感染(Upper respiratory tract infections)、下呼吸道感染(Lower respiratory tract infections or Pneumonia)、肺結核(Tuberculosis)。肺間質疾病(Interstitial lung diseases)包含：特發性肺纖維化(Idiopathic pulmonary fibrosis,IPF)、結節病(Sarcoidosis)、塵肺病(Pneumoconiosis)。血管性肺病(Vascular lung diseases)包含：肺水腫(Pulmonary edema)、肺栓塞(Pulmonary embolism)、肺動脈高壓(Pulmonary hypeitension)。
發明人依據長年的研究經驗，人類的癌症細胞常常有與正常細胞具有不同的表現性狀，型態上的差異或是作用機轉的變化或許也有可能被視為一種外來的侵入者，而每一種癌症細胞所在的位置不同，變異的狀態又與所處的環境有關，因此，第一個提 出使用呼吸系統疾病用藥抑制癌症細胞的發明概念並且進行實驗。
相對的，在這些已經使用數十年呼吸系統疾病用藥，是早已被FDA所認可的用藥，具有大量藥物機轉及人體研究成果資料，因此，若應用在癌症方面，這項新發展會更省時、減少成本，也能和其他治療方式結合來提高效果。目前尚未有任何研究針對本發明所使用之藥物，進行癌症治療研究。
儘管如此，藥物開發依然是重要的醫學議題，必須經過繁複的臨床前試驗才能進入臨床試驗，根據統計，平均每一萬個新藥約只有五個能夠進入第一期臨床試驗。此外，除了藥物本身是否能大量製造的難題外，還需克服藥物安全性、病人篩選、試用劑量等問題，即便藥物已經通過FDA的核准並上市，亦有可能因上市後於人體發現不良反應而強制下架回收，由此可見藥物開發具有一定的困難程度。
為解決上述的問題，本發明係針對通過臨床實驗的多種藥物進行新適應症的研發，而達到老藥新用的目標。
經過實驗設計結果顯示呼吸系統疾病用藥對正常細胞沒有或僅有微小的毒性，但至於呼吸系統疾病用藥在正常細胞與腫瘤細胞之間是否具有選擇性的影響，還待更多的研究釐清，而且 並非所有的呼吸系統疾病用藥在相同的條件下均能有效的抑制腫瘤細胞，需要有許多的問題進行克服。
名詞定義
呼吸系統疾病用藥依據藥物的結構可以分為九大類，包含鎮咳用藥、祛痰用藥、平喘用藥、呼吸興奮用藥、感冒用藥、急性支氣管炎用藥、慢性支氣管炎用藥、支氣管哮喘用藥類與其他類。
第一大類：鎮咳用藥通常是通過阻斷咳嗽反射而達到鎮咳目的的一類藥物。鎮咳用藥可作用于中樞神經系統，抑制延腦咳嗽中樞；也可作用於周邊神經系統，抑制咳嗽反射弧中的感受器和傳入神經纖維的末梢。廣義上而言，一個藥物凡有抑制咳嗽反射弧中的任何一個環節，都會具有鎮咳作用。按其作用和機制不同分為兩大類：中樞性鎮咳藥和末梢性鎮咳藥。本發明中的呼吸系統疾病用藥包含在本類別的有Guaifenesin(Guaiphenesin)、Dropropizine、Oxeladin Citrate。
第二大類：祛痰用藥，痰是呼吸道炎癥的產物，其可刺激呼吸道粘膜而引起咳嗽，並可能加重感染的程度。祛痰用藥可稀釋痰液或液化粘痰，使之易於咳出。按其作用方式可將祛痰藥分為三類：①噁心性祛痰藥和刺激性祛痰藥：前者如氯化氟、碘化鉀、 木酚甘油醚、桔梗、等口服后可刺激胃粘膜，引起輕微的噁心反映，反射性地促進呼吸道腺體分泌增加，使痰液稀釋，易於咳出。後者是一些揮發性物質，如校葉油、安息香酊等，將之加入沸水中，其蒸氣亦可刺激呼吸道粘膜，增加腺體分泌，使痰液變稀，易於咳出。②黏液溶解劑：如乙酰半胱氨酸，其可分解痰液的粘性成分如黏多糖和黏蛋白，液化痰液，黏滯性降低而易於咳出。③黏液調節劑：如溴己新和羧甲半胱氨酸，主要作用于氣管、支氣管的黏液產生細胞，促其分泌粘滯性低的分泌物，使呼吸道分泌的流變性恢復正常，痰液由黏變稀，易於咳出。本發明中的呼吸系統疾病用藥包含在本類別的有Acetylcysteine、Erdosteine、Scopolamine hydrobromide、Moguisteine、Emetine、Oxeladin Citrate。
第三大類：平喘藥，是指能作用於哮喘發病的不同環節，以緩解或預防哮喘發作的一類藥物。常用平喘藥可分為以下幾類：①β腎上腺素受體激動劑；②膽鹼受體拮抗劑；③磷酸二酯酶抑制劑；④過敏介質阻釋劑；⑤腎上腺皮質激素類；⑥白三烯受體拮抗劑。哮喘的特點為支氣管平滑肌痙攣性收縮，痰液積滯和呼吸道黏膜充血水腫，於是氣道阻塞，使空氣出入受到阻礙，以呼氣尤為嚴重，呈現喘息性吸入困難。平喘藥能通過不同作用機制而緩解支氣管平滑肌痙攣，使其鬆弛和擴張，因而可以緩解氣急，呼吸困難 的症狀。本發明中的呼吸系統疾病用藥包含在本類別的有Dyphylline(Dilor)、Aminophylline(Truphylline)、Ipratropium bromide、Atropine、Montelukast Sodium、Disodium Cromoglycate。
第四大類：急性支氣管炎用藥，急性支氣管炎是病毒或細菌等病原體感染所致的支氣管黏膜炎症。是嬰幼兒時期的常見病、多發病，往往繼發於上呼吸道感染之後，也常為肺炎的早期表現。本病多同時累及氣管、支氣管，故正確命名應為急性氣管支氣管炎。本發明中的呼吸系統疾病用藥包含在本類別的有Eprazinone。
第五大類：慢性支氣管炎用藥，慢性支氣管炎(chronic bronchitis)是由於感染或非感染因素引起氣管、支氣管黏膜及其周圍組織的慢性非特異性炎症。其病理特點是支氣管腺體增生、黏液分泌增多。臨床出現有連續兩年以上，每持續三個月以上的咳嗽、咳痰或氣喘等症狀。早期症狀輕微，多在冬季發作，春暖後緩解；晚期炎症加重，症狀長年存在，不分季節。疾病進展又可並發阻塞性肺氣腫、肺源性心臟病，嚴重影響勞動力和健康。本發明中的呼吸系統疾病用藥包含在本類別的有Erdosteine、Eprazinone。
第六大類：支氣管哮喘用藥，支氣管哮喘(Bronchial Asthma，簡稱哮喘)，是由多種細胞(比如肥大細胞、嗜酸性粒細胞、T淋巴細胞、中性粒細胞、氣道上皮細胞等)和細胞組分參與的氣道 慢性炎症性疾病。這種慢性炎症與氣道高反應性相關，通常出現廣泛多變的可逆性氣流受限，並引起反覆發作性的喘息、氣急、胸悶、咳嗽等症狀，常在夜間和(或)清晨發作、加劇，多數患者可自行緩解或經過治療緩解。支氣管哮喘如診治不及時，隨著病程的延長可發生氣道不可逆性縮窄和氣道重塑。而當哮喘得到控制後，多數患者很少出現哮喘發作，嚴重哮喘發作則更少見。來自全球哮喘負擔的數據表明，儘管從患者和社會的角度來看，控制哮喘的花費似乎很高，但不正確的治療可導致哮喘反覆發作，治療費用將會更高。因此，合理的防治至關重要。為此，世界各國的哮喘防治專家共同起草，並不斷更新了全球哮喘防治倡議(Global Initiative For Asthma，GINA)。本發明中的呼吸系統疾病用藥包含在本類別的有Tranilast(SB 252218)、Masitinib、Zileuton、Eprazinone、Metaproterenol Sulfate。
本發明提供一種呼吸系統疾病用藥用於製備治療癌症之用途，其中該醫藥組合物係選自由一有效劑量的一呼吸系統疾病用藥及一藥物可接受的鹽類所組成。
本發明一實施例中，其中該鎮咳用藥係選自由Guaifenesin(Guaiphenesin)、Dropropizine、Oxeladin Citrate所組成之藥物。
本發明一實施例中，其中該祛痰用藥係選自由Acetylcysteine、Erdosteine、Scopolamine hydrobromide、Moguisteine、Emetine、Oxeladin Citrate所組成之藥物。
本發明一實施例中，其中該平喘用藥係選自由Dyphylline(Dilor)、Aminophylline(Truphylline)、Ipratropium bromide、Atropine、Montelukast Sodium、Disodium Cromoglycate所組成之藥物。
本發明一實施例中，其中該急性支氣管炎用藥係選自由Eprazinone所組成之藥物。
本發明一實施例中，其中該慢性支氣管炎用藥係選自由Erdosteine、Eprazinone所組成之藥物。
本發明一實施例中，其中該支氣管哮喘用藥係選自由Tranilast(SB 252218)、Masitinib、Zileuton、Eprazinone、Metaproterenol Sulfate所組成之藥物。
本發明一實施例中，其中該癌症係選自由肺癌、腸道癌、大腸直腸癌、前列腺癌、膀胱癌、子宮頸癌、乳癌及血癌所組成之群組。
本發明一實施例中，其中該藥物的有效劑量濃度為20mg/kg/day~500mg/kg/day。
現今癌症藥物費用動輒上萬至數百萬元，若未來更進一步證實呼吸系統疾病用藥對腫瘤的療效，對於無法負擔昂貴治療的患者們，這些便宜而歷史悠久的藥物，會是帶來健康的新希望。
第一圖顯示本發明呼吸系統疾病用藥應用於抑制癌細胞分析結果。
建立細胞株
請參考表一，將不同癌症類型的細胞株進行繼代培養，計算細胞數目後，回種2x106細胞數，然後加入培養該細胞株之培養液補至體積為10ml，繼續培養2-3天。之後將細胞計數，並分裝至96孔盤，其中每孔的細胞數目固定為3000顆，且體積為100ul。
細胞存活分析方法
將96孔盤中原有的培養液吸掉，每孔加入濃度10um、體積100ul的市售藥物，放置72小時後，每孔再加入100ul已稀釋的WST-1試劑，該稀釋比例為培養液與WST-1原液的體積比為9：1，最後每個孔盤的總體積為200ul，然後將96孔盤放置於37度30~90分鐘，利用elisa reader於OD450偵測吸光值，並計算各癌症細胞株之存活率。
呼吸系統疾病用藥應用於抑制癌細胞分析結果
呼吸系統疾病用藥分為九大類，分別為抗感染用藥、鎮咳用藥、祛痰用藥、平喘用藥、呼吸興奮用藥、感冒用藥、急性支氣管炎用藥、慢性支氣管炎用藥、支氣管哮喘用藥類抑制癌 細胞生長的效果。
實驗結果明顯的顯示有許多的呼吸系統疾病用藥並無法有效的抑制癌症的細胞的生長(表二)。
而相對的各種的呼吸系統疾病用藥分子對於各種癌症細胞的抑制效果也不盡相同(圖一)，經過發明人實驗結果，證實呼吸系統疾病用藥藥物Masitinib(AB1010)、Ivacaftor(VX-770)、Tranilast(SB 252218)、Dyphylline(Dilor)、Acetylcysteine、Aminophylline(Truphylline)、Ipratropium bromide、Guaifenesin(Guaiphenesin)、Erdosteine、Disodium Cromoglycate、Chlormezanone(Trancopal)、Urapidil HCl、Lovastatin(Mevacor)、Atropine、abapentin(Neurontin)、Moguisteine、Vitamin C(Ascorbic acid)、Eprazinone 2HCl、Dropropizine、Benzocaine、Metaproterenol Sulfate、Oxeladin Citrate等藥物對於不同的癌症細胞有明顯的抑制效果。(表三)
如表三所示，Masitinib(AB1010)對肺癌，胃癌，直腸癌，皮膚癌有抑制效果；Ivacaftor(VX-770)對肺癌，胃癌，，結腸癌，皮膚癌，前列腺癌，膀胱癌，血癌有抑制效果；Tranilast(SB 252218)對肺癌，胃癌，皮膚癌，前列腺癌有抑制效果；Dyphylline(Dilor)對肺癌，胃癌，膀胱癌有抑制效果；Acetylcysteine對胃癌，膀胱癌，乳癌有抑制效果；Aminophylline(Truphylline)對胃癌有抑制效果；Ipratropium bromide對胃癌有抑制效果；Guaifenesin(Guaiphenesin)對皮膚癌，乳癌有抑制效果；Erdosteine對胃癌有抑制效果；Disodium Cromoglycate對肺癌，胃癌，，結腸癌，前列腺癌，乳癌有抑制效果；Chlormezanone(Trancopal)對肺癌，胃癌，直腸癌有抑制效果；Urapidil HCl對肺癌，胃癌，直腸癌有抑制效果；Lovastatin(Mevacor)對肺癌，胃癌，結腸癌，皮膚癌，前列腺癌，乳癌有抑制效果；Atropine對胃癌，皮膚癌，膀胱癌有抑制效果；Gabapentin(Neurontin)對胃癌有抑制效果；Moguisteine對肺癌，胃癌，肝癌，直腸癌，結腸癌，皮膚癌，前列腺癌，膀胱癌有抑制效果；Vitamin C(Ascorbic acid)對肺癌，胃癌，肝癌，直腸癌，結腸癌，皮膚癌，膀胱癌，乳癌有抑制效果；Eprazinone 2HCl對肺癌，胃癌，直腸癌，皮膚癌，乳癌有抑制效果；Dropropizine對肺癌，胃癌，直腸癌，皮膚癌，乳癌有抑制效果；Benzocaine對直腸癌，皮膚癌，乳癌有抑制效果；Emetine對肺癌，胃癌，肝癌，結腸癌，皮膚癌，前列腺癌，膀胱癌，乳癌，血癌有抑制效果；Metaproterenol Sulfate對肝癌有抑制效果；Oxeladin Citrate對肺癌，胃癌，結腸癌，皮膚癌，乳癌有抑制效果。
重複性實驗
依據表三所示結果，針對對癌症細胞株有效之藥物進行重覆性實驗，其結果如表四所示。
表四、具抑制癌症細胞株之呼吸系統疾病用藥
上列詳細說明係針對本發明之一可行實施例之具體說明，惟該實施例並非用以限制本發明之專利範圍，凡未脫離本發明技藝精神所為之等效實施或變更，均應包含於本發明之專利範圍中。

Claims (9)

  1. 一種呼吸系統疾病用藥用於治療癌症之用途，其中該醫藥組合物係選自由一有效劑量的一呼吸系統疾病用藥及一藥物可接受的鹽類所組成。
  2. 如申請專利範圍第1項所述之用途，其中該呼吸系統疾病用藥係選自由鎮咳用藥、祛痰用藥、平喘用藥、呼吸興奮用藥、感冒用藥、急性支氣管炎用藥、慢性支氣管炎用藥、支氣管哮喘用藥類及其他呼吸系統疾病用藥所組成群組之呼吸系統疾病用藥。
  3. 如申請專利範圍第2項所述之用途，其中該鎮咳用藥係選自由Guaifenesin(Guaiphenesin)、Dropropizine、Oxeladin Citrate所組成之藥物。
  4. 如申請專利範圍第2項所述之用途，其中該祛痰用藥係選自由Acetylcysteine、Erdosteine、Scopolamine hydrobromide、Moguisteine、Emetine、Oxeladin Citrate所組成之藥物。
  5. 如申請專利範圍第2項所述之用途，其中該平喘用藥係選自由Dyphylline(Dilor)、Aminophylline(Truphylline)、Ipratropium bromide、Atropine、Montelukast Sodium、Disodium Cromoglycate所組成之藥物。
  6. 如申請專利範圍第2項所述之用途，其中該急性支氣管炎用藥係選自由Eprazinone所組成之藥物。
  7. 如申請專利範圍第2項所述之用途，其中該慢性支氣管炎用藥係選自由Erdosteine、Eprazinone所組成之藥物。
  8. 如申請專利範圍第2項所述之用途，其中該支氣管哮喘用藥類係選自由Tranilast(SB 252218)、Masitinib、Zileuton、Eprazinone、Metaproterenol Sulfate所組成之藥物。
  9. 如申請專利範圍第1項所述之用途，其中該癌症係選自由肺癌、腸道癌、大腸直腸癌、前列腺癌、膀胱癌、子宮頸癌、乳癌及血癌所組成之群組。
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