AtopiclairTM 愛妥麗敷料擺脫皮膚炎的惡性循環!

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丰絮乘姜
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1 控制異位性皮膚炎擺脫癢抓傷惡性循環的新方法 - 耳鼻喉醫師觀點鄭元凱 M.D., Ph.D.

2 Atopic Dermatitis (AD) Atopic dermatitis is defined as a chronic, relapsing, inflammatory disorder of the skin 1 characterised by an itchy red rash that starts in infants and affects mainly children. There are periods of time - when the disease is worse (called exacerbations or flares) followed by periods when the skin improves or clears up entirely (called remissions). flares remissions 1. Leung & Bieber, Lancet 2003;361:151-60

There are periods of time - when the disease is worse (called exacerbations or flares) followed by periods

3 異位性皮膚炎 (AD) 病理學上診斷判定異位性皮膚炎的條件, 須符合下列條件三項或以上 : 皮膚搔癢濕疹樣皮膚炎或苔癬化皮膚炎, 同時病灶符合位置慢性持續或反覆性皮膚炎長達六個月以上個人或家族有異位性體質 Guideline: Taiwan society of pediatric allergy, asthma and immunology

4 Atopic Dermatitis 主要的臨床症狀極度的癢 : 病人會無法忍耐地一直搔抓, 最可怕的是晚上睡覺時特別癢, 因此對白天上課或上班的影響非常大皮膚乾燥

5 Prevalence & Incidence of AD 異位性皮膚炎影響全球 5~20% 的孩童 1 常從嬰兒時期 2-6 個月開始 2 45% 的 AD 患者 6 個月前就開始出現病症 6 60% 的 AD 患者 12 個月前就開始出現病症 6 65% 的 AD 患者 18 個月前就開始出現病症 5 90% 的 AD 患者 5 歲前就開始出現病症 3 75% 的人在 14 歲前會明顯改善異位性皮膚炎的嚴重度 ( 只有不到 50% 的人在 7 歲前會明顯改善 5 ); 然而, 剩餘 25% 以上的孩童會一直復發, 延續症狀直到成年期 2 臺灣的盛行率約 8~10% 4 美國的盛行率約 11~17% 5 1. Weston WL, Howe W. Epidemiology, clinical manifestations, and diagnosis of Atopic Dermatitis (eczema). [cited on 30th March 2011]. Available from: URL: Ong PY, Boguniewicz M. Atopic dermatitis. Prim Care. Mar 2008;35(1):105-17, vii. 4. 長庚醫訊 30 卷 4 期 5.Immunol Allergy Clin North Am Aug;30(3): Williams H et al. J Allergy Clin Immunol Jan;103(1 Pt 1): Hwang CY et al. Acta Derm Venereol Nov;90(6): Illi S et al. J Allergy Clin Immunol May;113(5):

4 美國的盛行率約 11~17% 5 1. Weston WL, Howe W. Epidemiology, clinical manifestations, and diagnosis of Atopic Dermatitis (eczema). [cited on 30th March 2011]. Available from: URL:http://www.uptodate.

6 異位性皮膚炎對生活品質的衝擊 (Impacts on Quality of Life) 異位性皮膚炎並不被視為很嚴重的疾病情況, 但會對患者生活品質造成很大負面的影響主要的衝擊有 : 減少睡眠 ( 平均達 2.5 小時 ) 1 兒童兒童 : 學習問題, 情緒冷淡成人 : 工作問題兒童自尊有負面的影響 2, 會覺得因自己與他人不同而感到沮喪皮膚不適 2 明顯搔癢疼痛等不適感, 情緒不穩定 1. Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006;60(8): Astellas Pharma Europe Ltd.

5 小時 ) 1 兒童兒童 : 學習問題, 情緒冷淡成人 : 工作問題兒童自尊有負面的影響 2, 會覺得因自己與他人不同而感到沮喪皮膚不適 2 明顯搔

7 Atopic dermatitis and the atopic march AD could be the first step in the atopic march Approximately 75-80% of AD patients develop allergic rhinitis (AR) More than 50% of AD patients develop asthma J Allergy Clin Immunol Dec;112(6 Suppl):S Atopic dermatitis and the atopic march.

rhinitis (AR) More than 50% of AD patients develop asthma J Allergy Clin

8 Atopic march from eczema to asthma and/or AR - Skin Barrier dysfunction TSLP(thymic stromal lymphopoietin) Allergy Oct 14. doi: /all.12268

9 Pediatrics dermatology-- 寶寶肌膚比成人薄 30% 成長中幼兒肌膚還在發育中, 皮膚比成人薄了 30%, 角質間隙大肌膚水分容易流失與大人皮膚相比, 嬰幼兒皮膚構造及功能更是不同遭受不良化學物質刺激後, 影響結果會較大人明顯, 也因此更容易被外界物質影響親子天下

10 FLG gene mutation FLG (filaggrin): 聚絲蛋白, 皮膚屏障的一種關鍵蛋白

11 Treatment Options 治療選擇 Skin care 皮膚照護擬訂日常護膚程序是預防紅斑發生的首要法則乳霜和軟膏在修復皮膚上的成效較佳每天清潔皮膚, 並於沐浴或淋浴後立即在尚未擦乾的皮膚上塗抹潤膚劑是基本動作清潔皮膚有助於趕走細菌和刺激原 Wet wrap therapy 潮溼包覆療法滋潤皮膚能減少磨擦和肌膚龜裂的情況 Protection from allergens exposure 避免暴露於過敏原環境中減少暴露過敏的環境或飲食 11

本動作清潔皮膚有助於趕走細菌和刺激原 Wet wrap therapy 潮溼包覆療法滋潤皮膚能減少磨擦和肌膚龜

12 Guideline 2007 NICE Eczema treatment guideline

13 Atopiclair approved by FDA - Indications for Use Under the supervision of a healthcare professional, the product is intended for the management and relief of burning, itching and redness associated with various types of dermatoses, including atopic dermatitis, radiation dermatitis and allergic contact dermatitis. may be used to relieve the pain of first and second degree burns. helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

dermatitis, radiation dermatitis and allergic contact dermatitis.

14 Atopiclair TM 愛妥麗敷料 FDA indication atopic dermatitis, radiation dermatitis, allergic contact dermatitis. may be used to relieve the pain of first and second degree burns. helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

may be used to relieve the pain of first and second degree burns.

15 醫療級 Atopiclair 愛妥麗打破皮膚癢抓傷的惡性循環 breaking the itch-scratch cycle

Atopiclair Mechanism of Action - Three in One REPAIRS Hydrating and repairing Barrier Function Hyaluronic acid Shea Butter The most powerful moisturiser known PROTECTS Itch Management/ Protection

16 Atopiclair Mechanism of Action - Three in One REPAIRS Hydrating and repairing Barrier Function Hyaluronic acid Shea Butter The most powerful moisturiser known PROTECTS Itch Management/ Protection Telmesteine Vitis Vinifera Vitamin C, E Limits the damage caused by elastase, collagenase and matrix proteinases Management of Inflammation Glycyrrhetinic acid Demonstrated (in vitro) ability to inhibit 11-β-hydroxysteroid hydrogenase, an enzyme responsible for metabolising hydrocortisone Synergistic action of key ingredients CALMS

elastase, collagenase and matrix proteinases Management of Inflammation Glycyrrhetinic acid Demonstrated (in vitro) ability to

17 Atopclair as prescription To purchase this item, you must have a valid prescription. Usage/Instructions Please take Atopiclair Cream 100ml as prescribed by your doctor or medical professional. Direction details will be available on your medication container.

Usage/Instructions Please take Atopiclair Cream 100ml as

18 醫療級 Atopiclair 愛妥麗效能限醫療器材管理辦法水性創傷與燒傷覆蓋材 (I.4022) 第一等級鑑別範圍醫器主類別一醫器次類別一 I 一般及整型外科手術裝置 I 4022 水性創傷與燒傷覆蓋材 I.4022 水性創傷與燒傷覆蓋材 Hydrogel wound dressing and burn 鑑別 : 水性創傷與燒傷覆蓋材為具有醫療用途之未滅菌或已滅菌器材其功能為直接敷蓋於傷口上以吸收傷口分泌物 (exudate) 控制出血或體液流失避免擦傷摩擦乾燥其材料為親水性非水解聚合物或其他含水材質 ( 水分至少需 50%), 用以吸收傷口分泌物 * Ref. TFDA * 分級 : (1) 適用於第三級燒燙傷免縫 ( 可取代外科縫線 ) 添加藥品具有動物來源之材料含有抑菌成分等屬於第二等級 ; (2) 非屬於第二等級列舉項目屬於第一等級

4022 水性創傷與燒傷覆蓋材 Hydrogel wound dressing and burn 鑑別 : 水性創傷與燒傷覆蓋材為具有醫療用途之未滅菌或已滅菌器材其功能為直接敷蓋於傷口上以吸收傷

19 Efficacy of Hydration Study A Double-Blind, Vehicle-Controlled Study - Atopiclair provided the skin barrier to reduce water lose - Atopiclair provides hydration up to 72 hours 18-65yrs Health n=20 Sodium lauryl sulfate (SLS) 24hrs R Atopiclair Vehicle 0% Reduce Transepidermal Water Loss (TEWL) 24 hrs 48 hrs 72 hrs Atopiclair = Placebo Vehicle plus some key ingredients including hyaluronate, GrA, vitis vinifera extract, and telmestine. -10% A Double-Blind, Vehicle-Controlled Study Sulphate-Induced Irritant Contact Dermatitis -20% Transepidermal Water Loss (TEWL) as indicator of skin water barrier alteration Baseline: TEWL 20 (g/m 2 /h) after 24hrs irritant. -30% -40% p=0.056 p=0.02 Atopiclair demonstrated benefit over vehicle clinically meaningful outcomes. -50% Atopiclair Placebo p= % Zhai et al. Exog Dermatol 2003;2: Tested by Tewameter (TM 210)

GrA, vitis vinifera extract, and telmestine.

Efficacy of Hydration Study A Double-Blind, Vehicle-Controlled Study - Atopiclair provided the skin barrier to reduce water lose - Atopiclair provides hydration up to 72 hours Blood flow volume (BFV)

20 Efficacy of Hydration Study A Double-Blind, Vehicle-Controlled Study - Atopiclair provided the skin barrier to reduce water lose - Atopiclair provides hydration up to 72 hours Blood flow volume (BFV) Skin color Atopiclair Atopiclair Parameter for inflammation Measured with Laser Blood Flow Monitor MBF3D Erythema was quantified by skin color reflectance Measurements using a colorimeter (Chroma Meter CR 300, Minolta, Osaka, Japan). Zhai et al. Exog Dermatol 2003;2: Tested by Tewameter (TM 210)

inflammation Measured with Laser Blood Flow Monitor MBF3D Erythema was quantified by skin color reflectance Measurements

療級 Atopiclair achieves fast relief from itch in less than 3 minutes Patients with mild-tomoderate AD were randomized to treatment with Atopiclair (n=72) or vehicle (n=70) for 43 days.

21 療級 Atopiclair achieves fast relief from itch in less than 3 minutes Patients with mild-tomoderate AD were randomized to treatment with Atopiclair (n=72) or vehicle (n=70) for 43 days. Assessment of itch (both Visual Analogue Scale (VAS) and ordinal scale) over time was performed using the Student s t test. Atopiclair demonstrates fast onset of itch relief in in 2.42 minutes. Atopiclair achieves fast relief from itch in less than 3 minutes Boguniewicz M. et al. J Pediatr. 2008; 152:

22 Atopiclair achieves fast relief from itch in less than 3 minutes Boguniewicz M. et al. J Pediatr. 2008; 152:

MSA063DP (Atopiclair) cream in AD infants and children study A Multicenter, Randomized, Vehicle-Controlled Study 6 M-12yrs, AD pts (Hanifin&Rajka s criteria) 3 major + 3 minor Study Design:

23 MSA063DP (Atopiclair) cream in AD infants and children study A Multicenter, Randomized, Vehicle-Controlled Study 6 M-12yrs, AD pts (Hanifin&Rajka s criteria) 3 major + 3 minor Study Design: Randomized Double-blind, Parallel-group Vehicle-controlled The vehicle used in the study was a cream with an emollient base similar to that of AS063DP, such as ethylhexyl palmitate and glyceryl stereate, without the key ingredients including GrA, vitis vinifera extract, and telmestine. R Day Atopiclair n=72; 3 times daily Vehicle n=70; 3 times daily Primary endpoint: IGA at day 22 (Investigator s Global Assessment) Secondary endpoints: IGA scores at other time points Subject/caregivers assessment of pruritus (100 mm VAS scale and 0-3 ordinal scale), Oset and duration of itch relief, Eczema Area and Severity Index (EASI) at study visits, subject/caregivers assessment of global response, Need for rescure medication in the event of an AD flare. J Pediatr 2008;152:

24 Investigator's Global Assessment (IGA) 紅斑, 丘疹, 滲出, 結痂 24

Atopiclair clear eczema in as early as 8 days with 77% treatment success by Day 22 Pediatric patients with mildto-moderate AD were randomized to treatment with Atopiclair (n=72) or vehicle (n=70) for

25 Atopiclair clear eczema in as early as 8 days with 77% treatment success by Day 22 Pediatric patients with mildto-moderate AD were randomized to treatment with Atopiclair (n=72) or vehicle (n=70) for 43 days. Investigator s global assessment on percentage of success. 39% of pediatric patients clears atopic dermatitis in as early as 8 days, versus 0% in vehicle group. 77% treatment success by Day 22 Atopiclair clear eczema in as early as 8 days with 77% treatment success by Day 22 Boguniewicz M. et al. J Pediatr. 2008; 152:

26 療級 ATOPICLAIR 愛妥麗敷料適用對象安全, 不含類固醇, 抗組織胺, 針對受損皮膚引起不適的嬰幼兒及成年患者皆可長期使用何時及如何使用每日二到三次或需要時取適量塗在皮膚後輕輕按摩以助吸收與藥物併用先使用外用藥物, 間隔時間至少分鐘後再取適量的 ATOPICLAIR 愛妥麗敷料在皮膚上輕輕按摩以助吸收

27 醫療級 Atopiclair Cream vs Atopiclair Lotion 愛妥麗保濕敷料與敷料 Atopiclair Cream 保濕敷料 Atopiclair Lotion 敷料包裝大小 40ml, 100ml 120 ml 包裝規格 Tube Bottle 延展性中等較好防腐劑 2 - Piroctone Olamine & DMDM Hydantoin 1 - Piroctone Olamine 有效期 3 years 3 years 產品顏色粉紅 - original vitis vinifera 白色 glycol ( 乙二醇 ) extract of vitis vinifera 毛髮處尚可建議適用局部小範圍身體大範圍治療期維持期 27

28 Atopiclair listing - Medical Center 臺北榮民總醫院台大醫院馬偕紀念醫院長庚醫療財團法人三軍總醫院臺北醫學大學附設醫院雙和醫院亞東紀念醫院醫國泰綜合醫院新光吳火獅紀佛教慈濟醫療中國醫藥大學附設醫院彰基醫療財團中山醫學大學附設醫院成功大學醫學院附設醫院奇美醫院高雄榮民總醫院高雄醫學大學附設醫院義大醫院

29 AD treatment: Topical Therapy Emollients Topical corticosteroids Topical calcineurin inhibitors Wet-wrap therapy Treatments for infections Emollient in guideline: Brand Class Evidences / Reference Atopiclair TM Medical device FDA approved indication for AD treatment Repair Protection J Pediatr. 2008; 152(6): Pediatr Allergy Immunol. 2008; 19(7): J Drugs Dermatol. 2006;5(3): J Drugs Dermatol. 2005;15(1): 31-6 Eur J Dermatol. 2005;15(1):31-6 Ref. Taiwan Atopic Dermatitis Diagnosis & Treatment Guideline

30 Taiwan AD Management Algorithm Mild Mild lesion Moderate Severe lesion <10% Severe Severe lesion 10%-30% Emollients Very Severe Severe lesion >30% (Low Potent)-> Topical Corticosteroids -> (High Potent) Antihistaminics (As needed) Pimecrolimus Tarcrolimus Oral Corticosteroids Ref. Taiwan Atopic Dermatitis Diagnosis & Treatment Guideline Phototherapy Systemic immune modulators

31 醫療級什麼是 ATOPICLAIR 愛妥麗敷料 Atopiclair 是一種保護皮脂膜之敷料, 不含類固醇抗組織胺香料及苯甲酸酯, 經美國 FDA 認可按照指示使用, 其可形成保護有助於受捐皮膚症狀的改善, 可防止表皮水分流失 (Trans-Epidermal Water Loss; TEWL), 幫助維持皮膚濕潤, 避免皮膚乾, 達到長效保濕保護的效果短時間內舒緩受捐皮膚引起的乾燥及肌膚不適臨床實驗證實, 使用 Atopiclair, 短時間內即可改善受損肌膚帶來的不適懷孕婦女可以使用 Atopiclair 愛妥麗敷料系列嗎? Atopiclair 愛妥麗敷料沒有針對使用於懷孕婦女的臨床研究, 對於那些病患, 會遵從醫師的臨床判斷 Atopiclair 已被證實使用於嬰兒孩童及成人是安全的其成分皆包含在 FDA GRAS (generally recognized as safe 安全認證 ) 表單上

32 ATOPICLAIR 不含類固醇, 抗組織胺, 香料的敷料系列 : Atopiclair has received marketing authorization in the US and the European Union for symptom relief of AD(eczema),contact and radiation dermatitis. 醫療級雙重保濕作用, 效果長達 72 小時臨床証實副作用與安慰劑同症狀改善, 使用時間越長效果越好提供良好皮膚屏障, 打破搔癢 - 抓傷惡性循環, 減緩搔癢及肌膚不適嬰幼兒, 兒童和成年人的不同患部皆適用急性期可以單一或合併治療, 並減少類固醇使用的機會新一代醫療級保濕敷料, 通過美國 FDA(K024367) 歐盟及台灣 TFDA 核准上市全新配方三合一作用轉機 - 鎮靜 (Calm) + 保護 (Protect) + 修復 (Repair), 短時間內緩解症狀, 長期修復與保護肌膚, 延長 remission 舒緩期, 改善生活品質

33 Thanks for your attention!

二兒歌選用情形 ( ) 2 ( ) ( ) 1. 158 2.

二兒歌選用情形 ( ) 2 ( ) ( ) 1. 158 2. 兒歌內容分析 ~ 以台灣省教育廳發行之大單元活動設計內之兒歌為例 ~ 摘要 82 76 158 一兒歌類目的分布情形 ( ) 26 23 22 16 61 38.6 16.5 ( ) 二兒歌選用情形 ( ) 2 ( ) ( ) 1. 158 2. 第一章緒論第一節研究動機 79 第二節研

AtopiclairTM 愛妥麗敷料 擺脫皮膚炎的惡性循環!

AtopiclairTM 愛妥麗敷料擺脫皮膚炎的惡性循環!