減肥新藥自己買 - Alli - FDA 准了




減肥新藥自己買 - Alli - FDA 准了



美國食品藥物管理局(The Food and Drug Administration,FDA)在 2007 年 2 月 7 日核准了一種非醫師處方籤之減肥新藥 Alli(英文音念:[ˈælaɪ],中文商品為「歐愛」)上市。他是「葛蘭素史克藥廠(GlaxoSmithKline)」推出的藥品。也許大家對於 Alli 還不熟悉,不過若是講「羅氏鮮(Orlistat)」也許大家就知道了。



圖1. 羅氏鮮罐裝包裝圖



圖2. 羅氏鮮藥丸圖


「Alli」內含的成分是 Orlistat,它其實就是「羅氏鮮」,只不過劑量減半罷了(羅氏鮮含有 120 毫克)。這個藥物預計今年夏天就能開始在美國藥局販售。不過還要經過評估,才能決定是否引進台灣。


圖3. 羅氏鮮成分結構圖


「歐愛」適用於 18 歲以上的成年人,每一餐可以阻止大約 1/4 的脂肪吸收,這款藥的藥劑只有 60 毫克,恰恰是羅氏鮮的一半,其藥性也相對較為溫和。連續服用一個星期的花費大約是 12 到 25 塊美元,相當台幣 350 到 750 左右。需要注意的是這種藥有腹瀉的副作用,同時若是接受過器官移植、服用抗凝血藥,以及有糖尿病跟甲狀腺疾病的民眾,並不適合服用這款減肥藥。而服用這個藥物的民眾也必須配合持續攝取低熱量、低脂肪的飲食和運動,才能達到減重效果。



圖4. 服用安慰劑、60 mg(Alli)與 120 mg(Orlistat)後體重下降比率。橫軸為週數,縱軸為體重下降比率。


Orlistat 之所以能達到減肥的效用主要是因為它透過可逆機制抑制了人體胰臟脂解酶(Human pancreatic lipase,HPL)的活性。


圖5. 人體胰臟脂解酶(Human pancreatic lipase,HPL),圖片來源:http://www.cs.stedwards.edu/chem/Chemistry/CHEM43/CHEM43/Lipases/main.html


脂解酶主要的功用是將飲食中的三酸甘油脂(triglycerides,TG)分解,而因為 Orlistat 將這個脂解酶的活性給抑制掉了,因此從飲食中所攝取到的三酸甘油脂就無法被水解成為自由的脂肪酸,使小腸對於油脂的吸收降低。


圖6. Orlistat 作用機制圖:此藥會與 HPL 活性位置 152 號氨基酸 Serine 的羥基作用。


此藥的生物可用率(bioavailable)極低,大約只有 2% 而已。主要是以口服的方式投予該藥,而藉由糞便或尿液的方式離開人體。服用此藥物時,身體對脂溶性(fat-soluble)維生素,如維他命 A、D、E、K 與 beta-胡蘿蔔素(beta-carotene)的吸收也會受到抑制。因此在服用此減肥藥物的同時,每天最好也服用一顆含有上述維他命成分的綜合維他命丸,而且最好是在服用減肥藥前兩小時或是後兩小時吃。

最後還是要提醒大家,雖然 FDA 已經准許一般大眾可以自己在藥房購買 Alli 這個減肥藥,但如果真的遇到體重過重或是肥胖的問題,還是要請教專科醫師會比較好!千萬別自己不懂卻硬裝懂,為了減肥卻也把健康給減掉了,尤其最怕民眾因認為該藥物劑量只有羅氏鮮的一半,因此將來購入後,在缺乏醫師指導下而一次服用兩顆、三顆甚至更多。尤其是愛美的青年朋友們 - 無論是女性還是男性 - 想維持苗條好身材還是持續運動且保持正常的三餐與作息才是最好!畢竟還是不希望看到如同新聞播報的一樣,減肥減到最後得到厭食症而斷送小命啊!



相關連結:
1. 貢丸的科普部落格:減肥藥安全嗎?

2. 貢丸的科普部落格:想減肥嗎?- 減肥研究新方向


參考資料:
1. FDA 新聞稿全文:http://www.fda.gov/bbs/topics/NEWS/2007/NEW01557.html

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FDA Approves Orlistat for Over-the-Counter Use

The Food and Drug Administration (FDA) today approved orlistat capsules as an over-the-counter (OTC) weight loss aid for overweight adults. Orlistat was initially approved in 1999 as a prescription drug to treat obesity, and remains a prescription drug for obesity at a higher dose than the OTC version. OTC orlistat will be manufactured by GlaxoSmithKline under the name Alli and is indicated for use in adults ages 18 years and older along with a reduced-calorie, low-fat diet, and exercise program.



"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes," said Dr. Douglas Throckmorton, Deputy Director for FDA's Center for Drug Evaluation and Research. "OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health."

OTC orlistat is not for people who have problems absorbing food or for those who are not overweight. Orlistat helps produce weight loss by decreasing the intestinal absorption of fat. The 60 mg capsule can be taken up to three times a day with each fat-containing meal. Because of the possible loss of certain nutrients, it is recommended that people using orlistat should also take a multivitamin(綜合維他命) at bedtime.

The most common side effect of the product is a change in bowel habits, which may include loose stools. Eating a low fat diet will reduce the likelihood of this side effect. Also, people who have had an organ transplant(器官移植) should not take OTC orlistat because of possible drug interactions. In addition, anyone taking blood thinning medicines(血液方面藥物) or being treated for diabetes(糖尿病) or thyroid disease(甲狀腺疾病) should consult a physician before using orlistat.

FDA approved OTC orlistat based on the review of the sponsor's safety data and after submitting the product for the consideration by an FDA advisory committee in January 2006. The committee voted in favor of OTC approval.

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2. Wiki 百科:http://en.wikipedia.org/wiki/Orlistat