之前寫過幾篇降磷藥物的分析,不囉嗦,先整理連結給大家點選複習一下:
1.基礎概念篇,2. 鋁片篇,3. 鈣片篇,4. 自費藥物選擇篇
寶齡生技公司所新研發的拿百磷,2015年1月獲台灣衛福部上市之後,有些需要的腎友已經開始服用,這也是自費降磷藥物的其中一種。
首先,拿百磷在美國的商品名是 Auryxia™(2014年九月美國FDA核准上市),在日本是Riona®,在歐洲是Fexeric®,都和台灣的英文商品名-“Nephoxil”不同,因此,要得到更詳細的研究結果,得用這些名稱去查才行。
拿百磷介紹,正文開始:
主要成分是檸檬酸鐵 (ferric citrate),其中的鐵帶正電(三價),可結合食物中的磷酸(帶負電),不讓腸胃吸收磷,而從大便排出去,達到減少吸收磷的效果,降低洗腎患者的血磷。
由上述可知,這個藥不含鈣,所以身體不會累積鈣,也就減少了血管鈣化的危險。另外,每一公克的拿百磷,含有210毫克的元素鐵,可以增加體內的鐵蛋白(ferritin)含量、運鐵蛋白飽和度(Tsat),有機會改善患者貧血。
可以增加多少?我用美國、日本與台灣的三個研究,來回答這個問題。首先是美國的數據:
上圖中藍色的對照組,是積極使用鈣片或磷能解的受試者,意思是對照組的患者也積極的使用降磷劑,而結果如圖中所示,使用拿百磷52周(約一年)之後,與鐵相關的數值都上升了,額外補充鐵劑的量減少,紅血球生成素(EPO)的用量也減少了,至於血中鈣與磷(在圖中右下角),算是控制的差不多。
要達到磷控制得宜的這個結果,要吞幾顆呢?
美國的實驗用的是1000毫克的Auryxia®(美國一顆抵兩顆台灣的拿百磷),平均一天要吞8顆,對照組的數量是平均一天7.7顆(鈣片或磷能解)。
接下來是日本研究:
分成兩組患者觀察12個禮拜,一組使用磷能解,另一組使用拿百磷,兩組控制鈣磷的程度差不多,而拿百磷能夠增加一點血紅素。
平均使用拿百磷的劑量為:3.25克/天;而磷能解的劑量平均是:4.94克/天。剛好都是大約六顆。
再來是台灣的研究:
使用8周的拿百磷,除了磷能夠下降1.6 mg/dl (4克/天) 到 2.27 mg/dl (6克/天) 之外,鐵蛋白與血紅素都有增加的趨勢。實驗中所用的劑量:4克,也就是8顆,6克,也就是12顆。
常見的副作用有:大便變黑(發生率約37%)、腹瀉(4-6%)、腹脹或便祕(1-2%)等等。
拿百磷是檸檬酸鐵,鐵是用來結合磷的,那檸檬酸呢?之前我們在講鈣片的時候,有講過不能用檸檬酸鈣,是因為檸檬酸可能會讓食物中的鋁,更容易吸收進體內,造成鋁堆積在體內。2015年的一篇研究指出,經過52周的服用拿百磷,體內血鋁的濃度並未顯著上升(由6.0 µg/L上升到7.0 µg/L),不過呢,體內的鋁並不是只存在於血中,其他部位如:骨頭、肺部、肌肉甚至腦都會有鋁的沉積,因此,這篇研究只抽血驗血中的鋁,不是很能夠說服人,後續還是要小心鋁的後續報導。
總之,這個降磷劑有兩個優點:
一是含鐵,所以體內鐵不足的患者,可以考慮使用。
二是不含鈣,所以體內鈣太高的患者,可以考慮使用。
三個缺點、一個疑慮:
一是含鐵,所以體內鐵太多的,就不能用囉。
二是會有腸胃道症狀、大便變色等等可能的副作用,至於會不會影響腸胃道出血的判斷,我想我可能會蠻頭痛的。
三是如果要吃到有降磷的效果,大概至少一天要吃4克,也就是八顆,也不少顆唷。
疑慮是不曉得會不會增加鋁的吸收,造成體內鋁的堆積,目前沒有強烈證據,就等後續研究結果吧。
聲明:本篇文章純屬學術研究分享,並非廠商贊助所撰寫,藥品使用與否,請與照顧的醫師討論之後,再做決定。
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