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FDA核准胰臟酵素補充療法

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本帖最後由 lsc0019 於 2009-9-20 22:55 編輯

作者:Yael Waknine  
出處:WebMD醫學新聞

  September 1, 2009 — 美國食品藥物管理局(FDA)已經核准胰脂酶緩釋膠囊(Zenpep;Eurand N. V.),用於治療罹患肺囊性纖維化(CF)或其他疾病病患的外分泌腺胰臟分泌不全(EPI)。
  
  根據該公司的一篇新聞稿,該產品是FDA核准的第一個胰臟酵素產品(PEP),且於收納1~12歲兒童與成人的臨床研究中接受評估。
  
  根據一項第三期臨床研究數據,胰脂酶緩釋膠囊,相較於安慰劑,對7~23歲有EPI的CF病患脂肪吸收平均係數統計上顯著增加(88%比上63%;P <0.001)。這些發現來自一項開放標記、單一組別,針對1~6歲兒童進行的第三期臨床研究,結果顯示,當從他們常用的PEP療程轉換到相似劑量的Zenpep時,病患可以維持症狀控制。
  
  Jamie Wooldridge醫師在一篇公司的新聞稿中表示,在小兒族群臨床證據的可獲得性,對於EPI的CF病患及其照護者來說是特別重要的,身體質量指數(BMI)顯著影響長期存活率。Wooldridge醫師是俄亥俄州辛辛那提兒童醫學中心、胸腔醫學、兒科的助理教授,也是Zenpep兒童研究的試驗主持人。
  
  胰脂酶緩釋膠囊並不能與其他胰脂酶產品互換,且將會以四種不同劑量上市來迎合所有年齡層兒童的劑量需求。年幼的兒童可以將膠囊內容物灑到食物上使用。
  
  兒童病患於臨床研究中所報告的不良事件與成人相仿,最常見的包括腹痛、脹氣、頭痛、咳嗽、體重降低、易飽與撞傷。
  
  FDA提醒高劑量的胰臟酵素補充療法已經被證實與罕見的纖維化大腸病變有關,尤其是長期使用這些藥物的CF病患。當投予胰脂酶緩釋膠囊時,單日總劑量不可超過每天每公斤10,000 脂酶單位,且建議對飲食時使用劑量超過每公斤2,500脂酶單位的病患提高警覺。
  
  胰脂酶也會造成黏膜刺激,應該確保藥物膠囊沒有殘留在口腔中。應避免咬碎、咀嚼、或是混合酸鹼值超過4.5的食物與膠囊內容物。食用撒在軟質食物的藥粉後,應該喝水或是果汁,以確保完全消化。
  
  因為這些與治療相關的風險,胰脂酶緩釋膠囊將會提供用藥指引作為風險評估與減輕策略的一部分,來確保其安全使用。

FDA Approves Pancreatic Enzyme Replacement Therapy

By Yael Waknine
Medscape Medical News

September 1, 2009 — The US Food and Drug Administration (FDA) has approved pancrelipase delayed-release capsules (Zenpep; Eurand N.V.) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.

According to a company news release, the product is the first FDA-approved pancreatic enzyme product (PEP) to be evaluated in clinical studies of children aged 1 to 12 years and adults.

Data from a phase?3 study of pancrelipase delayed-release capsules demonstrated a statistically significant increase, compared with placebo, in the mean coefficient of fat absorption for CF patients aged 7 to 23 years with EPI (88% vs 63%; P?? .001). These findings were supported by data from an open-label single-group phase?3 study of children, aged 1 to 6 years, showing that patients maintained symptom control when switched from their usual PEP regimen to Zenpep at similar doses.

"The availability of clinical evidence in a pediatric population is particularly important for EPI patients with CF and their caregivers, as early improvements in [body mass index] significantly affect long-term survivability," noted Jamie Wooldridge, MD, in a company news release. Dr. Wooldridge is assistant professor in the Department of Pediatrics, Division of Pulmonary Medicine, at Cincinnati Children's Hospital Medical Center in Ohio, and a principal investigator in the Zenpep pediatric trial.

Pancrelipase delayed-release capsules are not interchangeable with other pancrelipase products, and will be marketed in 4 strengths to meet dosing requirements for patients of all ages. Capsule contents can be sprinkled on food for very young children.

Adverse events reported in clinical trials were similar for adult and pediatric patients and most commonly included abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion.

The FDA warns that high-dose pancreatic enzyme replacement therapy has been linked to rare cases of fibrosing colonopathy, usually in CF patients receiving treatment over a prolonged period. When administering pancrelipase delayed-release capsules, total daily doses should not exceed 10,000 lipase units/kg body weight, and caution is advised with meal-time doses greater than 2,500 lipase units/kg.

Pancrelipase can also cause mucosal irritation, and care should be taken to ensure that no drug is retained in the mouth. Crushing, chewing, or mixing capsule contents in foods with a pH greater than 4.5 should be avoided. Doses sprinkled on soft foods should be followed with water or juice to ensure complete ingestion.

Because of these and other risks associated with treatment, pancrelipase delayed-release capsules will be distributed with a medication guide as part of a risk evaluation and mitigation strategy to ensure its safe usage.

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