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当前位置:药品说明书与价格首页 >> 综合药讯 >> ZENPEP (pancrelipase)延效版胶囊

ZENPEP (pancrelipase)延效版胶囊

2010-03-11 11:54:57  作者:新特药房  来源:中国新特药网天津分站  浏览次数:188  文字大小:【】【】【
简介: Manufacturer:EurandPharmacological Class:Pancreatic enzymes (porcine)Active Ingredient(s):Lipase 5000 units, protease 17000 units, amylase 27000 units; del-rel caps.Also:ZENPEP 10000 Lipa ...

制造商:
Eurand

药理分类:
胰腺酶(猪)

活性成分(补):
脂肪酶5000单位,17000单位蛋白酶,淀粉酶27000单位;德尔- REL的上限。

另外:
10000的Zenpep
脂肪酶10000单位,34000单位蛋白酶,淀粉酶55000单位;德尔- REL的上限。

15000的Zenpep
脂肪酶15000台,51000单位蛋白酶,淀粉酶82000单位;德尔- REL的上限。

20000的Zenpep
脂肪酶20000单位,68000单位蛋白酶,淀粉酶109000单位;德尔- REL的上限。

指示(补):
胰腺外分泌功能不全(如囊性纤维化)。

药理作用:
胰消化酶是一组包括脂肪酶,淀粉酶和蛋白酶。这些酶催化成肽和氨基酸,脂肪,淀粉monoglycerol,甘油和脂肪酸,蛋白质成糊精,在十二指肠和近端小肠短链糖类水解。

胰的Zenpep是一个产品,是从猪胰腺腺体提取物的准备。该胶囊含有肠溶珠直径和活动水平有所不同。该涂层是用来保护和胃酸的酶,并释放在pH值5.5或更高的酶。


临床试验:
研究涉及的34例1 7至23岁的外分泌胰腺囊肿性纤维化不全年。在这个双盲交叉研究中,患者随机接受安慰剂的Zenpep或6或7天,再交叉的6至7天之后的替代治疗。平均剂量为3900至5700脂酶单位/每日公斤。所有患者在治疗过程中消耗高脂肪的饮食。主要疗效终点是在脂肪的吸收和安慰剂之间的Zenpep(CFA)的系数平均差异。终审法院的平均88%的Zenpep相比,63%与安慰剂治疗。

研究二,开放式的标签,在19例1至6岁的无节制的研究,比较前后的Zenpep与餐/小吃行政脂肪吸收不良。患者改用自己的Zenpep从通常的治疗。在对电影节放映期间的通常的治疗,患者分别给予单独滴定,从2300到10000脂酶单位剂量的Zenpep /公斤,每天为14天。患者表现为粪便通过现场测试的脂肪吸收不良脂肪类似的控制开关开启时,就在类似的Zenpep剂量的治疗。


法律分类:
接收


成人和儿童:
相应剂量脂酶单位。整粒吞服(不粉碎),可以混合苹果酱或其他酸性食物内容,请用清水或果汁,采取外出,不要让任何药物留在嘴里。婴儿:每120毫升2000-4000公式或每母乳喂养(不混入配方奶或母乳直接)的单位; 12mos - 4yrs:1000单位/公斤,每一顿,最大2500单位/每公斤餐(或≤10000个/公斤/天);> 4yrs:500单位/公斤,每一顿,最大2500单位/公斤餐(或≤10000单位/公斤/天),或<4000个/克脂肪,每天摄取。每调整饮食和临床反应(如脂肪泻)。

警告/注意事项:
与同类产品不能互换。痛风。肾功能损害。高尿酸血症。妊娠(Cat.C)。哺乳的母亲。


不良反应(补):
腹痛,腹胀,头痛,咳嗽,体重降低,早饱,挫​​伤;纤维化大肠病变,高尿酸血症,过敏性反应。


如何提供:
帽(5000,10000,15000脂酶单位)-12,100
脂肪酶单位20000 - 12,100,500

Manufacturer:

Eurand

Pharmacological Class:

Pancreatic enzymes (porcine)

Active Ingredient(s):

Lipase 5000 units, protease 17000 units, amylase 27000 units; del-rel caps.

Also:

ZENPEP 10000
Lipase 10000 units, protease 34000 units, amylase 55000 units; del-rel caps.

ZENPEP 15000
Lipase 15000 units, protease 51000 units, amylase 82000 units; del-rel caps.

ZENPEP 20000
Lipase 20000 units, protease 68000 units, amylase 109000 units; del-rel caps.

Indication(s):

Exocrine pancreatic insufficiency (eg, cystic fibrosis).

Pharmacology:

Pancrelipase is a group of digestive enzymes including lipases, amylases, and proteases. These enzymes catalyze the hydrolysis of fats to monoglycerol, glycerol and fatty acids, protein into peptides and amino acids, and starch into dextrins and short chain sugars in the duodenum and proximal small intestine.

Zenpep is a pancrelipase product that is prepared from an extract of porcine pancreatic glands. The capsules contain enteric-coated beads that vary in diameter and activity levels. The coating is designed to protect the enzymes from gastric acids and to release the enzymes at a pH of 5.5 or greater.

Clinical Trials:

Study 1 involved 34 patients ages 7 to 23 years with exocrine pancreatic insufficiency associated with cystic fibrosis. In this double-blind crossover study, patients were randomized to either Zenpep or matching placebo for 6 or 7 days, followed by crossover to the alternative treatment for another 6 to 7 days. The mean dose ranged from 3900 to 5700 lipase units/kg per day. All patients consumed a high-fat diet during treatment. The primary efficacy endpoint was the mean difference in the coefficient of fat absorption (CFA) between Zenpep and placebo. Mean CFA for Zenpep was 88% compared to 63% with placebo treatment.

In study 2, an open-label, uncontrolled study in 19 patients 1 to 6 years of age, compared fat malabsorption before and after Zenpep administration with meals/snacks. Patients were switched to Zenpep from their usual treatment. Following a screening period on their usual treatment, patients were given Zenpep at individually titrated doses ranging from 2300 to 10000 lipase units/kg per day for 14 days. Patients showed similar control of fat malabsorption by spot fecal fat testing when switched to Zenpep treatment at similar doses.

Legal Classification:

Rx

Adults & Children:

Base dose on lipase units. Swallow whole (do not crush); may mix contents with applesauce or other acidic food, follow with water or juice; take with meals; do not let any drug remain in mouth. Infants: 2000–4000 units per 120mL formula or per breast-feeding (do not mix directly into formula or breast milk); 12mos–4yrs: 1000 units/kg per meal; max 2500 units/kg per meal (or ≤10000 units/kg/day); >4yrs: 500 units/kg per meal; max 2500 units/kg per meal (or ≤10000 units/kg/day), or <4000 units/g fat ingested per day. Adjust per diet and clinical response (eg, steatorrhea).

Warnings/Precautions:

Not interchangeable with similar products. Gout. Renal impairment. Hyperuricemia. Pregnancy (Cat.C). Nursing mothers.

Adverse Reaction(s):

Abdominal pain, flatulence, headache, cough, decreased weight, early satiety, contusion; fibrosing colonopathy, hyperuricemia, allergic reactions.

How Supplied:

Caps (5000, 10000, 15000 lipase units)—12, 100
20000 lipase units—12, 100, 500

Last Updated:

9/13/2010

     Eurand公司在2009年8月28日宣布:美国食品药品管理局(FDA)已经批准胰脂酶Zenpep(胰腺酶制剂,PEP)缓释胶囊用于治疗囊性纤维化(CF)或其他疾病引起的胰腺外分泌机能不全(EPI)。据该公司称,Zenpep是一种高稳定性制剂,提取自猪的胰腺,其生物学特性类似于在消化中不可或缺的人类内源性胰腺分泌物。Zenpep可替代缺失的胰腺酶,以促进食物的消化和吸收。

     Eurand公司研发生产的Zenpep(胰腺酶制剂,PEP)是治疗胰囊状纤维化症的新药,并且是FDA批准的唯一一个用于成人和儿童的促胰酶分泌药物,有四种不同的剂量适合婴儿、初走路的幼儿、青少年及成人。

     Zenpep是一种高稳定性制剂,提取自猪的胰腺,其生物学特性类似于在消化中不可或缺的人类内源性胰腺分泌物。Zenpep可替代缺失的胰腺酶,以促进食物的消化和吸收。

     Zenpep符合FDA的药品规范。过去,FDA并未对PEP类药物加以规范,也从未批准相关的药物。

     胰腺外分泌机能不全是一种因胰腺消化酶缺乏而导致无法正常消化食物的疾病。缺少胰酶会引起消化不良以及营养吸收不良。该疾病常见于CF和其他原因造成的胰腺外分泌功能受损(例如胰腺癌和慢性胰腺炎)以及曾接受胃肠手术者。EPI所引起的营养不良会影响患者的生长发育和免疫反应,并可导致寿命缩短。

     两项III期多中心临床试验对Zenpep治疗EPI的疗效进行了研究:其中一项的受试者为大龄儿童、青少年以及成年人,另一项的受试者为年龄在1~6岁的低龄儿童。2项研究均发现Zenpep在治疗CF和EPI上既安全又有效。在大龄儿童与成年人(7~23岁)的随机、双盲、安慰剂对照的关键性研究中,主要疗效终点为平均脂肪吸收系数(CFA),CFA被视为EPI严重程度的金标准。在该研究中,Zenpep治疗组的CFA 值显著高于安慰剂组(88.3%比 62.8%,P <0.001)。在低龄儿童的开放性单组试验中,将常用的PEP方案换成相似剂量的Zenpep 方案,并维持症状控制治疗。该试验中,Zenpep在儿童患者的安全性和有效性与成年人组相似。

    Zenpep在临床试验中并未发生任何严重的药物相关副作用。报告最多的副作用为胃肠道并发症,上述2项试验的各个年龄段在副作用类型及发生频率上均比较相似。最常见的副作用(至少发生2例,大于等于患者总数的6%)包括腹痛、腹胀、头痛、咳嗽、体重减轻、早饱和挫伤。发生于儿童患者的副作用类型和发生率与成年患者类似。

    Zenpep每天的总剂量不应超过10,000 LU/(kg·d),如果单餐剂量超过2,500 LU/(kg·d),应谨慎服用。应努力确保Zenpep不被咀嚼或含化,以免刺激口腔黏膜。胶囊或胶珠应配以足量液体送服,迅速吞咽。当必要时,Zenpep胶囊可与食物混合后服用。

责任编辑:admin


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