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【medical-news】ALTU-135 有望治疗囊性纤维化患者的
NEW YORK (Reuters Health) Dec 12 - The results of a new study support the safety and efficacy of orally administered ALTU-135 (Altus Pharmaceuticals), a novel proprietary formulation of microbial lipase, protease and amylase, for patients with cystic fibrosis (CF) and pancreatic insufficiency.
The findings of this phase II dose-finding study also suggest that an effective dose is 25,000 units of lipase, 25,000 units of protease, and 3750 units of amylase.
Based on "good preliminary safety and clinical activity" of ALTU-135 in CF patients with pancreatic insufficiency, investigators randomized 117 such patients to treatment with ALTU-135 containing 5000 (low), 25,000 (mid), or 100,000 (highest) units of lipase (1:1:0.15 of lipase:protease:amylase) for 28 days.
In The Journal of Pediatrics for November, Dr. Drucy Borowitz of the State University of New York at Buffalo and colleagues report that the mid and highest ALTU-135 doses effectively improved fat, protein, and carbohydrate absorption during the month-long study.
"Although numerically greater for the highest-dose group, the differences between the mid- and highest-dose groups for CFA (coefficient of fat absorption) and CNA (coefficient of nitrogen absorption), or maximum glucose change were not statistically significant," they note.
Subjects with baseline CFA and CNA values of less than 40% had the greatest improvements. "On the basis of these data, the subjects who have the worst fat and protein malabsorption are benefited most by ALTU-135 treatment," Dr. Borowitz and colleagues write.
There were no major safety concerns involving laboratory values and no marked between-group differences in treatment-emergent side effects or the number of serious side effects.
The most commonly reported side effect was gastrointestinal disturbance, reported by 106 (84.8%) of patients and most of these were described as mild in intensity, although four patients withdrew from the study because of GI-related side effects.
Most CF patients have severe exocrine pancreatic insufficiency and must take pancreatic enzyme replacement therapy, the authors note. The current results support the safety and efficacy of the ALTU-135 formulation at a ratio of 1:1:0.15 (lipase:protease:amylase).
The study was supported by a grant from the CF Foundation and Altus Pharmaceuticals.
J Pediatr 2006;149:658-662.
http://www.medscape.com/viewarticle/549236 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Enzyme Therapy Promising for Pancreatic Insufficiency in Cystic Fibrosis
ALTU-135 有望治疗囊性纤维化患者的胰腺功能不全
NEW YORK (Reuters Health) Dec 12 - The results of a new study support the safety and efficacy of orally administered ALTU-135 (Altus Pharmaceuticals), a novel proprietary formulation of microbial lipase, protease and amylase, for patients with cystic fibrosis (CF) and pancreatic insufficiency.
纽约(路透社健康版) 12月12日报道 -- 一项最新研究结果支持了ALTU-135 (Altus Pharmaceuticals) 口服给药的安全性和有效性。ALTU-135为Altus Pharmaceuticals的一项新产权，是由微生物脂酶，蛋白酶和淀粉酶组成的复合体，可用来治疗那些患有囊性纤维化病(CF)和胰腺功能不全的患者。
The findings of this phase II dose-finding study also suggest that an effective dose is 25,000 units of lipase, 25,000 units of protease, and 3750 units of amylase.
这项II期药物剂量摸索研究的结果还表明，有效剂量是25，000单位脂酶，25，000单位蛋白酶和3750单位淀粉酶。
Based on "good preliminary safety and clinical activity" of ALTU-135 in CF patients with pancreatic insufficiency, investigators randomized 117 such patients to treatment with ALTU-135 containing 5000 (low), 25,000 (mid), or 100,000 (highest) units of lipase (1:1:0.15 of lipase:protease:amylase) for 28 days.
为保证患有胰腺功能不全的CF患者服用的ALTU-135具有良好的前期安全性和临床活性，研究人员将117名患者随机分到不同剂量的ALTU-135治疗组中，5000单位（低浓度），25，000（中等浓度）或100，000（高浓度）单位的脂酶（脂酶：蛋白酶：淀粉酶的比例为1：1：0.15），观察28天。
In The Journal of Pediatrics for November, Dr. Drucy Borowitz of the State University of New York at Buffalo and colleagues report that the mid and highest ALTU-135 doses effectively improved fat, protein, and carbohydrate absorption during the month-long study.
位于Buffalo的纽约州立大学的Drucy Borowitz博士及其同事在11月版的儿科学杂志中报道，在长达一个月的研究中，中等浓度和高浓度的ALTU-135有效的改善了脂肪，蛋白质和糖类的吸收。
"Although numerically greater for the highest-dose group, the differences between the mid- and highest-dose groups for CFA (coefficient of fat absorption) and CNA (coefficient of nitrogen absorption), or maximum glucose change were not statistically significant," they note.
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作者:admin@医学,生命科学 2011-04-30 05:14
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