ENZYME REPLACEMENT THERAPY OF EXOCRINE PANCREATIC INSUFFICIENCY IN MAN RELATION BETWEEN INVITRO ENZYME-ACTIVITIES AND INVIVO POTENCY IN COMMERCIAL PANCREATIC EXTRACTS

ENZYME REPLACEMENT THERAPY OF EXOCRINE PANCREATIC INSUFFICIENCY IN MAN RELATION BETWEEN INVITRO ENZYME-ACTIVITIES AND INVIVO POTENCY IN COMMERCIAL PANCREATIC EXTRACTS
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DOI:
10.1056/nejm197706092962303
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发表时间:
1977-01-01
影响因子:
158.5
通讯作者:
GRAHAM, DY
GRAHAM, DY
中科院分区:
医学1区
文献类型:
--
作者:
GRAHAM, DY

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测定了16种市售胰腺提取物(胶囊、片剂和肠溶片)的酶活性,并评估了体外活性与体内效价之间的关系。脂肪酶活性范围为10 ~ 3600单位/单位,其中11种制剂含量< 600单位/单位。脂肪酶活性最高的制剂为Ilozyme(3600)、Kuzyme HP(2330)、feal(2073)、Cotazym(2014)和Viokase(1636)。脂酶活性与体内效价呈正相关,片剂和胶囊的脂漏效比为56.1 .+-。9%和48.6% +-。10%(平均+-。SEM[平均标准误差]),P < 0.001。肠溶片的效果较差(20.5%)。降低13%,P < 0.05)。胃pH值保持的时间越长。4 (r = 0.915, P < 0.01),平均十二指肠pH值越高(r = 0.966, P < 0.01),脂肪漏减少越明显。
Sixteen commercially available pancreatic extracts (representing capsules, tablets and enteric-coated tablets) were assayed for enzyme activities, and the relation between in vitro activities and in vivo potency were evaluated in man. Lipase activity ranged from 10-3600 units/unit, with 11 preparations containing < 600 units/unit. Preparations with the highest lipase activities were Ilozyme, 3600, Kuzyme HP, 2330, Festal, 2073, Cotazym, 2014 and Viokase, 1636 units. Lipase activity in vitro correlated with potency in vivo for tablets and capsules, with tablets and capsules being effective in reducing steatorrhea by 56.1 .+-. 9% and 48.6 .+-. 10% (mean .+-. SEM [standard error of the mean]) respectively, P < 0.001. Enteric-coated tablets were less effective (20 .+-. 13% reduction, P > 0.02). The longer the gastric pH remained .gtoreq. 4 (r = 0.915, P < 0.01) and the higher the average duodenal pH (r = 0.966, P < 0.01), the more marked was the reduction in steatorrhea.