Mischler E H, Parrell S, Farrell P M, Odell G B
Am J Dis Child. 1982 Dec;136(12):1060-3. doi: 10.1001/archpedi.1982.03970480026006.
To evaluate claims that enteric-coated pancreatic enzyme preparations are more effective than conventional digestants in managing malabsorption in cystic fibrosis (CF), we conducted a trial comparing the efficacy of pancrealipase (enzyme supplement containing lipase, amylase, and protease) in the form of pH-sensitive microspheres (Pancrease) with that in the form of encapsulated enzyme powder (Cotazym). Ten boys with CF received equivalent dosages in a controlled, double-blind fashion using a random sequence of capsule administration with crossover and "washout" periods. Patients experienced significantly enhanced nitrogen and fat absorption while receiving either enzyme when compared with placebo. The enteric-coated product promoted significantly improved fat absorption as compared with the conventional enzyme capsule. Both enzyme preparations caused significantly improved protein absorption as compared with placebo, but there as no significant difference between the two products in the degree of effect on azotorrhea.
为评估关于肠溶包衣胰酶制剂在治疗囊性纤维化(CF)患者吸收不良方面比传统消化剂更有效的说法,我们进行了一项试验,比较了pH敏感微球形式的胰脂肪酶(含脂肪酶、淀粉酶和蛋白酶的酶补充剂)(胰酶胶囊)与肠溶酶粉形式的胰脂肪酶(康彼身)的疗效。10名CF男孩以对照、双盲方式接受等效剂量,采用随机的胶囊给药顺序,并设有交叉和“洗脱”期。与安慰剂相比,患者在接受任何一种酶治疗时,氮和脂肪吸收均显著增强。与传统酶胶囊相比,肠溶包衣产品可显著改善脂肪吸收。与安慰剂相比,两种酶制剂均可显著改善蛋白质吸收,但两种产品在对脂肪泻的疗效程度上无显著差异。