Bowler I M, Wolfe S P, Owens H M, Sheldon T A, Littlewood J M, Walters M P
Regional Cystic Fibrosis Unit, St James's Hospital, Leeds.
Arch Dis Child. 1993 Feb;68(2):227-30. doi: 10.1136/adc.68.2.227.
A standard acid resistant microsphere pancreatic enzyme preparation was compared with identical capsules half filled with mini-tablets of a new high lipase preparation in a randomised double blind crossover study in children with cystic fibrosis. Each patient received his/her usual number of capsules and the same dose of lipase during each period of the study. Eighteen patients completed the study. There were fewer gastrointestinal symptoms when pancreatic enzyme was supplied as the high lipase preparation. There was also a significant improvement in fat absorption (17%, 95% confidence interval (CI) 6 to 27), reduction in faecal fat output (15.8 g/day, 95% CI 6.4 to 22.5), and faecal energy loss (789 kJ/day, 95% CI 211 to 1384). It is concluded that half filled capsules of the new high lipase preparation are more effective than the standard preparation and it is likely that filled capsules would allow patients to use fewer than half the number of pancreatic enzyme capsules.
在一项针对囊性纤维化患儿的随机双盲交叉研究中,将一种标准的耐酸微球型胰酶制剂与装有新型高活性脂肪酶制剂小片且半填充的相同胶囊进行了比较。在研究的每个阶段,每位患者都服用其通常数量的胶囊以及相同剂量的脂肪酶。18名患者完成了该研究。当以高活性脂肪酶制剂形式提供胰酶时,胃肠道症状较少。脂肪吸收也有显著改善(17%,95%置信区间(CI)6至27),粪便脂肪排出量减少(15.8克/天,95%CI 6.4至22.5),以及粪便能量损失减少(789千焦/天,95%CI 211至1384)。得出的结论是,装有新型高活性脂肪酶制剂的半填充胶囊比标准制剂更有效,并且全填充胶囊可能会使患者使用的胰酶胶囊数量少于一半。