Shah A, Dinwiddie R, Madge S, Prescott P, Hudson G
Cystic Fibrosis Unit, Hospital for Sick Children, London, United Kingdom.
Eur J Pediatr. 1993 Sep;152(9):763-4. doi: 10.1007/BF01953997.
New high dose pancreatic enzyme preparations could be potentially helpful to cystic fibrosis (CF) patients. The purpose of this study was to compare the efficacy of the new high dose pancreatic enzyme preparation, Nutrizym 22 with the standard preparation Nutrizym GR. Twenty-five CF children (aged 7-16 years) entered the study and 22 completed it; 3 did not, due to non-compliance. All were taking Nutrizym GR for at least 2 weeks before entering the study. A randomised double blind, crossover method using standard Nutrizym GR or double strength Nutrizym 22 capsules was carried out over two consecutive 14-day periods. Crossover analyses of variance showed no statistically significant differences in actual weight gain, appetite, abdominal pain, stool consistency or faecal fat during the prestudy and study periods. It is concluded that half the capsule numbers of the high strength preparation are just as effective as the standard capsule dosage.
新型高剂量胰酶制剂可能对囊性纤维化(CF)患者有潜在帮助。本研究的目的是比较新型高剂量胰酶制剂Nutrizym 22与标准制剂Nutrizym GR的疗效。25名CF儿童(年龄7 - 16岁)进入研究,22名完成研究;3名因未遵守规定未完成。所有儿童在进入研究前均服用Nutrizym GR至少2周。在连续两个14天的周期内,采用随机双盲交叉法,使用标准的Nutrizym GR或双倍剂量的Nutrizym 22胶囊。方差的交叉分析表明,在研究前和研究期间,实际体重增加、食欲、腹痛、大便稠度或粪便脂肪方面没有统计学上的显著差异。结论是,高强度制剂胶囊数量减半与标准胶囊剂量同样有效。