Vyas H, Matthew D J, Milla P J
Hospital for Sick Children, London, UK.
Eur J Pediatr. 1990 Jan;149(4):241-3. doi: 10.1007/BF02106281.
A comparative study of the efficacy of pH sensitive enteric coated microspheres (ECM) with an enteric coated tablet (ECT) pancreatic enzyme preparation was carried out in 20 children with cystic fibrosis in a double-blind double-placebo crossover manner. Steatorrhoea was assessed by 3 day faecal fat analysis and dosage of medication, stool frequency and consistency; abdominal pain and appetite were documented by a patient-kept diary card. ECM controlled steatorrhoea (11.8 +/- 9.2 g vs 23.2 +/- 18.9 g, P less than 0.02), stool frequency (1.7 +/- 0.6 vs 2.1 +/- 0.9, P less than 0.01) and abdominal pain (8.8 +/- 13.8 vs 23.4 +/- 24.1, P less than 0.05) significantly better than ECT. Out of 20 patients 17 preferred ECM to ECT (P less than 0.00036). ECM preparations should allow more satisfactory dietary management of patients with cystic fibrosis with longterm beneficial effect.
采用双盲双安慰剂交叉方式，对20名囊性纤维化患儿进行了pH敏感肠溶微球（ECM）与肠溶片剂（ECT）胰酶制剂疗效的对比研究。通过3天粪便脂肪分析评估脂肪泻，并记录用药剂量、排便频率和粪便稠度；腹痛和食欲通过患者记录的日记卡进行记录。与ECT相比，ECM能显著更好地控制脂肪泻（11.8±9.2克对23.2±18.9克，P<0.02）、排便频率（1.7±0.6对2.1±0.9，P<0.01）和腹痛（8.8±13.8对23.4±24.1，P<0.05）。在20名患者中，17名患者更喜欢ECM而非ECT（P<0.00036）。ECM制剂应能使囊性纤维化患者的饮食管理更令人满意，并具有长期有益效果。
