Safdi Michael, Bekal Pradeep K, Martin Stephen, Saeed Zahid A, Burton Frank, Toskes Phillip P
Greater Cincinnati Gastroenterology Associates, Cincinnati, OH 45219, USA.
Pancreas. 2006 Aug;33(2):156-62. doi: 10.1097/01.mpa.0000226884.32957.5e.
Creon 10 Minimicrospheres is an enteric-coated, delayed-release pancrelipase preparation designed to deliver active pancreatic enzymes to the small intestine. The primary objective of this study was to compare the effect of Creon 10 with placebo in the control of steatorrhea in chronic pancreatitis patients. Secondary objectives included evaluation of stool parameters and global improvement of symptoms scales.
The study was a randomized, double-blind, placebo-controlled, 2-week trial. After a placebo run-in ("washout") phase, the effect on coefficient of fat absorption (%), daily fat excretion before and after treatment, and stool frequency and consistency were assessed.
In Creon 10-treated subjects, the change in mean coefficient of fat absorption (%) from run-in to double-blind phase was significantly higher compared with placebo-treated subjects (+36.7 vs. +12.1, P = 0.0185). Stool consistency improved significantly more with Creon 10 than with placebo (P = 0.0102) resulting in more subjects with formed stool; stool frequency decreased significantly more with Creon 10 than with placebo (P = 0.0015) from 10.8 during placebo run-in to 5.2 stools per day during double-blind treatment; and daily mean fat excretion in stool decreased significantly more (-56.5 vs. -11.4 g/d, P = 0.0181) in Creon 10-treated subjects compared with placebo-treated subjects. Global disease symptom scores showed greater improvement for both physicians and subjects in the Creon 10 group relative to those receiving placebo. Between treatment difference reached statistical significance for Creon 10 (P = 0.0435) for physician score and showed a trend (P = 0.0634) favoring Creon for subject score.
This randomized, placebo-controlled trial found that Creon 10 treatment controlled steatorrhea, as reflected in reduced fat excretion, decreased stool frequency and improved stool consistency. Creon 10 treatment was safe and well tolerated.
克酶通10微型微球是一种肠溶包衣的缓释胰酶制剂，旨在将活性胰酶输送至小肠。本研究的主要目的是比较克酶通10与安慰剂对慢性胰腺炎患者脂肪泻的控制效果。次要目的包括评估粪便参数和症状量表的整体改善情况。
该研究为一项随机、双盲、安慰剂对照的2周试验。经过安慰剂导入（“洗脱”）期后，评估对脂肪吸收系数（%）、治疗前后每日脂肪排泄量以及粪便频率和稠度的影响。
与安慰剂治疗的受试者相比，克酶通10治疗的受试者从导入期到双盲期的平均脂肪吸收系数（%）变化显著更高（+36.7对+12.1，P = 0.0185）。克酶通10使粪便稠度改善明显优于安慰剂（P = 0.0102），导致更多受试者的粪便成形；克酶通10使粪便频率降低明显优于安慰剂（P = 0.0015），从安慰剂导入期的每天10.8次降至双盲治疗期的每天5.2次；与安慰剂治疗的受试者相比，克酶通10治疗的受试者粪便中每日平均脂肪排泄量下降明显更多（-56.5对-11.4 g/d，P = 0.0181）。总体疾病症状评分显示，相对于接受安慰剂的受试者，克酶通10组的医生和受试者的改善程度更大。治疗组间差异在医生评分方面克酶通10达到统计学显著性（P = 0.0435），在受试者评分方面显示出有利于克酶通的趋势（P = 0.0634）。
这项随机、安慰剂对照试验发现，克酶通10治疗可控制脂肪泻，表现为脂肪排泄减少、粪便频率降低和粪便稠度改善。克酶通10治疗安全且耐受性良好。
