The effects of oral pancreatic enzymes (Creon 10 capsule) on steatorrhea - A multicenter, placebo-controlled, parallel group trial in subjects with chronic pancreatitis
The effects of oral pancreatic enzymes (Creon 10 capsule) on steatorrhea - A multicenter, placebo-controlled, parallel group trial in subjects with chronic pancreatitis
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DOI：
10.1097/01.mpa.0000226884.32957.5e
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发表时间：
2006-08-01
期刊：
影响因子：
2.9
通讯作者：
Toskes, Phillip P.
中科院分区：
文献类型：
--
作者：
Safdi, Michael;Bekal, Pradeep K.;Toskes, Phillip P.
目的：Creon 10微球是一种肠包被的缓释胰酶制剂，旨在将活性胰酶输送到小肠。本研究的主要目的是比较Creon 10与安慰剂在控制慢性胰腺炎患者脂肪漏中的作用。次要目标包括评估大便参数和症状量表的整体改善。方法：随机、双盲、安慰剂对照，为期2周。在安慰剂磨合（“洗脱期”）阶段后，评估治疗前后对脂肪吸收系数（%）每日脂肪排泄，大便频率和一致性的影响。结果：在Creon 10治疗的受试者中，从磨合期到双盲期的平均脂肪吸收系数（%）的变化明显高于安慰剂治疗的受试者（+36.7 vs +12.1, P = 0.0185）。与安慰剂组相比，Creon 10组的粪便一致性改善明显（P = 0.0102），导致更多的受试者出现大便形成；Creon 10组的大便频率明显低于安慰剂组（P = 0.0015），从安慰剂组的10.8次/天下降到双盲治疗期间的5.2次/天；与安慰剂组相比，Creon 10组的每日平均粪便脂肪排泄量显著减少（-56.5 g/d vs -11.4 g/d, P = 0.0181）。总体疾病症状评分显示，与安慰剂组相比，Creon 10组的医生和受试者都得到了更大的改善。Creon 10在医师评分上的差异有统计学意义（P = 0.0435）， Creon在受试者评分上的差异有统计学意义（P = 0.0634）。结论：这项随机、安慰剂对照试验发现，Creon 10治疗可以控制脂肪溢，这反映在减少脂肪排泄、减少大便频率和改善大便一致性上。Creon 10治疗安全且耐受性良好。
Objectives: 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.Methods: 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.Results: 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.Conclusions: 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.