Department of Medical Gastroenterology, Poona Hospital & Research Centre, Pune, India.
Aliment Pharmacol Ther. 2012 Sep;36(5):426-36. doi: 10.1111/j.1365-2036.2012.05202.x. Epub 2012 Jul 4.
Pancreatic exocrine insufficiency (PEI) results in maldigestion, leading to abdominal pain, steatorrhoea, malnutrition and weight loss.
To assess the efficacy and safety of pancreatin (Creon 40000 MMS) in treating PEI due to chronic pancreatitis (CP).
This was a 1-week, double-blind, randomised, placebo-controlled, parallel-group, multicentre study in India. Men and women ≥18 years of age with proven CP and PEI [defined as a coefficient of fat absorption (CFA) ≤80% during run-in phase] were randomised 1:1 to pancreatin or placebo (two capsules orally per main meal, one with snacks). The primary outcome measure was change in CFA from baseline to end of double-blind treatment (analysis of covariance).
Of 62 patients randomised (34 pancreatin, 28 placebo), 61 completed treatment; one patient in the placebo arm withdrew consent before completion. Patient characteristics were similar in both groups except for the proportion of men (pancreatin 82% vs. placebo 68%). Patients receiving pancreatin had a statistically significant greater improvement in fat absorption from baseline to the end of double-blind treatment compared with those receiving placebo, with a least squares mean change (95% CI) in CFA of 18.5% (15.8-21.2) vs. 4.1% (1.0-7.2), respectively. This resulted in a treatment difference of 14.4% (10.3-18.5); P = 0.001. Patients receiving pancreatin also had a statistically significant greater improvement in nitrogen absorption and greater reductions in mean stool fat, stool frequency and stool weight compared with those receiving placebo. Treatment-emergent adverse events occurred in 12 patients on pancreatin and in seven on placebo; none led to study discontinuation.
The results provide evidence for the efficacy of pancreatin (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis, and confirm that this formulation is well tolerated, with a good safety profile, at the dose administered.
胰腺外分泌不足（PEI）导致消化不良，引起腹痛、脂肪泻、营养不良和体重减轻。
评估胰酶（Creon 40000 MMS）治疗慢性胰腺炎（CP）所致 PEI 的疗效和安全性。
这是在印度进行的为期 1 周、双盲、随机、安慰剂对照、平行组、多中心研究。年龄≥18 岁的男性和女性，经证实患有 CP 和 PEI[定义为在导入期内脂肪吸收系数（CFA）≤80%]，按 1:1 随机分配至胰酶或安慰剂（每主餐口服 2 粒胶囊，随餐服用 1 粒）。主要观察指标为从基线到双盲治疗结束时 CFA 的变化（协方差分析）。
62 例患者随机分组（胰酶 34 例，安慰剂 28 例），61 例完成治疗；安慰剂组 1 例患者在完成前撤回同意。两组患者的特征相似，除男性比例外（胰酶组 82%，安慰剂组 68%）。与安慰剂组相比，接受胰酶治疗的患者脂肪吸收从基线到双盲治疗结束时的改善具有统计学意义，CFA 的最小二乘均值变化（95%CI）分别为 18.5%（15.8-21.2）和 4.1%（1.0-7.2）。这导致治疗差异为 14.4%（10.3-18.5）；P=0.001。与安慰剂组相比，接受胰酶治疗的患者氮吸收的改善也具有统计学意义，粪便脂肪、粪便频率和粪便重量的平均值也有显著降低。胰酶组有 12 例患者和安慰剂组有 7 例患者出现治疗中出现的不良事件，但均未导致研究中止。
结果为胰酶（Creon 40000 MMS）治疗慢性胰腺炎所致胰腺外分泌不足的疗效提供了证据，并证实该制剂在给药剂量下具有良好的耐受性和安全性。
