Placebo controlled trial of enteric coated pancreatin microsphere treatment in patients with unresectable cancer of the pancreatic head region
Placebo controlled trial of enteric coated pancreatin microsphere treatment in patients with unresectable cancer of the pancreatic head region
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DOI：
10.1136/gut.42.1.92
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发表时间：
1998-01-01
期刊：
影响因子：
24.5
通讯作者：
van Leeuwen, DJ
中科院分区：
文献类型：
--
作者：
Bruno, MJ;Haverkort, EB;van Leeuwen, DJ
背景：胰头区域癌症患者由于胰管机械性阻塞而导致胰液流动受阻，导致胰腺外分泌功能不全，伴有脂肪泻和创造性腹泻。这可能会导致这些患者经常发生的严重体重减轻。目的 - 调查胰酶替代疗法是否可以防止这种体重减轻。 患者 - 21 名患有不可切除的胰头区域癌症的患者，疑似胰管阻塞，原位胆道内置假体，并且卡诺夫斯基体能状态大于 60，方法 - 为期八周的随机双盲试验，使用安慰剂或高剂量肠溶胰酶补充剂。所有患者均接受饮食咨询。结果-体重百分比变化的平均差异为 4.9%（p = 0.02，差异的 95% 置信区间：0.9 至 8.9）。服用胰酶的患者体重增加了 1.2%（0.7 公斤），而服用安慰剂的患者体重减轻了 3.7%（2.2 公斤）。使用胰酶的患者的脂肪吸收系数提高了 12%，而安慰剂患者的脂肪吸收系数下降了 8%（p = 0.13，差异的 95% 置信区间：- 6 至 45）。接受胰酶治疗的患者每日总能量摄入量为 8.42 MJ，安慰剂患者为 6.66 MJ（p = 0.04，差异的 95% 置信区间：0.08 至 3.44）。 结论 - 通过高剂量，至少在插入胆道内置假体后立即可以预防胰头区域不可切除癌症患者的体重减轻和胰管闭塞。肠溶胰酶补充剂与饮食咨询相结合。
Background-Impeded flow of pancreatic juice due to mechanical obstruction of the pancreatic duct in patients with cancer of the pancreatic head region causes exocrine pancreatic insufficiency with steatorrhoea and creatorrhoea. This may contribute to the profound weight loss that often occurs in these patients.Aims-To investigate whether pancreatic enzyme replacement therapy prevents this weight loss.Patients-Twenty one patients with unresectable cancer of the pancreatic head region with suspected pancreatic duct obstruction, a biliary endoprosthesis in situ, and a Karnofsky performance status greater than 60,Methods-Randomise double blind trial of eight weeks with either placebo or high dose enteric coated pancreatin enzyme supplementation. All patients received dietary counselling.Results-The mean difference in the percentage change of body weight was 4.9% (p = 0.02, 95% confidence interval for the difference: 0.9 to 8.9). Patients on pancreatic enzymes gained 1.2% (0.7 kg) body weight whereas patients on placebo lost 3.7% (2.2 kg). The fat absorption coefficient in patients on pancreatic enzymes improved by 12% whereas in placebo patients it dropped by 8% (p = 0.13, 95% confidence interval for the difference: - 6 to 45). The daily total energy intake was 8.42 MJ in patients on pancreatic enzymes and 6.66 MJ in placebo patients (p = 0.04, 95% confidence interval for the difference: 0.08 to 3.44).Conclusions-Weight loss in patients with unresectable cancer of the pancreatic head region and occlusion of the pancreatic duct can be prevented, at least for the period immediately after insertion of a biliary endoprosthesis, by high dose enteric coated pancreatin enzyme supplementation in combination with dietary counselling.