A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer
A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer
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DOI：
10.1097/mpa.0000000000001079
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发表时间：
2018-08-01
期刊：
影响因子：
2.9
通讯作者：
Koike, Kazuhiko
中科院分区：
文献类型：
--
作者：
Saito, Tomotaka;Nakai, Yousuke;Koike, Kazuhiko
目的 胰腺外分泌功能不全可能损害胰腺癌（PC）的营养状况，但胰酶替代疗法（PERT）的作用尚未得到充分评估。因此，我们进行了这项多中心开放标签随机对照试验，以评估 PERT 在 PC 患者中的作用。方法将接受化疗的不可切除 PC 患者随机分为胰脂肪酶组和非胰脂肪酶组。胰脂肪酶组的患者每餐口服48,000脂肪酶单位的胰脂肪酶。在基线时进行 N-苯甲酰-酪氨酰对氨基苯甲酸 (NBT-PABA) 测试。我们的主要终点是 8 周时体重指数 (BMI) 的变化。次要终点是8周时其他营养状况的变化和总生存率。 结果 2014年5月至2016年5月期间共有88名患者入组。NBT-PABA测试低于正常范围90%。 8周时BMI变化无显着差异：胰脂肪酶组和非胰脂肪酶组分别为0.975和0.980（P = 0.780）。其他营养指标也具有可比性。中位总生存期分别为 19.0 和 12.0 个月（P = 0.070）。 结论 在这项随机对照试验中，胰脂肪酶未能改善接受化疗的 PC 患者 8 周时的 BMI 变化。
Objective Exocrine pancreatic insufficiency may impair the nutritional status in pancreatic cancer (PC), but the role of pancreatic enzyme replacement therapy (PERT) is not fully evaluated. Therefore, we conducted this multicenter open-label randomized controlled trial to evaluate the role of PERT in PC patients.Methods Patients with unresectable PC receiving chemotherapy were randomly assigned to pancrelipase and nonpancrelipase groups. Patients in the pancrelipase group took oral pancrelipase of 48,000 lipase units per meal. N-benzoyl-tryrosyl para-aminobenzoic acid (NBT-PABA) test was performed at baseline. Our primary endpoint was change in body mass index (BMI) at 8 weeks. Secondary endpoints were change in other nutritional status at 8 weeks and overall survival.Results A total of 88 patients were enrolled between May 2014 and May 2016. The NBT-PABA test was lower than the normal range in 90%. There were no significant differences in change in BMI at 8 weeks: 0.975 and 0.980 in the pancrelipase and the nonpancrelipase groups, respectively (P = 0.780). The other nutritional markers were also comparable. The median overall survival was 19.0 and 12.0 months (P = 0.070).Conclusions In this randomized controlled trial, pancrelipase failed to improve the change in BMI at 8 weeks in PC patients receiving chemotherapy.