Ranitidine and omeprazole as adjuvant therapy to pancrelipase to improve fat absorption in patients with cystic fibrosis
Ranitidine and omeprazole as adjuvant therapy to pancrelipase to improve fat absorption in patients with cystic fibrosis
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DOI：
10.1097/00005176-200207000-00017
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发表时间：
2002-07-01
影响因子：
2.9
通讯作者：
Novak, DA
中科院分区：
文献类型：
--
作者：
Francisco, MP;Wagner, MH;Novak, DA
背景：囊性纤维化（CF）患者的胰腺功能不全治疗不充分会导致营养吸收不良，并产生严重后遗症。本研究的目的是测量抑酸疗法对接受 pH 敏感肠溶微片酶产品的 CF 患者脂肪吸收的影响。方法：对 12 名患有胰腺功能不足 CF 的儿童和 10 名成人进行了双盲、安慰剂对照交叉研究。所有受试者均接受胰脂肪酶治疗（Pancrease MT10 和 MT16：Ortho-McNeil，Spring-house，PA，U.S.A.），并且在研究中还接受安慰剂或雷尼替丁（Zantac：Glaxo-Wellcome，Research Triangle Park，NC U.S.A.）每日 5 mg/kg 或 10 mg/kg。成年受试者还接受奥美拉唑治疗（Prilosec. AstraZeneca/Merck, Wilmington, DE U.S.A.），每日 20 mg，作为胰酶的辅助治疗。临床研究中心进行了为期 3 天的连续脂肪平衡研究。使用个体配对 t 检验对数据进行分析，将每种治疗与安慰剂进行比较，并进行两次重复测量、一般线性模型 F 检验。结果：所有受试者的线性模型显示，总体辅助药物对脂肪吸收没有影响，P = 0.32。对成人受试者的第二次线性模型 F 检验分析比较了所有四种药物治疗（安慰剂、雷尼替丁每日 5 和 10 mg/kg 以及奥美拉唑），也显示脂肪吸收没有差异，P = 0. 15。成人的配对 t 检验亚组分析显示，与安慰剂相比，低剂量雷尼替丁的平均脂肪吸收改善了 4.97% (P = 0.003)。所有其他 t 检验分析显示安慰剂和抑酸治疗之间的脂肪吸收没有显着变化。脂肪吸收存在显着的受试者间和受试者内差异。结论：辅助治疗没有显示出脂肪吸收总体显着改善。尽管膳食脂肪和酶摄入量相同，但即使在比较安慰剂和基线治疗的同一受试者时，三天脂肪平衡研究测量的脂肪吸收也有很大差异。较大的变异性限制了我们测试脂肪吸收差异的能力，并且对于使用该测试（被认为是金标准）来确定酶剂量充足性具有重要意义。 (C) 2002 年利平科特·威廉姆斯·威尔金斯公司
Background: Inadequate treatment of pancreatic insufficiency in patients with cystic fibrosis (CF) causes malabsorption of nutrients with significant sequelae. The objective of this study was to measure the effect of acid suppressant therapy on fat absorption in patients with CF who received a pH-sensilive, enteric-coated microtablet enzyme product.Methods: A double-blind, placebo-controlled crossover study of 12 children and 10 adults with pancreatic insufficient CF was performed. All subjects were receiving pancrelipase therapy (Pancrease MT10 and MT16: Ortho-McNeil, Spring-house, PA, U.S.A.) and for the study also received either placebo or ranitidine (Zantac: Glaxo-Wellcome, Research Triangle Park, NC U.S.A.) 5 mg/kg or 10 mg/kg daily. The adult subjects also received omeprazole therapy (Prilosec. AstraZeneca/Merck, Wilmington, DE. U.S.A,), 20 mg daily, as adjuvant therapy to pancreatic enzymes. Serial 3-day fat-balance studies were performed in the Clinical Research Center. The data were analyzed using individual paired t tests that compared each treatment with placebo and two repeated-measures, general linear model F tests.Results: The linear model for all subjects showed no overall adjuvant drug effect on fat absorption, P = 0.32. A second linear model F test analysis of adult subjects, comparing all four drug treatments (placebo, ranitidine 5 and 10 mg/kg daily and omeprazole), also showed no difference in fat absorption, P = 0. 15. Paired t test subgroup analysis of the adults showed an improvement of 4.97% (P = 0.003) in mean fat absorption comparing low-dose ranitidine to placebo. All other t test analyses showed no significant change in fat absorption between placebo and acid suppressant treatment. There was marked intersubject and intrasubject variability in fat absorption.Conclusions: No overall significant improvement in fat absorption could be demonstrated with adjuvant therapy. Fat absorption measured by 3-day fat-balance studies varied greatly even when comparing the same subject for placebo and baseline treatments, despite identical dietary fat and enzyme intakes. The large variability limited our ability to test for a difference in fat absorption and has significant implication for the use of this test, considered the gold standard, for determining enzyme dosage adequacy. (C) 2002 Lippincott Williams Wilkins, Inc.