PDF(Pubmed)
Abstract：
UNASSIGNED: Pancreatic Exocrine Insufficiency (PEI) is a possible cause of recurrent/persistent symptoms in celiac disease. Although pancreatic enzyme supplementation may be used to treat non-responsive celiac disease (NRCD) in clinical practice, clinical outcomes are variable and there is limited and low quality evidence to support this practice. The aim of this study was to assess the efficacy of pancreatic enzyme supplements (PES) for improvement of gastrointestinal symptoms in NRCD.
UNASSIGNED: Prospective, randomized, placebo-controlled, double-blind, cross-over trial in adults with NRCD examining Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) scores on PES (pancrelipase co-administered with omeprazole) versus placebo (omeprazole only) during a 10-day treatment period. The study was registered under the clinical trials registry (https://clinicaltrials.gov/ number, NCT02475369) on 18 Jun 2015.
UNASSIGNED: Twelve participants (nine female) were included in the per-protocol analysis; one participant had low fecal elastase-1. Pancrelipase was not associated with significant change in CeD-GSRS compared to placebo (-0.03 versus -0.26; P = 0.366). There was a significant decrease in mean values of total CeD-GSRS scores (3.58 versus 2.90, P = 0.004), abdominal pain (2.92 versus 2.42, P = 0.009), and diarrhea sub-scores (3.44 versus 2.92, P = 0.037) during the run-in period with omeprazole.
UNASSIGNED: In this prospective, cross-over randomized, placebo-controlled study, PES did not improve symptoms in patients with NRCD. It is unclear whether this is a trial effect or related to administration of omeprazole.
UNASSIGNED: Prospective, randomized, placebo-controlled, double-blind, cross-over trial in adults with NRCD examining Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) scores on PES (pancrelipase co-administered with omeprazole) versus placebo (omeprazole only) during a 10-day treatment period. The study was registered under the clinical trials registry (https://clinicaltrials.gov/ number, NCT02475369) on 18 Jun 2015.
UNASSIGNED: Twelve participants (nine female) were included in the per-protocol analysis; one participant had low fecal elastase-1. Pancrelipase was not associated with significant change in CeD-GSRS compared to placebo (-0.03 versus -0.26; P = 0.366). There was a significant decrease in mean values of total CeD-GSRS scores (3.58 versus 2.90, P = 0.004), abdominal pain (2.92 versus 2.42, P = 0.009), and diarrhea sub-scores (3.44 versus 2.92, P = 0.037) during the run-in period with omeprazole.
UNASSIGNED: In this prospective, cross-over randomized, placebo-controlled study, PES did not improve symptoms in patients with NRCD. It is unclear whether this is a trial effect or related to administration of omeprazole.
摘要：
未经证实：胰腺外分泌功能不全(PEI)是乳糜泻中反复/持续症状的可能原因。尽管在临床实践中补充胰酶可用于治疗无反应性乳糜泻（NRCD），临床结局是可变的,支持这一实践的证据有限且质量低.这项研究的目的是评估胰酶补充剂（PES）改善NRCD胃肠道症状的功效。
未经批准：预期，随机化，安慰剂对照,双盲,在10天的治疗期内,在NRCD成人中进行交叉试验,检查了PES(胰脂肪酶与奥美拉唑共同给药)与安慰剂(仅奥美拉唑)的乳糜泻-胃肠道症状评定量表(CeD-GSRS)评分.该研究已在临床试验注册中心（https://clinicaltrials.gov/number，NCT02475369），2015年6月18日。
UNASSIGNED：12名参与者（9名女性）被纳入符合方案分析；一名参与者粪便弹性蛋白酶-1低。与安慰剂相比，胰脂肪酶与CeD-GSRS的显着变化无关（-0.03对-0.26；P=0.366）。总CeD-GSRS得分的平均值显着下降（3.58对2.90，P=0.004），腹痛（2.92对2.42，P=0.009），与奥美拉唑磨合期的腹泻子评分（3.44对2.92，P=0.037）。
未经批准：在此前瞻性中，交叉随机化，安慰剂对照研究，PES不能改善NRCD患者的症状。目前尚不清楚这是否是奥美拉唑的试验效果或与奥美拉唑的给药有关。
未经批准：预期，随机化，安慰剂对照,双盲,在10天的治疗期内,在NRCD成人中进行交叉试验,检查了PES(胰脂肪酶与奥美拉唑共同给药)与安慰剂(仅奥美拉唑)的乳糜泻-胃肠道症状评定量表(CeD-GSRS)评分.该研究已在临床试验注册中心（https://clinicaltrials.gov/number，NCT02475369），2015年6月18日。
UNASSIGNED：12名参与者（9名女性）被纳入符合方案分析；一名参与者粪便弹性蛋白酶-1低。与安慰剂相比，胰脂肪酶与CeD-GSRS的显着变化无关（-0.03对-0.26；P=0.366）。总CeD-GSRS得分的平均值显着下降（3.58对2.90，P=0.004），腹痛（2.92对2.42，P=0.009），与奥美拉唑磨合期的腹泻子评分（3.44对2.92，P=0.037）。
未经批准：在此前瞻性中，交叉随机化，安慰剂对照研究，PES不能改善NRCD患者的症状。目前尚不清楚这是否是奥美拉唑的试验效果或与奥美拉唑的给药有关。
