随机临床试验：大剂量胃酸抑制剂治疗慢性咳嗽——一项双盲、安慰剂对照研究
2010/12/31
摘要
背景：咳嗽可能是胃食管反流性疾病(GERD)的一个表现。GERD相关咳嗽中使用胃酸抑制剂的效果尚无定论。
目的：评价大剂量胃酸抑制剂（质子泵抑制剂[PPI]）对无或鲜有烧心症状的患者慢性咳嗽的影响。
方法：患者为非吸烟者，无哮喘病史，慢性咳嗽持续超过8周。所有研究对象均进行基线状态24-h pH值/阻抗检测、乙酰甲胆碱激发检测和喉镜检查。研究对象随机采用艾美拉唑（40 mg，每日两次）或安慰剂治疗12 周。主要检测结果为咳嗽特异性生命质量问卷调查(CQLQ)，次要检测结果为Fisman 咳嗽严重程度/频率评分中的反应和喉镜下改变。
结果：40名患者（22名接受PPI治疗，18名接受安慰剂治疗）参加随机分组并完成本试验。两组患者之间在CQLO（平均改善分别为9.8 vs. 5.9；P = 0.3）和Fisman 咳嗽严重程度/频率评分上未见显著差异。在CQLQ上，评分改善>1 s.d.的患者比率在安慰剂和PPI组分别为27.8%（5/18）和31.8%（7/22）。
结论：对于无或鲜有烧心症状的慢性咳嗽患者，大剂量质子泵抑制剂并不能改善与咳嗽相关生命质量和症状。
（林江涛 审校）
Aliment Pharmacol Ther. 2010 Nov 17. doi: 10.1111/j.1365-2036.2010.04511.x. [Epub ahead of print]
Randomised clinical trial: high-dose acid suppression for chronic cough - a double-blind, placebo-controlled study.
Shaheen NJ, Crockett SD, Bright SD, Madanick RD, Buckmire R, Couch M, Dellon ES, Galanko JA, Sharpless G, Morgan DR, Spacek MB, Heidt-Davis P, Henke D.
Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Department of Head and Neck Surgery, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Division of Pulmonary and Critical Care Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
Abstract
Background Cough may be a manifestation of gastro-oesophageal reflux disease (GERD). The utility of acid suppression in GERD-related cough is uncertain. Aim To assess the impact of high-dose acid suppression with proton pump inhibitors (PPI) on chronic cough in subjects with rare or no heartburn. Methods Subjects were nonsmokers without history of asthma, with chronic cough for >8 weeks. All subjects underwent a baseline 24-h pH/impedance study, methacholine challenge test and laryngoscopy. Subjects were randomised to either 40 mg of esomeprazole twice daily or placebo for 12 weeks. The primary outcome measure was the Cough-Specific Quality of Life Questionnaire (CQLQ). Secondary outcomes were response on Fisman Cough Severity/Frequency scores and change in laryngeal findings. Results Forty subjects were randomised (22 PPI, 18 placebo) and completed the study. There was no difference between PPI and placebo in CQLQ (mean improvement 9.8 vs. 5.9 respectively, P = 0.3), or Fisman Cough Severity/Frequency scores. Proportion of patients who improved by >1 s.d. on the CQLQ was 27.8% (five of 18) and 31.8% (seven of 22) in the placebo and PPI groups respectively. Conclusion In subjects with chronic cough and rare or no heartburn, high-dose proton pump inhibitor does not improve cough-related quality of life or symptoms.
Aliment Pharmacol Ther. 2010 Nov 17. doi: 10.1111/j.1365-2036.2010.04511.x. [Epub ahead of print]
背景：咳嗽可能是胃食管反流性疾病(GERD)的一个表现。GERD相关咳嗽中使用胃酸抑制剂的效果尚无定论。
目的：评价大剂量胃酸抑制剂（质子泵抑制剂[PPI]）对无或鲜有烧心症状的患者慢性咳嗽的影响。
方法：患者为非吸烟者，无哮喘病史，慢性咳嗽持续超过8周。所有研究对象均进行基线状态24-h pH值/阻抗检测、乙酰甲胆碱激发检测和喉镜检查。研究对象随机采用艾美拉唑（40 mg，每日两次）或安慰剂治疗12 周。主要检测结果为咳嗽特异性生命质量问卷调查(CQLQ)，次要检测结果为Fisman 咳嗽严重程度/频率评分中的反应和喉镜下改变。
结果：40名患者（22名接受PPI治疗，18名接受安慰剂治疗）参加随机分组并完成本试验。两组患者之间在CQLO（平均改善分别为9.8 vs. 5.9；P = 0.3）和Fisman 咳嗽严重程度/频率评分上未见显著差异。在CQLQ上，评分改善>1 s.d.的患者比率在安慰剂和PPI组分别为27.8%（5/18）和31.8%（7/22）。
结论：对于无或鲜有烧心症状的慢性咳嗽患者，大剂量质子泵抑制剂并不能改善与咳嗽相关生命质量和症状。
（林江涛 审校）
Aliment Pharmacol Ther. 2010 Nov 17. doi: 10.1111/j.1365-2036.2010.04511.x. [Epub ahead of print]
Randomised clinical trial: high-dose acid suppression for chronic cough - a double-blind, placebo-controlled study.
Shaheen NJ, Crockett SD, Bright SD, Madanick RD, Buckmire R, Couch M, Dellon ES, Galanko JA, Sharpless G, Morgan DR, Spacek MB, Heidt-Davis P, Henke D.
Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Department of Head and Neck Surgery, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Division of Pulmonary and Critical Care Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
Abstract
Background Cough may be a manifestation of gastro-oesophageal reflux disease (GERD). The utility of acid suppression in GERD-related cough is uncertain. Aim To assess the impact of high-dose acid suppression with proton pump inhibitors (PPI) on chronic cough in subjects with rare or no heartburn. Methods Subjects were nonsmokers without history of asthma, with chronic cough for >8 weeks. All subjects underwent a baseline 24-h pH/impedance study, methacholine challenge test and laryngoscopy. Subjects were randomised to either 40 mg of esomeprazole twice daily or placebo for 12 weeks. The primary outcome measure was the Cough-Specific Quality of Life Questionnaire (CQLQ). Secondary outcomes were response on Fisman Cough Severity/Frequency scores and change in laryngeal findings. Results Forty subjects were randomised (22 PPI, 18 placebo) and completed the study. There was no difference between PPI and placebo in CQLQ (mean improvement 9.8 vs. 5.9 respectively, P = 0.3), or Fisman Cough Severity/Frequency scores. Proportion of patients who improved by >1 s.d. on the CQLQ was 27.8% (five of 18) and 31.8% (seven of 22) in the placebo and PPI groups respectively. Conclusion In subjects with chronic cough and rare or no heartburn, high-dose proton pump inhibitor does not improve cough-related quality of life or symptoms.
Aliment Pharmacol Ther. 2010 Nov 17. doi: 10.1111/j.1365-2036.2010.04511.x. [Epub ahead of print]
