Bate C M, Griffin S M, Keeling P W, Axon A T, Dronfield M W, Chapman R W, O'Donoghue D, Calam J, Crowe J, Mountfords R A, Watts D A, Taylor M D, Richardson P D
Royal Albert Edward Infirmary, Wigan, UK.
Aliment Pharmacol Ther. 1996 Aug;10(4):547-55. doi: 10.1046/j.1365-2036.1996.44186000.x.
As many as 50% of patients with reflux symptoms have no endoscopic evidence of oesophagitis. This multicentre study was designed to assess symptom relief after omeprazole 20 mg once daily in patients with symptoms typical of gastro-oesophageal reflux disease but without endoscopic evidence of oesophagitis.
Patients (n = 209) were randomized in a double-blind study to receive either omeprazole 20 mg once daily (n = 98) or placebo (n = 111) for 4 weeks. Symptoms were assessed at clinic visits and using daily diary cards, with patient-completed questionnaires providing additional data on symptoms and on psychological disturbance.
On completion, symptom relief favoured omeprazole: 57% of patients on omeprazole were free of heartburn (vs. 19% on placebo), 75% were free of regurgitation (47%) and 43% were completely asymptomatic (14%), each with P < 0.0001. Fewer patients in the omeprazole group required alginate/antacid relief medication (P < 0.05). Symptom relief (time to first heartburn-free day) was more rapid with omeprazole (2 vs. 5 days on placebo; P < 0.01). A greater reduction in anxiety occurred in the omeprazole group (P < 0.05).
Omeprazole 20 mg once daily is effective in providing relief of the symptoms typical of gastro-oesophageal reflux disease in patients with essentially normal oesophageal mucosa.
多达50%有反流症状的患者没有食管炎的内镜检查证据。这项多中心研究旨在评估每日一次服用20毫克奥美拉唑对有胃食管反流病典型症状但无食管炎内镜检查证据的患者的症状缓解情况。
在一项双盲研究中，将209例患者随机分为两组，一组每日一次服用20毫克奥美拉唑（98例），另一组服用安慰剂（111例），为期4周。在门诊就诊时和使用每日日记卡评估症状，患者填写的问卷提供了关于症状和心理障碍的额外数据。
研究结束时，症状缓解情况有利于奥美拉唑组：服用奥美拉唑的患者中，57%无烧心症状（安慰剂组为19%），75%无反流症状（安慰剂组为47%），43%完全无症状（安慰剂组为14%），各项均P<0.0001。奥美拉唑组需要藻酸盐/抗酸缓解药物的患者较少（P<0.05）。奥美拉唑组症状缓解（至首个无烧心日的时间）更快（奥美拉唑组为2天，安慰剂组为5天；P<0.01）。奥美拉唑组焦虑程度降低更明显（P<0.05）。
对于食管黏膜基本正常的患者，每日一次服用20毫克奥美拉唑可有效缓解胃食管反流病的典型症状。
