Omeprazole and ranitidine in treatment of reflux oesophagitis: double blind comparative trial
Omeprazole and ranitidine in treatment of reflux oesophagitis: double blind comparative trial
复制标题
奥美拉唑和雷尼替丁治疗反流性食管炎：双盲比较试验
作者：
T. Havelund;L. Laursen;E. Skoubo;B. Andersen;S. Pedersen;K. B. Jensen;C. Fenger;F. Hanberg‐Sørensen;K. Lauritsen
162例经内镜证实的反流性食管炎患者按严重程度分层，66例为1级疾病（红斑和脆性），96例为2级或3级疾病（包括糜烂或溃疡），随机分配至奥美拉唑40 mg早晨或雷尼替丁150 mg每日2次双盲治疗组，持续12周。如果在治疗4 - 8周后观察到症状缓解和内镜下正常粘膜（0级），则可以更快地对患者进行评估。奥美拉唑治疗的患者比雷尼替丁治疗的患者反应明显更快（p<0.0001），奥美拉唑组1级疾病患者在4周、8周和12周的累积愈合率分别为90%、100%和100%，2级或3级疾病患者分别为70%、85%和91%。雷尼替丁组的相应发生率分别为55%、79%和88%（1级）和26%、44%和54%（2级或3级）。与雷尼替丁相比，奥美拉唑治疗期间胃灼热、反流和吞咽困难等主要症状的缓解以及粘膜组织学外观的改善发生得更早，并且再次更明显。在反流性食管炎的短期治疗中，观察到奥美拉唑40 mg早晨给药优于雷尼替丁150 mg每日两次给药，且无重大临床或生化副作用，但需要进一步研究奥美拉唑的长期使用及其诱导的酸抑制作用。
One hundred and sixty two patients with endoscopically proved reflux oesophagitis stratified for severity, 66 with grade 1 disease (erythema and friability) and 96 with grade 2 or 3 disease (including erosions or ulcerations), were allocated at random to double blind treatment with omeprazole 40 mg in the morning or ranitidine 150 mg twice daily for up to 12 weeks. A patient could be evaluated sooner if symptomatic relief and endoscopically normal mucosa (grade 0) were noted after four to eight weeks' treatment. Patients treated with omeprazole responded significantly more rapidly than those treated with ranitidine (p<0.0001), cumulative healing rates at four, eight, and 12 weeks being 90%, 100%, and 100% respectively for those with grade 1 disease and 70%, 85%, and 91% respectively for those with grade 2 or 3 disease in the omeprazole group. Corresponding rates in the ranitidine group were 55%, 79%, and 88% (grade 1) and 26%, 44%, and 54% (grade 2 or 3). Relief of the major symptoms of heartburn, regurgitation, and dysphagia and improvements in the histological appearance of the mucosa occurred earlier and were again more pronounced during treatment with omeprazole than with ranitidine. This observed superiority of omeprazole 40 mg in the morning over ranitidine 150 mg twice daily in the short term treatment of reflux oesophagitis was obtained without major clinical or biochemical side effects, but further research is needed into longer term use of omeprazole and the effects of the acid inhibition it induces.