Hetzel D J, Dent J, Reed W D, Narielvala F M, Mackinnon M, McCarthy J H, Mitchell B, Beveridge B R, Laurence B H, Gibson G G
Department of Medicine, Flinders Medical Centre, Repatriation General Hospital, Adelaide, Australia.
Gastroenterology. 1988 Oct;95(4):903-12. doi: 10.1016/0016-5085(88)90162-x.
We have studied the response of erosive or ulcerative esophagitis to treatment with omeprazole and its subsequent relapse on cessation of therapy in 196 patients. In the first phase of the study omeprazole (20 or 40 mg daily) was compared with placebo in 64 patients. After 4 wk there was endoscopic healing in 81% (25 of 31) of omeprazole-treated patients and in only 6% (2 of 32) of placebo-treated patients. Endoscopic healing of esophagitis was accompanied by symptom relief and histologic healing of ulceration. In the second (dose finding) phase a further 132 patients were randomized to omeprazole (20 or 40 mg daily) and endoscopic healing was assessed. In patients with the mildest grade of ulcerative esophagitis (grade 2), healing occurred at 4 wk in 87% receiving 20 mg and in 97% receiving 40 mg. In patients with grade 3 esophagitis, 67% (20 mg) and 88% (40 mg) were healed. Less than half the patients with grade 4 esophagitis (Barrett's ulcers or confluent ulceration) healed with either 20 mg (48%) or 40 mg (44%). Regression analysis in the 164 omeprazole-treated patients showed no evidence that healing was influenced by factors other than severity of esophagitis at entry and omeprazole dose. In phase 3 of the study the rate of endoscopic relapse was determined in 107 endoscopically healed patients after stopping omeprazole. Erosive or ulcerative esophagitis recurred in 88 of 107 (82%) by 6 mo. Neither initial dose, grade of esophagitis, nor smoking was shown to influence relapse rate. Omeprazole is a highly effective treatment for peptic esophagitis. The 40-mg/day dosage produces endoscopic healing slightly more quickly than the 20-mg/day dosage, and the initial endoscopic gradings are of prognostic value. Relapse occurs rapidly when treatment is stopped.
我们研究了196例糜烂性或溃疡性食管炎患者使用奥美拉唑治疗的反应以及治疗停止后疾病的复发情况。在研究的第一阶段，64例患者中，将奥美拉唑（每日20或40毫克）与安慰剂进行比较。4周后，接受奥美拉唑治疗的患者中有81%（31例中的25例）内镜愈合，而接受安慰剂治疗的患者中只有6%（32例中的2例）内镜愈合。食管炎的内镜愈合伴随着症状缓解和溃疡的组织学愈合。在第二阶段（剂量探索阶段），另外132例患者被随机分配接受奥美拉唑（每日20或40毫克）治疗，并评估内镜愈合情况。在溃疡性食管炎最轻度（2级）的患者中，接受20毫克治疗的患者4周时愈合率为87%，接受40毫克治疗的患者愈合率为97%。在3级食管炎患者中，20毫克组愈合率为67%，40毫克组愈合率为88%。4级食管炎（巴雷特溃疡或融合性溃疡）患者中，接受20毫克治疗的患者愈合率不到一半（48%），接受40毫克治疗的患者愈合率为44%。对164例接受奥美拉唑治疗的患者进行回归分析，结果显示，除了入组时食管炎的严重程度和奥美拉唑剂量外，没有证据表明其他因素会影响愈合情况。在研究的第三阶段，对107例内镜愈合的患者在停用奥美拉唑后测定内镜复发率。107例中有88例（82%）在6个月内出现糜烂性或溃疡性食管炎复发。初始剂量、食管炎分级和吸烟均未显示会影响复发率。奥美拉唑是治疗消化性食管炎的高效药物。每日40毫克的剂量比每日20毫克的剂量内镜愈合稍快，初始内镜分级具有预后价值。治疗停止后复发迅速。
