Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis
Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis
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DOI：
10.1111/j.1572-0241.2002.05532.x
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发表时间：
2002-03
影响因子：
9.8
通讯作者：
D. Castell;P. Kahrilas;J. Richter;N. Vakil;D. Johnson;Seth Zuckerman;W. Skammer;J. Levine
中科院分区：
文献类型：
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作者：
D. Castell;P. Kahrilas;J. Richter;N. Vakil;D. Johnson;Seth Zuckerman;W. Skammer;J. Levine
治疗：埃索美拉唑（奥美拉唑的S异构体）已被证明对糜烂性食管炎的愈合率高于奥美拉唑。本研究比较埃索美拉唑与兰索拉唑的愈合糜烂性食管炎和决议heartburn.METHODS：这美国多中心，随机，双盲，平行组试验进行了5241例成人患者（意向治疗人群）与内镜记录糜烂性食管炎，这是分级的严重程度在基线（洛杉矶分类）。患者在早餐前接受40 mg埃索美拉唑（n = 2624）或30 mg兰索拉唑（n = 2617），每日一次，持续8周。主要疗效终点是第8周糜烂性食管炎的愈合。次要评估包括第4周治愈的患者比例、治疗仪记录的胃灼热消退、患者日记记录的胃灼热首次消退时间和持续消退时间以及无胃灼热的昼夜比例。结果：第8周艾索马汀（40 mg）的治愈率（92.6%，95% CI = 91.5-93.6%）显著高于兰索拉唑（30 mg）（88.8%，95% CI = 87.5-90.0%）（p = 0.0001，生命表估计值，意向治疗分析）。在第4周也观察到有利于埃索美拉唑的愈合率的显著差异。埃索美拉唑和兰索拉唑之间的愈合率差异随着糜烂性食管炎基线严重程度的增加而增加。持续解决烧心发生更快，并在更多的患者与埃索美拉唑治疗。埃索美拉唑也能更快地持续缓解夜间胃灼热。两种治疗均耐受良好。结论：埃索美拉唑（40 mg）比兰索拉唑（30 mg）在治愈糜烂性食管炎和解决胃灼热方面更有效。无论基线疾病严重程度如何，埃索美拉唑的治愈率始终很高。
OBJECTIVES: Esomeprazole, the S isomer of omeprazole, has been shown to have higher healing rates of erosive esophagitis than omeprazole. This study compared esomeprazole with lansoprazole for the healing of erosive esophagitis and resolution of heartburn.METHODS:This United States multicenter, randomized, double blind, parallel group trial was performed in 5241 adult patients (intent-to-treat population) with endoscopically documented erosive esophagitis, which was graded by severity at baseline (Los Angeles classification). Patients received 40 mg of esomeprazole (n = 2624) or 30 mg of lansoprazole (n = 2617) once daily before breakfast for up to 8 wk. The primary efficacy endpoint was healing of erosive esophagitis at week 8. Secondary assessments included proportion of patients healed at week 4, resolution of investigator-recorded heartburn, time to first and time to sustained resolution of patient diary-recorded heartburn, and proportion of heartburn-free days and nights.RESULTS:Esomeprazole (40 mg) demonstrated significantly higher healing rates (92.6%, 95% CI = 91.5–93.6%) than lansoprazole (30 mg) (88.8%, 95% CI = 87.5–90.0%) at week 8 (p = 0.0001, life-table estimates, intent-to-treat analysis). A significant difference in healing rates favoring esomeprazole was also observed at week 4. The difference in healing rates between esomeprazole and lansoprazole increased as baseline severity of erosive esophagitis increased. Sustained resolution of heartburn occurred faster and in more patients treated with esomeprazole. Sustained resolution of nocturnal heartburn also occurred faster with esomeprazole. Both treatments were well tolerated.CONCLUSIONS:Esomeprazole (40 mg) is more effective than lansoprazole (30 mg) in healing erosive esophagitis and resolving heartburn. Healing rates are consistently high with esomeprazole, irrespective of baseline disease severity.