Hatlebakk J G, Berstad A, Carling L, Svedberg L E, Unge P, Ekström P, Halvorsen L, Stallemo A, Hovdenak N, Trondstad R
Dept. of Medicine, Haukeland University Hospital, Bergen, Norway.
Scand J Gastroenterol. 1993 Mar;28(3):224-8. doi: 10.3109/00365529309096076.
To evaluate the therapeutic potential of the newly developed proton pump inhibitor lansoprazole in patients with reflux oesophagitis, we performed a double-blind randomized clinical trial comparing 20 mg omeprazole and 30 mg lansoprazole, involving 229 patients at 9 Scandinavian hospitals. The treatment period was 4 or 8 weeks, and main efficacy variables were healing of endoscopic changes, relief of reflux symptoms, and occurrence of adverse events. No significant difference in terms of healing was found, either after 4 or after 8 weeks' treatment. Patients receiving lansoprazole experienced a greater improvement in heartburn after 4 weeks (p = 0.03), and there was a similar trend for acid regurgitation. Lansoprazole was found to be an effective and safe alternative to omeprazole in short-term treatment of moderate reflux oesophagitis.
为评估新开发的质子泵抑制剂兰索拉唑对反流性食管炎患者的治疗潜力,我们进行了一项双盲随机临床试验,比较20毫克奥美拉唑和30毫克兰索拉唑,9家斯堪的纳维亚医院的229名患者参与其中。治疗期为4周或8周,主要疗效变量为内镜改变的愈合情况、反流症状的缓解以及不良事件的发生。治疗4周或8周后,在愈合方面均未发现显著差异。接受兰索拉唑治疗的患者在4周后烧心症状有更大改善(p = 0.03),反酸情况也有类似趋势。在中度反流性食管炎的短期治疗中,兰索拉唑被证明是奥美拉唑的一种有效且安全的替代药物。