Park K N, Hahm J S, Kim H J
Department of Internal Medicine, Hanyang University Hospital, Seoul, Korea.
Eur J Gastroenterol Hepatol. 1994 Dec;6 Suppl 1:S103-7.
Two 4-week triple-therapy treatment regimens, metronidazole+tetracycline+bismuth subcitrate and omeprazole+amoxycillin+bismuth subcitrate, were compared in a randomly allocated double-blind trial for their efficacy in eradicating Helicobacter pylori from the gastric mucosa of patients with gastritis and/or peptic ulcer disease.
The presence of gastritis and/or peptic ulcers was confirmed by endoscopy in all patients included in the study. To evaluate drug effects, we used the urease test on gastric mucosa, and haematoxylin-eosin and specific Giemsa stains on biopsy tissues obtained by endoscopic procedures; we also evaluated the improvement in clinical symptoms before and after the 4-week treatments.
Among 164 patients with gastritis and/or peptic ulcers, H. pylori infection was confirmed in 93.9% (154 patients) by the urease test and in 87.8% (144 patients) by haematoxylin-eosin stain. Following 4 weeks of treatment with both combination regimens, negative conversion rates by the urease test and haematoxylin-eosin staining and rates of recovery from clinical symptoms were similar in both regimens (metronidazole+tetracycline+bismuth subcitrate: 82.3, 72.9 and 73.9%; omeprazole+amoxycillin+bismuth subcitrate: 89.6, 83.4 and 76.1%, respectively). Also, the extent of inflammatory activity and the H. pylori score by the Giemsa method indicated high rates of recovery, with improvements to grade 0 (lowest grade) from higher grades with both combination regimens (60.4 and 66.7% of patients taking metronidazole+tetracycline+bismuth subcitrate and 64.6 and 83.3 of those taking omeprazole+amoxycillin+bismuth subcitrate). However, the prevalence of side effects during the 4 weeks of treatment was doubled in the former group compared to the latter (25.5 versus 12.5% of patients).
Significant improvements in biochemical and histopathological findings and in the clinical symptoms of gastritis and/or peptic ulcer disease in patients with a high rate of H. pylori infection were observed equally with both regimens. However, there were notably fewer side effects in patients treated with omeprazole+amoxycillin+bismuth subcitrate. We therefore recommended this regimen in preference to metronidazole+tetracycline+bismuth subcitrate for the treatment of H. pylori-related gastritis and peptic ulcer disease.
在一项随机分配的双盲试验中，比较了两种为期4周的三联疗法治疗方案，即甲硝唑+四环素+次枸橼酸铋和奥美拉唑+阿莫西林+次枸橼酸铋，以评估它们根除胃炎和/或消化性溃疡病患者胃黏膜中幽门螺杆菌的疗效。
纳入研究的所有患者均通过内镜检查确诊为胃炎和/或消化性溃疡。为评估药物效果，我们对胃黏膜进行了尿素酶试验，并对通过内镜检查获得的活检组织进行了苏木精-伊红染色和特异性吉姆萨染色；我们还评估了4周治疗前后临床症状的改善情况。
在164例胃炎和/或消化性溃疡患者中，尿素酶试验证实幽门螺杆菌感染率为93.9%（154例患者），苏木精-伊红染色证实感染率为87.8%（144例患者）。两种联合治疗方案治疗4周后，尿素酶试验和苏木精-伊红染色的转阴率以及临床症状的恢复率在两种方案中相似（甲硝唑+四环素+次枸橼酸铋：分别为82.3%、72.9%和73.9%；奥美拉唑+阿莫西林+次枸橼酸铋：分别为89.6%、83.4%和76.1%）。此外，吉姆萨法检测的炎症活动程度和幽门螺杆菌评分显示恢复率较高，两种联合治疗方案均使患者从较高等级改善至0级（最低等级）（服用甲硝唑+四环素+次枸橼酸铋的患者中分别为60.4%和66.7%，服用奥美拉唑+阿莫西林+次枸橼酸铋的患者中分别为64.6%和83.3%）。然而，治疗4周期间前一组的副作用发生率是后一组的两倍（分别为25.5%和12.5%的患者）。
两种治疗方案均使幽门螺杆菌感染率高的患者的生化和组织病理学检查结果以及胃炎和/或消化性溃疡病的临床症状有显著改善。然而，服用奥美拉唑+阿莫西林+次枸橼酸铋的患者副作用明显较少。因此，我们推荐该方案优于甲硝唑+四环素+次枸橼酸铋方案用于治疗幽门螺杆菌相关性胃炎和消化性溃疡病。
