奥美拉唑、阿莫西林联合甲硝唑对幽门螺杆菌根除及十二指肠溃疡愈合的影响：与历史对照比较

Effect of omeprazole and amoxicillin plus metronidazole on the eradication of Helicobacter pylori and the healing of duodenal ulcer: comparison with a historical control.

作者信息

Schütze K, Hentschel E, Hirschl A M

机构信息

Medical Department I, Hanusch Hospital, Vienna, Austria.

出版信息

Hepatogastroenterology. 1999 Jul-Aug;46(28):2358-62.

PMID:10521998

Abstract

BACKGROUND/AIMS: To test the hypothesis of equivalence of an omeprazole 7-day triple therapy without subsequent acid suppression and a historical ranitidine 12-day triple therapy (recruiting phase 1989-91) with subsequent acid suppression in their effect on the eradication of Helicobacter pylori (H. pylori) and the healing of duodenal ulcer.

METHODOLOGY

Seventy-seven patients with H. pylori-positive duodenal ulcers received a 7-day treatment with amoxicillin 750 mg tid and metronidazole 500 mg tid. Additional omeprazole 20 mg or 40 mg once daily was given to 39 and 38 of the patients, respectively. Endoscopy was performed before treatment and four weeks after cessation of therapy.

RESULTS

The cumulative intention-to-treat (ITT) H. pylori-eradication rate was 66% (51/77) as compared to 89% (46/52) for the historical control (p < 0.05). The corresponding ulcer healing rates were 90% (69/77) and 92% (48/52). Primary metronidazole resistance (PMR) had escalated from 10% to 27% within 6 years resulting in eradication rates of 84% for sensitive and 19% for resistant strains (p < 0.001). PMR could be demonstrated in 45% of all female, but only in 17% of the male patients (p < 0.05). In the patients with H. pylori eradication, the ulcers healed in 98% (50/51) as compared to 73% (19/26) in those with persistent infection (p < 0.005). Analysis based on the presence of PMR showed ulcer healing rates of 95% (53/56) for sensitive and 76% (16/21) for resistant strains (p < 0.05). Improvement of pain also showed a significant correlation with successful eradication. H. pylori-eradication, healing and symptom relief were similar in the omeprazole 20 mg and 40 mg groups.

CONCLUSIONS

The effect of amoxicillin plus metronidazole plus antisecretory agent on the eradication of H. pylori has decreased markedly during the past 6 years due to the escalation of PMR. Doubling of the omeprazole dose does not affect outcome. Cure of the infection as well as metronidazole susceptibility enhance duodenal ulcer healing and symptom relief. Acid suppression following a successful 1-week anti-HP therapy is not required for duodenal ulcer treatment.

摘要

背景/目的：检验一种为期7天的奥美拉唑三联疗法（后续无抑酸治疗）与一种历史对照的雷尼替丁12天三联疗法（招募阶段为1989 - 1991年，后续有抑酸治疗）在根除幽门螺杆菌（H. pylori）及治愈十二指肠溃疡方面效果等效性的假设。

方法

77例幽门螺杆菌阳性十二指肠溃疡患者接受阿莫西林750毫克每日三次和甲硝唑500毫克每日三次的7天治疗。分别给予39例和38例患者额外的奥美拉唑20毫克或40毫克每日一次。治疗前及治疗结束后四周进行内镜检查。

结果

累积意向性治疗（ITT）幽门螺杆菌根除率为66%（51/77），而历史对照为89%（46/52）（p < 0.05）。相应的溃疡愈合率分别为90%（69/77）和92%（48/52）。原发性甲硝唑耐药（PMR）在6年内从10%升至27%，导致敏感菌株根除率为84%，耐药菌株为19%（p < 0.001）。在所有女性患者中45%可检测到PMR，而男性患者中仅17%可检测到（p < 0.05）。在幽门螺杆菌被根除的患者中，溃疡愈合率为98%（50/51），而持续感染患者中为73%（19/26）（p < 0.005）。基于PMR存在情况的分析显示，敏感菌株溃疡愈合率为95%（53/56），耐药菌株为76%（16/21）（p < 0.05）。疼痛改善也与成功根除显著相关。奥美拉唑20毫克组和40毫克组在幽门螺杆菌根除、溃疡愈合及症状缓解方面相似。