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兰索拉唑与阿莫西林联合疗法治疗幽门螺杆菌感染的双盲、多中心评估

Double-blind, multicenter evaluation of lansoprazole and amoxicillin dual therapy for the cure of Helicobacter pylori infection.

作者信息

Harford W, Lanza F, Arora A, Graham D, Haber M, Weissfeld A, Rose P, Siepman N

机构信息

Veterans Affairs Medical Center, Dallas, TX 75216, USA.

出版信息

Helicobacter. 1996 Dec;1(4):243-50. doi: 10.1111/j.1523-5378.1996.tb00046.x.

DOI:10.1111/j.1523-5378.1996.tb00046.x
PMID:9398875
Abstract

BACKGROUND

Treatment with amoxicillin plus omeprazole results in disappointing cure rates of Helicobacter pylori infection. The minimal inhibitory concentration of lansoprazole for H. pylori in vitro is lower than that for omeprazole, prompting interest in treatment with amoxicillin plus lansoprazole.

MATERIALS AND METHODS

H. pylori-infected patients with endoscopically documented duodenal ulcer either currently or within the past year were randomized to 14 days of (1) lansoprazole, 30 mg bid, plus amoxicillin, 1 gm tid; (2) lansoprazole, 30 mg tid, plus amoxicillin, 1 gm tid; (3) lansoprazole, 30 mg tid alone; or (4) amoxicillin, 1 gm tid alone. Endoscopy was done at enrollment and at 4 to 6 weeks after completion of treatment or for recurrent symptoms. H. pylori status was assessed by culture and histology. Ulcer prevalence was evaluated at follow-up endoscopy.

RESULTS

Two hundred sixty-two patients met enrollment criteria and were treated. By per-protocol analysis, H. pylori infection was cured in 57% of those treated with lansoprazole twice daily plus amoxicillin and in 67% of those treated with lansoprazole three times daily plus amoxicillin, compared with 0% treated with lansoprazole alone or amoxicillin alone (p < .001 for dual therapy versus either monotherapy). Amoxicillin resistance was not observed. At follow-up endoscopy, ulcer prevalence was 17% in patients treated with lansoprazole twice daily plus amoxicillin, 23% in those treated with lansoprazole three times daily plus amoxicillin, 33% in those treated with lansoprazole alone, and 35% in those treated with amoxicillin alone (p = .024; lansoprazole twice daily plus amoxicillin versus amoxicillin alone).

CONCLUSIONS

Treatment with amoxicillin plus lansoprazole, 30 mg tid, led to cure of H. pylori infection in 67% of patients with active or recently healed duodenal ulcer.

摘要

背景

阿莫西林联合奥美拉唑治疗幽门螺杆菌感染的治愈率令人失望。兰索拉唑对幽门螺杆菌的体外最低抑菌浓度低于奥美拉唑,这引发了人们对阿莫西林联合兰索拉唑治疗的兴趣。

材料与方法

将目前或过去一年内经内镜证实患有十二指肠溃疡的幽门螺杆菌感染患者随机分为四组,接受为期14天的治疗:(1)兰索拉唑,30毫克,每日两次,加阿莫西林,1克,每日三次;(2)兰索拉唑,30毫克,每日三次,加阿莫西林,1克,每日三次;(3)兰索拉唑,30毫克,每日三次,单独使用;或(4)阿莫西林,1克,每日三次,单独使用。在入组时以及治疗结束后4至6周或出现复发症状时进行内镜检查。通过培养和组织学评估幽门螺杆菌感染状况。在随访内镜检查时评估溃疡患病率。

结果

262例患者符合入组标准并接受了治疗。按照符合方案分析,每日两次兰索拉唑加阿莫西林治疗的患者中,幽门螺杆菌感染治愈率为57%;每日三次兰索拉唑加阿莫西林治疗的患者中,治愈率为67%;而单独使用兰索拉唑或阿莫西林治疗的患者治愈率为0%(联合治疗与单一治疗相比,p < 0.001)。未观察到阿莫西林耐药情况。在随访内镜检查时,每日两次兰索拉唑加阿莫西林治疗的患者溃疡患病率为17%,每日三次兰索拉唑加阿莫西林治疗的患者为23%,单独使用兰索拉唑治疗的患者为33%,单独使用阿莫西林治疗的患者为35%(p = 0.024;每日两次兰索拉唑加阿莫西林与单独使用阿莫西林相比)。

结论

30毫克,每日三次的阿莫西林联合兰索拉唑治疗使67%的活动性或近期愈合的十二指肠溃疡患者的幽门螺杆菌感染得到治愈。

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