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幽门螺杆菌相关性胃炎:阿莫西林双盲安慰剂对照试验

Campylobacter pylori-associated gastritis: a double-blind placebo-controlled trial with amoxycillin.

作者信息

Glupczynski Y, Burette A, Labbe M, Deprez C, De Reuck M, Deltenre M

机构信息

Department of Clinical Microbiology, Brugmann University Hospital, Brussels, Belgium.

出版信息

Am J Gastroenterol. 1988 Apr;83(4):365-72.

PMID:3279757
Abstract

We randomly assigned 45 adult patients with Campylobacter pylori-confirmed antral gastritis to 8 days of treatment with 1 g amoxycillin suspension twice a day, or placebo, according to a double-blind study design. At the end of therapy, 91% of patients treated with amoxycillin demonstrated clearance of the organism from the antrum, compared with 16% in the placebo group (p less than 0.001). Active antral gastritis resolved in 68% of patients in the amoxycillin group versus only 9% in the placebo group (p less than 0.001). No significant difference was observed when looking at the evolution of chronic only gastritis. No significant improvement was observed in the assessment of clinical symptoms and endoscopic appearance. Reappearance of C. pylori and significant worsening of the histological score of active gastritis was observed after 2 wk in all patients. In a second study phase, 18 patients initially not cleared of their bacteria received amoxycillin single blind for 14 days. Clearance of bacteria associated with improvement or resolution of active gastritis was observed in 72% of the cases. In this subgroup, all patients investigated after 1 month were recolonized with C. pylori and, again, had histological active gastritis. We conclude that amoxycillin is effective in treating active antral gastritis associated with C. pylori, but not in preventing relapses, which occur in all cases within 1 month after therapy.

摘要

我们根据双盲研究设计,将45例确诊为幽门螺杆菌相关性胃窦炎的成年患者随机分为两组,一组接受阿莫西林混悬液治疗,每日2次,每次1g,疗程8天;另一组接受安慰剂治疗。治疗结束时,接受阿莫西林治疗的患者中91%胃窦部幽门螺杆菌清除,而安慰剂组为16%(p<0.001)。阿莫西林组68%的患者活动性胃窦炎消退,而安慰剂组仅为9%(p<0.001)。观察单纯慢性胃炎的进展时未发现显著差异。临床症状和内镜表现评估未见明显改善。所有患者在2周后均观察到幽门螺杆菌再次出现以及活动性胃炎组织学评分显著恶化。在第二个研究阶段,18例最初未清除细菌的患者接受了为期14天的单盲阿莫西林治疗。72%的病例观察到细菌清除且伴有活动性胃炎改善或消退。在该亚组中,1个月后接受检查的所有患者均再次感染幽门螺杆菌,且再次出现组织学活动性胃炎。我们得出结论,阿莫西林对治疗幽门螺杆菌相关性活动性胃窦炎有效,但不能预防复发,治疗后1个月内所有病例均会复发。

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