幽门螺杆菌根除后十二指肠溃疡复发的前瞻性双盲试验

Prospective double-blind trial of duodenal ulcer relapse after eradication of Campylobacter pylori.

作者信息

Marshall B J, Goodwin C S, Warren J R, Murray R, Blincow E D, Blackbourn S J, Phillips M, Waters T E, Sanderson C R

机构信息

Department of Gastroenterology, Royal Perth Hospital, Western Australia.

出版信息

Lancet. 1988;2(8626-8627):1437-42. doi: 10.1016/s0140-6736(88)90929-4.

DOI:10.1016/s0140-6736(88)90929-4

PMID:2904568

Abstract

100 consecutive patients with both duodenal ulcer and Campylobacter pylori infection were followed up to see whether eradication of C pylori affected ulcer healing or relapse. Patients were randomly assigned to 8 weeks of treatment with cimetidine or colloidal bismuth subcitrate (CBS), with tinidazole or placebo being given concurrently from days 1 to 10, inclusive. Endoscopy, biopsy, and culture were done at entry, in weeks 10, 22, 34, and 62, and whenever symptoms recurred. There was no maintenance therapy. C pylori persisted in all of the cimetidine-treated patients and in 95% of those treated with cimetidine/tinidazole, but was eradicated in 27% of the CBS/placebo group and 70% of the CBS/tinidazole group. When C pylori persisted, 61% of duodenal ulcers healed and 84% relapsed. When C pylori was cleared 92% of ulcers healed (p less than 0.001) and only 21% relapsed during the 12 month follow-up period (p less than 0.0001).

摘要

对100例十二指肠溃疡合并幽门弯曲菌感染的患者进行随访，以观察根除幽门弯曲菌是否会影响溃疡愈合或复发。患者被随机分配接受西咪替丁或枸橼酸铋钾（CBS）治疗8周，从第1天至第10天（含第10天）同时给予替硝唑或安慰剂。在入组时、第10周、第22周、第34周和第62周以及症状复发时进行内镜检查、活检和培养。不进行维持治疗。在所有接受西咪替丁治疗的患者以及95%接受西咪替丁/替硝唑治疗的患者中，幽门弯曲菌持续存在，但在CBS/安慰剂组中有27%的患者以及CBS/替硝唑组中有70%的患者幽门弯曲菌被根除。当幽门弯曲菌持续存在时，61%的十二指肠溃疡愈合，84%复发。当幽门弯曲菌被清除时，92%的溃疡愈合（p<0.001），在12个月的随访期内只有21%复发（p<0.0001）。