出血性溃疡的抗幽门螺杆菌治疗：比较2天与7天铋剂四联疗法的随机对照试验

Anti-Helicobacter pylori treatment in bleeding ulcers: randomized controlled trial comparing 2-day versus 7-day bismuth quadruple therapy.

作者信息

Kung N N, Sung J J, Yuen N W, Ng P W, Wong K C, Chung E C, Lim B H, Choi C H, Li T H, Ma H C, Kwok S P

机构信息

Department of Medicine, United Christian Hospital, Hong Kong.

出版信息

Am J Gastroenterol. 1997 Mar;92(3):438-41.

PMID:9068464

Abstract

BACKGROUND

One-week bismuth triple therapy has been established to be highly effective in curing H. pylori infection, but patient compliance has been the major factor of success in therapy. For patients hospitalized for ulcer bleeding, an effective regimen that can completed before discharge will ensure full compliance.

AIM

To compare 2-day versus 1-wk bismuth triple therapy plus omeprazole in curing H. pylori infection and bleeding peptic ulcers.

METHODS

100 patients with non-actively bleeding duodenal (DU) or gastric ulcers (GU) and confirmed H. pylori infection were randomized to receive either bismuth subcitrate 120 mg, tetracycline 500 mg, and metronidazole 400 mg four times daily for 1 wk (OBTM-7) or bismuth subcitrate 240 mg, tetracycline 500 mg, and metronidazole 400 mg four times daily for 2 days (OBTM-2). Both groups of patients also received omeprazole 20 mg twice daily for the first week. In the OBTM-2 group, the anti-Helicobacter therapy was finished during hospitalization. Endoscopy was repeated 5 wk after randomization to monitor ulcer healing and determine H. pylori status. Side effects related to the anti-Helicobacter therapy was graded as follows: A, mild discomfort, which did not affect daily activity; B, moderate discomfort affecting daily activity; and C, severe discomfort and patients discontinued therapy.

RESULTS

Forty-six patients in the OBTM-2 group and 50 in the OBTM-7 group returned for follow-up endoscopy. With an intention-to-treat analysis, ulcer healing was achieved in 44 of 46 patients (95.7%) in the OBTM-2 group versus 49 of 50 (98%) in the OBTM-7 group, p = 0.61. H. pylori eradication was successful in 35 of 46 patients (76.1%) in the OBTM-2 and in all 50 patients (100%) in the OBTM-7 group, p = 0.00024. There was no difference in the severity of side effects experienced by the patients in the OBTM-2 group than in the OBTM-7 group (19 vs 32%, p = 0.16). None of the patients had rebled during the period of follow-up.

CONCLUSION

Despite similar efficacy in ulcer healing, the 2-day quadruple therapy is less effective than the 1-wk regimen in curing H. pylori infection.

摘要

背景

一周铋剂三联疗法已被证实对治疗幽门螺杆菌感染非常有效，但患者的依从性一直是治疗成功的主要因素。对于因溃疡出血住院的患者，一种能在出院前完成的有效治疗方案将确保完全依从性。

目的

比较两日与一周铋剂三联疗法加奥美拉唑治疗幽门螺杆菌感染和消化性溃疡出血的效果。

方法

100例无活动性出血的十二指肠溃疡（DU）或胃溃疡（GU）且确诊幽门螺杆菌感染的患者被随机分为两组，一组接受枸橼酸铋120mg、四环素500mg和甲硝唑400mg，每日4次，共1周（OBTM - 7）；另一组接受枸橼酸铋240mg、四环素500mg和甲硝唑400mg，每日4次，共2天（OBTM - 2）。两组患者在第一周均每日2次服用奥美拉唑20mg。在OBTM - 2组，抗幽门螺杆菌治疗在住院期间完成。随机分组5周后复查胃镜以监测溃疡愈合情况并确定幽门螺杆菌状态。抗幽门螺杆菌治疗相关的副作用分级如下：A，轻度不适，不影响日常活动；B，中度不适，影响日常活动；C，严重不适，患者停止治疗。

结果

OBTM - 2组46例患者和OBTM - 七组50例患者返回接受随访胃镜检查。采用意向性分析，OBTM - 2组46例患者中的44例（95.7%）溃疡愈合，OBTM - 7组50例中的49例（98%）溃疡愈合，p = = 0.61。OBTM - 2组46例患者中的35例（76.1%）幽门螺杆菌根除成功，OBTM - 7组50例患者全部（100%）成功根除，p = 0.00024。OBTM - 2组患者经历的副作用严重程度与OBTM - 7组相比无差异（19%对32%，p = 0.16）。随访期间无一例患者再次出血。