一周低剂量三联疗法且不进行抗酸治疗对根除幽门螺杆菌和溃疡愈合具有足够的疗效。

One-week low-dose triple therapy without anti-acid treatment has sufficient efficacy on Helicobacter pylori eradication and ulcer healing.

作者信息

Hsu Chia-Chang, Lu Sheng-Nan, Changchien Chi-Sin

机构信息

Division of Gastroenterology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung Medical Center, 123 Ta Pei Road, Niao Sung Hsiang, Kaohsiung Hsien, Taiwan.

出版信息

Hepatogastroenterology. 2003 Sep-Oct;50(53):1731-4.

PMID:14571829

Abstract

BACKGROUND/AIMS: The aim of this study was to determine the efficacy of a 1-week low-dose proton pump inhibitor-based triple therapy without further acid suppression for cure of Helicobacter pylori infection and the ulcer healing in peptic ulcer disease.

METHODOLOGY

Patients with endoscopically proven peptic ulcers who were H. pylori positive participated in this study. All patients were treated for 1 week with omeprazole 20 mg b.d., clarithromycin 250 mg b.d. and tinidazole 500 mg b.d., then patients were treated randomly for another 4 weeks with either omeprazole 20 mg once daily (OCM-O group; n = 40) or without acid suppressing agents (OCM group; n = 39). Patients were investigated endoscopically for H. pylori and ulcer status before treatment, four weeks (week 5) and 8 weeks later (week 9) after anti-H. pylori treatment. H. pylori infection was assessed by rapid urease test and histology.

RESULTS

The eradication rates of H. pylori were 72.5% (95% CI: 59-86%) and 76.3% (95% CI: 63-90%) by intention-to-treat analysis and by per protocol analysis respectively in the OCM-O group and were 87.2% (95% CI: 77-98%) and 97.1% (95% CI: 92-100%) by intention-to-treat analysis and by per protocol analysis respectively in the OCM group (p < 0.05 in per protocol analysis). In respect to ulcer healing status at week 5, 89.5% (34/38) of patients in the OCM-O group and 80% (28/35) of patients in the OCM group had healed ulcers; at week 9, 86.8% (33/38) of patients in the OCM-O group and 88.6% (31/35) of patients in the OCM group had healed ulcers (p = NS). When the ulcer status was analyzed in relation to the H. pylori status, at week 5 ulcer had healed in 84.4% (54/64) of patients with clearance of H. pylori infection and in 88.9% (8/9) of those with persistent infection. At week 9, ulcer healing increased up to 93.8% (60/64) of patients with clearance of H. pylori infection and decreased to 44.4% (4/9) of patients with persistent infection. The adverse events (20%) were mild in these two treatment groups and no patients required discontinuation of the study medications.

CONCLUSIONS

Continuation of antisecretory drug therapy beyond a one-week low-dose triple therapy consisting of omeprazole, clarithromycin and tinidazole is actually excessive regarding eradication efficacy and peptic ulcer healing.

摘要

背景/目的：本研究旨在确定为期1周的基于低剂量质子泵抑制剂的三联疗法在不进行进一步抑酸治疗的情况下，对幽门螺杆菌感染的治愈效果以及消化性溃疡疾病中溃疡愈合的疗效。

方法

经内镜证实为消化性溃疡且幽门螺杆菌阳性的患者参与了本研究。所有患者接受奥美拉唑20毫克每日两次、克拉霉素250毫克每日两次和替硝唑500毫克每日两次治疗1周，然后患者被随机分为两组，再接受4周治疗，一组为奥美拉唑20毫克每日一次（OCM - O组；n = 40），另一组不使用抑酸剂（OCM组；n = 39）。在抗幽门螺杆菌治疗前、治疗后4周（第5周）和8周后（第9周），对患者进行内镜检查，以评估幽门螺杆菌和溃疡状况。通过快速尿素酶试验和组织学评估幽门螺杆菌感染情况。

结果

在意向性分析中，OCM - O组幽门螺杆菌根除率分别为72.5%（95%置信区间：59 - 86%），按方案分析为76.3%（95%置信区间：63 - 90%）；OCM组在意向性分析中根除率分别为87.2%（95%置信区间：77 - 98%），按方案分析为97.1%（95%置信区间：92 - 100%）（按方案分析中p < 0.05）。关于第5周时的溃疡愈合状况，OCM - O组89.5%（34/38）的患者溃疡愈合，OCM组80%（28/35）的患者溃疡愈合；在第9周时，OCM - O组86.8%（33/38）的患者溃疡愈合，OCM组88.6%（31/35）的患者溃疡愈合（p = 无显著性差异）。当分析溃疡状况与幽门螺杆菌状态的关系时，在第5周，幽门螺杆菌感染清除的患者中84.4%（54/64）溃疡愈合，仍有感染的患者中88.9%（8/9）溃疡愈合。在第9周，幽门螺杆菌感染清除的患者中溃疡愈合率升至93.8%（60/64），仍有感染的患者中降至44.4%（4/9）。这两个治疗组的不良事件发生率均为20%，且均为轻度，无患者需要停用研究药物。