在非甾体抗炎药治疗前根除幽门螺杆菌以预防消化性溃疡的随机试验

Randomised trial of eradication of Helicobacter pylori before non-steroidal anti-inflammatory drug therapy to prevent peptic ulcers.

作者信息

Chan F K, Sung J J, Chung S C, To K F, Yung M Y, Leung V K, Lee Y T, Chan C S, Li E K, Woo J

机构信息

Department of Medicine, Prince of Wales Hospital, Shatin, New Territories, Hong Kong.

出版信息

Lancet. 1997 Oct 4;350(9083):975-9. doi: 10.1016/s0140-6736(97)04523-6.

DOI:10.1016/s0140-6736(97)04523-6

PMID:9329511

Abstract

BACKGROUND

Helicobacter pylori infection is common in patients with peptic ulcers caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs). But the pathogenic role of H pylori in this disease is controversial. We studied the efficacy of eradication of H pylori in the prevention of NSAID-induced peptic ulcers.

METHODS

We recruited patients with musculoskeletal pain who required NSAID treatment. None of the patients had previous exposure to NSAID therapy. Patients who had H pylori infection but no pre-existing ulcers on endoscopy were randomly allocated naproxen alone (750 mg daily) for 8 weeks or a 1-week course of triple therapy (bismuth subcitrate 120 mg, tetracycline 500 mg, metronidazole 400 mg, each given orally four times daily) before administration of naproxen (750 mg daily). Endoscopy was repeated after 8 weeks of naproxen treatment or when naproxen treatment was stopped early because of bleeding or intractable dyspepsia. All endoscopic examinations were done by one endoscopist who was unaware of treatment assignment. The primary endpoint was the cumulative rate of gastric and duodenal ulcers.

FINDINGS

202 patients underwent endoscopic screening for enrolment in the trial, and 100 eligible patients were randomly assigned treatment. 92 patients completed the trial (47 in the naproxen group, 45 in the triple-therapy group). At 8 weeks, H pylori had been eradicated from no patients in the naproxen group and 40 (89%) in the triple-therapy group (p < 0.001). 12 (26%) naproxen-group patients developed ulcers: five had ulcer pain and one developed ulcer bleeding. Only three (7%) patients on triple therapy had ulcers, and two of these patients had failure of H pylori eradication (p = 0.01). Thus, 12 (26%) patients with persistent H pylori infection but only one (3%) with successful H pylori eradication developed ulcers with naproxen (p = 0.002).

INTERPRETATION

Eradication of H pylori before NSAID therapy reduces the occurrence of NSAID-induced peptic ulcers.

摘要

背景

幽门螺杆菌感染在因使用非甾体抗炎药（NSAIDs）导致消化性溃疡的患者中很常见。但幽门螺杆菌在这种疾病中的致病作用存在争议。我们研究了根除幽门螺杆菌在预防NSAID诱导的消化性溃疡中的疗效。

方法

我们招募了需要NSAID治疗的肌肉骨骼疼痛患者。所有患者既往均未接受过NSAID治疗。幽门螺杆菌感染但内镜检查无既往溃疡的患者被随机分配，一组单独服用萘普生（每日750mg），持续8周；另一组在服用萘普生（每日750mg）前先接受为期1周的三联疗法（枸橼酸铋钾120mg、四环素500mg、甲硝唑400mg，均每日口服4次）。在萘普生治疗8周后或因出血或难治性消化不良而提前停止萘普生治疗时重复进行内镜检查。所有内镜检查均由一名不知道治疗分配情况的内镜医师完成。主要终点是胃和十二指肠溃疡的累积发生率。

结果

202例患者接受内镜筛查以纳入试验，100例符合条件的患者被随机分配接受治疗。92例患者完成试验（萘普生组47例，三联疗法组45例）。8周时，萘普生组无患者根除幽门螺杆菌，三联疗法组有40例（89%）根除（p<0.001）。萘普生组12例（26%）患者发生溃疡：5例有溃疡疼痛，1例发生溃疡出血。三联疗法组仅3例（7%）患者发生溃疡，其中2例幽门螺杆菌根除失败（p=0.01）。因此，12例（26%）持续幽门螺杆菌感染的患者中只有1例（3%）幽门螺杆菌成功根除的患者在服用萘普生时发生溃疡（p=0.002）。