Eradication of Helicobacter pylori and risk of peptic ulcers in patients starting long-term treatment with non-steroidal anti-inflammatory drugs:: a randomised trial
Eradication of Helicobacter pylori and risk of peptic ulcers in patients starting long-term treatment with non-steroidal anti-inflammatory drugs:: a randomised trial
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DOI：
10.1016/s0140-6736(02)07272-0
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发表时间：
2002-01-05
期刊：
影响因子：
168.9
通讯作者：
Sung, JJY
中科院分区：
文献类型：
--
作者：
Chan, FKL;To, KF;Sung, JJY
背景幽门螺杆菌是否会增加服用非甾体抗炎药（NSAIDs）患者发生溃疡的风险是有争议的。我们假设根除幽门螺杆菌感染将降低开始长期非甾体抗炎药治疗的患者发生溃疡的风险。方法纳入未接受非甾体抗炎药治疗、尿素呼气试验阳性、有消化不良或溃疡史、需要长期非甾体抗炎药治疗的患者。随机分为奥美拉唑三联治疗组（根除组）或奥美拉唑联合安慰剂抗生素组（安慰剂组），疗程1周。所有患者从随机分配开始给予双氯芬酸缓释100mg，持续6个月。在6个月或发生严重消化不良或胃肠道出血时进行内镜检查。主要终点是6个月内发生溃疡的概率。分析的目的是治疗。结果：210例关节炎患者中，128例（61%）幽门螺杆菌阳性。102例患者入组，其中100例纳入意向治疗分析。幽门螺杆菌在根除组的90%和安慰剂组的6%中被根除。51名根除组患者中有5名患有溃疡，49名安慰剂组患者中有15名患有溃疡。根除组6个月发生溃疡的概率为12.1% (95% CI 3.1-21.1)，安慰剂组为34.4% (21.1-47.7)（p=0.0085）。相应的6个月并发溃疡概率分别为4.2%（1.3-9.7）和27.1% （14.7-39.5;p=0.0026）。对幽门螺杆菌感染的筛查和治疗可显著降低开始长期非甾体抗炎药治疗的患者发生溃疡的风险。
Background Whether Helicobacter pylori increases the risk of ulcers in patients taking non-steroidal anti-inflammatory drugs (NSAIDs) is controversial. We hypothesised that eradication of H pylori infection would reduce the risk of ulcers for patients starting long-term NSAID treatment.Methods Patients were enrolled if they were NSAID naive, had a positive urea breath test, had dyspepsia or an ulcer history, and required long-term NSAID treatment. They were randomly assigned omeprazole triple therapy (eradication group) or omeprazole with placebo antibiotics (placebo group) for 1 week. All patients were given diclofenac slow release 100 mg daily for 6 months from randomisation. Endoscopy was done at 6 months or if severe dyspepsia or gastrointestinal bleeding occurred. The primary endpoint was the probability of ulcers within 6 months. Analyses were by intention to treat.Findings Of 210 arthritis patients screened, 128 (61%) were positive for H pylori. 102 patients were enrolled, and 100 were included in the intention-to-treat analysis. H pylori was eradicated in 90% of the eradication group and 6% of the placebo group. Five of 51 eradication-group patients and 15 of 49 placebo-group patients had ulcers. The 6-month probability of ulcers was 12.1% (95% CI 3.1-21.1) in the eradication group and 34.4% (21.1-47.7) in the placebo group (p=0.0085). The corresponding 6-month probabilities of complicated ulcers were 4.2% (1.3-9.7) and 27.1% (14.7-39.5; p=0.0026).Interpretation Screening and treatment for H pylori infection significantly reduces the risk of ulcers for patients starting long-term NSAID treatment.