首页> 外文期刊>Controlled clinical trials >A placebo-controlled randomized trial of eradication of Helicobacter pylori in the general population: study design and response rates of the Bristol Helicobacter Project.
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A placebo-controlled randomized trial of eradication of Helicobacter pylori in the general population: study design and response rates of the Bristol Helicobacter Project.

机译:一项在一般人群中根除幽门螺杆菌的安慰剂对照随机试验:布里斯托尔幽门螺杆菌项目的研究设计和缓解率。

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摘要

The Bristol Helicobacter Project is an ongoing, pragmatic, double-blind placebo-controlled trial of the effect of Helicobacter pylori eradication on symptoms of dyspepsia, health utilization and costs, and quality of life in the adult population. Commencing in 1996, 27,536 individuals ages 20-59 years who were registered with seven primary care centers in Bristol and the surrounding areas in southwest England were invited to undergo a 13C urea breath test. There was no selection on the basis of symptoms and 23.5% had dyspepsia on entry to the study. A total of 10,537 people were tested (38.3% of those invited), 1636 tested positive (15.5% of those tested), and 1558 (95.2% of those who tested positive) were randomized to H. pylori eradication therapy or placebo. The rate of participation in the screening phase increased with age (odds ratio [OR]: 1.42 per decade, 95% CI: 1.31 to 1.54) and female gender (OR: 1.35, 95% CI: 1.27 to 1.43) but decreased with lower socioeconomic status (OR: 0.70, 95% CI: 0.56 to 0.86 comparing lowest with highest category). H. pylori prevalence increased with age (OR: 1.69 per decade, 95% CI: 1.51 to 1.89) and lower socioeconomic status (OR: 1.33, 95% CI: 1.05 to 1.69) but was lower in women (OR: 0.87, 95% CI: 0.76 to 1.00). Population-based trials of H. pylori eradication are feasible but necessitate screening large numbers of people to identify those who are infected and who may benefit from eradication. In the Bristol Helicobacter Project the rate of participation varied inversely with both social deprivation and the prevalence of the infection.
机译:布里斯托尔幽门螺杆菌项目是一项正在进行的,实用的,双盲安慰剂对照试验,用于根除幽门螺杆菌对消化不良症状,健康利用和成本以及成年人群生活质量的影响。从1996年开始,邀请了27,536名年龄在20-59岁之间的人在布里斯托尔及英格兰西南部周边地区的七个初级保健中心进行了注册,他们接受了13C尿素呼气试验。没有根据症状进行选择,入研究时有23.5%的消化不良。共有10,537人被测试(被邀请者的38.3%),1636人被测试为阳性(被测试者的15.5%)和1558人(被测试为阳性的人95.2%)被随机分为幽门螺杆菌根除疗法或安慰剂。筛查阶段的参与率随年龄(优势比[OR]:每十年1.42,95%CI:1.31至1.54)和女性(OR:1.35,95%CI:1.27至1.43)而增加,但随着年龄的降低而降低社会经济地位(OR:0.70,95%CI:0.56至0.86,最低与最高类别相比)。幽门螺杆菌感染率随年龄增加(OR:每十年1.69,95%CI:1.51至1.89)和较低的社会经济地位(OR:1.33,95%CI:1.05至1.69),但女性较低(OR:0.87,95 %CI:0.76至1.00)。以人群为基础的幽门螺杆菌根除试验是可行的,但有必要筛选大量人群以鉴定感染者和可能从根除中受益的人。在布里斯托尔幽门螺杆菌项目中,参与率与社会匮乏和感染率呈反比。

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