Hsu P I, Lai K H, Tseng H H, Lo G H, Lo C C, Lin C K, Cheng J S, Chan H H, Ku M K, Peng N J, Chien E J, Chen W, Hsu P N
Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Taiwan, Republic of China.
Aliment Pharmacol Ther. 2001 Feb;15(2):195-201. doi: 10.1046/j.1365-2036.2001.00903.x.
Although the eradication of Helicobacter pylori infection benefits patients with gastric or duodenal ulcers, the value of eradicating the infection in the patients with functional dyspepsia (FD) remains controversial.
To determine whether eradicating H. pylori can prevent the subsequent development of ulcers or relieve the symptoms of functional dyspepsia patients.
In a double-blind, placebo-controlled trial, 161 patients infected with H. pylori who had functional dyspepsia were randomly assigned to 7 days of treatment with a lansoprazole-based triple therapy or placebo and then followed for 1 year. The main outcome measures were the development of peptic ulcers and the resolution of symptoms.
H. pylori was eradicated in 63 out of 81 patients (78%) in the treatment group and none of the 80 patients (0%) in the placebo group. During the follow-up period, two patients in the treatment group and six patients in the placebo group developed peptic ulcers at repeat endoscopy (2.5% vs. 7.5%; 95% CI: -12 to 2). The reduction in ulcer rates was statistically significant in the 'ulcer-like' sub-group (0% vs. 16.7%; 95% CI: -32 to -2), but not in the 'dysmotility-like' and 'unclassifiable' sub-groups. Regarding symptom response, the resolution rates of symptoms were similar between the treatment and placebo groups (58.0% vs. 55.0%, 95% CI: -12 to 18). Additionally, no significant differences existed in the symptom responses between the treatment and control arms in each of the dyspepsia sub-groups.
Eradicating H. pylori can prevent the subsequent development of peptic ulcers in the patients with 'ulcer-like' functional dyspepsia. However, this approach does not significantly reduce the symptoms of functional dyspepsia patients.
尽管根除幽门螺杆菌感染对胃溃疡或十二指肠溃疡患者有益,但在功能性消化不良(FD)患者中根除该感染的价值仍存在争议。
确定根除幽门螺杆菌是否能预防溃疡的后续发展或缓解功能性消化不良患者的症状。
在一项双盲、安慰剂对照试验中,161例感染幽门螺杆菌且患有功能性消化不良的患者被随机分配接受基于兰索拉唑的三联疗法或安慰剂治疗7天,然后随访1年。主要结局指标为消化性溃疡的发生和症状的缓解。
治疗组81例患者中有63例(78%)幽门螺杆菌被根除,安慰剂组80例患者中无一例(0%)被根除。在随访期间,治疗组有2例患者和安慰剂组有6例患者在重复内镜检查时发生消化性溃疡(2.5%对7.5%;95%置信区间:-12至2)。“溃疡样”亚组的溃疡发生率降低具有统计学意义(0%对16.7%;95%置信区间:-32至-2),但“动力障碍样”和“无法分类”亚组无统计学意义。关于症状反应,治疗组和安慰剂组的症状缓解率相似(58.0%对55.0%,95%置信区间:-12至18)。此外,各消化不良亚组中治疗组和对照组的症状反应无显著差异。
根除幽门螺杆菌可预防“溃疡样”功能性消化不良患者消化性溃疡的后续发展。然而,这种方法并不能显著减轻功能性消化不良患者的症状。