Veldhuyzen van Zanten S J, Sherman P M
Division of Gastroenterology, Dalhousie University, Halifax, NS.
CMAJ. 1994 Jan 15;150(2):189-98.
To determine (a) the advantages and disadvantages of treatment options for the eradication of Helicobacter pylori and (b) whether eradication of H. pylori is indicated in patients with duodenal ulcer, nonucler dyspepsia and gastric cancer.
A MEDLINE search for articles published in English between January 1983 and December 1992 with the use of MeSH terms Helicobacter pylori (called Campylobacter pylori before 1990) and duodenal ulcer, gastric cancer, dyspepsia and clinical trial. Six journals and Current Contents were searched manually for pertinent articles published in that time frame.
For duodenal ulcer the search was limited to studies involving adults, studies of H. pylori eradication and randomized clinical trials comparing anti-H. pylori therapy with conventional ulcer treatment. For nonulcer dyspepsia with H. pylori infection the search was limited to placebo-controlled randomized clinical trials.
The quality of each study was rated independently on a four-point scale by each author. For the studies of duodenal ulcer the outcome measures assessed were acute ulcer healing and time required for healing, H. pylori eradication and ulcer relapse. For the studies of nonulcer dyspepsia with H. pylori infection the authors assessed H. pylori eradication, the symptoms used as outcome measures and whether validated outcome measures had been used.
Eight trials involving duodenal ulcer met our inclusion criteria: five were considered high quality, two were of reasonable quality, and one was weak. Six trials involving nonulcer dyspepsia met the criteria, but all were rated as weak. Among treatment options triple therapy with a bismuth compound, metronidazole and either amoxicillin or tetracycline achieved the highest eradication rates (73% to 94%). Results concerning treatment indications for duodenal ulcer were consistent among all of the studies: when anti-H. pylori therapy was added to conventional ulcer treatment acute ulcers healed more rapidly. Ulcer relapse rates were dramatically reduced after H. pylori eradication. All of the studies involving nonulcer dyspepsia assessed clearance rather than eradication of H. pylori. No study used validated outcome measures. A consistent decrease in symptom severity was no more prevalent in patients in whom the organism had been cleared than in those taking a placebo. Of the studies concerning gastric cancer none investigated the effect of eradication of H. pylori on subsequent risk of gastric cancer.
There is sufficient evidence to support the use of anti-H. pylori therapy in patients with duodenal ulcers who have H. pylori infection, triple therapy achieving the best results. There is no current evidence to support such therapy for nonulcer dyspepsia in patients with H. pylori infection. Much more attention must be paid to the design of nonulcer dyspepsia studies. Also, studies are needed to determine whether H. pylori eradication in patients with gastritis will prevent gastric cancer.
确定(a)根除幽门螺杆菌治疗方案的优缺点;(b)十二指肠溃疡、非溃疡性消化不良及胃癌患者是否需要根除幽门螺杆菌。
利用医学主题词“幽门螺杆菌”(1990年前称为弯曲杆菌属幽门菌)、“十二指肠溃疡”、“胃癌”、“消化不良”及“临床试验”检索1983年1月至1992年12月期间发表的英文文献。人工检索6种期刊及《现刊目次》以查找此期间发表的相关文章。
对于十二指肠溃疡,检索限于涉及成人的研究、幽门螺杆菌根除研究以及比较抗幽门螺杆菌治疗与传统溃疡治疗的随机临床试验。对于幽门螺杆菌感染的非溃疡性消化不良,检索限于安慰剂对照的随机临床试验。
每位作者独立地按四分制对每项研究的质量进行评分。对于十二指肠溃疡研究,评估的结果指标为急性溃疡愈合情况及愈合所需时间、幽门螺杆菌根除情况及溃疡复发情况。对于幽门螺杆菌感染的非溃疡性消化不良研究,作者评估幽门螺杆菌根除情况、用作结果指标的症状以及是否使用了经过验证的结果指标。
八项涉及十二指肠溃疡的试验符合纳入标准:五项被认为质量高,两项质量尚可,一项质量差。六项涉及非溃疡性消化不良的试验符合标准,但均被评为质量差。在治疗方案中,铋剂、甲硝唑与阿莫西林或四环素的三联疗法根除率最高(73%至94%)。所有研究中关于十二指肠溃疡治疗指征的结果一致:在传统溃疡治疗基础上加用抗幽门螺杆菌治疗时,急性溃疡愈合更快。根除幽门螺杆菌后溃疡复发率显著降低。所有涉及非溃疡性消化不良的研究评估的是幽门螺杆菌的清除而非根除情况。没有研究使用经过验证的结果指标。在清除幽门螺杆菌的患者中,症状严重程度持续降低的情况并不比服用安慰剂的患者更普遍。关于胃癌的研究中,没有一项研究调查根除幽门螺杆菌对后续胃癌风险的影响。
有充分证据支持对幽门螺杆菌感染的十二指肠溃疡患者使用抗幽门螺杆菌治疗,三联疗法效果最佳。目前没有证据支持对幽门螺杆菌感染的非溃疡性消化不良患者进行此类治疗。必须更加关注非溃疡性消化不良研究的设计。此外,需要进行研究以确定胃炎患者根除幽门螺杆菌是否能预防胃癌。