Ford A C, Delaney B C, Forman D, Moayyedi P
Leeds General Infirmary, Centre for Digestive Diseases, Great George Street, Leeds, West Yorkshire, UK, LS1 3EX.
Cochrane Database Syst Rev. 2006 Apr 19(2):CD003840. doi: 10.1002/14651858.CD003840.pub4.
Peptic ulcer disease is the cause for dyspepsia in about 10% of patients. 95% of duodenal and 70% of gastric ulcers are associated with Helicobacter pylori. Eradication of H pylori reduces the relapse rate of ulcers but the magnitude of this effect is uncertain.
The primary outcomes were the proportion of peptic ulcers healed initially and proportion of patients free from relapse following successful healing. Eradication therapy was compared to placebo or pharmacological therapies in H. pylori positive patients. Secondary aims included symptom relief and adverse effects.
Searches were conducted on the Cochrane Central register of Controlled Trials - CENTRAL (which includes the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register) on The Cochrane Library (Issue 3 2002) MEDLINE (1966 to July 2002) and EMBASE (1980 to July 2002). Reference lists from trials selected by electronic searching were handsearched to identify further relevant trials. Published abstracts from conference proceedings from the United European Gastroenterology Week (published in Gut) and Digestive Disease Week (published in Gastroenterology) were handsearched. The search was updated in September 2003, November 2004 and November 2005. Members of the Cochrane UGPD Group, and experts in the field were contacted and asked to provide details of outstanding clinical trials and any relevant unpublished materials
Randomised controlled trials of short and long-term treatment of peptic ulcer disease in H. pylori positive adults were analysed. Patients received at least one week of H pylori eradication compared with ulcer healing drug, placebo or not treatment. Trials were included if they reported assessment from 2 weeks onwards.
Data were collected on ulcer healing, recurrence, relief of symptoms and adverse effects.
63 trials were eligible. Data extraction was not possible in 7 trials, and 56 trials were included. In duodenal ulcer healing, eradication therapy was superior to ulcer healing drug (UHD) (34 trials, 3910 patients, relative risk [RR] of ulcer persisting = 0.66; 95% confidence interval [CI] = 0.58, 0.76) and no treatment (2 trials, 207 patients, RR = 0.37; 95% CI 0.26, 0.53). In gastric ulcer healing, no significant differences were detected between eradication therapy and UHD (14 trials, 1572 patients, RR = 1.25; 95% CI = 0.88, 1.76). In preventing duodenal ulcer recurrence no significant differences were detected between eradication therapy and maintenance therapy with UHD (4 trials, 319 patients, relative risk [RR] of ulcer recurring = 0.73; 95% CI = 0.42, 1.25), but eradication therapy was superior to no treatment (27 trials 2509 patients, RR = 0.20; 95% CI = 0.15, 0.26). In preventing gastric ulcer recurrence, eradication therapy was superior to no treatment (11 trials, 1104 patients, RR = 0.29; 95% CI 0.20, 0.42).
AUTHORS' CONCLUSIONS: A 1 to 2 weeks course of H. pylori eradication therapy is an effective treatment for H. pylori positive peptic ulcer disease.
消化性溃疡病是约10%消化不良患者的病因。95%的十二指肠溃疡和70%的胃溃疡与幽门螺杆菌有关。根除幽门螺杆菌可降低溃疡复发率,但这种效果的程度尚不确定。
主要结局是消化性溃疡最初愈合的比例以及成功愈合后无复发的患者比例。在幽门螺杆菌阳性患者中,将根除治疗与安慰剂或药物治疗进行比较。次要目标包括症状缓解和不良反应。
在Cochrane对照试验中央注册库(CENTRAL,其中包括Cochrane上消化道和胰腺疾病组试验注册库)、《Cochrane图书馆》(2002年第3期)、MEDLINE(1966年至2002年7月)和EMBASE(1980年至2002年7月)上进行检索。对通过电子检索选择的试验的参考文献列表进行手工检索,以识别更多相关试验。对欧洲胃肠病学联合周会议论文集(发表于《胃肠病学》)和消化系统疾病周会议论文集(发表于《胃肠病学》)的已发表摘要进行手工检索。检索在2003年9月、2004年11月和2005年11月进行更新。联系了Cochrane上消化道和胰腺疾病组的成员以及该领域的专家,要求他们提供未发表的临床试验和任何相关未发表材料的详细信息。
分析了幽门螺杆菌阳性成年人消化性溃疡病短期和长期治疗的随机对照试验。与溃疡愈合药物、安慰剂或不治疗相比,患者接受至少一周的幽门螺杆菌根除治疗。如果试验报告了从2周起的评估,则纳入试验。
收集了关于溃疡愈合、复发、症状缓解和不良反应的数据。
63项试验符合条件。7项试验无法进行数据提取,纳入了56项试验。在十二指肠溃疡愈合方面,根除治疗优于溃疡愈合药物(UHD)(34项试验,3910例患者,溃疡持续存在的相对风险[RR]=0.66;95%置信区间[CI]=0.58,0.76)和不治疗(2项试验,207例患者,RR=0.37;95%CI 0.26,0.53)。在胃溃疡愈合方面,根除治疗与UHD之间未检测到显著差异(14项试验,1572例患者,RR=1.25;95%CI=0.88,1.76)。在预防十二指肠溃疡复发方面,根除治疗与UHD维持治疗之间未检测到显著差异(4项试验,319例患者,溃疡复发的相对风险[RR]=0.73;95%CI=0.42,1.25),但根除治疗优于不治疗(27项试验,2509例患者,RR=0.20;95%CI=0.15,0.26)。在预防胃溃疡复发方面,根除治疗优于不治疗(11项试验,1104例患者,RR=0.29;95%CI 0.20,0.42)。
为期1至2周的幽门螺杆菌根除治疗疗程是幽门螺杆菌阳性消化性溃疡病的有效治疗方法。