Hassan C, De Francesco V, Zullo A, Scaccianoce G, Piglionica D, Ierardi E, Panella C, Morini S
Gastroenterology and Digestive Endoscopy, 'Nuovo Regina Margherita' Hospital, Rome, Italy.
Aliment Pharmacol Ther. 2003 Sep 15;18(6):641-6. doi: 10.1046/j.1365-2036.2003.01694.x.
Several studies have shown that Helicobacter pylori eradication rates with standard 7-day triple therapy are unsatisfactory. A novel 10-day sequential treatment regimen recently achieved a significantly higher eradication rate. To improve the pharmacotherapeutic cost, we evaluated whether an acceptable eradication rate could be achieved in peptic ulcer patients by halving the dose of clarithromycin.
In a prospective, open-label study, 152 duodenal ulcer patients with H. pylori infection, assessed by rapid urease test and histology, were enrolled. Patients were randomized to receive either a 10-day sequential treatment comprising rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days (high-dose therapy), or a similar schedule with the clarithromycin doses halved to 250 mg b.d. (low-dose therapy). No further antisecretory drugs were offered. Four to six weeks after therapy, H. pylori eradication and ulcer healing rates were assessed by endoscopy.
Similar H. pylori eradication rates were observed following high- and low-dose regimens for both per protocol (97.3% vs. 95.9%; P = N.S.) and intention-to-treat (94.7% vs. 92.2%; P = N.S.) analyses. No major side-effects were reported. At repeat endoscopy, peptic ulcer healing was observed in 93% and 93% of patients following high- and low-dose therapy, respectively.
The cheaper low-dose sequential regimen may be suggested for H. pylori eradication in duodenal ulcer patients, even without continued proton pump inhibitor therapy after eradication treatment.
多项研究表明,标准7天三联疗法的幽门螺杆菌根除率并不理想。一种新型的10天序贯治疗方案最近取得了显著更高的根除率。为了提高药物治疗成本,我们评估了将克拉霉素剂量减半是否能在消化性溃疡患者中实现可接受的根除率。
在一项前瞻性、开放标签研究中,纳入了152例经快速尿素酶试验和组织学评估确诊为幽门螺杆菌感染的十二指肠溃疡患者。患者被随机分为两组,一组接受10天序贯治疗,前5天给予雷贝拉唑20mg每日2次加阿莫西林1g每日2次,后5天给予雷贝拉唑20mg每日2次、克拉霉素500mg每日2次和替硝唑500mg每日2次(高剂量疗法);另一组接受类似方案,但克拉霉素剂量减半至250mg每日2次(低剂量疗法)。不再给予其他抗分泌药物。治疗4至6周后,通过内镜检查评估幽门螺杆菌根除率和溃疡愈合率。
在意向性分析(94.7%对92.2%;P=无显著性差异)和符合方案分析(97.3%对95.9%;P=无显著性差异)中,高剂量和低剂量方案的幽门螺杆菌根除率相似。未报告重大副作用。在重复内镜检查时,高剂量和低剂量治疗后分别有93%和93%的患者出现消化性溃疡愈合。
对于十二指肠溃疡患者根除幽门螺杆菌,即使在根除治疗后不继续使用质子泵抑制剂治疗,也可建议使用成本较低的低剂量序贯方案。