胃癌患者术前与术后幽门螺杆菌根除治疗的随机试验
Preoperative versus postoperative Helicobacter pylori eradication therapy in gastric cancer patients: a randomized trial.
作者信息
Kim Chan Gyoo, Song Ho June, Kook Myeong-Cherl, Hong Eun Kyung, Park Sohee, Lee Jong Yeul, Lee Jun Ho, Ryu Keun Won, Kim Young-Woo, Bae Jae-Moon, Choi Il Ju
机构信息
Research Institute and Hospital, National Cancer Center, Goyang, Korea.
出版信息
Am J Gastroenterol. 2008 Jan;103(1):48-54. doi: 10.1111/j.1572-0241.2007.01482.x. Epub 2007 Aug 21.
OBJECTIVES
Helicobacter pylori (H. pylori) eradication is strongly recommended for gastric cancer patients who undergo subtotal gastrectomy. The efficacy of proton pump inhibitor-based triple therapy for H. pylori eradication has not been adequately assessed in the gastric remnant. The aim of this study was to compare the efficacy of postoperative versus preoperative H. pylori eradication therapy.
METHODS
A total of 138 distal gastric cancer patients with H. pylori infection were randomized to receive either preoperative (preop, N = 68) or postoperative (postop, N = 70) proton pump inhibitor-based triple therapy for H. pylori eradication. The regimen consisted of rabeprazole 10 mg, clarithromycin 500 mg, and amoxicillin 1,000 mg, all twice daily for 7 days. Eradication was assessed by rapid urease test and histology 12 wk after surgery.
RESULTS
By intention-to-treat (ITT) analysis, H. pylori eradication rates were 84.6% (95% CI 73.5-92.4) in the preop group and 83.1% (95% CI 71.7-91.2) in the postop group (P= 0.99). By per protocol (PP) analysis, the rates were 87.3% (95% CI 76.5-94.4) in the preop group and 86.9% (95% CI 75.8-94.2) in the postop group (P= 0.99). In the postop group, eradication rates did not differ with reconstruction method (Billroth I vs II, 80.4%[95% CI 66.1-90.6]vs 89.5%[95% CI 66.9-98.7] by ITT analysis (P= 0.49), and 85.7%[95% CI 71.5-94.6]vs 89.5% (95% CI 66.9-98.7) by PP analysis, P= 0.99).
CONCLUSIONS
In distal gastric cancer patients, the effect of proton pump inhibitor-based triple therapy for H. pylori eradication was not different whether given postoperatively or preoperatively.
目的
对于接受胃大部切除术的胃癌患者,强烈建议根除幽门螺杆菌(H. pylori)。基于质子泵抑制剂的三联疗法对胃残端H. pylori根除的疗效尚未得到充分评估。本研究的目的是比较术后与术前H. pylori根除治疗的疗效。
方法
总共138例感染H. pylori的远端胃癌患者被随机分为两组,分别接受术前(术前组,N = 68)或术后(术后组,N = 70)基于质子泵抑制剂的三联疗法以根除H. pylori。治疗方案为雷贝拉唑10 mg、克拉霉素500 mg和阿莫西林1000 mg,均每日2次,共7天。术后12周通过快速尿素酶试验和组织学评估根除情况。
结果
按意向性分析(ITT),术前组H. pylori根除率为84.6%(95%CI 73.5 - 92.4),术后组为83.1%(95%CI 71.7 - 91.2)(P = 0.99)。按符合方案(PP)分析,术前组根除率为87.3%(95%CI 76.5 - 94.4),术后组为86.9%(95%CI 75.8 - 94.2)(P = 0.99)。在术后组中,根除率在重建方法上无差异(毕Ⅰ式与毕Ⅱ式,ITT分析分别为80.4%[95%CI 66.1 - 90.6]与89.5%[95%CI 66.9 - 98.7],P = 0.49;PP分析分别为85.7%[95%CI 71.5 - 94.6]与89.5%(95%CI 66.9 - 98.7),P = 0.99)。
结论
在远端胃癌患者中,基于质子泵抑制剂的三联疗法根除H. pylori的效果在术后或术前给药时并无差异。