台湾地区根除幽门螺杆菌的混合疗法与序贯疗法：一项前瞻性随机试验
Hybrid vs sequential therapy for eradication of Helicobacter pylori in Taiwan: A prospective randomized trial.
作者信息
Chen Kuan-Yang, Lin Tsung-Jung, Lin Chin-Lin, Lee Hsi-Chang, Wang Chung-Kwe, Wu Deng-Chyang
机构信息
Kuan-Yang Chen, Institute of Clinical Medicine, National Yang-Ming University, Taipei City 10629, Taiwan.
出版信息
World J Gastroenterol. 2015 Sep 28;21(36):10435-42. doi: 10.3748/wjg.v21.i36.10435.
AIM
To evaluate the efficacy of sequential vs hybrid therapy in patients with Helicobacter pylori (H. pylori) infection.
METHODS
From March 2013 to May 2014, one hundred and seventy-five H. pylori infected patients who had not been treated for H. pylori before were randomized to receive either sequential therapy (rabeprazole 20 mg and amoxicillin 1 g twice daily for 5 d, followed by rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 5 d) or hybrid therapy (rabeprazole 20 mg and amoxicillin 1 g for 7 d, followed by rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 d). H. pylori status was confirmed by positive results of both rapid urease test and histology examination or a positive result of culture. Eradication efficacy was assessed by follow-up endoscopy with rapid urease test and histological examination 8 wk after the end of anti-H. pylori therapy, or (13)C-urea breath test at least 4 wk after completion of treatment. The primary outcome was H. pylori eradication by intention-to-treat (ITT) and per-protocol (PP) analyses.
RESULTS
One hundred and sixty-seven patients (83 patients in the sequential group and 84 patients in the hybrid group) completed the study. The compliance rates were 97.6% and 97.7% for the two groups, respectively. The eradication rate was 78.2% for the sequential group and 92% for the hybrid group by ITT analysis (P = 0.01). The eradication rate was 81.9% for the sequential group and 96.4% for the hybrid group by PP analysis (P = 0.01). Univariate analysis for the clinical and bacterial factors did not identify any risk factors associated with treatment failure. Severe adverse events were observed in 2.3% of patients in the sequential group and 2.4% of those in the hybrid group.
CONCLUSION
Due to a grade A (> 95%) success rate for H. pylori eradication by PP analysis, similar compliance and adverse events, hybrid therapy seems to be an appropriate eradication regimen in Taiwan.
目的
评估序贯疗法与联合疗法对幽门螺杆菌（H. pylori）感染患者的疗效。
方法
2013年3月至2014年5月，175例既往未接受过幽门螺杆菌治疗的幽门螺杆菌感染患者被随机分为接受序贯疗法（雷贝拉唑20 mg和阿莫西林1 g，每日2次，共5天，随后雷贝拉唑20 mg、克拉霉素500 mg和甲硝唑500 mg，每日2次，共5天）或联合疗法（雷贝拉唑20 mg和阿莫西林1 g，共7天，随后雷贝拉唑20 mg、阿莫西林1 g、克拉霉素500 mg和甲硝唑500 mg，每日2次，共7天）。通过快速尿素酶试验和组织学检查结果均为阳性或培养结果为阳性来确认幽门螺杆菌感染状态。在抗幽门螺杆菌治疗结束8周后通过随访内镜检查及快速尿素酶试验和组织学检查评估根除疗效，或在治疗完成后至少4周进行（13）C - 尿素呼气试验。主要结局是意向性治疗（ITT）和符合方案（PP）分析的幽门螺杆菌根除情况。
结果
167例患者（序贯组83例，联合组84例）完成了研究。两组的依从率分别为97.6%和97.7%。ITT分析显示序贯组的根除率为78.2%，联合组为92%（P = 0.01）。PP分析显示序贯组的根除率为81.9%，联合组为96.4%（P = 0.01）。对临床和细菌学因素的单因素分析未发现任何与治疗失败相关的危险因素。序贯组2.3%的患者和联合组2.4%的患者观察到严重不良事件。
结论
由于PP分析中幽门螺杆菌根除成功率达到A级（> 95%），且依从性和不良事件相似，联合疗法似乎是台湾地区一种合适的根除方案。
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