Prapitpaiboon Hatainuch, Mahachai Varocha, Vilaichone Ratha-Korn
Gastroenterology Unit, Thammasat University Hospital, Pathumthani, Thailand E-mail :
Asian Pac J Cancer Prev. 2015;16(10):4353-6. doi: 10.7314/apjcp.2015.16.10.4353.
Levofloxacin is an effective medication for second line Helicobacter pylori (H. pylori) eradication. However, limited studies have approved its use as an effective antibiotic in first line therapy. Dexlansoprazole is a new PPI and lacks of evidence in support of a role in H. pylori eradication. This study was designed to evaluate efficacy of levofloxacin-dexlansoprazole-based quadruple therapy for H. pylori eradication in Thailand.
This prospective randomized control study was performed during June 2014 to December 2014. H. pylori infected gastritis patients were randomized to receive 7- or 14-day levofloxacin-dexlansoprazole based on quadruple therapy (levofloxacin 500 mg OD, dexlansoprazole 60 mg bid, clarithromycin MR 1000 mg OD, bismuth subsalicylate 1048 mg bid). CYP2C19 genotyping and antibiotic susceptibility tests were conducted for all patients. A 13C urea breath test was performed to confirm H. pylori eradication at least 4 weeks after treatment.
A total of 100 patients were enrolled, comprising 44 males and 56 females (mean age of 52.6 years). Eradication rate by PP analysis was 85.7% (42/49) with the 7-day regimen and 98% (48/49) with the 14-day regimen (85.7% vs 98%; p-value=0.059). ITT analysis was 84% and 96% with 7- and 14-day regimens, respectively (84% vs 96%; p-value=0.092). Antibiotic susceptibility testing demonstrated 35.1% resistance to metronidazole, 18.3% to clarithromycin, and 13.5% to levofloxacin. CYP2C19 genotyping revealed 54.1% RM, 34.7% IM and 11.2% PM. The 14-day regimen provided 100% eradication in patients with clarithromycin or dual clarithromycin and metronidazole H. pylori resistant strains. Moreover, the eradication rate was 96.6% in patients with CYP2C19 genotype RM.
The 14-day levofloxacin-dexlansoprazole based quadruple therapy provides high H. pylori eradication regardless of CYP2C19 genotype, clarithromycin or dual clarithromycin and metronidazole resistant strains. This regimen could be use as an alternative first line therapy for H. pylori eradication in Thailand.
左氧氟沙星是用于二线根除幽门螺杆菌（H. pylori）的有效药物。然而，仅有有限的研究证实其可作为一线治疗的有效抗生素。右兰索拉唑是一种新型质子泵抑制剂（PPI），目前缺乏其在根除幽门螺杆菌方面发挥作用的证据。本研究旨在评估基于左氧氟沙星 - 右兰索拉唑的四联疗法在泰国根除幽门螺杆菌的疗效。
本前瞻性随机对照研究于2014年6月至2014年12月进行。幽门螺杆菌感染的胃炎患者被随机分配接受基于四联疗法（左氧氟沙星500 mg每日一次、右兰索拉唑60 mg每日两次、克拉霉素缓释片1000 mg每日一次、次水杨酸铋1048 mg每日两次）的7天或14天治疗方案。对所有患者进行CYP2C19基因分型和抗生素敏感性测试。治疗结束至少4周后进行13C尿素呼气试验以确认幽门螺杆菌是否被根除。
共纳入100例患者，其中男性44例，女性56例（平均年龄52.6岁）。按符合方案（PP）分析，7天治疗方案的根除率为85.7%（42/49），14天治疗方案的根除率为98%（48/49）（85.7%对98%；p值 = 0.059）。意向性分析（ITT）中，7天和14天治疗方案的根除率分别为84%和96%（84%对96%；p值 = 0.092）。抗生素敏感性测试显示，对甲硝唑耐药率为35.1%，对克拉霉素耐药率为18.3%，对左氧氟沙星耐药率为13.5%。CYP2C19基因分型显示，快速代谢型（RM）占54.1%，中间代谢型（IM）占34.7%，慢代谢型（PM）占11.2%。14天治疗方案对克拉霉素或克拉霉素与甲硝唑双重耐药的幽门螺杆菌菌株患者的根除率为100%。此外，CYP2C19基因分型为RM的患者根除率为96.6%。
基于左氧氟沙星 - 右兰索拉唑的14天四联疗法无论CYP2C19基因分型如何，对克拉霉素或克拉霉素与甲硝唑双重耐药菌株均能实现较高的幽门螺杆菌根除率。该方案可作为泰国根除幽门螺杆菌的替代一线治疗方案。
