Vilaichone Ratha-korn, Prapitpaiboon Hatainuch, Gamnarai Pornpen, Namtanee Juraiwan, Wongcha-um Arti, Chaithongrat Supakarn, Mahachai Varocha
Gastroenterology Unit, Department of Medicine, Thammasat University Hospital, Pathumthani, Thailand E-mail :
Asian Pac J Cancer Prev. 2015;16(14):6089-92. doi: 10.7314/apjcp.2015.16.14.6089.
BACKGROUND: The prevalence of metronidazole-resistant H. pylori is almost 50% in Thailand which severely limits the use of this drug for eradication therapy. The aims of this study were to evaluate the efficacy and safety profiles of 7-day bismuth-based quadruple therapy including metronidazole as an initial treatment for H. pylori infection in a high metronidazole resistance area. MATERIALS AND METHODS: This study was performed at Thammasat University Hospital and King Chulalongkorn Memorial Hospital during January 2009 to October 2010. Patients with non-ulcer dyspepsia (NUD) with active H. pylori infection were assigned to receive seven days of quadruple therapy (pantoprazole 40 mg bid, bismuth subsalicylate 1,048 mg bid, amoxicillin 1 gm bid and metronidazole 400 mg tid). H. pylori infection was defined as positive H. pylori culture or two positive tests (rapid urease test and histology). Antibiotic susceptibility test for metronidazole by Epsilometer test (E-test) was performed in all positive cultures. At least four weeks after treatment, 13C urea breath test (13C-UBT) was performed to confirm H. pylori eradication. RESULTS: A total of 114 patients were enrolled in this study, 50 males and 64 females with a mean age of 49.8 years. All 114 patients had a diagnosis of NUD. Overall eradication as confirmed by negative 13C-UBT was achieved in 94 out of 114 patients (82.5%). 44 patients had positive cultures and success for E-test. In vitro metronidazole resistance was observed in 22/44 (50%) patients. Eradication rate in patients with metronidazole resistant strains was 16/22 (72.7%) and 20/22 (90.1%) with metronidazole sensitive strains (72.7% vs 90.1%, p-value=0.12; OR=3.75 [95%CI=0.6-31.5]). Minor adverse reactions included nausea, bitter taste, diarrhea and black stools but none of the patients dropped out from the study. CONCLUSIONS: Initial treatment with 7-day bismuth-based quadruple therapy including metronidazole, amoxycillin and pantoprazole is highly effective and well tolerated for metronidazole-sensitive H. pylori infections. However, the efficacy markedly decline with metronidazole resistance. Longer duration of this regimen might be required to improve the eradication rate and larger multi-center studies are needed to confirm this hypothesis.
背景：在泰国，对甲硝唑耐药的幽门螺杆菌感染率近50%，这严重限制了该药在根除治疗中的应用。本研究旨在评估含甲硝唑的7天铋剂四联疗法作为高甲硝唑耐药地区幽门螺杆菌感染初始治疗方案的疗效和安全性。 材料与方法：本研究于2009年1月至2010年10月在泰国法政大学医院和朱拉隆功国王纪念医院进行。将患有活动性幽门螺杆菌感染的非溃疡性消化不良（NUD）患者分配接受7天的四联疗法（泮托拉唑40mg，每日2次；次水杨酸铋1048mg，每日2次；阿莫西林1g，每日2次；甲硝唑400mg，每日3次）。幽门螺杆菌感染定义为幽门螺杆菌培养阳性或两项检测结果均为阳性（快速尿素酶试验和组织学检查）。对所有阳性培养物进行Epsilometer试验（E试验）检测甲硝唑的抗生素敏感性。治疗后至少4周，进行13C尿素呼气试验（13C-UBT）以确认幽门螺杆菌是否被根除。 结果：本研究共纳入114例患者，其中男性50例，女性64例，平均年龄49.8岁。所有114例患者均诊断为NUD。经13C-UBT证实为阴性的总体根除率在114例患者中的94例（82.5%）。44例患者培养阳性且E试验成功。在22/44（50%）例患者中观察到甲硝唑体外耐药。甲硝唑耐药菌株患者的根除率为16/22（72.7%），甲硝唑敏感菌株患者的根除率为20/22（90.1%）（72.7%对90.1%，p值=0.12；OR=3.75[95%CI=0.6-31.5]）。轻微不良反应包括恶心、口苦、腹泻和黑便，但无患者退出研究。 结论：含甲硝唑、阿莫西林和泮托拉唑的7天铋剂四联疗法作为初始治疗方案，对甲硝唑敏感的幽门螺杆菌感染高效且耐受性良好。然而，随着甲硝唑耐药，疗效显著下降。可能需要延长该方案的疗程以提高根除率，需要更大规模的多中心研究来证实这一假设。
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