Guttner Yvonne, Windsor Helen M, Viiala Charlie H, Dusci Leon, Marshall Barry J
Department of Gastroenterology, Sir Charles Gairdner Hospital, University of Western Australia, Perth, Australia.
Antimicrob Agents Chemother. 2003 Dec;47(12):3780-3. doi: 10.1128/AAC.47.12.3780-3783.2003.
Nitazoxanide (NTZ) is an antibiotic with microbiological characteristics similar to those of metronidazole but without an apparent problem of resistance. The aim of this study was the prospective evaluation of NTZ given as a single agent in the treatment of Helicobacter pylori infection. Twenty culture-positive patients with dyspepsia who had previously failed at least one course of H. pylori eradication therapy were enrolled. Subjects received 1 g of NTZ twice daily for 10 days. The safety and tolerability of the drug were assessed by physical examination, monitoring of adverse events, and clinical laboratory evaluation. Urea breath tests (UBTs) were performed 6 weeks posttreatment. H. pylori was isolated from UBT-positive patients by the string test or endoscopy with biopsy, and the MICs for these isolates were compared to those for isolates obtained pretherapy. The levels of tizoxanide, the active deacylated derivative of NTZ, were measured in blood, saliva, and tissue from two patients during treatment. The UBT results were positive for all 20 patients after completion of NTZ therapy. The MIC results demonstrated that the NTZ susceptibilities of none of the strains isolated from the patients posttherapy had changed significantly. No major adverse reactions were observed, but frequent minor side effects were observed. In conclusion, NTZ did not eradicate H. pylori when it was given as a single agent.
硝唑尼特（NTZ）是一种抗生素，其微生物学特性与甲硝唑相似，但不存在明显的耐药问题。本研究的目的是对NTZ作为单一药物治疗幽门螺杆菌感染进行前瞻性评估。招募了20名消化不良且培养阳性的患者，这些患者此前至少一个疗程的幽门螺杆菌根除治疗失败。受试者每天两次服用1克NTZ，持续10天。通过体格检查、不良事件监测和临床实验室评估来评估药物的安全性和耐受性。治疗后6周进行尿素呼气试验（UBT）。通过线试验或内镜活检从UBT阳性患者中分离出幽门螺杆菌，并将这些分离株的最低抑菌浓度（MIC）与治疗前获得的分离株进行比较。在两名患者治疗期间，测量了血液、唾液和组织中NTZ的活性脱酰基衍生物替唑尼特的水平。NTZ治疗完成后，所有20名患者的UBT结果均为阳性。MIC结果表明，治疗后从患者中分离出的菌株对NTZ的敏感性均未发生显著变化。未观察到重大不良反应，但观察到频繁的轻微副作用。总之，NTZ作为单一药物时未能根除幽门螺杆菌。
