Bismuth, lansoprazole, amoxicillin and metronidazole or clarithromycin as first-line Helicobacter pylori therapy
Bismuth, lansoprazole, amoxicillin and metronidazole or clarithromycin as first-line Helicobacter pylori therapy
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铋剂、兰索拉唑、阿莫西林和甲硝唑或克拉霉素作为幽门螺杆菌一线治疗
DOI：
10.1136/gutjnl-2015-309900
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发表时间：
2015-11-01
期刊：
影响因子：
24.5
通讯作者：
Lu, Hong
中科院分区：
文献类型：
--
作者：
Zhang, Wei;Chen, Qi;Lu, Hong
目的评价阿莫西林替代四环素在铋剂四联疗法中的疗效和耐受性。设计将幽门螺杆菌感染且未接受治疗的受试者随机（1：1）分配接受14天的改良铋剂四联疗法：兰索拉唑30 mg，阿莫西林1 g，枸橼酸铋钾220 mg（元素铋），每日两次，同时服用甲硝哒唑400 mg，每日四次（甲硝哒唑组）或克拉霉素500 mg，每日两次（克拉霉素组）。治疗6周后，H.通过C-13-尿素呼气试验评估幽门螺杆菌根除情况。药敏试验采用琼脂二倍稀释法。这是一个非劣效性试验。结果215例受试者被随机化。含甲硝唑和克拉霉素的治疗方案治愈率高：94/97（96.9%，95% CI 93.5%-100%）和93/98（94.9%，95% CI 90.5%-99.3%），意向治疗分别为88.9%（95% CI 83.0%-94.8%）和88.8%（95% CI 82.8%-94.8%）。阿莫西林、甲硝唑和克拉霉素的耐药率分别为1.5%、45.5%和26.5%。仅克拉霉素耐药降低了治疗成功率（例如，敏感98.6%，耐药76.9%，p = 0.001）。不良事件更常见的甲硝唑group.Conclusions这些结果表明，阿莫西林可以取代四环素在修改后的14天铋四联疗法作为一线治疗，仍然克服甲硝唑耐药的甲硝唑和克拉霉素耐药率高的地区。使用克拉霉素而不是甲硝唑是有效的，只有在敏感菌株的存在。
Objective To evaluate the efficacy and tolerability of replacing tetracycline with amoxicillin in bismuth quadruple therapy.Design Subjects who were infected with Helicobacter pylori and naive to treatment were randomly (1: 1) assigned to receive a 14-day modified bismuth quadruple therapy: lansoprazole 30 mg, amoxicillin 1 g, bismuth potassium citrate 220 mg (elemental bismuth), twice a day with metronidazole 400 mg four times a day (metronidazole group) or clarithromycin 500 mg twice a day (clarithromycin group). Six weeks after treatment, H. pylori eradication was assessed by C-13-urea breath test. Antimicrobial susceptibility was assessed by the twofold agar dilution method. This was a non-inferiority trial.Results Two hundred and fifteen subjects were randomised. Metronidazole and clarithromycin containing regimens achieved high cure rates: 94 of 97 (96.9%, 95% CI 93.5% to 100%) and 93 of 98 (94.9%, 95% CI 90.5% to 99.3%) by per-protocol and 88.9% (95% CI 83.0% to 94.8%) and 88.8% (95% CI 82.8% to 94.8%) by intention-to-treat, respectively. Amoxicillin, metronidazole and clarithromycin resistance rates were 1.5%, 45.5% and 26.5%, respectively. Only clarithromycin resistance reduced treatment success (eg, susceptible 98.6%, resistant 76.9%, p=0.001). Adverse events were more common in the metronidazole group.Conclusions These results suggest that amoxicillin can substitute for tetracycline in modified 14 day bismuth quadruple therapy as first-line treatment and still overcome metronidazole resistance in areas with high prevalence of metronidazole and clarithromycin resistance. Using clarithromycin instead of metronidazole was only effective in the presence of susceptible strains.