Page 42 - 中国全科医学2022-09

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3.Day Surgery Center，West China hospital of Sichuan University，Chengdu 610041，China
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Corresponding author：MA Hongsheng，Professor；E-mail：mahongsheng@wchscu.cn
【Abstract】 Background The antibiotic resistance rate of Helicobacter pylori（H.pylori） is increasing while its
eradication rate is decreasing year by year. So it is urgent to explore more effective treatment regimens. Objective To explore the
clinical efficacy of a modified bismuth triple regimen in eradicating H.pylori infection. Methods A total of 360 eligible patients
with H.pylori infection were selected from the Gastroenterology & Hepatology Clinic，West China Hospital of Sichuan University
from April 2019 to December 2020. They were equally randomized into a modified bismuth triple regimen group〔EBA group，
esomeprazole 40 mg/time，colloidal bismuth pectin capsules 300 mg/time，and amoxicillin 1 g/time，twice a day for 14 days），
and a standard bismuth quadruple regimen group〔EBAT group，esomeprazole（strength：20 mg，produced by AstraZeneca）
20 mg/time，colloidal bismuth pectin capsules 300 mg/time，amoxicillin 1g/time，and tetracycline 750 mg/time，twice a
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day for 14 days〕. The C- or C-urea breath test was performed 4-8 weeks after the treatment，and the negative result was
defined as successful eradication treatment of H.pylori infection. The eradication rate of H.pylori infection and the improvement
of related symptoms were compared between two groups. Results 259 newly treated patients with H.pylori infection （138 in
EBA group and 121 in EBAT group） and 101 retreated patients （42 in EBA group and 59 in EBAT group） were included.
The treatment completion rate of EBA group was 83.3% （150/180，including 112 cases of newly treated，and 38 retreated），
and that of EBAT group was 86.7% （156/180，including 104 newly treated patients and 52 retreated）. No statistical difference
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in completion rate was found between the two groups （χ =0.784，P=0.376）. Intention-to-treat analysis revealed that，the
eradication rate of H.pylori infection in newly treated patients in EBA group was not statistically different from that of those in
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EBAT group〔69.6% （96/138） vs 80.2% （97/121）〕 （χ =4.313，P=0.116）. Furthermore，per-protocol analysis found
that，the eradication rates in newly treated patients in EBA group and EBAT group were 85.7% （96/112） and 93.3% （97/104），
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respectively，demonstrating no statistically significant intergroup difference （χ =3.235，P=0.072）.For retreated patients，
intention-to-treat analysis indicated that，the eradication rates for those in EBA group and EBAT group were 54.8% （23/42），
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and 72.9% （43/59），respectively，showing no statistically significant intergroup difference（χ =5.678，P=0.058）.
However，based on the per-protocol analysis，the eradication rates for those in EBA group and EBAT group were 60.5% （23/38）
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and 82.7% （43/52），respectively，manifesting statistically significant intergroup difference（χ =5.516，P=0.019）. The
rates of symptom improvements in newly treated patients with pre-treatment symptoms in EBA and EBAT groups showed no
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statistically significant difference〔88.3%（83/94） vs 92.0%（80/87）〕（χ =0.897，P=0.639）. And the rates of symptom
improvements in retreated patients with pre-treatment symptoms in EBA and EBAT groups also showed no statistically significant
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difference〔88.6% （31/35） vs 75.0% （33/44）〕 （χ =2.353，P=0.308）. Conclusion For newly treated patients with H.pylori
infection，the modified bismuth triple regimen had effects similar to those of the standard bismuth quadruple regimen in terms of
eradication rate of H.pylori infection and symptoms improvement rate，which could be used as a new treatment option. However，
this modified triple regimen was not suitable for retreated patients，although the symptoms improvement rate was similar to that of
the quadruple regimen，the eradication rate of H.pylori infection was too lower.
【Key words】 Helicobacter pylori；Proton pump inhibitors；Modified bismuth triple regimen；Anti-bacterial agents；
Treatment outcome

幽门螺杆菌（H.pylori）自 20 世纪 80 年代被 及以上抗生素 ［7-9］ ，这不仅使得治疗过程中患者不良反
Warren 和 Marshall 发现以来 ［1］ ，其一直是医疗界的研 应增加，更导致初次治疗失败后复治时可供选择的抗生
究热点。目前全球 H.pylori 感染率达 50%，部分地区甚 素种类更为局限。因此，为减少抗生素的使用，降低人
至高达 80% ［2］ 。H.pylori 被世界卫生组织定义为Ⅰ类致 群对抗生素的耐药率和 2 种及以上抗生素合并使用时的
癌物 ［3］ ，感染后会导致慢性活动性胃炎，参与胃癌和 不良反应，为提高患者的依从性，继续寻求新的治疗方
黏膜相关淋巴组织结外边缘区 B 细胞（MALT）淋巴瘤 案显得至关重要。质子泵抑制剂（PPI）作为抑酸剂，
的发病，且与胃外疾病相关，如缺铁性贫血、特发性血 可强效抑制胃酸分泌，迅速提升胃内 pH 值，使抗生素
小板减少性紫癜和维生素 B 12 缺乏等 ［4］ 。我国第五次全 更好地发挥抗菌活性，从而增强杀菌效果。铋黏膜保护
国幽门螺杆菌感染处理共识报告（以下简称第五次全国 剂具有一定的杀菌作用，与抗生素联用后不仅可增强抗
共识）指出 H.pylori 感染患者均应行根除治疗，并推荐 菌药物的抗菌活性，还可克服抗生素的耐药性 ［10］ 。阿
含铋剂四联疗法作为经验性治疗方案 ［5］ 。随着全球抗 莫西林耐药率低，抗菌效果佳，最常用于根除 H.pylori，
生素耐药率逐年上升，H.pylori 感染根除率逐年下降 ［6］ 。 其抗菌活性与胃内 pH 值密切相关 ［11］ 。因此，结合各
目前各指南推荐的铋剂和非铋剂四联方案中均包含 2 种 种抗 H.pylori 药物特性，本研究拟将 PPI 剂量加倍、使