To explore the clinical efficacy of a modified bismuth triple regimen in eradicating H.pylori infection.

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 day for 14 days〕. The ¹³C- or ¹⁴C-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.

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 in completion rate was found between the two groups (χ²=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 EBAT group〔69.6% (96/138) vs 80.2% (97/121) 〕 (χ²=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) , respectively, demonstrating no statistically significant intergroup difference (χ²=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) , and 72.9% (43/59) , respectively, showing no statistically significant intergroup difference (χ²=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) and 82.7% (43/52) , respectively, manifesting statistically significant intergroup difference (χ²=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 statistically significant difference〔88.3% (83/94) vs 92.0% (80/87) 〕 (χ²=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 difference〔88.6% (31/35) vs 75.0% (33/44) 〕 (χ²=2.353, P=0.308) .

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.

探索改良铋剂三联疗法根除H.pylori感染的临床疗效。

选取2019年4月至2020年12月在四川大学华西医院消化内科门诊就诊和治疗的H.pylori感染患者360例。采用随机数字表法将符合纳入标准的患者随机分为改良铋剂三联方案组（EBA组）和标准铋剂四联方案组（EBAT组），每组180例。EBA组给予埃索美拉唑40 mg/次、2次/d，胶体果胶铋胶囊300 mg/次、2次/d，阿莫西林1g/次、2次/d，疗程14 d。EBAT组给予埃索美拉唑（规格：20 mg/片，阿斯利康制药有限公司）20 mg/次、2次/d，胶体果胶铋胶囊300 mg/次、2次/d，阿莫西林1 g/次、2次/d，四环素750 mg/次、2次/d，疗程14 d。治疗结束4~8周后行¹³C/¹⁴C尿素呼气试验，结果阴性者判断为H.pylori根除成功。比较两组患者H.pylori根除率及症状改善情况。

H.pylori感染初治患者259例（EBA组138例，EBAT组121例），复治患者101例（EBA组42例，EBAT组59例）。EBA组治疗完成率为83.3%（150/180，其中初治患者完成112例，复治患者完成38例）；EBAT组治疗完成率为86.7%（156/180，其中初治患者完成104例，复治患者完成52例）。两组患者治疗完成率比较，差异无统计学意义（χ²=0.784，P=0.376）。对于H.pylori感染初治患者，按照意向性分析，EBA组H.pylori根除率为69.6%（96/138），EBAT组H.pylori根除率为80.2%（97/121），两组H.pylori感染初治患者根除率比较，差异无统计学意义（χ²=4.313，P=0.116）；按照符合方案集分析，EBA组H.pylori根除率为85.7%（96/112），EBAT组H.pylori根除率为93.3%（97/104），两组H.pylori感染初治患者根除率比较，差异无统计学意义（χ²=3.235，P=0.072）。对于H.pylori感染复治患者，按照意向性分析，EBA组H.pylori根除率为54.8%（23/42），EBAT组H.pylori根除率为72.9%（43/59），两组H.pylori感染复治患者根除率比较，差异无统计学意义（χ²=5.678，P=0.058）；按照符合方案集分析（符合方案集分析），EBA组H.pylori根除率为60.5%（23/38），EBAT组H.pylori根除率为82.7%（43/52），两组H.pylori感染复治患者根除率比较，差异有统计学意义（χ²=5.516，P=0.019）。H.pylori感染初治患者中，EBA组治疗前有症状者94例，EBAT组87例，EBA组症状改善率为88.3%（83/94），EBAT组为92.0%（80/87），两组症状改善率比较，差异无统计学意义（χ²=0.897，P=0.639）。H.pylori感染复治患者中，EBA组治疗前有症状者35例，EBAT组44例，EBA组症状改善率为88.6%（31/35），EBAT组为75.0%（33/44），两组症状改善率比较，差异无统计学意义（χ²=2.353，P=0.308）。

对于H.pylori感染初治患者，改良铋剂三联疗法的H.pylori根除率及症状缓解率不劣于标准铋剂四联方案，可考虑作为新的治疗方案应用于临床。对于H.pylori感染复治患者，改良铋剂三联方案症状缓解情况与标准铋剂四联方案相似，但H.pylori感染根除率明显更低，因此，改良铋剂三联方案不适用于复治患者的补救。