Introduction
Helicobacter pylori (H. pylori) infection has a high prevalence (44.8%) in China and is an important risk factor of gastrointestinal diseases including gastric cancer. Bismuth quadruple therapy (BQT; bismuth + acid suppressant + 2 antibiotics [ABs]) is the currently recommended first-line regimen for H. pylori in China. Increasing AB resistance poses a vital challenge and remarkably reduces the eradication rate (ER) from 95% to 80% globally and 89% to 78% in China. Real-world ER analysis assessed only quadruple therapy in a few single centers and did not focus on different antibiotic combinations and other different regimens.
Aims & Methods
This study was designed to evaluate the diagnosis and treatment pattern of H. pylori infection and the effectiveness of eradication therapy in real-world settings in China. In this retrospective, multicenter study (NCT05073367), de-identified patient data were extracted from the electronic medical records database of 3 hospitals between January 1, 2019, and March 31, 2021. Patients aged ≥18 years with a record of H. pylori infection diagnosis were included. Here we presented the eradication rate of different treatment regimens and the eradication rate of different years with different treatment regimens.
Results
A total of 1426 patients received ET with efficacy evaluation duration＞4 weeks after the eradication therapy and the total eradication rate was 72.09% (n=1028). Most patients (80.36%; n=1146) received standard BQT with an ER of 76.70% (n=879). 158 patients (11.08%) received dual therapy (ER=56.96%; n=90) and 122 patients (8.56%) received triple therapy (ER=48.36%; n=59). Compared with triple and dual therapies, BQT was the predominant regimen in all the years with an ER of 77.86%, 67.64%, and 82.78% in 2019, 2020, and 2021, respectively. The ER of dual therapy was 50% in 2020 and 61.22% in 2021. The triple therapy ER showed a decreasing trend with 78.57% (n=11), 46.25% (n=37), 39.29% (n=11) from 2019 to 2021. Among the BQT regimens, amoxicillin plus furazolidone based regimens showed a higher ER (87.44%; n=181), while the ER of amoxicillin plus levofloxacin, amoxicillin plus clarithromycin based BQT was 77.94% (n=159) and 76.07% (n=391), respectively. Amoxicillin plus furazolidone based BQT showed a higher ER of 87.30%, 83.02%, and 90.11% in 2019, 2020, and 2021 respectively (Table 1).
Table 1. Eradication rate of H. pylori positive patients based on the type of eradication therapy
Total (N=1426) →
/Treatment regimens ↓
| ER-success
n (%)b | Year 2019 Success
n (%)b | Year 2020
Success
n (%) b | Year 2021
Success
n
(%)b |
| Total | 1028 (72.09) | 454 (77.87) | 253 (60.96) | 321 (75.00) |
Bismuth Quadruple Therapy
Amoxicillin and Clarithromycin
Amoxicillin and Furazolidone
Amoxicillin and Levofloxacin
Amoxicillin and Metronidazole
Other Bismuth Quadruple Therapy | 879 (76.70)
391 (76.07)
181 (87.44)
159 (77.94)
2 (50.00)
146 (67.28) | 443 (77.86)
169 (78.24)
55 (87.30)
126 (79.25)
2 (50.00)
91 (71.65) | 186 (67.64)
106 (67.95)
44 (83.02)
10 (55.56)
0 (0.00)
26 (54.17) | 250 (82.78)
116 (81.69)
82 (90.11)
23 (85.19)
0 (0.00)
29 (69.05) |
Triple therapyc
Dual therapyc | 59 (48.36)
90 (56.96) | 11 (78.57)
0 (0.00) | 37 (46.25)
30 (50.00) | 11 (39.29)
60 (61.22) |
Abbreviations: N, total number; n, number in respective category.
a% = The total usage count of BQT/Triple therapy/Dual therapy eradication therapy/the total usage count of all standard eradication therapies taken by eligible participants. Of BQT, the total usage count of different BQT/the total usage count of all BQT.
b% = The number of participants with a negative efficacy evaluation result/the number of participants receiving certain eradication therapy.
cConsidering the table size, outcomes of different treatment regimens under dual and triple therapy were not included in the table.
Conclusion
BQT-based regimens were predominantly prescribed for H. pylori management and the current H. pylori treatment regimens have a suboptimal eradication rate in the real-world settings.
Disclosure
The study was funded by Takeda China. Wensheng Pan, Yan Zhao, and Hongwei Xu have no conflicts of interest. Pengfei Li, Fang Zhou, and Li Xie are employees of Takeda, and they hold Takeda stock options. Medical writing for the development of this abstract was provided by Swathirajan CR, PhD, and Kusuma Kumari G, PhD, of Indegene Private Limited, and funded by Takeda China. Authors retained full control of the abstract content.