| Summary: | 碩士 === 高雄醫學大學 === 臨床醫學研究所 === 105 === Background
The culture method has been strongly emphasized in the clinical setting of Helicobacter pylori (H. pylori) eradication failure because retreatment strategy can be tailored based on the culture antibiotics susceptibility test. However, the culture method yields low accuracy, especially in treatment-experienced H. pylori infection. The current clinical unmet need in the setting of treatment-experienced H. pylori infection is one diagnostic method with satisfying accuracy as well as the ability to perform the antibiotics susceptibility test. Theoretically, gastric juiced-based PCR is able to provide both strengths, but there is no clinical data. Our study intended to provide the data regarding the diagnostic accuracy of gastric juice-based PCR in the treatment-experienced H. pylori infection and compare the results of gastric juice-based PCR with that of the culture method.
Methods
We included 711 patients and categorized them into 4 groups based on their previous treatment history: treatment-naïve, post 1st line therapy, post 2nd line therapy and post 3rd line therapy. The status of H. pylori infection in each subject was confirmed according to the following clinical gold standards: concordant positive histology and rapid urease test or positive urease breath test. We performed gastric juice-based PCR and culture in each subject and then calculated the sensitivity, specificity, positive predictive value, negative predictive value and accuracy of gastric juice-based PCR as well as culture method. Finally, we compared the results with Fisher’s exact test.
Results
Our findings demonstrated that the accuracy of gastric juice-based PCR was higher than that of the traditional culture method in treatment-naïve patients (96% vs 87%, p values = 0.0001), in patients post 1st line therapy (97% vs 79%, p values = 0.0002), in patients post 2nd line therapy (96% vs 77%, p values = 0.0012) and in patients post 3rd line therapy (100% vs 70%, p values = 0.0092). The sensitivity of gastric juice-based PCR was also better than that of the traditional culture method in treatment-naïve patients (92% vs 58%, p values < 0.0001), in patients post 1st line therapy (90% vs 35%, p values < 0.0001), in patients post 2nd line therapy (93% vs 60%, p values = 0.0006) and in patients post 3rd line therapy (100% vs 22%, p values = 0.0023). The specificity, positive predictive and negative predictive values were calculated as well. The results indicated that gastric juice-based PCR outperformed the traditional culture method in diagnosis of treatment-experienced H pylori.
Conclusion
The gastric juice-based PCR yields more accurate diagnosis in treatment-experienced H. pylori than the traditional culture method and also provides the anti-microbial susceptibility test to guide subsequent retreatment therapy. Our study demonstrated that gastric juice-based PCR suits the current unmet need for the management of treatment-experienced H pylori and has very promising potential for widespread application in the setting of treatment failure.
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