專利公告 Patents
胃幽門螺旋桿菌抗藥基因型檢測與治療
刊登日期：2025/10/21
| ‧ 專利名稱 | 胃幽門螺旋桿菌的樣本保存與抗藥基因型檢測的試劑與方法 |
| ‧ 專利證書號 | I902231 |
| ‧ 專利權人 | 國立臺灣大學 |
| ‧ 專利國家 (申請日) |
中華民國 (2024/04/22) 美國 (2024/04/22) |
| ‧ 單位 | 醫學系 內科 |
| ‧ 發明人 / PI | 吳明賢,劉志銘,陳美志,陳介章, |
| ‧ 簡歷 / Experience |
技術摘要 / Our Technology：
近年來的研究發現幽門桿菌對於clarithromycin 以及levofloxacin 的抗藥性，分別與其16S RNA及gyrase A 基因上的點突變有相關，我們之前的研究證實這些點突變與除菌失敗有相關，並開發直接利用胃切片檢體進行抗藥性基因檢測的方法，包括優化檢體保存、DNA萃取及PCR條件等，提升抗藥性基因檢測的成功率(98-99%)與準確率(>95%)。在2017 年至 2021期間，我們更進一步透過臺灣胃腸疾病與幽門桿菌臨床試驗聯盟的多中心平台，進行兩個臨床試驗，比較依照抗藥性基因分子檢測技術與依照細菌培養與敏感性測試，在引導幽門桿菌第一線與第三線治療的療效差異。我們共招募了 560 名未曾接受除菌的幽門桿菌感染者，以及 320 名多次治療失敗的幽門桿菌感染者，結果顯示在第一線的試驗中，分子檢測引導治療組的除菌率為86% (241/280)，不亞於藥物敏感檢測引導組的除菌率(87%，243/280)。在第三線的試驗中，分子檢測引導治療組的除菌率為88% (141/160)，不亞於藥物敏感檢測引導組的除菌率(87%，139/160)。這兩個臨床試驗的結果顯示分子檢測引導的幽門桿菌精準治療在一線治療與第三線治療，不亞於藥物敏感檢測引導的療效，研究結果支持分子檢測引導可用於引導幽門桿菌的精準治療。
Recent research has found that the resistance of H. pylori to clarithromycin and levofloxacin is associated with point mutations in the 16S RNA and gyrA genes, respectively. Our previous studies have confirmed that these point mutations are correlated to treatment failure, and we have developed a method for directly detecting antibiotic resistance genes using gastric tissue specimens. This includes optimizing sample storage, DNA extraction, and PCR conditions, resulting in improved success rates (98-99%) and accuracy (>95%) of antibiotic resistance gene detection.
From 2017 to 2021, through the multicenter platform of the Taiwan Gastrointestinal and Helicobacter pylori Clinical Trial Consortium, we conducted two clinical trials to compare the efficacy of first-line and third-line treatments guided by molecular testing for antibiotic resistance gene versus traditional bacterial culture and susceptibility testing. We recruited a total of 560 H. pylori-infected individuals who were naïve to eradication therapy and 320 individuals who had failed multiple treatments. Our results showed that in the first-line trial, the eradication rate of the molecular detection-guided treatment group was 86% (241/280), which was comparable to the eradication rate of the drug sensitivity testing-guided group (87%, 243/280). In the third-line trial, the eradication rate of the molecular detection-guided treatment group was 88% (141/160), which was also comparable to the eradication rate of the drug sensitivity testing-guided group (87%, 139/160). The results of these two clinical trials indicate that molecular detection-guided precision treatment of H. pylori is as effective as culture based susceptibility testing-guided treatment in both first-line and third-line therapy. The research findings support the use of molecular detection-guided treatment for precise guidance of H. pylori eradication.
Molecular testing of antibiotic resistance for H. pylori infection can be performed directly on gastric biopsy samples without the need for culture, making it faster (completed within 1 day) and more successful (98%) compared to culture-based drug susceptibility testing (75-90%). Molecular testing for antibiotic resistance has a high accuracy rate, with a 95.5% accuracy in detecting clarithromycin resistance using the 23S rRNA test and a 92.4% accuracy in detecting levofloxacin resistance using the Gyrase A test.
Recent research has found that the resistance of H. pylori to clarithromycin and levofloxacin is associated with point mutations in the 16S RNA and gyrA genes, respectively. Our previous studies have confirmed that these point mutations are correlated to treatment failure, and we have developed a method for directly detecting antibiotic resistance genes using gastric tissue specimens. This includes optimizing sample storage, DNA extraction, and PCR conditions, resulting in improved success rates (98-99%) and accuracy (>95%) of antibiotic resistance gene detection.
From 2017 to 2021, through the multicenter platform of the Taiwan Gastrointestinal and Helicobacter pylori Clinical Trial Consortium, we conducted two clinical trials to compare the efficacy of first-line and third-line treatments guided by molecular testing for antibiotic resistance gene versus traditional bacterial culture and susceptibility testing. We recruited a total of 560 H. pylori-infected individuals who were naïve to eradication therapy and 320 individuals who had failed multiple treatments. Our results showed that in the first-line trial, the eradication rate of the molecular detection-guided treatment group was 86% (241/280), which was comparable to the eradication rate of the drug sensitivity testing-guided group (87%, 243/280). In the third-line trial, the eradication rate of the molecular detection-guided treatment group was 88% (141/160), which was also comparable to the eradication rate of the drug sensitivity testing-guided group (87%, 139/160). The results of these two clinical trials indicate that molecular detection-guided precision treatment of H. pylori is as effective as culture based susceptibility testing-guided treatment in both first-line and third-line therapy. The research findings support the use of molecular detection-guided treatment for precise guidance of H. pylori eradication.
Molecular testing of antibiotic resistance for H. pylori infection can be performed directly on gastric biopsy samples without the need for culture, making it faster (completed within 1 day) and more successful (98%) compared to culture-based drug susceptibility testing (75-90%). Molecular testing for antibiotic resistance has a high accuracy rate, with a 95.5% accuracy in detecting clarithromycin resistance using the 23S rRNA test and a 92.4% accuracy in detecting levofloxacin resistance using the Gyrase A test.
聯繫方式 / Contact：
臺大產學合作總中心 / Center of Industry-Academia Collaboration, NTU
Email：ordiac@ntu.edu.tw
電話/Tel：02-3366-9945