Lansoprazole
| 證據等級: L5 | 預測適應症: 2 個 |
目錄
Lansoprazole: From Acid-Related GI Disease (PPI Class) to Duodenogastric Reflux
One-Sentence Summary
Lansoprazole is a proton pump inhibitor (PPI); this evidence pack does not document its originally approved indication or a detailed mechanism of action. The TxGNN model predicts a possible link to duodenogastric reflux, but the only supporting evidence is 0 clinical trials and 2 publications — one an animal carcinogenesis study, the other a general PPI review — and neither supports therapeutic benefit for this specific indication.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not documented in this evidence pack (drug classified only as a Proton Pump Inhibitor via the mechanistic rationale field) |
| Predicted New Indication | Duodenogastric reflux |
| TxGNN Prediction Score | 99.69% |
| Evidence Level | L5 |
| US Market Status | Not marketed |
| Number of NDAs | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in this evidence pack (flagged as a blocking-severity data gap, DG002). Based on the mechanistic rationale that was captured, lansoprazole is a PPI that inhibits gastric parietal cell H+/K+-ATPase to reduce gastric acid secretion.
Acid suppression can theoretically relieve acid-related symptoms, but it has no mechanism to reduce duodenogastric (bile) reflux itself — the reflux event is unaffected by acid suppression. More importantly, the one directly relevant piece of evidence in this pack is an animal study reporting that long-term lansoprazole administration promoted gastric carcinogenesis in a duodenogastric reflux rat model, via a proposed low-acid-environment nitrosamine/bile co-carcinogenesis mechanism. This is a potential harm signal in the opposite direction from therapeutic benefit, not supporting evidence.
Given this, the TxGNN model’s high prediction score (99.69%) does not align with the direction of the actual literature evidence, and the mechanistic case for repurposing is weak to potentially concerning rather than reasonable.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 15052437 | 2004 | Animal/Preclinical | Gastric Cancer | Lansoprazole promoted gastric carcinogenesis in rats with induced duodenogastric reflux — a potential harm signal, not a treatment benefit |
| 18679668 | 2008 | Review | Eur J Clin Pharmacol | General review of PPI clinical use and pharmacokinetics; not specific to duodenogastric reflux treatment |
US Market Information
Not marketed in the US — no NDA authorizations on file.
Safety Considerations
Please refer to the package insert for safety information.
(Note: retrieval of TFDA/FDA label warnings and contraindications is flagged as a blocking data gap in this evidence pack — safety cannot be formally assessed until resolved.)
Conclusion and Next Steps
Decision: Hold
Rationale: There are no clinical trials for this indication, and the only literature evidence is a preclinical study suggesting a possible carcinogenesis-promoting effect rather than benefit — the opposite of what the high TxGNN score would suggest. Combined with a blocking-severity data gap on drug label safety information, this candidate does not meet the bar to proceed.
To proceed, the following is needed:
- TFDA/FDA label warnings and contraindications (blocking gap, DG001)
- Detailed mechanism of action data (DG002)
- Mechanistic or clinical evidence that directly supports benefit in duodenogastric reflux, and that addresses the conflicting carcinogenesis signal from the 2004 animal study
Additional note: This evidence pack also included a second TxGNN-predicted indication, duodenal obstruction (score 99.68%, L5, Hold). On review, all 4 associated clinical trials and the 1 associated publication were unrelated to treating duodenal obstruction (e.g., oncology immunotherapy trials, general ulcer-prevention studies). Duodenal obstruction is typically a mechanical condition (malrotation, SMA syndrome, tumor compression, adhesions) that acid suppression cannot address. This appears to be a keyword co-occurrence false positive and is not considered a viable repurposing candidate.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.