Ciprofloxacin

證據等級: L5 預測適應症: 10

目錄

  1. Ciprofloxacin
  2. Ciprofloxacin: From Bacterial Infections to Diffuse Scleroderma
    1. One-Sentence Summary
    2. Quick Overview
    3. Why Is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. Safety Considerations
    7. Conclusion and Next Steps
    8. Disclaimer

## 藥師評估報告

Ciprofloxacin: From Bacterial Infections to Diffuse Scleroderma

One-Sentence Summary

Ciprofloxacin is a broad-spectrum fluoroquinolone antibiotic, widely used in clinical practice to treat a range of serious bacterial infections. The TxGNN model predicts it may be effective for Diffuse Scleroderma, with 0 clinical trials and 2 publications currently supporting this direction. The overall evidence base is limited, placing this candidate at an early exploratory research stage.


Quick Overview

Item Content
Original Indication Broad-spectrum bacterial infections (fluoroquinolone antibiotic)
Predicted New Indication Diffuse Scleroderma
TxGNN Prediction Score 99.87%
Evidence Level L3
Australia Market Status Not marketed
Number of ARTG Entries 0
Recommended Decision Hold (Research Question)

Why Is This Prediction Reasonable?

Detailed mechanism of action data is not currently available in this evidence pack. Based on established pharmacology, Ciprofloxacin is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and Topoisomerase IV, thereby disrupting bacterial DNA replication and cell division. Beyond its antibacterial properties, in vitro research has demonstrated that Ciprofloxacin can suppress dermal fibroblast proliferation and collagen synthesis — an antifibrotic effect that is mechanistically relevant to scleroderma pathophysiology.

Diffuse scleroderma (systemic sclerosis) is an autoimmune connective tissue disorder characterised by microvascular injury, excessive fibrosis of the skin and viscera, and immune dysregulation. The TxGNN repurposing hypothesis operates via two biologically plausible pathways: (1) direct antifibrotic action — suppression of fibroblast activity and collagen deposition in the skin; and (2) treatment of small intestinal bacterial overgrowth (SIBO) — a frequent complication of scleroderma-related gastrointestinal dysmotility that contributes significantly to malabsorption and disease burden.

The TxGNN knowledge graph assigns a high prediction score (99.87%) to this association, likely capturing the established molecular connections between fluoroquinolone targets and fibrosis-related pathways. Importantly, a 2010 pilot randomised controlled trial (PMID 20507401) specifically investigated oral Ciprofloxacin as an antifibrotic agent in scleroderma patients, providing the only direct — albeit preliminary — clinical evidence for this repurposing hypothesis.


Clinical Trial Evidence

Currently no related clinical trials registered.


Literature Evidence

PMID Year Type Journal Key Findings
20507401 2010 Pilot RCT The Journal of Dermatology Controlled, double-blind randomised clinical trial evaluating whether oral Ciprofloxacin reduces scleroderma severity via its antifibrotic properties (suppression of fibroblast proliferation and collagen synthesis)
7728404 1995 Observational British Journal of Rheumatology 24 systemic sclerosis patients investigated for SIBO using jejunal aspiration; characterises the relationship between SIBO and scleroderma gastrointestinal disease, supporting antibiotic treatment rationale including use of Ciprofloxacin

Safety Considerations

Please refer to the TGA-approved Product Information (PI) for safety information.


Conclusion and Next Steps

Decision: Hold (Research Question)

Rationale: The mechanistic hypothesis is biologically plausible, supported by in vitro antifibrotic data and a single small pilot RCT from 2010; however, the evidence base is insufficient to advance without further validation. Ciprofloxacin is currently not marketed in Australia (0 ARTG entries), adding a regulatory pathway consideration alongside the clinical evidence gap.

To proceed, the following is needed:

  • Full review of the 2010 pilot RCT (PMID 20507401) results, including effect size, sample size adequacy, and safety outcomes
  • Retrieval of detailed MOA data from DrugBank (DB00537) to formally characterise the antifibrotic mechanism
  • Safety review via the TGA Product Information for key warnings, contraindications, and relevant drug interactions
  • Assessment of Ciprofloxacin’s regulatory pathway for Australian market authorisation, given there are currently 0 ARTG entries
  • Consultation with Australian rheumatology and gastroenterology specialists to determine clinical feasibility of a Phase 2 proof-of-concept study in diffuse scleroderma

⚠️ Disclaimer: This report is for research reference only and does not constitute medical advice. All drug repurposing candidates require clinical validation before any therapeutic application.

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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