Safety and Effectiveness of the Use of Luciforte^? 500 mg Vial with Patients Admitted to the Intensive Care Unit for Impaired Conscious Level: A Multi-Center, Retrospective, Observational Study

摘要

Background: Meclofenoxate, the active ingredient of Luciforte~(?) 500 mg, is a cholinergic nootropic used as a drug in the treatment of symptoms of senile dementia and Alzheimer's disease to improve memory and cognitive function. This study was aiming to assess its safety and effectiveness in patients admitted to the intensive care unit (ICU) due to different neurological backgrounds. Methodology: An observational retrospective study was conducted in the ICU of three hospitals. Data of 300 patients who were admitted to the ICU due to central nervous system (CNS) dysfunction and treated with Luciforte~(?) 500 mg Vial twice daily were collected from the ICU records. Results: There was a statistically significant improvement of the level of consciousness as measured by Glasgow coma score (GCS) after treatment; p-value <0.001. The GCS was 11.82 ± 1.60 on ICU admission and 14.57 ± 1.05 on discharge. This improvement was consistent regardless of the cause of disturbed conscious level, the underlying brain lesions, or the baseline APACHE II Score. Patients who showed improvement of GCS were 294 (98.0%) within a median period of 8 (I-Q range = 6-10) days. GCS remained unchanged in only 6 patients (2.0%). No serious or non-serious adverse events were reported within the period of hospital stay. Conclusion: Luciforte~(?)~( )500 mg vials is a safe, well tolerated and effective drug in improving the conscious level of ICU patients. These results are promising and could justify the conduct of a well-designed randomized controlled clinical trial for assessment of both the short-term as well as the sustained drug effect.