Objective  Evaluation of the off-label use of flupentixol melitracen based on an evidence-based medicine approach and recommendations for graded management.

Methods  The off-label prescriptions of flupentixol melitracen for outpatient clinics in our hospital from November 1, 2023, to October 31, 2024, were collected to count the clinical diagnoses of off-label use of flupentixol melitracen tablets. Searching foreign drug manuals, authoritative medical monographs, as well as guidelines and literature databases such as the US National Guidelines Clearinghouse (NGC), Guidelines International Network (GIN), Medlive, Yaozh.com, PubMed, Cochrane Library, Embase, WanFang Data, VIP, CNKI and other guidelines and literature databases, to collect literature on evidence-based medical evidence related to the flupentixol melitracen tablets for off-label use. The literature was screened according to the pre-established inclusion and exclusion criteria, and the quality of evidence was assessed and graded to determine the evidence of evidence-based medicine for off-label use, and to make recommendations for grading management.

Results  Flupentixol melitracen tablets off-label use involves 13 clinical diagnoses of gastritis, sleep disorders, dizziness, neurological disorders, gastroesophageal reflux, gastrointestinal disorders, headache (tension-type headache), abdominal pain (functional abdominal pain syndrome), palpitations, constipation, neurasthenia, cardiac neurosis, and neuralgia. A total of 8 evidence-based medical literature related to off-label use were included, including 4 guidelines, 1 Meta-analysis, and 3 clinical randomised controlled trials (RCTs). Based on the evaluation of evidence-based medicine methodology, the quality grade of a Meta-analysis was extremely low, and 3 RCTs were at high risk of bias. There was evidence-based medical evidence for the determination of treating chronic gastritis, which is recommende as level A management and agreed to be used. There was evidence-based medical evidence for the adjudication of treating sleep disorders, headache (tension-type headache), abdominal pain (functional abdominal pain syndrome), neuralgia, and chronic constipation, which was recommended as level B management and restriction for use. There was no evidence-based medical evidence for the remaining off-label uses of the drug.

Conclusion  The evidence-based medicine evidence for flupentixol melitracen in the treatment of chronic gastritis, sleep disorders, headache, abdominal pain, neuralgia, and chronic constipation are relatively sufficient and their use are reasonable, while the rationale for other off-label use are relatively low and are recommended to be contraindicated. Through the evidence-based medicine methods, the evaluation system for off-label use of flupentixol melitracen has been improved, providing a basis for rational clinical medication and ensuring the safety of patients' medication.

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