阿米替林超适应证用药的循证药学证据评价与分级管理建议OA

AIM To evaluate the current status of off-label amitriptyline use through evidence-based pharmacy methods and to propose hierarchical management recommendations based on the level of evidence.METHODS Outpatient prescriptions containing amitriptyline issued between June 1 and December 31,2024,were retrospectively collected.Off-label prescriptions were identified according to the latest version of the drug label.An evidence evaluation framework was constructed,relevant evidence was systematically retrieved,and its methodological quality was assessed,ultimately leading to the formulation of hierarchical management recommendations.RESULTS Off-label use of amitriptyline was common,accounting for 80.49％(297/369)of the sampled prescriptions and involving 29 distinct clinical diagnoses.Among the off-label indications,chronic tension-type headache,migraine,neuralgia,and childhood enuresis were supported by foreign drug labels or authoritative textbooks,providing sufficient evidence-based support;these were recommended for Grade A management(approved use).Somatoform pruritus was supported by moderate-level evidence from clinical guidelines and was recommended for Grade B management(restricted use).Pruritus of dermatological origin was supported by low-level evidence from clinical guidelines and was recommended for Grade C management(special use).Other off-label indications,including tinnitus,gastrointestinal dysfunction,and sleep disorders,had insufficient or no supporting evidence and were recommended for Grade D management(prohibited use).CONCLUSION Off-label use of amitriptyline is common in our hospital and poses potential risks.Implementation of a hierarchical management strategy based on evidence level is recommended to standardize off-label use.