Analysis of off-label use of compound Danshen dripping pills in treatment of oral mucosal diseases
Li Luyao
Liu Shuibing
Feng Bin
Zhao Jie
Zhang Huan
Lin Yao
Abstract：Objective To analyze the application of compound Danshen dripping pills in oral mucosal diseases,evaluate the rationality of use,and provide evidence for judging the rationality of off-label use.Methods The data of 801 prescriptions of com-pound Danshen dripping pills in the Department of Oral Mucosal Diseases of the Third Affiliated Hospital of Air Force Military Medical University from July 1,2022 to June 30,2024 were retrospectively analyzed.In terms of indications,usage and dosage,course of treat-ment,and safety,combined with the existing evidence-based medical evidence,the rationality of use was analyzed.Results In the treatment of oral mucosal diseases,compound Danshen dripping pills were mainly used for oral submucous fibrosis,oral lichen planus,white keratosis and oral leukoplakia.All 801 prescriptions in this study were off-label drug use.According to the GRADE classification system,there was moderate-quality research evidence that compound Danshen dropping pills could be used for oral submucous fibrosis beyond instructions,and the evidence-based medical evidence was relatively sufficient.In this study,compound Danshen dropping pills were used alone in the treatment of this disease,with the prescriptions accounting for 67.69%(486/801).The medium-quality research evidence showed that compound Danshen dripping pills could be used to treat oral lichen planus,with lack of basic research,and they were not recommended in existing textbooks and guidelines.The level of evidence for white keratosis and oral leukoplakia was low,and the off-label use was not recommended.Conclusion The off-label use of compound Danshen dripping pills in oral mucosal diseases has certain clinical value,but further high-quality clinical studies are needed to verify the effectiveness and safety.It is suggested that medical institutions should improve the filing procedures of off-label drug use and administer drugs after ensuring that patients are fully informed.At the same time,medical institutions should strengthen the safety monitoring of off-label drug use to ensure the safety of pa-tients'home medication.
Keywords：Compound Danshen dripping pillOral mucosal diseaseOral submucous fibrosisOral lichen planusOff-label medicationMedication safety
Publication Date：2025-06-25
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 495-498 )