昆明山海棠片治疗口腔黏膜病超说明书用药的回顾性调查分析

Retrospective investigation and analysis of the off-label use of tripterygium hypoglaucum hutch tablets in the treatment of oral mucosal diseases

目的了解昆明山海棠片治疗口腔黏膜病的情况,为口腔黏膜病用药提供参考。方法采用回顾性调查分析方法,对空军军医大学第三附属医院2023年口腔黏膜科昆明山海棠片处方信息进行统计,采用推荐分级的评估、制定与评价(GRADE)体系评价证据质量。结果共调取昆明山海棠片用药处方90张,其中适应证超说明书处方86张(96%),分别用于口腔扁平苔藓(68%)、复发性阿弗他溃疡(12%)、类天疱疮(8%)、寻常型天疱疮(3%)、线性IgA病(2%)、口内糜烂(2%)患者的治疗。用于口腔扁平苔藓及复发性阿弗他溃疡的治疗有直接循证医学证据,GRADE证据分级为C;用于类天疱疮、寻常型天疱疮、线性IgA病及口内糜烂的治疗无直接循证医学证据,GRADE证据分级为D。结论空军军医大学第三附属医院昆明山海棠片超说明书治疗口腔黏膜病有其合理性,但循证医学证据尚不充分,临床需开展随机对照试验证实其疗效,医疗机构应加强超说明书用药管理,促进临床合理用药。

Objective To investigate the effects of tripterygium hypoglaucum hutch tablets in the off-label treatment of oral mucosal diseases,so as to provide reference for the medication of oral mucosal diseases.Methods A retrospective investigation and analysis method was conducted to analyze the prescription information of tripterygium hypoglaucum hutch tablets from the Department of Oral Mucosa,Third Affiliated Hospital of Air Force Medical University in 2023.And the GRADE(Grading of Recommendations Assessment,Development and Evaluation)system was used to evaluate the quality of evidence.Results A total of 90 prescriptions of tripterygium hypoglaucum hutch tablets were collected,including 86 off-label prescriptions for indications(96%).They were used for the treatment of oral lichen planus(68%),recurrent aphthous ulcer(12%),pemphigoid(8%),pemphigus vulgaris(3%),linear IgA disease(2%),and oral erosions(2%).There was direct evidence-based medicine for its use in the treatment of oral lichen planus and recurrent aphthous ulcers,with GRADE evidence classification of C;There was no direct evidence-based medicine for the treatment of pemphigus vulgaris,pemphigus vulgaris,linear IgA disease,with GRADE evidence classification of D.Conclusion The off-label use of tripterygium hypoglaucum hutch tablets in the treatment of oral mucosal disease is reasonable,but the current evidence-based medicine evidence is not enough.It is necessary to carry out randomized controlled trials to confirm its efficacy.Medical institutions should strengthen the management of off-label use of drugs and promote clinical rational drug use.