{"title":"Evaluation of the effectiveness of oral Pirfenidone in the treatment of oral submucous fibrosis: A non-randomised pilot clinical trial.","authors":"Vedashree Mahajan, Bhakti Patil, Deepa Das","doi":"10.4103/jomfp.jomfp_319_24","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Oral submucous fibrosis (OSMF) is a potentially malignant disorder with a high rate of malignant transformation. Pirfenidone is an anti-fibrotic drug currently used in the treatment of idiopathic lung fibrosis (ILF). As both ILF and OSMF are mediated through transforming growth factor-beta, Pirfenidone could be beneficial in treating early stages of OSMF.</p><p><strong>Objectives: </strong>To evaluate the effectiveness of oral Pirfenidone in increasing the mouth opening, reducing fibrosis and burning sensation.</p><p><strong>Settings and design: </strong>A single-arm prospective clinical trial conducted in the Department of Oral Medicine and Radiology, at a recognised dental college.</p><p><strong>Materials and methods: </strong>Eleven subjects of either sex, of 21-55 years diagnosed with OSMF Stage 2 according to Chandramani More <i>et al</i>. classification, were recruited for the study and prescribed Pirfenidone 200 mg, 1 tablet TID with meals for 1 week, and later 2 tablets TID with meals for 5 weeks. The patients were monitored for adverse effects, and treatment response was assessed as unit of improvement. Data were analysed using SPSS; parametric tests such as ANOVA followed by <i>post hoc</i> test and non-parametric tests such as Friedman's followed by Wilcoxon signed rank test were applied with significance at <i>P</i> < 0.05.</p><p><strong>Results: </strong>60% of the patients showed +1 unit of improvement with no serious adverse effect.</p><p><strong>Conclusions: </strong>The patient-related clinical outcomes were quite significant showing the effectiveness of Pirfenidone as a promising adjuvant therapy in the management of OSMF.</p>","PeriodicalId":38846,"journal":{"name":"Journal of Oral and Maxillofacial Pathology","volume":"29 3","pages":"424-429"},"PeriodicalIF":0.0000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12507360/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Oral and Maxillofacial Pathology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/jomfp.jomfp_319_24","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/9/26 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Oral submucous fibrosis (OSMF) is a potentially malignant disorder with a high rate of malignant transformation. Pirfenidone is an anti-fibrotic drug currently used in the treatment of idiopathic lung fibrosis (ILF). As both ILF and OSMF are mediated through transforming growth factor-beta, Pirfenidone could be beneficial in treating early stages of OSMF.
Objectives: To evaluate the effectiveness of oral Pirfenidone in increasing the mouth opening, reducing fibrosis and burning sensation.
Settings and design: A single-arm prospective clinical trial conducted in the Department of Oral Medicine and Radiology, at a recognised dental college.
Materials and methods: Eleven subjects of either sex, of 21-55 years diagnosed with OSMF Stage 2 according to Chandramani More et al. classification, were recruited for the study and prescribed Pirfenidone 200 mg, 1 tablet TID with meals for 1 week, and later 2 tablets TID with meals for 5 weeks. The patients were monitored for adverse effects, and treatment response was assessed as unit of improvement. Data were analysed using SPSS; parametric tests such as ANOVA followed by post hoc test and non-parametric tests such as Friedman's followed by Wilcoxon signed rank test were applied with significance at P < 0.05.
Results: 60% of the patients showed +1 unit of improvement with no serious adverse effect.
Conclusions: The patient-related clinical outcomes were quite significant showing the effectiveness of Pirfenidone as a promising adjuvant therapy in the management of OSMF.
期刊介绍：
The journal of Oral and Maxillofacial Pathology [ISSN:print-(0973-029X, online-1998-393X)] is a tri-annual journal published on behalf of “The Indian Association of Oral and Maxillofacial Pathologists” (IAOMP). The publication of JOMFP was started in the year 1993. The journal publishes papers on a wide spectrum of topics associated with the scope of Oral and Maxillofacial Pathology, also, ensuring scientific merit and quality. It is a comprehensive reading material for the professionals who want to upgrade their diagnostic skills in Oral Diseases; allows exposure to newer topics and methods of research in the Oral-facial Tissues and Pathology. New features allow an open minded thinking and approach to various pathologies. It also encourages authors to showcase quality work done by them and to compile relevant cases which are diagnostically challenging. The Journal takes pride in maintaining the quality of articles and photomicrographs.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
