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Oral lichen planus (OLP) is a common chronic inflammatory disease of the oral mucosa and is considered a precancerous condition. It is characterized by white reticular changes in the oral mucosa, which can progress to erosions and cause pain in severe cases. The pathogenesis of OLP is still unclear, but it is believed to be a T-lymphocyte-mediated autoimmune disease. Currently, only symptomatic treatments are available, and there is no definitive cure.
In this project, we plan to use TCM differentiation to categorize OLP patients and conduct a randomized controlled clinical trial to demonstrate the enhanced therapeutic effect of paeoniflorin combined with photodynamic therapy for OLP. The implementation of this project will provide new insights into the clinical management of OLP, improve our understanding of the treatment mechanisms, and have important theoretical and clinical implications.
Paeoniflorin, a compound extracted from the traditional Chinese medicine, has anti-inflammatory and immunomodulatory effects. Photodynamic therapy is a novel local treatment approach, where photosensitizers selectively target and destroy diseased cells. Both treatments have shown efficacy in treating OLP when used individually.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| total glucosides of paeony treatment | Active Comparator | Total glucosides of paeony capsules were given 0.6 g once, 3 times a day. |
|
| photodynamic therapy treatment | Active Comparator | Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode. |
|
| glucosides of paeony and photodynamic therapy combined treatment | Experimental | Glucosides of paeony and photodynamic therapy are combined for the treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total glucosides of paeony treatment | Drug | Total glucosides of paeony capsules were given 0.6 g once, 3 times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy at 1 month of treatment | According to the trial standard for evaluating the efficacy of atrophic and erosive oral lichen planus (OLP), the evaluation includes both objective and subjective measures. Objective measure: The size of the lesion is measured by an observer. The physician records and takes photographs of the lesion, noting the location, color, and changes in the area. The color and area changes of the lesion are compared and determined based on the photographic records. Subjective measure: Visual analogue scales (VAS) are used, which consist of 10 levels. The pain level is recorded, and the assessment is done by the patient. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| The curative effect at the later follow-up visit | According to the trial standard for evaluating the efficacy of atrophic and erosive oral lichen planus (OLP), the evaluation includes both objective and subjective measures. Objective measure: The size of the lesion is measured by an observer. The physician records and takes photographs of the lesion, noting the location, color, and changes in the area. The color and area changes of the lesion are compared and determined based on the photographic records. Subjective measure: Visual analogue scales (VAS) are used, which consist of 10 levels. The pain level is recorded, and the assessment is done by the patient. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhihui Zhang, Dr. | Contact | 010-82266125 | wisdomzhangzhihui@163.com | |
| Lin Zeng | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Zhihui Zhang | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12969224 | Background | van der Meij EH, van der Waal I. Lack of clinicopathologic correlation in the diagnosis of oral lichen planus based on the presently available diagnostic criteria and suggestions for modifications. J Oral Pathol Med. 2003 Oct;32(9):507-12. doi: 10.1034/j.1600-0714.2003.00125.x. | |
| 21453765 | Background | Li J, Chen CX, Shen YH. Effects of total glucosides from paeony (Paeonia lactiflora Pall) roots on experimental atherosclerosis in rats. J Ethnopharmacol. 2011 May 17;135(2):469-75. doi: 10.1016/j.jep.2011.03.045. Epub 2011 Mar 29. |
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| photodynamic therapy treatment | Other | Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode. |
|
| glucosides of paeony and photodynamic therapy combined treatment | Other | Glucosides of paeony and photodynamic therapy are combined for the treatment |
|
| through study completion, an average of 1 year |
| 32220595 | Background | Villa A, Sankar V, Bassani G, Johnson LB, Sroussi H. Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral lichen planus: a preliminary study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Jun;129(6):585-590. doi: 10.1016/j.oooo.2020.02.014. Epub 2020 Mar 25. |
| 31478283 | Background | Lavaee F, Shadmanpour M. Comparison of the effect of photodynamic therapy and topical corticosteroid on oral lichen planus lesions. Oral Dis. 2019 Nov;25(8):1954-1963. doi: 10.1111/odi.13188. Epub 2019 Oct 2. |
| 27129091 | Background | Zhou L, Cao T, Wang Y, Yao H, Du G, Tian Z, Tang G. Clinical observation on the treatment of oral lichen planus with total glucosides of paeony capsule combined with corticosteroids. Int Immunopharmacol. 2016 Jul;36:106-110. doi: 10.1016/j.intimp.2016.03.035. Epub 2016 Apr 26. |
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |