Efficacy and safety of Nocardia rubra cell wall skeleton for the treatment of erosive oral lichen planus.
- Author:
Zheng Da ZHU
1
;
Yan GAO
2
;
Wen Xiu HE
1
;
Xin FANG
1
;
Yang LIU
1
;
Pan WEI
1
;
Zhi Min YAN
1
;
Hong HUA
1
Author Information
1. Department of Oral Medicine, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.
2. Department of Oral Pathology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.
- Publication Type:Randomized Controlled Trial
- Keywords:
Cell wall skeleton;
Nocardia rubra;
Oral lichen planus;
Safety;
Treatment outcome
- MeSH:
Adult;
Aged;
Cell Wall Skeleton;
Humans;
Lichen Planus, Oral/drug therapy*;
Middle Aged;
Pain Measurement;
Rhodococcus
- From:
Journal of Peking University(Health Sciences)
2021;53(5):964-969
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To observe the efficacy and safety of Nocardia rubra cell wall skeleton (Nr-CWS) for the treatment of erosive oral lichen planus (EOLP).
METHODS:Sixty patients with clinically and pathologically diagnosed EOLP were randomly divided into the experimental group and control group according to the random number. Patients in the experimental group were treated with lyophilized powder containing Nr-CWS combined with normal saline. Patients in the control group received topical placebo without Nr-CWS combined with normal saline. Changes in the EOLP lesion area and the patient's pain level were recorded at the timepoints of weeks 1, 2, and 4 after the two different treatments, respectively. The changes of the patient's REU scoring system (reticulation, erythema, ulceration), the visual analogue scale and the oral health impact score (OHIP-14) were compared between the experimental group and control group after treatment, and the safety indicators of the two groups at the initial diagnosis and after 4 weeks' treatment were also observed, respectively.
RESULTS:Totally, 62 patients with clinically and pathologically diagnosed EOLP were enrolled, 2 of whom were lost to the follow-up, with 31 in the experimental group, and 29 in the control group. The mean age of the experimental group and control group were (52.9±12.4) years and (54.07±12.40) years, respectively. There was no significant difference in the oral periodontal index between the experimental group and control group. In the experimental group, the erosive area of oral lichen planus was significantly reduced 1, 2, and 4 weeks after the Nr-CWS's treatment (P < 0.05), the reduction rate was 81.75%, the patient's pain index was also decreased (P < 0.05), and in addition, the OHIP-14 was reduced (P < 0.05). The changes of the REU scoring system, the visual analogue scale and the OHIP-14 were significantly different between the experimental group and control group after treatment. There was no significant difference in the safety index between the two groups.
CONCLUSION:The priliminary data show that the Nr-CWS is effective and safe to treat EOLP.
