Journal of Peking University (Health Sciences) ›› 2021, Vol. 53 ›› Issue (5): 964-969. doi: 10.19723/j.issn.1671-167X.2021.05.026

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Efficacy and safety of Nocardia rubra cell wall skeleton for the treatment of erosive oral lichen planus

ZHU Zheng-da1,GAO Yan2,HE Wen-xiu1,FANG Xin1,LIU Yang1,WEI Pan1,YAN Zhi-min1,HUA Hong1,()   

  1. 1. Department of Oral Medicine, 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
  • Received:2019-09-29 Online:2021-10-18 Published:2021-10-11
  • Contact: Hong HUA E-mail:honghua1968@aliyun.com
  • Supported by:
    National Natural Science Foundation of China(81730030)

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.

Key words: Nocardia rubra, Cell wall skeleton, Oral lichen planus, Treatment outcome, Safety

CLC Number: 

  • R781.5

Table 1

REU scoring system for oral lichen planus"

Clinical typing Score
Reticular/Keratosis (R) 0=normal; 1=reticular or keratosis
Erythema (E) 0=no erythema; 1=between 0 and 0.1 cm2; 2=between 0.1 and 0.3 cm2; 3=0.3 cm2 or greater
Ulceration (U) 0=no ulceration; 1=between 0 and 0.1 cm2; 2=between 0.1 and 0.3 cm2; 3=0.3 cm2 or greater
Total score (∑) ∑=∑R+∑(E×1.5)+∑(U×2.0)

Table 2

Visual analogue scale for oral lichen planus"

Pain level VAS score Grade
No pain 0 0
Mild pain 1-3 1
Moderate pain 4-6 2
Severe pain 7-10 3

Figure 1

Flow diagram of trial Nr-CWS, Nocardia rubra cell wall skeleton."

Table 3

Baseline characteristics of study population in the experimental group and control group"

Items Nr-CWS Placebo P value
Age/years 52.90±12.40 54.07±12.40 0.717
Female, n (%) 23 (74.19) 19 (65.52) 0.464
Disease duration/month 9.06±3.46 9.90±3.12 0.337
VAS pain score 2 (1, 3) 2 (1, 3) 0.217
OHIP score 20.00±9.95 17.62±9.74 0.354
REU score 2.5 (2.5, 5.5) 2.5 (2.5, 4.0) 0.014
Erosion area/cm2 1.26±1.97 0.49±0.51 0.010

Table 4

Comparison of the REU scoring system of two groups"

Items Nr-CWS Placebo P value
Week 0 2.5 (2.5, 5.5) 2.5 (2.5, 4.0) 0.014#
Week 1 2.5 (1.0, 4.0) 2.5 (1.0, 4.0) 0.851#
Changes (week 1) 0 (-1.5, 0) 0 (-1.5, 0) 0.012#
Week 2 2.5 (1.0, 4.0) 2.5 (1.0, 4.0) 0.132#
Changes (week 2) -1.5 (-3.0, 0) 0 (-1.5, 1.5) <0.001#
Week 4 1.0 (1.0, 4.0) 2.5 (1.0, 4.0) 0.002#
Changes (week 4) -1.5 (-3.0, 0) 0 (-1.5, 1.5) <0.001#
P value <0.001* 0.070*
Changes (two groups) 95%CI -1.5 (-1.5, -1.5)

Table 5

Comparison of the VAS of two groups"

Items Nr-CWS Placebo P value
Week 0 2 (1, 3) 2 (1, 3) 0.217#
Week 1 1 (0, 2) 2 (0, 3) 0.005#
Changes (week 1) -1 (-2, 0) 0 (-1, 1) <0.001#
Week 2 1 (0, 2) 2 (0, 3) 0.001#
Changes (week 2) -1 (-3, 0) 0 (-1, 1) <0.001#
Week 4 0 (0, 2) 2 (0, 3) <0.001#
Changes (week 4) -2 (-3, 0) 0 (-1, 1) <0.001#
P value <0.001* 0.021*
Changes (two groups)
95%CI
-1 (-2, -1)

Table 6

Comparison of the OHIP-14 of two groups"

Items Nr-CWS Placebo P value
Week 0 20.00±9.95 17.62±9.74 0.354#
Week 1 9.71±5.27 15.35±11.40 0.051#
Changes (week 1) -10.29±7.32 -2.28±3.30 <0.001#
Week 2 7.45±6.66 14.34±11.91 0.011#
Changes (week 2) -12.55±7.87 -3.28±3.55 <0.001#
Week 4 4.48±3.65 14.86±11.18 <0.001#
Changes (week 4) -15.52±8.39 -2.76±4.65 <0.001#
P value <0.001* 0.001*

Figure 2

Treatment efficiency of two groups Nr-CWS, Nocardia rubra cell wall skeleton."

Figure 3

Lesion conditions before and after treatment of two groups Nr-CWS, Nocardia rubra cell wall skeleton."

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