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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)

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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."

[1] 华红, 刘宏伟. 口腔黏膜病学 [M]. 北京: 北京大学医学出版社, 2014.
[2] 陈谦明. 口腔黏膜病学 [M]. 北京: 人民卫生出版社, 2012.
[3] Olson MA, Rogers RS 3rd, Bruce AJ. Oral lichen planus [J]. Clin Dermatol, 2016, 34(4):495-504.
doi: 10.1016/j.clindermatol.2016.02.023
[4] Payeras MR, Cherubini K, Figueiredo MA, et al. Oral lichen planus: focus on etiopathogenesis [J]. Arch Oral Biol, 2013, 58(9):1057-1069.
doi: 10.1016/j.archoralbio.2013.04.004
[5] Kurago ZB. Etiology and pathogenesis of oral lichen planus: an overview [J]. Oral Surg Oral Med Oral Pathol Oral Radiol, 2016, 122(1):72-80.
doi: 10.1016/j.oooo.2016.03.011
[6] Lodi G, Scully C, Carrozzo M, et al. Current controversies in oral lichen planus: report of an international consensus meeting. Part 2. Clinical management and malignant transformation [J]. Oral Surg Oral Med Oral Pathol Oral Radiol Endod, 2005, 100(2):164-178.
doi: 10.1016/j.tripleo.2004.06.076
[7] González-Moles MA, Ruiz-Ávila I, González-Ruiz L, et al. Malignant transformation risk of oral lichen planus: A systematic review and comprehensive meta-analysis [J]. Oral Oncol, 2019, 96:121-130.
doi: S1368-8375(19)30247-7 pmid: 31422203
[8] García-Pola MJ, González-Álvarez J, Garcia-Martin JM, et al. Treatment of oral lichen planus. Systematic review and therapeutic guide [J]. Med Clin (Barc), 2017, 149(8):351-362.
doi: 10.1016/j.medcli.2017.06.024
[9] Chiang CP, Chang YF, Wang YP, et al. Oral lichen planus: Differential diagnoses, serum autoantibodies, hematinic deficiencies, and management [J]. J Formos Med Assoc, 2018, 117(9):756-765.
doi: 10.1016/j.jfma.2018.01.021
[10] Oray M, Abusamra K, Ebrahimiadib N, et al. Long-term side effects of glucocorticoids [J]. Expert Opin Drug Saf, 2016, 15(4):457-465.
doi: 10.1517/14740338.2016.1140743
[11] Wang G, Wu J, Miao M, et al. Nocardia rubra cell-wall skeleton promotes CD4+T cell activation and drives Th1 immune response [J]. Int J Biol Macromol, 2017, 101:398-407.
doi: 10.1016/j.ijbiomac.2017.03.060
[12] Wang Y, Hu Y, Ma B, et al. Nocardia rubra cell wall skeleton accelerates cutaneous wound healing by enhancing macrophage activation and angiogenesis [J]. J Int Med Res, 2018, 46(6):2398-2409.
doi: 10.1177/0300060518764210 pmid: 29665712
[13] Meng Y, Sun J, Wang X, et al. The biological macromolecule Nocardia rubra cell-wall skeleton as an avenue for cell-based immunotherapy [J]. J Cell Physiol, 2019, 234(9):15342-15356.
doi: 10.1002/jcp.v234.9
[14] Kato H, Inoue M, Yamamura Y, et al. Effect of recombinant human granulocyte colony-stimulating factor (rhG-CSF) on cytotoxi-city of PSK-induced peritoneal polymorphonuclear leukocytes (PMNs) [J]. Biotherapy, 1992, 5(3):177-186.
pmid: 1384634
[15] Ohara K, Hirano Y, Ishida H, et al. Possible involvement of lymphocyte activating factor (LAF) as an endogenous pyrogen in fever induced by the cell wall skeleton of Nocardia rubra (N-CWS) [J]. Chem Pharm Bull (Tokyo), 1990, 38(3):804-806.
doi: 10.1248/cpb.38.804
[16] 陶俊, 王颖, 叶波平, 等. 红色诺卡氏菌细胞壁骨架对小鼠急性肝损伤的保护作用 [J]. 中华肝脏病杂志, 2005, 13(8):618-619.
[17] Meij EHVD, Waal IVD. Lack of clinicopathologic correlation in the diagnosis of oral lichen planus based on the presently available diagnostic criteria and suggestions for modifications [J]. J Oral Pathol Med, 2003, 32(9):507-512.
pmid: 12969224
[18] 刘青兰, 刘琳, 李留炀, 等. 曲安奈德口腔软膏治疗充血糜烂型口腔扁平苔藓的疗效及安全性观察 [J]. 实用口腔医学杂志, 2017, 33(4):536-540.
[19] Gorouhi F, Solhpour A, Beitollahi JM, et al. Randomized trial of pimecrolimus cream versus triamcinolone acetonide paste in the treatment of oral lichen planus [J]. J Am Acad Dermatol, 2007, 57(5):806-813.
pmid: 17658663
[20] Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials [J]. BMJ, 2011, 9(8):672-677.
[21] Park HK, Hurwitz S, Woo SB. Oral lichen planus: REU scoring system correlates with pain [J]. Oral Surg Oral Med Oral Pathol Oral Radiol, 2012, 114(1):75-82.
doi: 10.1016/j.oooo.2012.02.013
[22] Chainani-Wu N, Silverman S Jr, Reingold A, et al. Validation of visual analogue scale, numeric rating scale, change in symptoms scale, and modified oral mucositis index for measurement of symptoms and signs of oral lichen planus [J]. Oral Surg Oral Med Oral Pathol Oral Radiol Endod, 2006, 102(3):328.
[23] Sampogna F, Derfeldt B, Axtelius B, et al. Comparison of patients’ and providers’ severity evaluation of oral mucosal conditions [J]. J Am Acad Dermatol, 2011, 65(1):69-76.
doi: 10.1016/j.jaad.2010.05.001
[24] 周刚, 刘宏伟, 林梅, 等. 口腔扁平苔藓(萎缩型、糜烂型)疗效评价标准(试行) [J]. 中华口腔医学杂志, 2005, 40(2):92-93.
[25] 黄悦勤. 临床流行病学 [M]. 北京: 人民卫生出版社, 2014.
[26] Mauskar M. Erosive lichen planus [J]. Obstet Gynecol Clin North Am, 2017, 44(3):407-420.
doi: 10.1016/j.ogc.2017.04.004
[27] Aghbari SMH, Abushouk AI, Attia A, et al. Malignant transformation of oral lichen planus and oral lichenoid lesions: A meta-analysis of 20 095 patient data [J]. Oral Oncol, 2017, 68:92-102.
doi: S1368-8375(17)30074-X pmid: 28438300
[28] Carrozzo M, Porter S, Mercadante V, et al. Oral lichen planus: A disease or a spectrum of tissue reactions? Types, causes, diagnostic algorhythms, prognosis, management strategies [J]. Periodontology 2000, 2019, 80(1):105-125.
doi: 10.1111/prd.12260 pmid: 31090143
[29] 李春, 刘恩生, 穆荣, 等. 羟氯喹所致视网膜病变的文献分析 [J]. 药物不良反应杂志, 2010, 12(1):21-25.
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