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北京大学学报（医学版） ›› 2021, Vol. 53 ›› Issue (5): 964-969. doi: 10.19723/j.issn.1671-167X.2021.05.026

• 论著 • 上一篇    下一篇

红色诺卡氏菌细胞壁骨架治疗糜烂型口腔扁平苔藓的疗效及安全性

朱正达1,高岩2,何汶秀1,方鑫1,刘洋1,魏攀1,闫志敏1,华红1,△()   

  1. 北京大学口腔医学院·口腔医院,1.口腔黏膜科,北京 100081
    2.口腔病理科 国家口腔疾病临床医学研究中心 口腔数字化医疗技术和材料国家工程实验室 口腔数字医学北京市重点实验室,北京 100081
  • 收稿日期:2019-09-29 出版日期:2021-10-18 发布日期:2021-10-11
  • 通讯作者: 华红 E-mail:honghua1968@aliyun.com
  • 基金资助:
    国家自然科学基金(81730030)

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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摘要：

目的: 初步观察红色诺卡氏菌细胞壁骨架(Nocardia rubra cell wall skeleton,Nr-CWS)治疗糜烂型口腔扁平苔藓(erosive oral lichen planus,EOLP)的疗效及安全性。方法: 选择60例经临床及组织病理确诊为EOLP的患者,根据随机号随机分入两组,试验组局部使用含Nr-CWS的冻干粉,配合使用生理盐水,对照组局部使用安慰剂(不含Nr-CWS的冻干粉), 配合使用生理盐水。分别于初诊以及用药后第1、2、4周复查时记录患者糜烂病损面积大小和疼痛程度的变化,比较治疗前后患者REU量表(reticulation, erythema, ulceration)、视觉模拟量表以及口腔健康影响程度量表(oral health impact profile, OHIP-14)(中文版)评分的差异,并观察初诊和治疗4周后的安全性指标。结果: 共纳入EOLP患者62例,其中2例失访,试验组31例,对照组29例,平均年龄分别为(52.9±12.4)岁和(54.07±12.40)岁,两组患者的一般情况及口腔卫生状况差异无统计学意义(P>0.05)。试验组患者在治疗后第1、2、4周口腔扁平苔藓的充血糜烂面积明显缩小(P<0.05),缩小率为81.75%,患者的疼痛指数明显降低(P<0.05),口腔健康影响程度计分明显降低(P<0.05),与对照组相比差异有统计学意义(P<0.05),安全性指标与对照组相比差异无统计学意义。结论: Nr-CWS治疗EOLP具有良好的疗效和安全性。

关键词: 红色诺卡氏菌, 细胞壁支架, 口腔扁平苔藓, 治疗结果, 安全

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

中图分类号: 

  • R781.5

表1

口腔扁平苔藓患者的REU量表"

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)

表2

口腔扁平苔藓患者视觉模拟评分法"

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

图1

试验流程图"

表3

试验组和对照组研究人群的基线特征"

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

表4

两组REU体征计分对比"

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)

表5

两组VAS计分对比"

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)

表6

两组OHIP-14量表计分对比"

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*

图2

试验组和对照组治疗有效率"

图3

试验组和对照组用药前后病损情况"

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ISSN 1671-167X
CN 11-4691/R
主管单位：中华人民共和国教育部
主办单位：北京大学
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