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

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

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。

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.