糜烂型口腔扁平苔藓三种治疗方法的随机对照研究  

Randomized,positive-controlled trial of three methods for erosive oral lichen planus: pilot study

作　　者：周永梅[1] 戚清权[2] 刘伟[3] 周曾同[1] 沈雪敏[1] ZHOU Yong- mei;QI Qinq- quart;LIU Wei;ZHOU Zeng- tong;SHEN Xue- min(Department of Oral Mucosal Diseases, Shanghai Ninth People ＇s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology, 639 Zhizaoju Road, Shanghai 200011, China;Department of Traditional Chinese Medicine, Shanghai 200011, China;Departmerit of Oral ＆ Maxillofacial-Head ＆ Neck Oncology ,Shanghai 200011, China.)

机构地区：[1]上海交通大学医学院附属第九人民医院口腔黏膜科.上海市口腔医学重点实验室,上海200011 [2]上海交通大学医学院附属第九人民医院中医科,上海200011 [3]上海交通大学医学院附属第九人民医院口腔颌面头颈肿瘤科,上海200011

出　　处：《临床口腔医学杂志》2018年第6期358-362,共5页Journal of Clinical Stomatology

基　　金：上海市科学技术委员会医学引导项目(13401905700);上海交通大学医学院附属第九人民医院临床研究助推计划(JYLJ008);上海市中医药新兴交叉学科资助计划建设项目([2017]10)

摘　　要：目的:通过随机、阳性药物平行对照研究,客观评价中医药治疗糜烂型口腔扁平苔藓的疗效及安全性,优化扁平苔藓诊疗方案。方法:分别用单纯西药、单纯中药和中西医结合治疗糜烂型口腔扁平苔藓3个月,比较治疗前后口腔黏膜损害评分、疼痛指数评分和体重,并分析综合疗效和不良反应。结果:共收集90例受试者,83例完成实验。3组受试者的年龄、性别构成、治疗前损害评分差异无统计学意义。3组治疗前后口腔黏膜损害评分,单纯西药组(治疗前后差值2.21分)、中西医结合组(2.17分)的差值较单纯中药组(1.27分)有统计学意义;3组治疗前后疼痛指数评分差异无统计学意义。3组发生的不良事件,单纯西药组29例、单纯中药组7例、中西医结合组11例。3组总有效率,单纯西药组82.1%、单纯中药组73.1%、中西医结合组89.7%,3组差异无统计学意义。结论:中西医结合是治疗糜烂型口腔扁平苔藓较理想的方法,疗效好且具有相对较好的安全性。Objective： To investigate the efficacy and safety of traditional Chinese medicine used in the treatment of erosive oral lichen planus（ EOLP） by randomized,positive-controlled trial. Methods： The volunteerswere assigned randomly to three groups which received Chinese medicine,western medicine,or combination of Chinese and western medicine respectively. The advantages and disadvantages of the three methods were assessed by comparing the score of oral lesions and pain,patients＇ weight,and adverse effects before and after the treatment. The safety was evaluated by the adverse events that appeared including symptoms,physical and biochemical examination. Results： Totally,90 volunteers were enrolled in this study with 83 completing the trial. No significant difference was found among the three groups in the demographic characters and sexual baseline. The reduced oral lesions score below the baseline in the three groups（ Chinese medicine,western medicine,or combination of Chinese and western medicine） was 1. 27,2. 21 and 2. 17 repectively,and the decrease was statistically larger in the latter two groups than in the Chinese medicine group. No significant difference was found among the three groups in the reduced pain score. The number of adverse events was reported in three groups was 7,29 and 11 respectively. The total efficacy rates of three groups was 73. 1%,82. 1% and 89. 7% respectively,with no significant difference found. Conclusion： The treatment of Chinese integrative medicine is a preferred method for erosive oral lichen planus which boasts of both better efficacy and relatively good safety.

关 键 词：口腔扁平苔藓 中西医结合 临床试验 

分 类 号：R781.5[医药卫生—口腔医学]