基于预后分析的复方绞股蓝胶囊预防口腔白斑癌变的回顾性队列研究  

A retrospective cohort study on Compound Jiaogulan Capsule for prevention of oral leukoplakia canceration based on prognostic analysis

作　　者：王震 武文妍[2] 周曾同[2] WANG Zhen;WU Wenyan;ZHOU Zengtong(Department of Oral and Maxillofacial-Head and Neck Oncology,Shanghai Ninth People’s Hospital,Shanghai JiaoTong University School of Medicine,Shanghai 200011,China;Department of Oral Mucosal Diseases,Shanghai NinthPeople’s Hospital,Shanghai Jiao Tong University School of Medicine,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颌面头颈肿瘤科,上海200011 [2]上海交通大学医学院附属第九人民医院口腔黏膜科,上海200011

出　　处：《上海中医药杂志》2019年第9期51-55,共5页Shanghai Journal of Traditional Chinese Medicine

基　　金：上海市科委中药现代化专项(10DZ1974200)

摘　　要：目的基于病理分级分析口腔白斑患者的预后影响因素,探讨复方绞股蓝胶囊对口腔白斑的预防作用,并构建预后模型。方法收集整理口腔颌面头颈肿瘤科收治的192例具有自身对照样本口腔白斑患者的病历资料,根据是否服用复方绞股蓝胶囊分为中西医结合组(98例)、西医组(94例)。统计癌变率,采用Kaplan-Meier法计算平均癌变时间,并进行单因素分析;运用Cox回归模型分析影响疾病进展和癌变的独立预测因素,完成数据分析并建立预后模型。结果①中西医结合组、西医组癌变率分别为16.0%(15/94)和26.5%(26/98)。中西医结合组与西医组平均癌变时间分别为125.2个月、75.1个月,差异有统计学意义(P=0.005)。②中度异常增生(P=0.03)、重度异常增生(P<0.01)、饮酒(P=0.022)、服用复方绞股蓝胶囊(P=0.006)是口腔白斑进展或癌变的独立预测因素。③建立预后模型h(t)=h0(t)Exp(0.767×中度异常增生+2.88×重度异常增生+0.944×饮酒-0.934×服用复方绞股蓝胶囊)。结论中度异常增生、重度异常增生、饮酒是口腔白斑的危险因素,服用复方绞股蓝胶囊是保护因素。定期随访及口服复方绞股蓝胶囊是预防口腔白斑进展或癌变的重要手段。Objective To analyze the prognostic factors of patients with oral leukoplakia, discuss the preventive effect of Compound Jiaogulan Capsule on oral leukoplakia, and establish a prognostic model based on pathological grading. Methods Medical records were collected from 192 patients with oral leukoplakia who had self-control samples in Department of Oral and Maxillofacial-Head and Neck Oncology in this hospital. The patients were divided into integrated Chinese and Western medicine group(98 cases) and Western medicine group(94 cases). The canceration rate was measured, the average time of canceration was calculated by Kaplan-Meier method and a univariate analysis was carried out. A Cox regression model was used to analyze the independent predictors for disease progression and canceration, data analysis was completed and a prognostic model was established. Results ①The canceration rate was 16.0%(15/94) and 26.5%(26/98) in the integrated Chinese and Western medicine group respectively. The average time of canceration was 125.2 and 75.1 months in the integrated Chinese and Western medicine group, respectively, with significant difference(P=0.005).②Moderate dysplasia(P=0.03), severe dysplasia(P<0.01), drinking(P=0.022), taking Compound Jiaogulan Capsule(P=0.006) were independent predictors for progression or canceration of oral leukoplakia.③The prognostic model h(t)=h0(t)Exp(0.767 × moderate dysplasia + 2.88 × severe dysplasia + 0.944 × drinking-0.934 × taking Compound Jiaogulan Capsule) was established. Conclusion Moderate dysplasia, severe dysplasia and drinking are risk factors, and taking Compound Jiaogulan Capsule is a protective factor for oral leukoplakia. Regular follow-up and oral administration of Compound Jiaogulan Capsule are important means to prevent progression or canceration of oral leukoplakia.

关 键 词：口腔白斑 复方绞股蓝胶囊 病理 生存分析 队列研究 

分 类 号：R276.8[医药卫生—中医五官科学]