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. MethodsMedical 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)=h,0,(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.