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目的早期病毒学应答可以预测核苷酸类药物治疗的长期疗效,拟建立替比夫定初治慢性乙型肝炎(CHB)患者早期病毒学应答预测模型。方法收集2007年1月-2014年8月于福建医科大学孟超肝胆医院就诊的CHB患者135例,接受替比夫定(600 mg,1次/d)治疗至少24周,每2周进行1次随访,记录患者基线资料及治疗过程中的检测数据。计量资料组间比较采用t检验,计数资料组间比较采用χ~2检验,Cox比例风险回归模型分析早期病毒学应答的影响因素,并建立预测模型。结果无HBV感染家族史(P=0.000 3)、较高基线TBil(P=0.002 6)和AST(P=0.007 4)水平、较低水平的HBV DNA载量(P=0.002 3)更可能出现早期病毒学应答。根据这些变量建立预测模型,在24周时共有18例患者取得早期病毒学应答,受试者工作特征曲线下面积为62.3%,95%可信区间为38.8%~85.9%(P=0.049),最佳临界值为0.85。CHB患者的风险评分>0.85的CHB患者更可能获得早期病毒学应答。结论通过家族史以及基线TBil、AST和HBV DNA水平4个变量建立的模型可以很好地预测替比夫定初治CHB患者的早期病毒学应答。
Objective Early virological response predicts the long-term efficacy of nucleotide therapy. To establish a predictive model of early virological response in patients with telbivudine-treated chronic hepatitis B (CHB). Methods A total of 135 CHB patients treated at Mengchao Hepatobiliary Hospital of Fujian Medical University from January 2007 to August 2014 were enrolled and treated with telbivudine (600 mg once daily) for at least 24 weeks every 2 weeks Follow-up, records of patients with baseline data and treatment of the test data. The t test was used to compare the measurement data. The chi-square test was used to compare the data between the two groups. Cox proportional hazards regression model was used to analyze the influencing factors of early virological response and the prediction model was established. Results There was no family history of HBV infection (P = 0.0003), higher baseline TBil (P = 0.002 6), and AST (P = 0.007 4), with lower levels of HBV DNA load (P = 0.002 3) Early virological response. Based on these variables, a predictive model was established. At 24 weeks, 18 patients achieved early virological response. The area under the receiver operating characteristic curve was 62.3% with a 95% confidence interval of 38.8% to 85.9% (P = 0.049) The best cut-off is 0.85. CHB patients with a risk score> 0.85 CHB patients are more likely to get an early virological response. Conclusion The model established by family history, baseline TBil, AST and HBV DNA levels can be a good predictor of early virological response in telbivudine-treated CHB patients.