替比夫定初治慢性乙型肝炎患者早期病毒学应答预测模型的建立

Establishment of a predictive model for early virologic response in previously untreated chronic hepatitis B patients treated with telbivudine

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 To investigate the establishment of a predictive model for early virologic response in previously untreated chronic hepatitis B（ CHB） patients treated with telbivudine,since early virologic response can predict the long- term efficacy of nucleotide analogues.Methods A total of 135 CHB patients who visited Mengchao Hepatobiliary Hospital of Fujian Medical University from January 2007 to August 2014 were enrolled and treated with telbivudine（ 600 mg qd） for at least 24 weeks. Follow- up was performed once every 2 weeks,and the patients＇ baseline data and data measured during treatment were recorded. The t- test was used for comparison of continuous data between groups,the chi- square test was used for comparison of categorical data between groups,and the Cox proportional hazards regression model was used to analyze the influencing factors for early virologic response and establish the predictive model. Results The patients without a family history of hepatitis B virus（ HBV） infection（ P = 0. 000 3） and with high baseline levels of total bilirubin（ TBil）（ P = 0. 002 6）and aspartate aminotransferase（ AST）（ P = 0. 007 4） and a low HBV DNA load（ P = 0. 002 3） tended to show early virologic response.The predictive model was established based on these variables,and the risk score（ R） of CHB patients was calculated. The CHB patients with R〉0. 85 were more likely to achieve early virologic response. Conclusion The model established based on the four variables of family history,baseline TBil level,baseline AST level,and HBV DNA level can well predict early virologic response in previously untreated CHB patients treated with telbivudine.