启东慢性乙型肝炎临床队列:建立及基线特征

目的 在启东现场建立目标人群为慢性乙型肝炎（乙肝）患者的前瞻队列并分析其基线特征。方法 自2016年1月1日，对启东市第三人民医院门诊慢性乙肝患者开展基线调查，内容包括问卷调查、肝功能及HBV感染相关血清学指标检测、上腹部B超。计划纳入慢性乙肝患者不少于1 000例，基线调查资料采用EpiData软件录入，导入SAS 9.3软件后对研究对象的主要基线特征进行统计分析。结果 截至2016年7月18日，共1 006例研究对象签署知情同意并参加基线调查，其中男性615例，年龄为（44.26±9.97）岁，女性391例，年龄为（46.66±11.17）岁。肝病家族史性别间的差异无统计学意义（P>0.05），年龄、文化程度、吸烟、饮酒、饮茶、抗病毒治疗构成比的组间差异均有统计学意义（P<0.05）。临床指标方面，男性中ALT及总胆红素异常率高于女性，差异有统计学意义（P<0.05），HBeAg状态、HBsAg定量、HBV DNA载量、白蛋白、门静脉和脾静脉宽度异常构成比的组间差异均无统计学意义（P>0.05）。结论 在启东现场成功开展慢性乙肝门诊患者前瞻队列的基线调查，根据亚组间的基线特征差异，后续可进行相应的亚队列研究。

Qidong Chronic Hepatitis B Cohort:participants enrollment and comparison of baseline characteristics by gender stratification

Objective To establish a study cohort of chronic hepatitis B (CHB) in Qidong and evaluate its baseline characteristics. Methods CHB outpatients of the Third People''s Hospital of Qidong were invited to participate in baseline survey from January 1, 2016, including questionnaire survey, liver function detection, serum detection of HBV infection and upper abdomen ultrasound detection. Anticipated sample size was at least one thousand. Baseline data were inputted by EpiData 3.1 software and then cleaned and analyzed by SAS 9.3 software. Results As of 18 July, 2016, a total of 1 006 participants had been enrolled into the current study, including 615 males with an average age of (44.26±9.97) years and 391 females with an average age of (46.66±11.17) years. The difference in family history of liver disease was not significant between males and females (P>0.05), while the differences in other key information, such as age, education level, tobacco consumption, alcohol drinking, tea consumption, and antiviral intervention, were significant between males and females (P<0.05). Among the key clinical parameters, such as ALT, HBeAg, HBsAg, HBV DNA, albumin, and width of splenic vein and portal vein, only the abnormal rates of ALT and total bilirubin levels were higher in males than in females, the difference was significant (P<0.05). Conclusion Outpatient department-based CHB cohort was established successfully in Qidong, and sub-cohort could be divided according to the differences on baseline characteristics.