Analysis of Renal Impairment Characteristics and High-Risk Factors in Patients With Chronic Hepatitis B Receiving Long-Term Oral Nucleos(t)Ide Analogues
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Serum creatinine level
研究概览
简要总结
This is a single-center retrospective observational study. A total of 300 patients with non-alcoholic fatty liver disease treated in our hospital will be included. We collect clinical data, laboratory indicators and imaging results, and analyze the correlation between long-term nucleoside antiviral drugs and renal function changes in patients. The study does not use any new intervention measures, and only conducts statistical analysis on existing medical record data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for chronic hepatitis B specified in the 2019 Chinese Society of Infectious Diseases guidelines.
- •Patients received continuous NAS antiviral treatment for at least 12 months.
- •Patients voluntarily participated in the study and signed informed consent.
- •Complete records of liver function, renal function, urinary indicators and HBV-DNA data are available.
排除标准
- •Combined with chronic nephritis, nephrotic syndrome and other primary kidney diseases.
- •Co-infection with hepatitis C virus, hepatitis E virus and other hepatitis viruses.
- •Duration of antiviral treatment less than 12 months.
- •Patients with drug resistance during anti-HBV treatment who switched or combined other antiviral agents.
- •Autoimmune hepatitis, alcoholic liver disease, schistosomal liver disease and other liver diseases.
- •Malignant tumor, severe cardiovascular and other systemic serious diseases.
结局指标
主要结局
Serum creatinine level
时间窗: At baseline (the index assessment).
Serum creatinine levels will be obtained from medical records and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Serum creatinine will be reported in μmol/L.
Estimated glomerular filtration rate
时间窗: At baseline (the index assessment).
Estimated glomerular filtration rate will be determined from serum creatinine using the prespecified equation and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Values will be reported in mL/min/1.73 m².
Blood urea nitrogen level
时间窗: At baseline (the index assessment).
Blood urea nitrogen levels will be obtained from medical records and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Blood urea nitrogen will be reported in mmol/L.
次要结局
未报告次要终点
研究者
Lan haiyan
Resident Physician, Department of Hepatology
Foshan Hospital of Traditional Chinese Medicine