Re-compensation and Its Clinical Characteristics in Treatment-naïve HBV Decompensated Cirrhosis on Antiviral Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- Cumulative incidence of re-compensation
研究概览
简要总结
In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. Clinical data from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. In this retrospective study, the incidence of re-compensation and its clinical characteristics were mainly explored.
详细描述
In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. WBC, RBC, HGB, PLT, CRP, PT, PTA, INR, ALT, AST, TB, DB, ALB, GLO, ALP, GGT, CHE, BUN, Cr, Na, GLU, CHOL, TG, HDL-C, LDL-C, AFP, HBsAg, HBV-DNA, LSM, BUS, MRI/CT and gastroscope from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. This retrospective study aimed to explore the incidence of re-compensation and its clinical characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ascites and/or variceal hemorrhage (VH) as the first decompensated events;
- •Initiating antiviral therapy within 3 months of the first decompensated events;
- •Clinical parameters were available at the first decompensated events, including PLT, ALT, ALB, TB, PT/INR, Cr, HBV DNA, BUS,
- •Clinical outcomes were classified:
- •Without further decompensation: medical records at year-1, year 2 to 4, and year-5 were available.
- •With ≥ 2 episodes of decompensation: medical records for decompensation were available.
排除标准
- •Hepatocellular carcinoma prior to /within 6 months of first decompensated events;
- •Liver transplantation /death within 6 months of first decompensated events;
- •complicated with other chronic liver diseases, including HCV, DILI, AIH, NAFLD, ALD.
- •Any complication of severe heart, lung, kidney, brain, blood diseases or other severe systematic diseases;
- •Pregnant women.
结局指标
主要结局
Cumulative incidence of re-compensation
时间窗: Year 5
Patients who did not occur further decompensation
次要结局
- Cumulative incidence of re-compensation(Year 1, 2, 3, and 4)
- Annual incidence of second decompensation(Year 1, 2, 3, 4, and 5)
- Cumulative incidence of liver-related death / liver transplantation(Year 1, 2, 3, 4, and 5)
- Dynamic changes of Child-Pugh score in re-compensated and not re-compensated group(Year 1, 2, 3, 4, and 5)
- Dynamic changes of APRI score in re-compensated and not re-compensated group(Year 1, 2, 3, 4, and 5)
- Dynamic changes of FIB-4 score in re-compensated and not re-compensated group(Year 1, 2, 3, 4, and 5)
- Dynamic changes of liver stiffness values measured by Transient Elastography in re-compensated and not re-compensated group(Year 1, 2, 3, 4, and 5)
- Cumulative incidence of HCC(Year 1, 2, 3, 4, and 5)
- Dynamic changes of MELD score in re-compensated and not re-compensated group(Year 1, 2, 3, 4, and 5)
研究者
Hong You
Vice director
Beijing Friendship Hospital