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核苷(酸)类似物治疗慢性乙型肝炎安全停药临床研究
Clinical analysis on safety of drug withdrawal for chronic hepatitis B patients treated with nucleoside/nucleotide analogues
【摘要】 目的探讨核苷(酸)类似物(NUCs)治疗慢性乙型肝炎(CHB)停药后复发与停药时血清HBs Ag的量、HBVDNA水平的相关性。方法选取205例2010年1月至2014年6月在济宁市传染病医院门诊给NUCs治疗达到《慢性乙型肝炎防治指南》制订的停药标准计划停药的CHB患者为研究对象,停药时对其进行HBV M定量、高灵敏度HBV DNA定量检测。停药后随访1年,HBV DNA>103IU/m L定义为复发。结果在1年时CHB总的复发率65.9%(135/205)。HBs Ag定量≤100 m IU/m L组,复发率仅23.9%(11/46),HBs Ag定量>100 m IU/m L组,复发率78.0%(124/159),两组之间复发率差异有统计学意义(χ2=46.4,P<0.005)。HBV DNA定量≤20 IU/m L组,复发率56.4%(62/110),HBV DNA定量>20 IU/m L组,复发率76.8%(73/95),两组之间复发率差异有统计学意义(χ2=9.5,P<0.01)。同时符合HBs Ag定量≤100IU/m L、HBV DNA定量≤20 IU/m L组,复发率14.3%(5/35),其余病例复发率76.5%(130/170),两组之间复发率差异有统计学意义(χ2=49.9,P<0.005)。结论 NUCs治疗CHB停药后的复发与停药时HBs Ag的量、HBV DNA水平有一定相关性,HBs Ag定量≤100 m IU/m L和或HBV DNA定量≤20 IU/m L作为NUCs抗乙型肝炎病毒治疗停药指标,以达到最大的安全停药。
【Abstract】 Objective To investigate the correlation of the relapse of chronic hepatitis B(CHB)after nucleoside/nucleotide analogues(NUCs)withdrawal with HBs Ag level and HBV DNA level at the time of withdrawal in CHB patients.Methods A total of 205 CHB outpatients treated with NUCs who met the Guidelines for Prevention and Treatment of CHB fordrug withdrawal standard,in our hospital from January 2010 to June 2014 were subjected in this study. Their HBVMquantification and high sensitivity HBV DNA quantification were detected at the time of withdrawal. All subjects were followedup for 1 year after stopping the drug. The patients with HBV DNA>103IU/m L was defined as relapse of the disease. Results After 1 year’s follow-up,the total relapse rate of CHB was 65.9%(135/205)in the subject. However,for the patients withHBs Ag ≤100 m IU/m L,the relapse rate was only 23.9%(11/46),but was 78.0%(124/159)in the patients with HBs Ag>100 m IU/m L,with significant difference between the 2 groups(χ2=46.4,P<0.005). The relapse rate was 56.4%(62/110)and 76.8%(73/95)in the patients with HBV DNA level ≤20 and >20 IU/m L,respectively,and significant difference was observed betweenthem(χ2=9.5,P<0.01). Among the patients with simutaneous HBs Ag ≤100 IU/m L and HBV DNA ≤20 IU/m L,the relapse ratewas decreased to 14.3%(5/35). Whereas,the rate was 76.5%(130/170)for the other patients. There was significant differencebetween the above 2 groups of patients(χ2=49.9,P<0.005). Conclusion The CHB relapse after NUCs withdrawal iscorrelated with the HBs Ag and HBV DNA levels at the time of withdrawal. HBs Ag ≤100 m IU/m L and/or HBV DNA ≤20 IU/m L can be regarded as the targets for NUCs withdrawal in CHB patients to achieve the maximum safety of drug stopping.
【Key words】 Hepatitis B; High sensitivity HBV DNA quantification; HBsAg quantitation; Relapse rate;
- 【文献出处】 中国热带医学 ,China Tropical Medicine , 编辑部邮箱 ,2016年08期
- 【分类号】R512.62
- 【被引频次】3
- 【下载频次】91