
慢性乙肝病毒携带者抗病毒治疗有效性与安全性研究现状
李芮, 唐霓, 游子杰, 姚云清
慢性乙肝病毒携带者抗病毒治疗有效性与安全性研究现状
Efficacy and safety of antiviral therapy in chronic hepatitis B virus carriers
目的 通过检索国内外数据库,对慢性乙型肝炎病毒携带者(chronic hepatitis B virus carriers,CHBVC)抗病毒治疗的有效性与安全性进行系统评价。 方法 采用计算机检索PubMed、Embase、Cochrane Library、Web of Science、知网、万方、维普和中国生物医学文献数据库,筛选关于CHBVC抗病毒治疗核苷类似物(nucleoside analogue,NA)单用方案,α干扰素(interferon alpha,IFNα)单用方案及NA+IFNα联合方案的临床随机对照研究或队列研究文献,并使用Stata17进行Meta分析。 结果 共纳入28篇文献,涉及1 623例CHBVC患者接受抗病毒治疗。有效性分析:HBsAg血清清除率为20%(338/1 421),其中HBeAg阴性组HBsAg清除率高达52.9%,阳性组仅为1.5%;HBeAg阴性组中HBV DNA<2 000 IU/mL组的HBsAg清除率为45.6%,HBV DNA<20 IU/mL组的HBsAg清除率可达59.9%。HBsAg血清转化率为15.3%(196/946),其中HBeAg阴性组HBsAg转化率较高(38.2%),阳性组未见明显变化;HBeAg阴性组中HBV DNA<2 000 IU/mL组的HBsAg转化率为34.5%,而HBV DNA<20 IU/mL组的HBsAg血清转化率可达49.4%。HBeAg血清阴转率为6.6%(34/465),随着治疗时间延长呈逐渐上升趋势,在192周时可达8.8%。HBeAg血清转化率为8%(63/700),在96周时最高(24%),同时NA+IFNα联合方案比NA单用更具优势(8.1% vs. 5.4%)。HBV DNA血清阴转率总体达到70.1%(500/738)。安全性分析:共有494例患者被纳入8篇文献进行不良事件发生情况统计,总体不良事件发生率约为5.4%(28/494)。 结论 CHBVC抗病毒治疗有较高的有效性和安全性,NA+IFNα联合方案及长期治疗方案对改善CHBVC效益更为明显。
Objective To investigate the efficacy and safety of antiviral therapy in chronic hepatitis B virus carriers(CHBVCs) through a systematical review by searching the databases in China and globally. Methods PubMed,Embase,the Cochrane Library,Web of Science,CNKI,Wanfang Data,VIP,and CMB were searched for randomized controlled clinical trials or cohort studies on antiviral therapy for CHBVC,with the regimens of nucleos(t)ide analogue(NA) alone,interferon-α(IFNα) alone,and NA combined with IFNα,and Stata17 was used to perform the meta-analysis. Results A total of 28 articles were included,involving 1623 CHBVCs who received antiviral therapy. As for the analysis of efficacy,serum HBsAg clearance rate was 20% (338/1421),and the HBeAg negative group had an HBsAg clearance rate as high as 52.9%,while the HBeAg positive group had a clearance of 1.5%; in the HBeAg negative group,the HBV DNA<2000 IU/mL group had an HBsAg clearance rate of 45.6%,while the HBV DNA<20 IU/mL group had an HBsAg clearance rate of 59.9%. The HBsAg seroconversion rate was 15.3%(196/946),and the HBeAg negative group had a relatively high HBsAg seroconversion rate of 38.2%,while no significant change was observed in the HBeAg positive group; in the HBeAg negative group,the HBV DNA<2000 IU/mL group had an HBsAg seroconversion rate of 34.5%,while the HBV DNA<20 IU/mL group had an HBsAg seroconversion rate of 49.4%. The serum HBeAg clearance rate was 6.6%(34/465),which gradually increased over the course of treatment and reached 8.8% at week 192. The HBeAg seroconversion rate was 8%(63/700),with the highest rate of 24% at week 96,and the combination of NA and IFNα was superior to NA alone(8.1% vs. 5.4%). The overall serum HBV DNA clearance rate reached 70.1%(500/738). In the analysis of safety,a statistical analysis of adverse events was performed among 494 patients in 8 articles,and the results showed that the overall incidence rate of adverse events was about 5.4%(28/494). Conclusion Antiviral therapy has good efficacy and safety in CHBVCs,and the NA+IFNα regimen and the long-term treatment regimen have significant benefits in CHBVCs.
慢性乙型肝炎病毒携带者 / 抗病毒治疗 / 核苷类似物 / α干扰素 / Meta分析
chronic hepatitis B virus carriers / antiviral therapy / nucleos(t)ide analogue / interferon-α / meta-analysis
R512.6+2
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