A Better Antiviral Efficacy Found in Nucleos(t)ide Analog (NA) Combinations with Interferon Therapy than NA Monotherapy for HBeAg Positive Chronic Hepatitis B: A Meta-Analysis.
A Better Antiviral Efficacy Found in Nucleos(t)ide Analog (NA) Combinations with Interferon Therapy than NA Monotherapy for HBeAg Positive Chronic Hepatitis B: A Meta-Analysis.
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DOI：
10.3390/ijerph120810039
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发表时间：
2015-08-21
影响因子：
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通讯作者：
You H
中科院分区：
文献类型：
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作者：
Wei W;Wu Q;Zhou J;Kong Y;You H
背景：核苷类似物（NAs）联合干扰素（IFN）治疗与NAs单药治疗慢性乙型肝炎（CHB）的临床疗效尚无定论。本荟萃分析的目的是确定NAs + IFN方案是否提供协同效应，证明这种联合治疗对慢性乙型肝炎患者的成本和负担是合理的。方法：通过检索MEDLINE、EMBASE、Cochrane图书馆、中国生物医学文献数据库、万方数据库、中国知网数据库，检索1966 - 2014年7月的相关文献。共纳入17项研究，其中6项为英文研究，11项为中文研究。然后，我们通过系统地对确定的单个研究的质量和合格性进行分级，建立了用于荟萃分析的最终研究列表。我们使用乙肝抗原（HBeAg）丢失、HBV-DNA不可检出率、HBeAg血清转化、乙肝表面抗原（HBsAg）丢失、HBsAg血清转化和治疗结束时的组织学评分来评估疗效。采用定量荟萃分析（Review Manager, Version 5.1.0）来评估NAs和IFN联合治疗和NAs单药治疗之间的差异。结果：我们的分析显示，联合治疗组的HBeAg损失（RR = 1.73, 95% CI = 1.32 ~ 2.26, p < 0.001）、HBV-DNA不可检出率（RR = 1.58, 95% CI = 1.22 ~ 2.04, p < 0.001）、HBeAg血清转化（RR = 1.68, 95% CI = 1.36 ~ 2.07, p < 0.001）和HBsAg损失（RR = 2.51, 95% CI = 1.32 ~ 4.75, p < 0.001）显著高于单药治疗组。两组患者HBsAg血清转化率（RR = 4.25, 95% CI = 0.62-29.13, p = 0.14）、持续病毒学反应率、生化反应率均无显著差异。结果显示，联合治疗组HBV组织学改善程度高于NAs单药治疗组（RR = 1.14, 95% CI = 0.93-1.39, p = 0.22）。结论：在治疗结束时，NAs与IFN或Peg-IFN联合治疗在HBeAg损失、HBV-DNA未检出率、HBeAg血清转化和HBsAg损失方面优于NA单药治疗组；然而，两种治疗方案在HBsAg转化方面没有显著差异。
Background: The clinical efficacy of nucleos(t)ide analogues (NAs) combined with interferon (IFN) therapy vs. NAs monotherapy for chronic hepatitis B (CHB) remains inconclusive. The aim of this meta-analysis was to determine whether the NAs plus IFN regimen offers synergistic efficacy that justifies the cost and burden of such a combination therapy in CHB patients. Methods: Related publications covering the period of 1966 to July 2014 were identified through searching MEDLINE, EMBASE, Cochrane library, Chinese Biomedical Literature Database, WANFANG, and CNKI database. A total of 17 studies were enrolled, including 6 in English and 11 in Chinese. Then, we established a final list of studies for the meta-analysis by systematically grading the quality and eligibility of the identified individual studies. We used hepatitis B antigen (HBeAg) loss, HBV-DNA undetectable rate, HBeAg seroconversion, hepatitis B surface antigen (HBsAg) loss, HBsAg seroconversion, and histological score at the end of treatment for efficacy evaluation. A quantitative meta-analysis (Review Manager, Version 5.1.0) was performed to assess the differences between NAs and IFN combination therapy and NAs monotherapy. Results: Our analysis demonstrated that HBeAg loss (RR = 1.73, 95% CI = 1.32–2.26, p < 0.001), HBV-DNA undetectable rate (RR = 1.58, 95% CI = 1.22–2.04, p < 0.001), HBeAg seroconversion (RR = 1.68, 95% CI = 1.36–2.07, p < 0.001), and HBsAg loss (RR = 2.51, 95% CI = 1.32–4.75, p < 0.001) in the combination therapy group were significantly higher than those in the monotherapy group. However, there were no significant differences in HBsAg seroconversion (RR = 4.25, 95% CI = 0.62–29.13, p = 0.14), sustained virological response rates, and biochemical response rates observed between the two groups. The results showed that the combination therapy group had more improved HBV histology than the NAs monotherapy group (RR = 1.14, 95% CI = 0.93–1.39, p = 0.22). Conclusions: NAs and IFN or Peg-IFN combination therapy had a better efficacy in terms of HBeAg loss, HBV-DNA undetectable rate, HBeAg seroconversion, and HBsAg loss, compared to the NA monotherapy group at the end of treatment; however, there was no significant difference in HBsAg seroconversion between the two regimens.