基于聚乙二醇干扰素的慢性乙型肝炎患者延长治疗方案，侧重于乙型肝炎表面抗原丢失：系统评价和荟萃分析。
Extended duration therapy regimens based on Pegylated interferon for chronic hepatitis B patients focusing on hepatitis B surface antigen loss: A systematic review and meta-analysis.
机构信息
International Medical Department, Beijing You-an Hospital, Capital Medical University, Beijing, China.
International Medical Department, Beijing You-an Hospital, Capital Medical University, Beijing, China.
出版信息
Infect Genet Evol. 2020 Nov;85:104492. doi: 10.1016/j.meegid.2020.104492. Epub 2020 Aug 5.
AIMS
Hepatitis B surface antigen (HBsAg) loss is associated with disease control and improvement of prognosis. Therefore, it is regarded as the optimal treatment endpoint for chronic hepatitis B (CHB) patients. Pegylated interferon (PegIFN)-based extended therapy regimens was assessed in several studies. In order to summarize a conclusion on the HBsAg loss rate and safety in this regimen, a systematic review and meta-analysis was performed.
METHODS
Studies on Hepatitis B and PegIFN were searched thoroughly in Pubmed, EMBASE, and the Cochrane Library from inception to November 18, 2019. The primary endpoint of this study was the HBsAg loss rate at the end of the extended duration therapy. The secondary endpoint was safety. All analyses were performed by using the R3.6.1 version Software. Quality assessment of RCTs was carried out by using Review manager 5.3.
RESULTS
A total of nine studies, including 545 CHB patients met the inclusion criteria. The pooled HBsAg loss rate after PegIFN-based extended duration therapy was 11% (95% CI: 0.05-0.19), I = 82%, P < 0.01(Q test). The extended duration therapy regimen was safe and tolerable. Subgroup analysis showed HBsAg loss rates were 14% (95% CI: 0.04-0.29) and 10% (95% CI: 0.02-0.20) respectively for HBeAg positive and HBeAg negative patients (P = 0.52). HBsAg loss rates were 11%(95%CI:0.03-0.22)and 12%(95%CI:0.04-0.24)respectively for PegIFN monotherapy and PegIFN with Nucleos(t)ide analogs (NAs) therapy (P = 0.84). HBsAg loss rates were 25% (95% CI: 0.19-0.31) and 8% (95% CI: 0.03-0.15) respectively for the advantageous group and non-advantageous group (P = 0.001).
CONCLUSIONS
For CHB patients, extended duration of PegIFNα-based treatment for more than 48 weeks is likely to improve HBsAg clearance rate. Specially, the advantageous group will benefit a lot. In addition, the extended duration therapy regimen is safe and tolerable.
目的
乙肝表面抗原（HBsAg）的清除与疾病控制和预后改善相关，因此被认为是慢性乙型肝炎（CHB）患者的最佳治疗终点。几项研究评估了基于聚乙二醇干扰素（PegIFN）的延长治疗方案。为了总结该方案中 HBsAg 清除率和安全性的结论，进行了系统评价和荟萃分析。
方法
在 Pubmed、EMBASE 和 Cochrane Library 中全面检索了关于乙型肝炎和 PegIFN 的研究，检索时间截至 2019 年 11 月 18 日。本研究的主要终点是延长治疗结束时的 HBsAg 清除率。次要终点是安全性。所有分析均使用 R3.6.1 版本软件进行。使用 Review manager 5.3 对 RCTs 的质量进行评估。
结果
共有 9 项研究，包括 545 例 CHB 患者符合纳入标准。基于 PegIFN 的延长治疗后 HBsAg 的清除率为 11%（95%CI：0.05-0.19），I²=82%，P<0.01（Q 检验）。延长治疗方案是安全且可耐受的。亚组分析显示，HBeAg 阳性和 HBeAg 阴性患者的 HBsAg 清除率分别为 14%（95%CI：0.04-0.29）和 10%（95%CI：0.02-0.20）（P=0.52）。PegIFN 单药治疗和 PegIFN 联合核苷（酸）类似物（NAs）治疗的 HBsAg 清除率分别为 11%（95%CI：0.03-0.22）和 12%（95%CI：0.04-0.24）（P=0.84）。优势组和非优势组的 HBsAg 清除率分别为 25%（95%CI：0.19-0.31）和 8%（95%CI：0.03-0.15）（P=0.001）。
结论
对于 CHB 患者，基于 PegIFNα 的治疗延长至 48 周以上可能会提高 HBsAg 清除率。特别是优势组将受益匪浅。此外，延长治疗方案是安全且耐受良好的。
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