扶正解毒颗粒联合长效干扰素促进慢性HBV感染临床治愈的真实世界研究OA
A real-world clinical study on the efficacy and adverse reactions of Fuzheng Jiedu granules combined with long-acting interferon in promoting clinical cure of chronic HBV infection
目的:分析扶正解毒颗粒联合聚乙二醇干扰素α-2b(Peg-IFNα-2b)促进慢性乙型肝炎病毒(HBV)感染者临床治愈的疗效及不良反应.方法:采用回顾性研究方法,选取2024年4月至2025年2月于湖南中医药大学第一附属医院肝病科门诊就诊的慢性HBV感染患者60例(HBsAg＜1 500 IU/ml),根据治疗方案不同分为治疗组与对照组,每组30例.对照组患者采用核苷(酸)类似物+长效干扰素治疗,治疗组患者在对照组基础上加用扶正解毒颗粒.两组患者均治疗24周.比较两组患者乙型肝炎表面抗原(HBsAg)转阴率HBsAg血清学转换率HBV DNA阴转率及不良反应发生率.结果:治疗24周后,治疗组患者HBsAg转阴率为63.3％(19/30),显著高于对照组的30.0％(9/30),差异有统计学意义(x2=6.696,P=0.01);治疗组HBsAg血清学转换率为33.3％(10/30),显著高于对照组的10.0％(3/30),差异有统计学意义(x2=4.812,P=0.03);两组HBV DNA阴转率比较(91.7％vs 90.0％),差异无统计学意义(P＞0.05);两组不良反应总发生率比较(83.3％ vs 90.0％),差异无统计学意义(P＞0.05).结论:扶正解毒颗粒联合Peg-IFNα-2b能够有效促进慢性HBV感染的临床治愈率和血清学转换率,且未增加不良反应发生率,安全性良好.
Objective:To compare the efficacy and adverse reactions of Fuzheng Jiedu Granules combined with pegylated interferon α-2b(Peg-IFNα-2b)in promoting clinical cure in patients with chronic hepatitis B virus(HBV)infection.Methods:Based on patients' preferences and actual treatment records,a retrospective analysis was conducted on 60 patients with chronic HBV infection(HBsAg＜1 500 IU/mL)who attended the Hepatology Department outpatient clinic of the First Affiliated Hospital of Hunan University of Chinese Medicine between April 2024 and February 2025.The patients were divided into two groups according to treatment regimen:the control group received nucleos(t)ide analogues(NAs)plus Peg-IFNα-2b,while the treatment group received additional Fuzheng Jiedu Granules.Both groups were treated for 24 weeks.The HBsAg loss rate,HBsAg seroconversion rate,HBV DNA undetectable rate,and adverse reactions were compared between the two groups.Results:The HBsAg loss rate was 63.3％(19/30)in the treatment group and 30％(9/30)in the control group,showing a statistically significant difference(x2=6.696,P=0.01).The HBsAg seroconversion rate was 33.3％(10/30)in the treatment group and 10％(3/30)in the control group,which was also statistically significant(x2=4.812,P=0.03).The HBV DNA undetectable rate was 91.7％(11/12)in the treatment group and 90％(9/10)in the control group,with no significant difference(x2=0.18,P=0.892).There was no significant difference in the overall incidence of adverse reactions between the treatment group and the control group(83.3％ vs.90％,x2=0.577,P=0.448).Baseline HBsAg levels(P=0.636)and HBV DNA levels(P=0.525)were comparable between the two groups,and no significant differences were observed in clinical characteristics(P＞0.05).Conclusion:The combination of Fuzheng Jiedu Granules and Peg-IFNα-2b significantly improved the clinical cure rate and seroconversion rate in patients with chronic HBV infection.However,there was no significant difference in the overall incidence of adverse reactions between the two groups(P＞0.05),indicating that the combination therapy did not demonstrate a superior safety profile.
李吕豪;张艳萍;彭建平;孙克伟
湖南中医药大学第一附属医院肝病/传染科(湖南 长沙,410007)湖南中医药大学第一附属医院肝病/传染科(湖南 长沙,410007)湖南中医药大学第一附属医院肝病/传染科(湖南 长沙,410007)湖南中医药大学第一附属医院肝病/传染科(湖南 长沙,410007)
医药卫生
慢性HBV感染扶正解毒颗粒聚乙二醇干扰素α-2b临床治愈真实世界研究
chronic HBV infectionFuzheng Jiedu granulespegylated interferon α-2bclinical curereal world study
《中西医结合肝病杂志》 2026 (4)
441-444,4
湖南省自然科学基金(No.2022JJ30458),中医治疗优势病种(临床循证能力提升项目)(No.CZXM-kyb-JBGS-B2-07)
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