摘要
目的 探究肝复乐胶囊、艾米替诺福韦片联合聚乙二醇干扰素α-2b(Peg-IFN-α-2b)治疗慢性乙型病毒性肝炎(CHB)的临床疗效及对免疫功能的影响.方法 将2019年2月至2023年8月北京大学第一医院太原医院收治的100例CHB患者纳入本次前瞻性研究,并按照随机数字表法将其分为试验组(n=50)和对照组(n=50).对照组患者接受艾米替诺福韦片+Peg-IFN-α-2b治疗,试验组患者接受肝复乐胶囊+艾米替诺福韦片+Peg-IFN-α-2b,两组均治疗24周.比较两组的临床疗效[乙型肝炎病毒(HBV)抗原(HBsAg)清除率、HBVe抗原(HBeAg)转阴率和HBV-DNA转阴率]、治疗前及治疗24周后的肝功能指标[丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、总胆红素和γ-谷氨酰转移酶(GGT)]、免疫功能指标(CD4+、CD8+、CD4+/CD8+比值)和不良反应发生率.结果 试验组的HBsAg清除率和HBeAg转阴率分别为20.00％、40.00％,均高于对照组(6.00％、18.00％),差异均有统计学意义(P＜0.05);两组的HBV-DNA转阴率比较,差异无统计学意义(P＞0.05).治疗24周后,两组的AST、ALT、总胆红素和GGT水平均较治疗前显著下降,且试验组的AST、ALT、总胆红素和GGT水平分别为(38.77±11.05)U/L、(43.95±13.07)U/L、(20.79±6.99)µmol/L、(42.63±12.90)U/L,均低于对照组[(42.69±10.81)U/L、(49.67±12.83)U/L、(24.17+7.05)μmol/L、(46.89±13.14)U/L],差异均有统计学意义(P＜0.05).治疗 24 周后,两组的 CD4+、CD4+/CD8+均较治疗前显著增加,而CD8+较治疗前显著降低,且试验组的CD4+、CD4+/CD8+分别为(41.82±5.63)％、1.36±0.19,均明显高于对照组[(37.80±5.59)％、1.15±0.17],CD8+为(34.02±4.11)％,显著低于对照组[(37.16±4.26)％],差异均有统计学意义(P＜0.05).试验组的总不良反应发生率与对照组比较(34.00％vs.26.00％),差异无统计学意义(P＞0.05).结论 肝复乐胶囊、艾米替诺福韦片联合Peg-IFN-α-2b治疗CHB的临床疗效良好,可显著改善患者肝功能和免疫功能,且安全性较高.
Abstract
Objective To explore the effects of ganfule capsule,tenofovir amibufenamide tablets combined with polyethylene glycol inter-feron α-2b(Peg-IFN-α-2b)in patients with chronic hepatitis B(CHB)and its influence on immune function.Methods A total of 100 CHB patients admitted to Taiyuan Hospital,Peking University First Hospital from February 2019 to August 2023 were included in this prospective study and divided into the experimental group(n=50)and the control group(n=50)according to the random number table method.Patients in the control group received tenofovir amibufenamide tablets+Peg-IFN-α-2b,patients in the experimental group received Ganfule capsule+tenofovir amibufenamide tablets+Peg-IFN-α-2b for 24 weeks.The clinical efficacy[including hepatitis B surfase antigen(HBsAg)clear-ance rate,hepatitis B e antigen(HBeAg)and HBV-DNA conversion rate],liver function indicators[including alanine transaminase(ALT),aspartate transaminase(AST),total bilirubin and gamma glutamyl transpeptidase(GGT)],immune function indicators(including CD4+,CD8+,CD4+/CD8+)before treatment and after 24 weeks of treatment and incidence of adverse reactions were compared between the two groups.Results The HBsAg clearance rate and HBeAg negative conversion rate of the experimental group were 20.00％and 40.00％,respec-tively,which were higher than those of the control group(6.00％and 18.00％),and the differences were statistically significant(P＜0.05);there was no statistically significant difference in HBV-DNA negative conversion rate between the two groups(P＞0.05).After 24 weeks of treatment,the levels of AST,ALT,total bilirubin and GGT in the two groups were significantly lower than those before treatment,and the levels of AST,ALT,total bilirubin and GGT in the experimental group were(38.77±11.05)U/L,(43.95±13.07)U/L,(20.79±6.99)μmol/L,(42.63±12.90)U/L,respectively,which were lower than those in the control group[(42.69±10.81)U/L,(49.67±12.83)U/L,(24.17±7.05)µmol/L,(46.89±13.14)U/L],the differences were statistically significant(P＜0.05).After 24 weeks of treatment,CD4+and CD4+/CD8+in the two groups were significantly higher than those before treatment,while CD8+was significantly lower than that before treat-ment,and CD4+and CD4+/CD8+in the experimental group were(41.82±5.63)％and 1.36±0.19,respectively,which were significantly higher than those in the control group[(37.80±5.59)％and 1.15±0.17],while CD8+was(34.02±4.11)％,which was significantly lower than that in the control group[(37.16±4.26)％],the differences were statistically significant(P＜0.05).There was no statistically significant difference in the incidence of total adverse reactions between the experimental group and the control group(34.00％vs.26.00％)(P＞0.05).Conclusion Ganfule capsule,tenofovir amibufenamide tablets combined with Peg-IFN-α-2b has better clinical efficacy in the treatment for CHB,which can significantly improve liver function and immune function,and has high safety.
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