重组细胞因子基因衍生蛋白与干扰素α-2b分别联合恩替卡韦治疗HBeAg阳性慢性乙型肝炎患者疗效研究

Comparison of response to recombinant cytokine gene-derived protein or human interferonα-2b and entecavir combination in the treatment of patients with serum HBeAg positive chronic hepatitis B

目的观察比较应用重组细胞因子基因衍生蛋白或干扰素α-2b分别联合恩替卡韦治疗血清HBeAg阳性的慢性乙型肝炎(CHB)患者的疗效.方法2019年3月~2021年3月我院诊治的65例血清HBeAg阳性的CHB患者被分成两组,分别给予干扰素α-2b联合恩替卡韦治疗或重组细胞因子基因衍生蛋白联合恩替卡韦治疗48 w.常规检测血清生化学、血清学和病毒学指标.结果在治疗12 w末,恩替卡韦联合重组细胞因子基因衍生蛋白治疗组血清HBeAg转阴率和HBeAg血清转换率分别为34.4%和25.0%,均显著高于恩替卡韦联合干扰素α-2b治疗组的9.1%和6.1%,差异有统计学意义(P<0.05);在治疗48 w末,恩替卡韦联合重组细胞因子基因衍生蛋白治疗组血清ALT复常率、血清HBeAg转阴率和HBeAg血清转换率分别为87.5%、62.5%和40.6%,均显著高于恩替卡韦联合干扰素α-2b治疗组的78.8%、30.3%和18.2%,差异有统计学意义(P<0.05);在治疗期间,联合干扰素治疗组乏力和发热头痛发生率分别为21.2%和84.9%,显著高于联合衍生蛋白治疗组的3.1%和3.1%(P<0.05),而两组中性粒细胞减少、血小板减少、食欲下降和低钙血症等不良反应发生率比较差异无统计学意义(P>0.05).结论相比于干扰素α-2b联合恩替卡韦,应用重组细胞因子基因衍生蛋白联合恩替卡韦治疗血清HBeAg阳性的CHB患者能够获得更好的血清学转换率和较小的不良反应,值得进一步观察研究.

Objective The aim of this study was to compare the antiviral efficacy of recombinant cytokine gene-derived protein(RCGDP)or human interferonα-2b and entecavir combination in the treatment of patients with serum HBeAg positive chronic hepatitis B(CHB).Methods 65 patients with serum HBeAg-positive CHB were recruited in our hospital between March 2019 and March 2021,and were divided into two groups.The interferonα-2b and entecavir combination were given in 33 patients and the RCGDP and entecavir combination were given in 32 patients with CHB.The regimen lasted for 48 weeks in both groups.Serum alanine aminotransferase(ALT)levels,HBV DNA loads and serum HBeAg seroconversion were recorded.Results At the end of 12 week treatment,serum HBeAg negative and HBeAg seroconversion rates in patients receiving entecavir and RCGDP combination were 34.4%and 25.0%,both significantly higher than 9.1%and 6.1%in patients receiving entecavir and interferonα-2b combination therapy(P<0.05);at the end of 48 week treatment,serum ALT normalization,serum HBeAg negative and HBeAg seroconversion rates in patients receiving entecavir and RCGDP combination were 87.5%,62.5%and 40.6%,all significantly higher than 78.8%,30.3%and 18.2%in patients receiving entecavir and interferonα-2b combination therapy(P<0.05);during the treatment period,the incidences of fatigue,and fever and headache in entecavir and interferonα-2b combination-treated patients were 21.2%and 84.9%,both significantly higher than 3.1%and 3.1%(P<0.05)in entecavir and RCGDP combination–treated patients,while there were no significant differences as respect to the incidences of neutropenia,thrombocytopenia,decreased appetite,and hypocalcemia between the two groups(P>0.05).Conclusion The administration of recombinant cytokine gene-derived protein and oral entecavir combination is efficacious in treatment of patients with serum HBeAg positive CHB,with a high HBeAg seroconversion and less untoward effects,as compared with interferonα-2b and entecavir combination therapy,which needs further multi-central clinical investigation.