补肾健脾方对聚乙二醇干扰素α-2b在慢性乙型肝炎临床治愈过程中不良反应的影响

Effect of kidney-tonifying and spleen-invigorating prescription on adverse reactions caused by pegylated interferonα-2b during clinical cure of chronic hepatitis B

目的:观察补肾健脾方对核苷(酸)类似物(NAs)联合或序贯聚乙二醇干扰素α-2b(PEG-IFNα-2b)治疗慢性乙型肝炎(CHB)患者过程中不良反应的干预效果。方法:将44例CHB患者随机分为治疗组和对照组,每组各22例。对照组予以NAs联合或序贯PEG-IFNα-2b治疗,治疗组在对照组治疗的基础上加用补肾健脾方治疗。比较2组治疗前及治疗第4、8、12周的血常规[白细胞计数(WBC)、中性粒细胞计数(N)、血小板计数(PLT)]及肝功能[丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、γ-谷氨酰转肽酶(GGT)]情况;治疗第1、2、4周的常见不良反应中医证候总积分,治疗期间严重不良事件发生率(甲状腺功能异常、情绪异常),PEG-IFNα-2b的减量及停药例数。结果:治疗组治疗第4、8、12周WBC、N、PLT、ALT、AST等指标均优于对照组(P<0.05),且其治疗第1、2、4周不良反应中医证候总积分、治疗期间严重不良事件发生率、PEG-IFNα-2b减量例数及停药例数均少于对照组(均P<0.05)。结论:补肾健脾方能降低NAs联合或序贯PEG-IFNα-2b治疗CHB患者的不良反应发生率,改善肝功能,减少不良事件导致的减量或停药情况。

Objective:To investigate the interventional effect of kidney-tonifying and spleen-invigorating prescription on adverse reactions in chronic hepatitis B(CHB)patients during treatment with nucleos(t)ide analogues(NAs)combined with or followed by pegylated interferonα-2b(PEG-IFNα-2b).Methods:A total of 44 CHB patients were randomly divided into treatment group and control group,with 22 patients in each group.The patients in the control group were given NAs combined with or followed by PEG-IFNα-2b,and those in the treatment group were given kidney-tonifying and spleen-invigorating prescription in addition to the treatment in the control group.The two groups were compared in terms of routine blood test results(white blood cell count[WBC],neutrophil[N],and platelet count[PLT])and liver function(alanine aminotransferase[ALT],aspartate aminotransferase[AST],and gamma-glutamyl transpeptidase[GGT])before treatment and at weeks 4,8,and 12 of treatment,total traditional Chinese medicine(TCM)syndrome score of common adverse reactions at weeks 1,2,and 4 of treatment,the incidence rate of serious adverse events(thyroid dysfunction and mood disorders)during treatment,and the number of cases with PEG-IFNα-2b dose reduction and withdrawal.Results:Compared with the control group,the treatment group had significantly better WBC,N,PLT,ALT,and AST at weeks 4,8,and 12 or treatment(P<0.05),as well as significantly lower total TCM syndrome score of adverse reactions,incidence rate of serious adverse events,and number of cases with PEG-IFNα-2b dose reduction and withdrawal(all P<0.05).Conclusion:For CHB patients treated with NAs combined with or followed by PEG-IFNα-2b,kidney-tonifying and spleen-invigorating prescription can reduce the incidence rate of adverse reactions,improve liver function,and reduce dose reduction or drug withdrawal caused by adverse events.