凯因益生伴侣颗粒在重组人干扰素α2b联合核苷类抗病毒药物治疗慢性乙型肝炎中的辅助治疗作用

摘要

目的 观察凯因益生伴侣颗粒在重组人干扰素α2b联合核苷类抗病毒药物治疗慢性乙型肝炎( CHB)中的辅助治疗作用. 方法 将128例确诊的CHB患者随机分为2组. 治疗组( n=63):给予重组人干扰素α2b注射液300万IU皮下注射,每日1次,连续4周,之后改为2日1次,持续20周;阿德福韦酯10 mg口服,每日1次,持续48周,凯因益生伴侣颗粒4.5 g口服,每日2次,持续24周. 对照组( n=65):重组人干扰素α2b注射液联合阿德福韦酯,用法同治疗组. 治疗24 周时比较2组血小板计数( PLT)、肝功能、HBV血清学标志物、HBV DNA定量及HBV DNA转阴率. 结果 治疗24 周时,2 组PLT、肝功能均比治疗前改善( P<0.01),HBsAg、HBeAg及HBV DNA水平均比治疗前明显降低(P<0.01). 治疗24周时,治疗组丙氨酸氨基转移酶(ALT)、HB-sAg、HBeAg的水平均低于对照组(P<0.01),PLT水平高于对照组(P<0.01),2 组间HBV DNA水平及HBV DNA转阴率差异无统计学意义(P>0.05). 治疗组和对照组不良反应发生率分别为4.76%和9.23%,差异无统计学意义( P>0 .05 ). 结论 凯因益生伴侣颗粒在重组人干扰素α2 b联合阿德福韦酯治疗CHB中具有辅助治疗作用.%Objective To observe the assistant therapeutic efficacy of Kaiyinyisheng partner particles ( trade name for a compound preparation of traditional Chinese medicine, main ingredients:A stragalus propinquus, Ganoderma, Radix Salviae Miltiorrhizae, Radix Paeoniae Alba, taurine, Pericarpium Citri Reticulatae, and Fructus Crataegi, etc) in recom-binant human interferonα2b combined with nucleoside antiviral drugs for the treatment of chronic hepatitis B (CHB). Methods A total of 128 patients with CHB were randomly divided into 2 groups.The treatment group ( n=63) received recombinant human interferonα2b injection at 3 ×106 IU· d-1 , im, for 4 weeks and then at 3 ×106 IU, im, once every other day for 20 weeks.Adefovir dipivoxil was given orally at 10 mg qd for 48 weeks.At the same time, 63 patients were given Kaiyinyisheng partner particles at 4.5 g 2 times a day for 24 weeks.The control group ( n=65) were treated with recombinant human interferon α2b injection and adefovir dipivoxil in the same way as treatment group.The platelet count, liver function, the levels of serological markers of hepatitis B virus ( HBV) and HBV DNA, as well as the nega-tive rate of HBV DNA were observed after treatment for 24 weeks.Results After 24 weeks of treatment, all patients in both groups were improved in platelet count and liver function compared with before treatment ( P<0.01).HBsAg, HBeAg, and HBV DNA levels were significantly lowered in both groups compared with before treatment (P<0.01).Af-ter 24 weeks of treatment, the levels of ALT, HBsAg, and HBeAg in the treatment group were lower than in the controlgroup (P<0.01), while the PLT level was higher than in the control group (P<0.01);no significant statistical differ-ences of HBV DNA level and the negative rate of HBV DNA were found between the 2 groups (P>0.05).The rate of adverse reaction was 4.76%and 9.23%, respectively in the treatment group and control group,no significant differences were found between the 2 groups (P>0.05).Conclusion Kaiyinyisheng partner particles has assistant therapeutic effi-cacy in recombinant human interferonα2b combined with adefovir dipivoxil for the treatment of CHB.