【作者】 郑玲； 潘晨； 高海兵；

【Author】 Zheng Ling,PAN Chen,GAO Hai-bing.Fujian Medical University Teaching Hospital(Fuzhou Municipal Hospital of Infection),Fuzhou 350025,China

【机构】 福州市传染病医院；

【摘要】 目的评价国产阿德福韦酯（阿甘定）和进口阿德福韦酯（贺维力）治疗HBeAg阳性的慢性乙型肝炎（CHB）病人的疗效和成本。方法 90例核苷类初治的HBeAg阳性的慢性乙型肝炎病人,分为阿甘定组41例和贺维力组49例,分别接受两种阿德福韦酯10mg/d治疗48周。观察两组病人血清HBV DNA水平、HBeAg和肝脏生化功能的变化。结果两组的人口学及临床特征没有明显差别,具有可比性。经过48周的治疗,贺维力和阿甘定两组病人的血清HBVDNA平均下降幅度分别为4.05 log₁₀拷贝/ml和4.01 log₁₀拷贝/ml,经非参数检验,差异没有统计学意义（P=0.32）;ALT正常化比例分别为93.88%和90.24%,经卡方检验,差异无统计学意义（x²=0.00,P=1.0）;HbeAg消失的比例分别为34.69%和58.54%,HbeAb血清转换率分别为10.2%和19.51%。经卡方检验,阿甘定组HbeAg消失率高于贺维力组,差异有统计学意义（x²=5.12,P=0.034）。两组的HBeAb血清转换率差异无统计学意义（x²=1.57,P=0.21）;在治疗结束时,2组共有3例病人出现了HBV DNA的反跳,其中贺维力组2例,阿甘定组1例。成本一效果分析显示在ALT复常率、HBV DNA阴转率、HBeAg血清转换率3个判定疗效指标中,阿甘定组分别为60.05元、86.74元、338.71元,贺维力组每效果单位成本分别为120.66元、198.25元、1308.24元。说明阿甘定组成本一效果比优于贺维力组。结论 （1）阿甘定和贺维力治疗HbeAg阳性的慢性乙型肝炎病人,两者抗病毒效果和对肝脏生化功能的改善没有区别,阿甘定组治疗48周HbeAg消失率高于贺维力组。（2）阿甘定的成本—效果比显著优于贺维力。更多还原

【Abstract】 Objective To evaluate the efficacy and cost between home made adefovir dipivoxil(AGanDing) and Hepsera in the 48 weeks treatment of HBeAg-positive chronic hepatitis B patients.Methods 90 HBeAg-positive chronic hepatitis B patients who never received nucleos(t)ide analogues treatments ago were recruited for research.They were divided into group AGanDing including 41 case and group Hepsera including 49,and all were administered with adefovir dipivoxil 10 mg once daily for 48 weeks.Meanwhile serum HBV DNA loads,HBeAg and liver functions were observed. Results There were no differences between group AGanDing and group Hepsera in demography and clinical feature.In group Hepsera and group AGanDing At week 48,the median reduction in serum HBV DNA loads,the rate of alanine aminotransferase(ALT) normalization and HBeAg seroconversion were 4.05 and 4.01 log10 copies/ml,93.88%和90.24%,10.2%和19.51%,respectively,which were not statistically significant(P=0.32;x2=0.00,P = 1.0;x2=1.57,P=0.21),but the rate of HBeAg loss in group AGanDing was significantly higher than that in group Hepsera(34.69%vs58.54%,x2=5.12,P =0.034).At the end of treatment,breakthrough in HBV DNA occurred on one patients in group AGanDing and two in group Hepsera.The cost per effect in ALT normalization,HBV DNA negativity and HBeAg seroconversion was 120.66,198.25,1308.24 yuan respectively in group Hepsera,and 60.05,86.74,338.71 yuan respectively in group AGanDing by cost-effect analysis.Conclusions (1)There may be no differences between group AGanDing and group Hepsera in the rate of ALT normalization and HBV DNA negativity,but greater rate of HBeAg loss seems to be observed more offen in group AGanDing than group Hepsera.(2)As far as cost-effect ratio is concerned,group AGanDing may be superior to group Hepsera.更多还原