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目的比较ETV和ADV治疗核苷初治慢性乙型肝炎患者早期抗病毒疗效;通过12周治疗,探索治疗(ETV或ADV)起始时期HBV动力学应答情况;比较12周时达到HBV DNA临床显著性降低(<104copies/ml)的患者比例;与ADV比较,评价ETV的安全性。方法随机、开放、比较ETV 0.5mg/d,ADV 10mg/d的疗效。在给药的第1～14天、第3、4、6、8、10、12周时对血清HBV DNA进行检测。2个双相模型分别采用了2种治疗:①3-参数样条模型测评斜率;②4-参数指数式衰减模型测评疗效和游离病毒的半衰期。显著性评价依据双侧t检验。结果HBV DNA平均基线为10.45log10copies/ml(ETV)和9.89log10copies/ml(ADV),12周时HBV DNA平均改变值(log10copies/ml),ETV组患者(n=33)为:-6.23,而ADV组患者(n=32)仅为-4.42(P<0.0001)。所有ETV治疗的患者HBV DNA平均至少降低3.88log10copies/ml,ADV治疗的患者仅为0.95log10copies/ml。此外,与ETV相比,ADV治疗组不同患者之间病毒载量下降的差异性较大。治疗导致2组病毒载量出现双相下降,第一相下降迅速,持续10d。由此得出,循环的病毒半衰期为14h(ETV)和26h(ADV)。2个治疗组病毒下降的差异在第10天就体现出来,ETV治疗组病毒下降更低,2组间有显著差异。12周时,52%(17/33)ETV治疗患者HBV DNA低于10000 copies/ml,而ADV组为25%(8/32)。整个研究过程中,2种抗病毒药物耐受性均好,安全性相似。结论治疗HBeAg(+)核苷初治患者,与ADV比较,ETV能迅速、强效降低HBV DNA,显示出更好的抗病毒活性。
Objective To compare the early antiviral efficacy of ETV and ADV in the treatment of nucleoside-naive chronic hepatitis B patients and to explore the dynamic response of HBV during the initial period of treatment (ETV or ADV) by 12-week treatment. The proportion of patients with sexual decline (<104 copies / ml) was compared with ADV to assess the safety of ETV. Methods Randomized, open, compared ETV 0.5mg / d, ADV 10mg / d efficacy. Serum HBV DNA was detected at the first, the fourth and the 14th, the 8th, the 12th, the 12th and the 12th weeks after administration. The two biphasic models were used two kinds of treatment: ① 3-parameter spline model to measure the slope; ② 4-parameter exponential decay model to evaluate the efficacy and free half-life of the virus. Significance assessment based on two-tailed t test. Results The mean baseline HBV DNA was 10.45 log10 copies / ml (ETV) and 9.89 log10 copies / ml (ADV), with an average of 10 log 10 copies / ml at 12 weeks and -6.23 in the ETV group (n = 33) The ADV group (n = 32) was only -4.42 (P <0.0001). HBV DNA was reduced by an average of at least 3.88log10copies / ml in all ETV-treated patients and only 0.95log10copies / ml in ADV-treated patients. In addition, variability in viral load decreased significantly among patients treated with ADV compared to ETV. Treatment resulted in a biphasic decline in viral load in both groups, with the first phase declining rapidly for 10 days. It follows that circulating virus has a half-life of 14 h (ETV) and 26 h (ADV). Differences in virus reduction in the two treatment groups were demonstrated on day 10, with a lower decrease in virus in the ETV treatment group, with significant differences between the two groups. At 12 weeks, 52% (17/33) of ETV-treated patients had HBV DNA less than 10,000 copies / ml compared with 25% (8/32) for ADV. Throughout the study, the two antivirals were well tolerated and similar in safety. Conclusions Compared with ADV, the treatment of patients with newly diagnosed HBeAg (+) nucleosides can rapidly and potently reduce HBV DNA and show better antiviral activity.