替诺福韦抗乙型肝炎病毒应答临床相关因素分析

目的探讨真实世界中的富马酸替诺福韦二吡呋酯(TDF)抗乙型肝炎病毒(HBV)应答的相关因素。方法收集2017年至2019年在某院接受某原研TDF片300 mg/d抗HBV治疗的慢性乙型肝炎(CHB)患者的性别、年龄、治疗初治指标乙型肝炎e抗原(HBeAg)、乙型肝炎表面抗原(HBsAg)、HBV DNA、丙氨酸氨基转移酶(ALT)水平]及体内血药浓度等临床资料。按HBeAg水平分为阴性组(<1 IU/mL)、低水平组(1～<50 IU/mL)、中水平组(50～1 000 IU/mL)高水平组(> 1 000 IU/mL)。监测不同组患者血清中的代谢相(服药后约12 h)药物浓度,考察该血药浓度与HBV DNA达标时间的关系;采用Pearson检验对影响因素进行相关性分析。结果 87例患者代谢相血药浓度为(125.29±35.06)ng/mL;HBV DNA由103IU/mL降至<30 IU/mL所需时间为(8.71±6.95)月;HBV DNA 6个月达标率,低、中、高水平组内均存在显著差异(P <0.05),血药浓度在100～150 ng/mL时各组间...

Clinical Related Factors of Anti-HBV Virological Response of Tenofovir

Objective To investigate the related factors of anti-HBV virological response of Tenofovir Disoproxil Fumarate(TDF)Tablets in the real world.Methods The clinical data such as gender,age,initial levels of treatment indicators(levels of HBeAg,HBsAg,HBV DNA,ALT)and blood drug concentration of patients with chronic hepatitis B(CHB)treated with 300 mg/d of original patented TDF Tablets for anti-HBV treatment in a hospital from 2017 to 2019 were collected and divided into the negative group(<1 IU/mL),low-level group(1-<50 IU/mL),medium-level group(50-1000 IU/mL)and high-level group(>1000 IU/mL)according to the HBeAg levels.The blood drug concentration of metabolic phase(about 12 h after administration)in serum of patients in different groups was monitored to investigate the relationship between the blood drug concentration and the time of HBV DNA reaching the standard.Pearson test was used to analyze the correlation of influencing factors.Results The blood drug concentration of metabolic phase in 87 patients was(125.29±35.06)ng/mL.The time required for HBV DNA to decrease from 10³ IU/mL to<30 IU/mL was(8.71±6.95)months.There were significant differences in the percentage of HBV DNA reaching the standard within six months among the low-,medium-and high-level groups(P<0.05),while there were significant differences among the three groups when the blood drug concentration was in the range of 100-150 ng/mL(P=0.001).There were significant differences in the percentage of HBV DNA reaching the standard within six months among patients with different blood drug concentrations(P<0.001),and the percentage of HBV DNA reaching the standard within six months was more than 95%in the patients with blood drug concentration of metabolic phase>150 ng/mL.Pearson correlation analysis showed that the time(months)of HBV DNA reaching the standard was negatively correlated with the blood drug concentration of the metabolic phase(P<0.001),but positively correlated with the initial HBeAg and HBsAg(lg)levels and the patient grouping(P<0.001),and had no correlation with the gender,age,initial HBV DNA and ALT of the included patients(P>0.05).Conclusion The anti-HBV virological response(the time of HBV DNA reaching the target)of TDF Tablets is affected by the blood drug concentration of metabolic phase and the initial HBeAg and HBsAg levels.The higher the blood drug concentration,the shorter the time to reach the standard.The higher the initial HBeAg and HBsAg levels,the longer the time to reach the standard.