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摘要：
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摘要：目的 探讨富马酸丙酚替诺福韦（tenofovir alafenamide fumarate，TAF）初始治疗慢性乙型肝炎
（chronic hepatitis B，CHB）患者的早期疗效。方法 回顾性收集2019年6月至2020年1月于首都医科
大学附属北京佑安医院就诊并使用TAF初始抗病毒治疗的32例CHB患者的临床资料，比较治疗4周、
12周和24周患者丙氨酸氨基转移酶（alanine transaminase，ALT）、HBV DNA、乙型肝炎病毒e抗原
（hepatitis B virus e antigen，HBeAg）和乙型肝炎病毒表面抗原（hepatitis B virus surface antigen，
HBsAg）水平变化。结果 32例患者TAF抗病毒治疗24周，ALT复常率为87.5%（28/32），与12周和基
线相比，HBV DNA [（1.79 ± 0.87）lgIU/ml vs（2.53 ± 0.73）lgIU/ml vs（7.38 ± 0.98）lgIU/ml]显著降
低（F = 415.238，P ＜ 0.001），完全病毒学应答（HBV DNA ＜ 10 IU/ml）率为25.0%（8/32）。其
中20例患者具有基线、4周、12周和24周HBV DNA检测数据，结果表明抗病毒治疗4周时HBV DNA
较基线降幅最大[（3.79 ± 0.98）lgIU/ml vs（7.47 ± 0.71）lgIU/ml]，平均下降3.68 lgIU/ml。共19例患
者具有基线和治疗12周时HBeAg和HBsAg的数据，12周HBeAg [（1.29 ± 1.47）lgCOI vs（2.27 ±
1.18）lgCOI）]和HBsAg [（3.60 ± 0.50）lgIU/ml vs（3.83 ± 0.68）lgIU/ml]较基线显著降低（t =
3.912，P = 0.001；t = 2.403，P = 0.027），HBeAg清除率为26.3%（5/19）。与基线相比，CHB患者治
疗24周时血Cr [（63.86 ± 18.66）μmol/L vs（63.14 ± 19.97）μmol/L]、eGFR [（112.87 ± 17.08）ml/min vs
（113.63 ± 18.40）ml/min]无显著变化，TC [（4.90 ± 0.75）mmol/L vs（4.78 ± 0.75）mmol/L]和LDL-C
[（2.96 ± 0.86）mmol/L vs（2.68 ± 0.79）mmol/L]有升高趋势，TG [（0.96 ± 0.30）mmol/L vs（1.27 ±
0.81）mmol/L]有下降趋势，但差异均无统计学意义（P均＞ 0.05）。结论 TAF初治治疗CHB早期疗效
显著，总体安全性良好。
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Abstract: Objective To investigate the early efficacy of tenofovir alafenamide fumarate (TAF) in initial treatment
of chronic hepatitis B (CHB). Methods The clinical data of 32 CHB patients who received TAF as initial antiviral
therapy in Beijing YouAn Hospital, Capital Medical University from June 2019 to January 2020 were retrospectively
collected. The changes of ALT, HBV DNA, HBeAg and HBsAg in 4 weeks, 12 weeks and 24 weeks after antiviral
treatment were analyzed. Results After 24 weeks of TAF antiviral treatment, the normalization rate of ALT of all 32
patients was 87.5% (28/32). HBV DNA [(1.79 ± 0.87) lgIU/ml vs (2.53 ± 0.73) lgIU/ml vs (7.38 ± 0.98) IgIU/ml]
of patients with CHB was significantly lower than those at 12 weeks and baseline (F = 415.238，P ＜ 0.001),
the complete virological response (HBV DNA ＜ 10 IU/ml) rate was 25.0% (8/32). Among them, 20 patients
had HBV DNA testing results at baseline, 4 weeks, 12 weeks and 24 weeks. Further analysis showed that HBV
DNA at 4 weeks decreased the most compared with the baseline [(3.8 ± 0.98) lgIU/ml vs (7.5 ± 0.71) lgIU/ml],
with an average decrease of 3.68 lg IU/ml. Among the 19 patients with complete data of HBeAg and HBsAg at
baseline and 12 weeks after TAF antiviral treatment, HBeAg [(1.29 ± 1.47) lgCOI vs (2.27 ± 1.18) lgCOI] and
HBsAg [(3.60 ± 0.50) lgIU/ml vs (3.83 ± 0.68) lgIU/ml] at 12 weeks decreased significantly compared with
the baseline (t = 3.912, P = 0.001; t = 2.403, P = 0.027), and the HBeAg clearance rate was 26.3% (5/19).
Compared with baseline, serum Cr [(63.86 ± 18.66) μmol/L vs (63.14 ± 19.97) μmol/L] and eGFR [(112.87 ±
17.08) ml/min vs (113.63 ± 18.40) ml/min] had no significant changes, TC [(4.90 ± 0.75) mmol/L vs (4.78 ±
0.75) mmol/L] and LDL-C [(2.96 ± 0.86) mmol/L vs (2.68 ± 0.79) mmol/L] showed an increasing trend and
TG [(0.96 ± 0.30) mmol/L vs (1.27 ± 0.81) mmol/L] showed a descending trend at 24 weeks after treatment,
however, the differences were not statistically significant (P ＞ 0.05). Conclusions TAF is effective and safe in
the initial treatment of CHB.
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