A Clinical Study on the Use of Propofol Tenofovir in the Treatment of Chronic Hepatitis B
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摘要:
目的 观察慢性乙型肝炎(CHB)患者使用富马酸丙酚替诺福韦(TAF)的临床疗效及肾脏安全性。 方法 选取2018年1月至2020年2月期间在昆明市第三人民医院肝病门诊就诊的180例之前服用TDF抗病毒治疗48周至49周的慢性乙型肝炎患者为研究对象。根据用药的不同将其分为TAF治疗组和TDF治疗组。TAF治疗组患者将既往用TDF患者换用TAF治疗,TDF组患者采用继续用TDF进行治疗。持续用药48周后,对比两组患者的临床疗效和肾功能损伤发生情况。 结果 在持续用药48周时的治疗疗效中,两组HBV-DNA抑制率差异有统计学意义(χ2 = 10.250,P = 0.001),TAF组HBV-DNA抑制率优于TDF组;两组ALT复常率差异有统计学意义(χ2 = 6.871,P = 0.009),TAF组ALT复常率优于TDF组,两组HBeAg血清学转化差异有统计学意义(χ2 = 3.881,P = 0.049),TAF组HBeAg血清学转化优于TDF组;在安全性方面,两组尿α1-微球蛋白异常差异有统计学意义(χ2 = 13.703,P = 0.000),TAF组的尿α1-微球蛋白异常率低于TDF组,血β2微球蛋白检测两组之间差异无统计学意义(P ≥ 0.05)。 结论 TAF治疗组临床疗效明显优于TDF治疗组且对肾脏安全性高于TDF,有较强的抗病毒效力、减少了肾功能损伤等副作用的发生率和降低患者肝硬化和肝癌的风险。 Abstract:Objective to observe the efficacy and safety in the clinic practice of Propofol Tenofavir Fumarate(TAF)as a treatment of Chronic Hepatitis B(CHB) Method A total of 180 Chronic-Hepatitis-B patients who had taken TDF antiviral therapy for 48 to 49 weeks were chosen between January 2018 and February 2020. They were further separated into two groups regarding to the following treatments: one continues TDF treatment while the other replaces with TAF. The comparison was made based on the clinic efficacy and renal safety from such two groups after a 48-week continuous medication. Results TAF group showed a statistical difference significantly better in HBV-DNA inhibition rate, ALT normalization rate, and HBeAg serum conversion with χ2 = 10.250, P = 0.001 and χ2 = 6.871, P = 0.009, and χ2 = 3.881, P = 0.049 respectively. In terms of the safety, TAF group also demonstrates a difference significantly lower in the urinary α1 microglobulin abnormal rate with χ2 = 13.703, P = 0.000. On the other hand, there was no significant difference in bloom β2 microglobulin among the groups owning to P values ≥ 0.05. Conclusion With the statistical comparison between TAF and TDF treatments in this clinic study, TAF is observed to have a stronger antiviral effectiveness, fewer side effects such as less induced harm to the renal function, and reduce the risks deriving from the liver cirrhosis and cancer. -
Key words:
- Chronic Hepatitis B /
- TAF /
- Efficacy /
- Safety
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表 1 TAF组和TDF组治疗前的HBV-DNA、ALT、HBeAg、尿a1-微球蛋白、血β2微球蛋白的基线水平
Table 1. baseline levels of HBV-DNA,alt,HBeAg,urine A1 microglobulin and blood β 2-microglobulin in TAF and TDF groups before treatment
项目 TAF组(n = 90) TDF组(n = 90) F/χ2 P 年龄(岁) 48.19 ± 7.79(26~60) 49.36 ± 8.91(20~60) 0.071 0.790 性别[n(%)] 0.022 0.881 男 47(52.22) 46(50.11) 女 43(47.78) 44(48.89) HBV-DNA(IU/mL) 28468.32 ± 80045.92 23383 ± 73421.64 0.576 0.449 ALT(U/L) 64.08 ± 26.25 56.40 ± 30.62 1.557 0.241 HBeAg(COI) 231.30 ± 478.03 248.97 ± 508.74 0.497 0.482 尿a1-微球蛋白(mg/L) 21.95 ± 18.64 23.22 ± 17.89 0.120 0.730 血β2微球蛋白(mg/L) 2.90 ± 4.14 2.42 ± 1.59 1.876 0.173 表 2 TAF组和TDF组治疗后的HBV-DNA、ALT、HBeAg的疗效评价[n(%)]
Table 2. Efficacy Evaluation of HBV-DNA,ALT and HBeAg in TAF and TDF groups [n(%)]
指标 时间 TAF组(n = 90) TDF组(n = 90) χ2 P HBV-DNA抑制率 12周 68(75.56) 59(65.56) 1.507 0.220 ALT复常率 44(48.89) 36(40.00) 1.440 0.230 HBeAg血清学转化率 10/72(13.89) 7/73(9.56) 1.590 0.207 HBV-DNA抑制率 24周 72(80.00) 61(67.78) 3.484 0.062 ALT复常率 52(57.78) 41(45.55) 2.692 0.101 HBeAg血清学转化率 17/72(23.61) 10/73(13.70) 2.350 0.125 HBV-DNA抑制率 48周 81(90.00) 64(71.11) 10.250 0.001* ALT复常率 62(72.22) 48(53.33) 6.871 0.009* HBeAg血清学转化率 23/72(31.94) 13/73(17.81) 3.881 0.049* 表 3 TAF组和TDF组治疗后尿α1-微球蛋白、血β2微球蛋白的安全评价[n(%)]
Table 3. safety evaluation of urinary A1 microglobulin and blood β 2-microglobulin in TAF and TDF groups after treatment [n(%)]
指标 时间(周) TAF组(n = 90) TDF组(n = 90) χ2 P 尿a1-微球蛋白异常率 12 0 3(3.33) 0.123 血β2微球蛋白异常率 0 0 尿a1-微球蛋白异常率 24 3(3.33) 8(8.89) 0.106 血β2微球蛋白异常率 0 3(3.33) 0.123 尿a1-微球蛋白异常率 48 5(5.55) 23(25.56) 13.703 0.000* 血β2微球蛋白异常率 0 3(3.33) 0.123 -
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