恩替卡韦分散片治疗乙型肝炎E抗原阴性代偿期慢性乙型病毒性肝炎的临床研究

Clinical trial of entecavir dispersible tablets in the treatment of HBe Ag negative compensated patients with chronic hepatitis B

目的观察恩替卡韦分散片治疗乙型肝炎E抗原(HBe Ag)阴性的代偿期慢性乙型病毒性肝炎(CHB)患者的临床疗效及安全性。方法将95例HBe Ag阴性代偿期CHB患者按血清HBV DNA水平分为对照组42例(低病毒载量,HBV DNA<7.00 log10U·m L^(-1))和试验组53例(高病毒载量,HBV DNA≧7.00log10U·m L^(-1))。2组患者均给予恩替卡韦0.5 mg,qd,空腹口服,连续48周。比较2组患者治疗48周后临床有效率以及药物不良反应(ADR)的发生情况;治疗前和治疗后12周,用放射免疫法检测血清HBV DNA、III型前胶原肽(PCIII);用生化分析仪测定谷丙转氨酶(ALT)水平。结果治疗48周后,试验组和对照组的总有效率分别为83.02%,85.71%,差异无统计学意义(P>0.05)。治疗12周后,试验组和对照组血清HBV DNA、PCIII和ALT水平分别为(4.92±0.78)log10U·m L^(-1),(162.34±13.28)μg·L^(-1),(95.31±12.19)U·L^(-1);(3.89±0.75)log10U·m L^(-1),(140.56±10.42)μg·L^(-1),(79.62±11.91)U·L^(-1),差异均有统计学有意义(均P<0.05)。治疗24,48周后,试验组和对照组的以上指标差异均无统计学意义(均P>0.05)。试验组和对照组ADR发生率分别为7.55%,7.14%,组间差异无统计学意义(P>0.05)。结论恩替卡韦分散片能降低患者HBV DNA水平,减缓肝纤维化进程和改善肝功能,其对不同病毒载量患者在24周以后的远期效果无明显差异,且较为安全。

Objective To observe the clinical efficacy and safety of en- tecavir dispersible tablets in the treatment of HBeAg negative compensated patients with chronic hepatitis B. Methods HBeAg negative com- pensated patients with chronicviral hepatitis type B （CHB）from January 2013 to May 2015 were divided into control group with 42 cases（ low viral load group, HBV DNA 〈 7.00 log10 U · mL- 1 ） and treatment group with 53 cases（high viral load group, HBV DNA≥7. 00 log10U·mL-1）. Two groups received entecavir with 0. 5 mg, qd, fasting oral for 48 weeks. Clinical efficiency and adverse drugs reaction （ADR）were investigated after treatment for 48 weeks. The serum HBV DNA, procollagen type III （PC HI ）were determined by radioimmunoassay. The alanine aminotrans- ferase （ALT） levels was determined by biochemistry analyzer. Results After treatment for 48 weeks, the total effective rate in treatment group and the control group were 83.02% and 85.71%, and the difference was not statistically significant（ P 〉 0. 05 ）. After treatment for 12 weeks, serum levels of HBV DNA, PCIII and ALT in treatment group and control group were （4. 92 ±0. 78）log10U· mL-1, （162.34 ± 13.28） μg· L-1, （95.31± 12. 19） U · L-1 and（3.89 ±0.75） log10 U·mL-1, （ 140. 56 ±10. 42 ） μg · L-1 , （ 79. 62 ± 11.91 ） U · L-1, the differences were statistically significant （ P 〈 0. 05 ）. After treatment for 24 and 48 weeks, the difference of the factors between two groups were not statistically significant（P 〉0. 05）. The incidence of ADR in treatment group and control group were 7.55% and 7. 14% ,the di- fferences were not statistically significant（P 〉 0. 05 ）. Conclusion Entecavir dispersible tablets can reduce serum HBV DNA levels, and relieve liver fibrosis degree of HBeAg - negative compensated patients with chronic hepatitis B ; but there was no significant difference in the long - term effect of the patients with different viral load after 24 weeks and it is safe.