摘要
目的评价恩替卡韦对重庆地区拉米夫定治疗失效的CHB患者3年的疗效和安全性。方法选取拉米夫定治疗失效的CHB患者32例，其中恩替卡韦组28例（剂量1．0mg／d），安慰剂组4例。完成12周的双盲治疗后，所有患者均接受开放的恩替卡韦1．0mg／d，持续治疗至168周。定期检测血清HBV DNA水平、HBeAg、抗-HBe和肝功能的变化隋况。结果在接受恩替卡韦治疗后，患者血清HBV DNA水平对数值的均数在2周内由9．14log10拷贝／ml迅速下降至6．72log10拷贝／ml，其后持续平稳下降，4、8、12、24、48周分别下降至6．28log10、5．46log10、5．10log10、4．49log10、4．41log10拷贝／ml，至96周时下降至3．91log10拷贝／ml，其后下降速度减慢，至144周和168周时分别为4．05log10、4．21log10拷贝／ml。HBVDNA〉10^5拷贝／ml的百分比治疗前为100％，随着服药时间的延长逐渐下降，在12周时下降至46．43％，其后仍逐渐下降，到96周时仅为17．86％。与其相反，HBV DNA〈10^3拷贝／ml的百分比在治疗前为0，从第8周开始逐渐上升（7．14％），12周时为10．71％，尤其在96周明显上升至46．43％，到168周时为57．14％。168周末HBeAg阴转率为10．07%。服用恩替卡韦后ALT下降较迅速，12周后均数达正常水平，且3年内持续低于40U／L。3年治疗期间，患者不良事件发生率为21％，有1例发生严重不良事件。结论恩替卡韦治疗拉米夫定失效的CHB患者，可明显抑制HBV DNA复制，HBV DNA水平降低迅速且持久;能促进ALT复常，使用安全，耐受性良好。
Objective To evaluate the efficacy and safety of entecavir （ETV） in treating lamivudine refractory chronic hepatitis B （CHB） patients. Methods This was part of a multicenter, double-blinded, randomized （4 ： 1） and placebo-controlled trial comparing the safety and efficacy of ETV （1.0 mg once q.d.） for 12 weeks in lamivudine refractory CHB patients. All patients were treated with ETV （1.0 mg q.d.） for 168 weeks. During the treatment period, HBV DNA levels were regularly measured by quantitative PCR. Liver function tests, HBV serology and safety assessments were also conducted. Results The mean of HBV DNA log10 decreased from 9.14 to 6.27 at week 2, decreased to 6.28 at week 4, to 5.46 at week 8, to 5.10 at week 12, to 4.49 at week 24, to 4.41 at week 48, to 3.91 at week 96, to 4.05 at week 144, and decreased to 4.21 at week 168. The proportion of HBV DNA〉105 copies/ml gradually dropped from 100% at baseline to 46.43% at week 12 and to 17.86% at week 96. HBV DNA〈10^3 copies/ml raised from 0 at baseline to 7.14% at week 8, to 10.71% at week 12, to 46.43% at week 96, and raised to 57.14% at week 168. The proportion with HBeAg seroconversion was 10.07% at the end of the study. The mean of ALT became normal at week 12 and remained normal throughout week 168. There was one patient who had a severe adverse event during the trial. Conclusion ETV can effectively inhibit the replication of HBV DNA and normalize the levels of ALT in lamivudine refractory CHB oatients, and from our study we think the use of ETV is safe.
出处
《中华肝脏病杂志》
CAS
CSCD
北大核心
2007年第1期13-15,共3页
Chinese Journal of Hepatology
