摘要
目的观察拉米夫定（LAM）和阿德福韦酯（ADV）初始联合治疗慢性乙型肝炎和代偿期乙型肝炎肝硬化患者替换为恩替卡韦（ETV）单药治疗的疗效和安全性。方法将接受LAM和ADV初始联合治疗1年以上的慢性乙型肝炎和代偿期肝硬化患者随机均分为2组，一半替换成ETV单药治疗，另一半继续LAM和ADV联合治疗。每3个月检测患者肝脏生物化学指标、肾脏生物化学指标、肾小球滤过率估计值、甲胎蛋白、HBV血清学标志物、血清HBVDNA，每6个月检测尿D2一微球蛋白和视黄醇结合蛋白，随访3年。两组间均数比较用t检验，率的比较用X。检验。结果共收集580例患者资料，290例替换成ETV单药治疗，另外290例继续LAM和ADV联合治疗。替换成ETV组第1、2年和第3年的HBVDNA阴转率分别为77．6％、84．5％和94．5％，而继续LAM和ADV联合治疗组第1、2和第3年的HBVDNA阴转率分别为69．3％，73．4％和80．3％，其中第2年和第3年的HBVDNA阴转率比较，P〈0．05，差异有统计学意义；替换成ETV组3年累计基因耐药发生率为1．4％，而继续联合治疗组累计基因耐药发生率高达8．6％，两组比较，P〈0．05，差异有统计学意义；替换成ETV组患者血肌酐和肾小球滤过率估计值随访3年基本维持基线水平，而继续联合治疗组血清肌酐较基线水平升高，肾小球滤过率估计值则下降；研究结果显示继续联合治疗组和替换成ETV组在1、2、3年时分别有6．2％、12．1％、22．1％和0、0．3％、1．0％的患者肾小球滤过率估计值较基线时下降30％以上，差异有统计学意义妒值均〈0．05）；继续应用联合治疗组第1、2年和第3年时血肌酐较基线上升〉50umol／L的比例分别为1．7％、4．5％、6．6％，而替换成ETV组在第1、2年和第3年数值分别为0，0，0．7％，其中第2年和第3年差异有统计学意义（P〈0．05）；继续应用联合治�
Objective To observe the efficacy and safety of de novo combination of Lamivudine（LAM） and Adefovir Dipivoxil （ADV） therapy counter to Entecavir （ETV） monotherapy in patients with chronic hepatitis B （CHB）- related compensated liver cirrhosis. Methods Patients with chronic hepatitis B-related compensated cirrhosis who were initially treated with LAM and ADV for more than 1 year were randomly assigned to two groups, one half replaced with ETV monotherapy, and the other half continued LAM and ADV co-therapy. Liver biochemistry, renal biochemistry, estimated glomerular filtration rate, alpha-fetoprotein, HBV serology markers and serum HBV DNA were measured every 3 months. Urine [32-microglobulin was measured every 6 months And retinol binding protein, followed up for 3 years. The mean values of the two groups were compared with t-test, and the rate of comparison was analyzed by x2 test. Results A total of 580 cases were collected, 290 cases were replaced with ETV monotherapy, the other 290 patients continued to LAM and ADV combination therapy. In the ETV group, the rates ofHBV DNA negative conversion at 1 year, 2 years and 3 years were 77.6%, 84.5% and 94.5% respectively, while the HBV DNA negative conversion rates at 1, 2 and 3 years in the LAM and ADV combination groups were 69.3%, 73.4% and 80.3% respectively. Among them, the negative rates ofHBV DNA in the second year and the third year were P 〈 0.05, the difference was statistically significant. The 3-year cumulative gene-resistant rate in the ETV group was 1.4%, while the combined treatment was as high as 8.6%, and the difference was statistically significant in the two groups. The estimated value of serum creatinine and glomerular filtration rate in ETV group was followed by 3 years, and the baseline level was maintained, in the same group, the serum creatinine was higher than baseline, and the estimated value of glomerular filtration rate decreased. The results showed that there were 6.2%, 12.1%, 22.1% and 0, 0.3%, 1%, respectively, in 1, 2
出处
《中华肝脏病杂志》
CAS
CSCD
北大核心
2018年第2期113-118,共6页
Chinese Journal of Hepatology
关键词
肝炎
乙型
慢性
拉米夫定
治疗结果
安全
Hepatitis B, chronic
Lamivudine
Treatment outcome
Safety
