五灵胶囊联合恩替卡韦治疗慢性乙型肝炎的临床疗效  

Clinical efficacy of Wuling Capsule combined with Entecavir for chronic hepatitis B patients

作　　者：周晓元 罗润齐[1] 万蕾 王俊洁 张宿荣 许晓明 叶晓光[1] ZHOU Xiaoyuan;LUO Runqi;WAN Lei;WANG Junjie;ZHANG Surong;XU Xiaoming;YE Xiaoguang(Department of Infectious Diseases,the Second Affiliated Hospital of Guangzhou Medical University,Guangzhou 510260,China)

机构地区：[1]广州医科大学附属第二医院感染病科,广州510260

出　　处：《实用医学杂志》2021年第22期2939-2945,共7页The Journal of Practical Medicine

基　　金：广州市卫生和计划生育科技项目西医类一般引导项目(编号:20181A011075,20171A011305);广州医科大学青年科研基金资助项目(编号:52010202-0940)。

摘　　要：目的评价五灵胶囊联合恩替卡韦对慢性乙型肝炎(CHB)患者的临床疗效。方法回顾性收集广州医科大学附属第二医院2019年4月至2020年9月期间诊治的CHB患者117例,随机分为观察组62和对照组55例,给予对照组恩替卡韦分散片(ETV)0.5 mg口服,1次/d,观察24周;观察组在对照组治疗的基础上,给予口服五灵胶囊1.75 g口服,3次/d,观察24周。测定两组患者治疗前后生物化学和病毒学指标。采用重复测量方差分析比较0、4、12、24周肝功能水平的差异,同时采用t检验、Mann-Whitney U检验、χ^(2)检验比较观察组与对照组肝功能指标的复常率、肝纤维化指标、HBV-DNA和HBeAg转阴率的差异,logistic回归分析评估肝功能复常的因素,生存分析Kaplan-Meier分析ALT累积复常中位时间。结果观察组在治疗4、12、24周末,肝功能指标:ALT、AST水平均显著低于对照组(P <0.05),其中4周末ALT、AST水平下降最为明显;观察组治疗24周末TBIL水平及肝纤维化指标(HA、LN、IV-C、PIIINP)显著低于对照(P <0.05);观察组治疗24周末ALT、AST、TBIL复常率分别为90.3%、80.6%、48.3%均高于对照组43.6%、32.7%、10.9%(P <0.05);观察组是ALT、AST、TBIL复常的保护因素[OR(ALT)=12.056,P<0.05;OR(AST)=8.56,P<0.05;OR(TBIL)=2.58,P<0.05];HBV-DNA及HBeAg低于检测下限的比率比较差异均无统计学意义(χ^(2)=3.81,P> 0.05;χ^(2)=2.23,P> 0.05);观察组与对照组的ALT累积复常中位时间分别为24周和36周(P<0.05)。结论五灵胶囊联合ETV治疗CHB患者,可以实现更快更好的肝功能恢复,为优化现有临床药物的重新组合提供了有效的新证据。Objective To evaluate the efficacy of Entecavir(ETV)combined with Wuling Capsule for chronic hepatitis B(CHB)patients. Methods Data of 117 CHB patients were collected from the Second Affiliated Hospital,Guangzhou Medical University from April 2019 and September 2020. Sixty-two patients received ETV0.5 mg/d + Wuling Capsule 1.75 g/d(treatment group)and 55 patients received ETV 0.5 mg/d(control group)for24 weeks. Biochemical and virological indexes during the treatment were collected. The differences of liver function indexes at baseline,the 4 thweek,the 12 thweek,and the 24 thweek were studied by repeated measures analysis of variance,while the differences in the normalization rate of liver function,decrease of liver fibrosis,HBV DNA negative conversion rates and HBeAg negative conversion rates between treatment group and control group were evaluated by independent samples t test,Mann-Whitney U test,and chi-square test. The factors of normalization of liver function was evaluated by logistic regression. The median time to cumulativly achieve normal ALT level was evaluated by Kaplan-Meier. Results The decrease of ALT,AST level at the 4 thweek,the 12 thweek,and the 24 th week after treatment was statistically significant when compared with that of the control group(P < 0.05). The most significantly decrease of ALT,and AST level occurred at the 4 thweek. The decrease of TBIL level and liver fibrosis(HA,LN,IV-C and PIIINP levels)were statistically significant when compared with the control group(P < 0.05).In treatment group,the ALT,AST and TBIL normalization rate at the 24 thweek was 90.3%,80.6% and 48.3%respectively,significantly higher than that of the control group(P < 0.05). Logistic regression analysis found that the treatment group was protective factor correlated with ALT,AST and TBIL normalization rate(ORALT=12.056,P<0.05、OR AST = 8.56,P<0.05,ORTBIL=2.58,P<0.05). HBV DNA negative conversion rate and HBeAg negative conversion rate in the treatment group were not statistically significant when compared with th

关 键 词：慢性乙型肝炎 恩替卡韦 五灵胶囊 肝功能 抗病毒 

分 类 号：R512.62[医药卫生—内科学]