摘要
目的:研究疏肝健脾中药对替比夫定治疗HBeAg阳性慢性乙型肝炎肝郁脾虚证的抗病毒疗效及肌酸激酶的影响.方法:将符合入组条件的90例病例,随机分为治疗组45例和对照组45例.治疗组予疏肝健脾中药联合替比夫定治疗;对照组予替比夫定单药治疗.两组用药疗程均为52wk.观察和比较两组患者的中医证侯积分、生物化学应答、病毒学应答、HBeAg血清学应答、血清CK水平等.结果:共有81例(治疗组41例,对照组40例)患者完成52wk的研究.两组患者年龄、性别、基线ALT水平、HBVDNA对数值、中医证侯积分比较,均无统计学差异(P>0.05).临床证侯疗效方面治疗组总有效率优于对照组(90.24%vs70.00%,P<0.01).治疗组在中医证侯缓解、生物化学应答、病毒学应答、HBeAg血清学应答方面均优于对照组(P<0.05).本研究没有原发无应答患者,共有5例出现病毒学突破,均发生在对照组,与治疗组比较,有统计学差异(P<0.05).不良反应方面两组均有患者CK升高,其中治疗组18例,占43.9%;对照组30例,占75%,两组比较有显著差异(P<0.01).结论:疏肝健脾中药可提高替比夫定治疗肝郁脾虚型HBeAg阳性慢性乙型肝炎的抗病毒疗效,减少血清肌酸激酶的异常率.
AIM： To study the influences of liver-soothing and spleen-strengthening traditional Chinese medicine on the efficacy and safety of telbivu-dine in the treatment of HBeAg-positive chronic hepatitis B patients with liver-qi stagnation and spleen-qi deficiency syndrome. METHODS： Ninety patients were enrolled and randomly divided into treatment group （n = 45） and control group （n = 45）. The control group received telbivudine monotherapy, while the treatment group was treated with liver-soothing and spleen-strengthening traditional Chinese medicine and telbivudine. The treatment lasted 52 weeks. The traditional Chinese medicine syn- drome score, biochemical response, virological response, serological response, creatine kinase level, and adverse reactions in two groups were observed and compared. RESULTS： A total of 81 patients （41 in the treat- ment group and 40 in control group） completed the 52-week study. There were no significant differences in gender, age, baseline HBV DNA or ALT levels between the groups before treat- ment （all P 〉 0.05）. After treatment, mitigation in the traditional Chinese medicine syndrome score, biochemical response, virological re- sponse, HBeAg serological responses was more significant in the treatment group than in the control group （all P 〈 0.05）. No primary treat- ment failure occurred. Five patients had viro- logical breakthrough, and all cases occurred in the control group. The percentage of patients with elevated CK was significantly lower in the treatment group than in the control group （43.9% vs 75.0%, P 〈 0.01）. CONCLUSION： Liver-soothing and spleen- strengthening traditional Chinese medicine can increase the efficacy and decrease the incidence of elevated creatine kinase in HbeAg-positive chronic＇hepatitis B treated with telbivudine.
出处
《世界华人消化杂志》
CAS
北大核心
2011年第21期2279-2284,共6页
World Chinese Journal of Digestology
基金
四川省科技厅重大科技招标基金资助项目
No.310312
国家"十一五"科技重大专项课题基金资助项目
No.2009ZX10005-019
No.2009ZX10005-020~~
关键词
疏肝健脾中药
替比夫定
中西医结合疗法
慢性乙型肝炎
HBEAG
肝郁脾虚证
随机对照临床研究
Liver-soothing and spleen-strengthen-ing traditional Chinese medicine
Telbivudine
Inte-grated traditional Chinese and Western medicine
Chronic hepatitis B
HBeAg
Liver-qi stagnation andspleen-qi deficiency
Randomized controlled trial
