复方垂盆草胶囊治疗慢性乙型肝炎的疗效及安全性  

Efficacy and safety of compound Sedi Herba capsules in the treatment of chronic hepatitis B

作　　者：尤本明[1] 王志君[1] 潘勇华[1] 尹伟[2] 刘继勇[1] 范文瀚[2] YOU BenMing WANG ZhiJun PAN YongHua YIN Wei LIU JiYong FAN WenHan(Department of Pharmacy, Changhai Hospital, Second Military Medical University, Shanghai 200433, China Department of Infectious Diseases, Changhai Hospital,Second Military Medical University,Shanghai 200433 ,China)

机构地区：[1]第二军医大学长海医院药学部,上海200433 [2]第二军医大学长海医院感染科,上海200433

出　　处：《药学服务与研究》2017年第3期194-197,共4页Pharmaceutical Care and Research

基　　金：上海市中医药发展三年行动计划(ZY3-JSFC-2-1051)

摘　　要：目的:研究复方垂盆草胶囊在慢性乙型肝炎(chronic hepatitis B,CHB)治疗中的有效性及安全性。方法:将104例初治的CHB病人随机分为对照组和治疗组。对照组(n=53)给予口服替比夫定600mg,qd,联合安慰剂4粒/次,tid;治疗组(n=51)给予口服替比夫定600mg,qd,联合复方垂盆草胶囊4粒/次,tid。治疗至12周时,停用复方垂盆草胶囊和安慰剂,继续替比夫定抗病毒治疗。分别观察基线,第2、4、8、12、24、48周等时间点病人的血清学指标动态变化,评价疗效及安全性。结果:两组病人乏力、纳差、尿黄及厌油腻等临床症状在1周内均有明显好转。治疗组病人丙氨酸氨基转移酶(ALT)的下降幅度比对照组在2、4、12、24周更加明显(P<0.05),治疗组病人的乙肝病毒DNA(HBV DNA)阴转率在第2周更高,有统计学差异(P<0.05)。两组病人的乙型肝炎表面抗原(HBsAg)载量中位数在4、12、24、48周逐步下降,在各时间点均无组间差异。治疗期间,两组病人均未出现严重药品不良反应。结论:复方垂盆草胶囊能够显著改善CHB病人肝脏的炎症反应,降低ALT水平,对抗病毒药物的疗效起到辅助作用。Objective：To study the efficacy and safety of compound Sedi Herba capsules in the treatment of chronic hepatitis B（CHB）.Methods：Totally,104 cases of CHB were randomly divided into the control group and the treatment group.Patients in the control group（n=53）were orally given telbivudine 600 mg,qd,combined with placebo 4pills,tid.Patients in the treatment group（n=51）received oral administration of telbivudine 600 mg,qd,combined with compound Sedi Herba capsules 4pills,tid.Compound Sedi Herba capsules and placebo were both withdrawn at the 12 th week,while telbivudine treatment continued.Dynamic changes of biochemical indexes were observed at baseline,2nd,4th,8th,12 th,24th and 48 th weeks,respectively,and efficacy and safety were evaluated.Results：Sympotoms of fatigue,anorexia,jaundice and apositia were all significantly relieved after one-week treatment in the patients of the two groups.The level of ALT in the treatment group was lower than that in the control group at 2nd,4th,12 th and 24 th weeks（P0.05）.HBV DNA negative rate was significantly higher in the treatment group at the 2nd week with statistical significance（P0.05）.Median values of HBsAg were gradually decreased at the4 th,12th,24 th and 48 th weeks in the treatment,but without any significant difference between the two groups.No serious adverse drug reactions were observed in the patients of the 2groups.Conclusion：Compound Sedi Herba capsules could effectively inhibit inflammatory reactions of CHB,reduce the level of ALT and supplement the efficacy of antiviral drugs.

关 键 词：复方垂盆草胶囊 肝炎 乙型 抗病毒治疗 

分 类 号：R978.7[医药卫生—药品]