补肾健脾胶囊治疗慢性乙肝病毒携带者的随机双盲实验

A Randomized Double-blind Placebo-controlled Clinical Trial on a Chinese Herbal Formula (Invigorating the Kidney and the Spleen Gelatin Capsule) in the Treatment of Chronic Hepatitis B Virus Carriers

目的:观察补肾健脾胶囊对慢性乙肝病毒携带者的抗病毒作用。方法:采用随机、双盲、安慰剂对照的研究方法。90例慢性乙肝病毒携带者均为HBeAg阳性,HBV DNA定量大于107 copies/mL,ALT水平男性在30～40 IU/mL,女性在20～40U.mL-1。被随机分成2组,试验组60例,对照组30例。试验组接受补肾健脾胶囊治疗,对照组接受安慰剂治疗,每次4粒,每日3次,疗程48周。观察血清HBV DNA定量、血清乙肝标志物(HBsAg,HBsAb,HbeAg,HBeAb,HbcAb)、肝功能(ALT,AST,GGT,TBil)的变化,以及血常规、大便常规、尿常规、肾功能、心电图等安全性指标的情况,分别于治疗前及第48周各检查1次。结果:治疗后,试验组的血清HBV DNA定量下降水平中位数为3.4 log 10 copies/mL,而对照组为0.1 log 10 copies/mL(P<0.01)。60例试验组患者中有13例(21.7%)血清HBV DNA水平下降至3 log 10 copies/mL以下,而30例安慰剂对照组患者中仅观察到1例(3.3%)(P<0.01)。试验组的HBeAg阴转率为20%(12/60),对照组为3.3%(1/30)(P<0.01)。在血清HBeAg/HBeAb转换率方面,试验组为15%(9/60),对照组为0%(0/30),两组比较,差异显著(P<0.05)。结论:补肾健脾胶囊能有效抑制乙肝病毒复制,并增加血清HBeAg转化率,可用于慢性乙肝病毒携带者的治疗。

Objective：The aim of this study is to investigate the anti-viral effects of a Chinese Herbal Formula（invigorating the kidney and the spleen gelatin capsule） in treating chronic hepatitis B Virus carriers.Method：This was a randomized,double-blind,placebo-controlled study.90 patients enrolled in the study who were satisfied with the following criteria：presence of hepatitis B surface antigen and hepatitis B e antigen,HBV DNA level greater than 7 log 10 copies /mL,and normal alanine aminotransferase level（30 ～ 40 U·mL^-1 for male,and 20 ～ 40 U·mL^-1 for female）.They were randomly divided into trial group（n = 60） and control group（n = 30）.During the trial period,patients in both trial group and control group received medication invigorating the kidney and the spleen gelatin capsule and a placebo for 48 weeks respectively,4 capsules per time,3 times perday.The serum HBV DNA level,serum markers of HBV（HBsAg,HBsAb,HbeAg,HBeAb,HbcAb） and serum biochemistry of liver functions（ALT,AST,GGT,TBil） were measured at the before and 48th week of the treatment.And the indexes of safety,such as blood analysis,stool analysis,urinalysis,renal functions and electrocardiogram were also detected.Result：After treatments,the median decrease in serum HBV DNA levels was 3.4 log 10 copies /mL in the trial group and 0.1 log 10copies /mL in the control group（P 0.01）.Serum HBV DNA 3log 10copies /mL was observed in 13 of the 60 subjects（21.7%） in the trial group and 1 of the 30 subjects（3.3%） in the placebo group（P 0.01）.The proportion of patients with HBeAg loss was 20%（12 /60） and 3.3%（1 / 30） respectively in the trial group and control group（P 0.01）.The ratio of HBeAg seroconversion to anti-HBe was 15%（9 /60） in the trial group and 0%（0 /30） in the control group（P 0.05）.Conclusion：Invigorating the kidney and the spleen gelatin capsule is effective in inhibiting the copy of hepatitis B virus and increase the ratio of HBeAg seroconversion,which can be used to treat Chronic Hepatitis B Virus carriers.