九代清源口服液联合拉米夫定治疗慢性乙型肝炎的临床实验研究

Clinical experimental research on the treatment of chronic hepatitis-B with the combination of jiudaiqingyuan oral solution and lamivudine

目的探讨九代清源口服液单用及联合拉米夫定在治疗慢性乙型肝炎(CHB)、清除HBV中的作用。方法选取108例CHB病人,随机分为3组,分别为九代清源口服液治疗组(简称九代组)、拉米夫定治疗组(简称拉米夫定组)和九代清源口服液联合拉米夫定治疗组(简称联合组),每组各36例病人。分别于治疗前、治疗后3、6、9、12个月及随访期第3、6、12个月进行实验室ALT、HBVM和HBVDNA检查。结果治疗12个月和随访12个月时,联合组ALT复常例数、HBVDNA转阴例数、HBeAg转阴例数、HBeAg抗HBe血清转换率和总有效率分别为944%、861%、556%、528%、750%和833%、722%、472%、472%、722%,明显优于九代组和拉米夫定组(均P<005或P<001)。九代组和拉米夫定组比较,疗效相似,各期各指标均无显著性差异(P>005)。结论九代清源口服液单用和联用均有一定的抗HBV作用,与拉米夫定联合治疗CHB病人,疗效大大提高,取得了较好的近期及远期疗效。

Objective:To explore the effect of jiudaiqingyuan oral solution in the treatment of chronic hepatitis-B(CHB) and in the elimination of HBV when used alone and combined with lamivudine.Methods:108 CHB patients were randomly divided into three groups:treatment group with Jiudaiqingyuan Oral Solution (Jiudai group),Lamivudine treatment group (lamivudine group),and treatment group with the combination of Jiudaiqingyuan Oral Solution and lamivudine (combination group),with each group including 36 cases.Laboratory tests were done before treatment,3,6,9 and 12 months after treatment,and at the 3rd,6th and 12th month of follow-up.The laboratory tests consisted of ALT,HBV-M and HBV-DNA.Results:At the 12th month of treatment and 12th month of follow-up,cases with normal ALT conversion cases with negative HBV-DNA conversion,cases with negative HBeAg conversion,HBeAg/anti-HBe serum conversion rate,and total effective rate of the combination group were respectively 94.4%,86.1%,55.6%,52.8%,75.0% and 83.3%,72.2%,47.2%,47.2%,72.2%,which were markedly better than those of Jiudai group or lamivudine group,with significant statistc difference in each index (P<0.05 or P<0.01).The therapeutic effect of Jiudai group was similar to that of lamivudine group,with no significant difference in each index (P<0.05).Conclusion:Jiudaiqingyuan Oral Solution has anti-HBV effect either used alone or combined with lamivudine.The effect of Jiudaiqingyuan Oral Solution is greatly improved when combined with lamivudine in treating CHB patients,with both good short-term and long-term therapeutic effect. [