辨证施治联合拉米夫定序贯治疗慢性乙型肝炎的临床观察

An observation on TCM′s syndrome differentiation plus lamivudine sequential therapy for chronic hepatitis-B

目的 观察辨证施治治疗慢性乙型肝炎丙氨酸转氨酶 (ALT)反跳后再联合拉米夫定的序贯治疗作用。方法 病例为慢性乙型肝炎伴有乙型肝炎病毒 (HBV) DNA阳性、乙型肝炎病毒e抗原 (HBeAg)阳性及ALT≤ 1～ 2正常上限值 (ULN)。序贯治疗第 1步 :治疗组主方随证加减 ,对照组主方不变 ;序贯治疗第 2步 :对治疗中陆续复出ALT >2～ 5ULN反跳且为大三阳 [乙型肝炎病毒表面抗原 (HBsAg)、HBeAg、乙型肝炎病毒核心抗体 (抗 HBc) ]及YMDD未变异者 ,随即在两组中联合拉米夫定继续观察。治疗组 2 3例 ,主方不变对照组 2 0例 ,拉米夫定对照组 2 3例 ,疗程 12个月。检测ALT、HBV DNA、HBeAg、乙型肝炎病毒e抗体 (抗 HBe)及YMDD变异情况。结果 治疗组血清转换率为 6 5 2 % ,明显高于主方不变对照组 35 % (P <0 0 5 )和拉米夫定对照组2 6 1% (P <0 0 1)。治疗组与主方不变对照组合计YMDD变异率 2 3% ,低于拉米夫定对照组 13 0 % (P <0 0 5 )。结论 辨证施治中ALT反跳后再联合拉米夫定的序贯治疗可提高免疫耐受突破发生后的HBeAg血清转换率。联合拉米夫定治疗可降低YMDD变异的发生。

Objective To observe the effects of TCM′s syndrome differentiation for managing chronic hepatitis-B,and of a sequential therapy of the TCM combined with a chemical agent lamivudine being used if any ALT rebound occurred.Methods The cases were chronic hepatitis-B,with positive HBV-DNA,positive HBeAg and ALT≤1～2 ULN (upper limit of normal).At the first step of sequential therapy the treated group received the original recipe with symptomatologic modification,while the control group received the original recipe unchanged;at the second step of sequential therapy the two groups received TCM recipe plus lamivudine if successive occurrence of ALT>2～5 ULN rebounds with “big three-positivity” but YMDD negative.In this study there were 23 cases in the treated group,20 cases in the control group (with original recipe unchanged),and 23 cases in the lamivudine group;the course of treatment covered 12 months.Variations of ALT,HBV-DNA,HBeAg,HBeAb,and YMDD were all detected.Results Seroconversion rate of the treated group was 65.2%,markedly higher than that (35%) of the control group (P<0.05) or that (26.1%) of the lamivudine group (P<0.01).The group who received TCMs had a total YMDD variation rate of 2.3%,lower than that of 13.0% in the lamivudine group (P<0.05).Conclusion The sequential therapy of TCM′s syndrome differentiation for treating chronic hepatitis-B,or its combination with lamivudine (if any ALT rebound occurred) can improve the seroconversion rate of HBeAg after the breakthrough of immunotolerance;the combination with lamivudine can reduce YMDD variation.