Tang Bo-zong, Li Man, Gao Yue-qiu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Key Laboratory of Liver and Kidney Diseases of Ministry of Education, Shanghai.
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2010 Aug;30(8):823-7.
To study the effect of Yidu Recipe (YDR) in treating patients of chronic hepatitis B (CHB) with positive hepatitis B e-antigen (HBeAg) and its influence on the quantity and function of T-cell subsets.
Fifty-seven CHB patients measured up the inclusive criteria were randomly assigned to the control group and the treated group, treated respectively by entecavir alone and entecavir + YDR for 6 months. Changes of alanine a minotransferase (ALT), aspartate a minotransferase (AST), HBV-DNA, HBV-M, interleukin-4 (IL-4) and Chinese medicine syndrome score, as well as amounts of natural killer (NK) T cell, gamma-interferon (gamma-IFN), Th1, Th2, Tc1 and Tc2 cells in peripheral blood (detected by flow cytometry) before and after treatment were observed. And the liver function normalization rate, negative inversion rates of HBV-DNA and HBeAg were estimated at terminal of the trial.
Seven cases were dropped out in the observation period. Compared with the control group, levels of ALT, AST, HBV-DNA and Chinese medicine syndrome score were lower after treatment (P < 0.05), and liver function normalization rate was higher in the treated group, while the difference between groups in negative inversion rates HBV-DNA and HBeAg were insignificant (P > 0.05). Amount of IFN-gamma increased, IL-4 reduced, and Tc1 cell raised after treatment, which led to the rise of Tcl/Tc2 ratio in both groups; while in the treated group, in addition to the above-mentioned changes, the Th1 cell was increased also, and thus to make elevation of Th1/Th2 ratio (P < 0.05).
The efficacy of entecavir + YDR in treating HBeAg positive CHB patients is better than that of entecavir alone. YDR can effectively improve patients' liver function, inhibit HBV-DNA replication and improve clinical symptoms, its action may be realized by way of increasing the amount of NKT cells, inducing increase of IFN-gamma and decrease of IL-4 secretions, and regulating the balance between Th1/Th2 and Tc1/Tc2.
研究益督方（YDR）治疗乙肝e抗原（HBeAg）阳性慢性乙型肝炎（CHB）患者的疗效及其对T细胞亚群数量和功能的影响。
将57例符合纳入标准的CHB患者随机分为对照组和治疗组，分别给予恩替卡韦单药及恩替卡韦+YDR治疗6个月。观察治疗前后丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、HBV-DNA、乙肝病毒标志物（HBV-M）、白细胞介素-4（IL-4）及中医证候积分变化，以及外周血自然杀伤（NK）T细胞、γ干扰素（γ-IFN）、Th1、Th2、Tc1和Tc2细胞数量（采用流式细胞术检测）。并在试验结束时评估肝功能正常化率、HBV-DNA和HBeAg阴转率。
观察期间脱落7例。治疗后，治疗组ALT、AST、HBV-DNA水平及中医证候积分低于对照组（P<0.05），肝功能正常化率高于对照组，而两组HBV-DNA和HBeAg阴转率差异无统计学意义（P>0.05）。治疗后两组IFN-γ数量增加、IL-4减少、Tc1细胞升高，导致Tcl/Tc2比值升高；而治疗组除上述变化外，Th1细胞也增加，从而使Th1/Th2比值升高（P<0.05）。
恩替卡韦+YDR治疗HBeAg阳性CHB患者的疗效优于恩替卡韦单药。YDR可有效改善患者肝功能，抑制HBV-DNA复制，改善临床症状，其作用可能通过增加NKT细胞数量、诱导IFN-γ分泌增加及IL-4分泌减少、调节Th1/Th2和Tc1/Tc2之间平衡来实现。
