Objective: To evaluate the predictive value of CD4+ CD25 + regulatory T cells for HBeAg seroconversion of chronic hepatitis B and intervention effect of the Baihua Xianglian detoxification formula. Methods: Two hundred and forty patients with HBeAg positive chronic hepatitis B were randomly divided into experimental and control group, and the control group were given adefovir capsules l0mg, day 1, the experimental group on the basis of the control group were given Baihua Xianglian detoxification formula, 2 times daily for 48 weeks . Twenty healthy volunteers were recruited as the normal control group. The ratio of CD4 + CD25+ Tregs/CD4+ in peripheral blood mononuclear cells (PBMC) detected by flow cytometry and HBeAg/HBeAb de-rntected by ELISA. Results: ①HBeAg seroconversion: The treatment of 48 weeks there were 40 cases occur serum HBeAg sero-conversion, the experimental group were 26 cases (22.03% ), the control group were 14 cases (11. 96% ), the difference was statistically significant (P<0. 05) . ②CD4 + CD25 + Tregs ratio; 12 weeks of treatment, the experimental group reduce value was (1. 85 ± 1. 18) % , control group was (1. 39 ± 1.03)% , the difference was statistically significant ( P < 0. 05) . ③Pre-dictive of CD4 + CD25 + Tregs; 12 weeks of treatment, the HBeAg seroconversion group CD4 + CD25 + Tregs ratio reduce value was (3.64±1.02)% , and without HBeAg seroconversion group was (1. 23 ± 0. 78) % , the difference was statistically significant ( P < 0. 05 ) . The area under the ROC curve was 0. 935 , and best cut-off values for HBeAg seroconversion of CD4 + CD25 + Tregs was reduced 3. 21% , the sensitivity was 93% , specificity was 85% , accuracy was 91. 7% . Conclusion: The CD4 CD25 + Tregs significant increase in peripheral blood of HBeAg positive chronic hepatitis B, the reduce of CD4 + CD25+ Tregs on 12 weeks of treatment could serve as a predictive indicator for HBeAg seroconversion. The Baihua Xianglian detoxification formula could increase the HBeAg seroconversion rates, its mechanism may be related to reduce CD4 + CD25 + Treg ratios, recovery HBV-specific immune function.%目的:探讨外周血CD4+ CD25+调节性T细胞(CD4+ CD25+ Tregs)变化对慢性乙型肝炎(CHB) HBeAg血清学转换的预测价值及白花香莲解毒方的干预作用.方法:240例HBeAg阳性CHB患者随机分为试验组和对照组,对照组患者给予阿德福韦酯胶囊10mg/次,1次/d,试验组患者在对照组基础上加用白花香莲解毒方,2次/d,疗程为48周,并招募20例健康志愿者作为正常对照组.流式细胞仪测定0、12周外周血单个核细胞(PBMC)中CD4+CD25+ Tregs/CD4+的比率,ELISA法检测治疗24周、48周HBeAg/HBeAb滴度.结果:①HBeAg血清学转换情况:治疗48周,共有40例发生HBeAg血清学转换,其中试验组有26例(22.03％),对照组14例(11.96％),差异有统计学意义(P＜0.05).②CD4+ CD25+ Tregs比率变化:治疗12周,试验组平均下降(1.85±1.18)％,对照组为(1.39±1.03)％,差异有统计学意义(P＜0.05).③CD4+ CD25+ Tregs比率对HBeAg血清学转换的预测:48周发生HBeAg血清学转换组12周CD4+ CD25+ Tregs比率平均降低(3.64±1.02)％,未发生转换组为(1.23±0.78)％,差异具有统计学意义(P＜0.05),以治疗12周外周血CD4+ CD25+ Trges比率变化预测血清学转换的受试者工作特征曲线(ROC曲线)下面积为0.935,最佳Cutoff值为下降3.21％,预测血清学转换的敏感度为93％、特异度为85％,准确性91.7％.结论:HBeAg阳性CHB患者外周血CD4+ CD25+ Tregs比率显著升高,治疗12周CD4+ CD25+Tregs比率的下降值可作为HBeAg血清学转换的预测性指标,壮药白花香莲解毒方能提高HBeAg血清学转换率,其机制可能与降低CD4+ CD25+ Treg比率,恢复机体对HBV的特异性免疫功能有关.
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