泰来肽治疗HBV携带者临床疗效观察以及对细胞免疫功能影响

A Clinical Observation and Follow-up for Patients with HBV Carrier after the Treatment of Anti-hepatitis B Placenta Transfer Factor.

目的观察泰来肽治疗HBV携带者的临床疗效及其可能作用机制。方法选择100例HBV-DNA和HBeAg阳性的HBV携带者,分为治疗组(45例)和对照组(54例)。结果治疗24周时,治疗组HBeAg阴转率、血清转换率和HBV-DNA阴转率分别为11.11%、6.67%和17.78%明显高于对照组(P<0.01);治疗组和对照组ALT异常率分别为4.44%、1.92%,两组间无显著性差异(P>0.05)。随访24周后,治疗组HBeAg阴转率、血清转换率和HBV-DNA阴转率分别为26.67%、17.78%和37.78%明显高于对照组(P<0.01);治疗组和对照组ALT异常率分别为4.44%、5.77%,两组比较无显著性差异(P>0.05)。组织学炎症分期为G1、G2的HBeAg阴转率(36.36%,50%)、血清转换率(22.27%,40%)、HBV-DNA阴转率(44.54%,60%)均明显高于G0-1(P<0.01)。治疗组外周血T细胞(CD3+)、CD4+T细胞(CD3+CD4+)和NK细胞(CD16+CD56+)计数较治疗前明显增高(P<0.05),而CD8+T细胞(CD3+CD8+)计数较治疗前明显降低(P<0.05),外周血B细胞(CD19+)计数无明显变化(P>0.05)。结论泰来肽能使HBV携带者HBeAg和HBV-DNA阴转,以及HBeAg发生血清转换,且与肝组织学炎症分期有关,提高细胞免疫功能是其主要作用机制。

Objective To investigate the effects of anti - hepatitis B placenta transfer factor on HBV carrier and reveal the underlying mechanisms. Methods A total of 100 patients divided into two groups with HBeAg - positive and HBV - DNA positive HBV carrier received either anti - hepatitis B placenta transfer factor（ treatment group, n = 45） or placebo（ control group, n = 54）. All the Patients were treated for 24 weeks and followed for additional 24 weeks. Results After 24 weeks of treatment, HBeAg negatively conversed in 11.11% patients of treatment group versus 0% in control group（P 〈 0.01 ）, HBeAg seroconversion achieved in 6.67% patients of treatment group versus 0% in control group （ P 〈 0. 01 ）. The rate of patients with HBV DNA load below 1,000 copies per milliliter was 17.78% in treatment group versus 3.85 % in control group （ P 〈 0. 01 ）. No significant differences were found between the rate of ALT abnormality of the two groups （4.44% vs. 1.92% ,P 〉0.05） After 24 weeks of followup, the treatment groups displayed significant higher HBeAg negative rate, proportion of HBeAg seroconversion, and HBV DNA negative rate （26.67% , 17.78% , and 37.78% , respectively,P 〈 0.01 ） compared with the control group. There were no significant differences found between the rate of ALT abnormality of the two groups （4. 44% vs. 5.77% , P 〉 0.05 ）. Compared with patients with inflammation stage G0-1 ,patients with inflammation stage G1 and G2 displayed significantly higher HBeAg negative rate, proportion of HBeAg seroconversion, and HBV DNA negative rate（P 〈 0.01 ）. In the treatment group, the counts of peripheral CD3^＋ T cells, CD4^＋ T （ CD3^＋ CD4^＋） cells, and NK cells（ CD16^＋ CD56 ^＋） were significantly higher while the count of CD8^＋ T cell（ CD3^＋ CD8 ^＋） was significantly lower after treatment. No significant difference were found between the counts of peripheral B cells （ CD19^＋） before and after treatment. Conclusions The HBeAg and HBV - DNA in the HBV carrier can be facilitated appearance of seronegative conversion by the anti - hepatitis B placenta transfer factor. Meanwhile the HBeAg seroconversion occurred. All these are related to the stage of the inflammation in hepatic histology. In these processes, the main mechanism is to increase the cell immunity function.