补肾疏肝优化方治疗慢性HBV携带状态的临床观察及对血清中PD-1水平的影响

Clinical Observation of Optimized Bushen Shugan Decoction in Treating Chronic HBV Carrying State and Its Effect on PD-1

目的观察补肾疏肝优化方治疗慢性乙型肝炎病毒(HBV)携带状态的临床疗效及对患者血清中程序性死亡受体1(PD-1)水平的影响。方法将86例慢性HBV携带状态患者随机分为治疗组和对照组,其中治疗组44例,对照组42例。治疗组给予补肾疏肝优化方治疗,对照组服用安慰剂,疗程为48周。观察两组患者治疗前后血清HBV DNA、e抗原(HBeAg)、表面抗原(HBsAg)、PD-1水平的变化及补肾疏肝优化方的临床疗效和安全性。结果试验过程中治疗组脱落1例,违背方案剔除3例,共纳入研究40例;对照组脱落2例,共纳入研究40例。治疗后,治疗组总有效率为32.50%(13/40),对照组总有效率为10.00%(4/40),治疗组总有效率明显高于对照组(P<0.05)。治疗后,治疗组患者的血清HBV DNA、HBeAg、HBsAg水平均较治疗前显著降低(P<0.05),且均低于对照组(P<0.05)。治疗后,治疗组HBeAg下降>0.5 lg、1 lg、2 lg COI的比例均高于对照组(P<0.05),治疗组HBeAg发生血清学转换的比例高于对照组,但差异无统计学意义(P>0.05)。治疗后,治疗组HBsAg下降>0.5 lg、1 lg COI的比例均高于对照组(P<0.05),治疗组HBsAg>2 lg COI的比例高于对照组,但差异无统计学意义(P>0.05)。治疗后,治疗组患者的血清PD-1水平较治疗前明显下降(P<0.05),且低于对照组(P<0.05)。两组患者治疗过程中安全性指标均未见明显异常。结论补肾疏肝优化方可在一定程度上降低慢性HBV携带状状态患者血清HBV DNA及病毒标志物水平,通过降低血清PD-1水平调节免疫,抑制HBV复制,疗效明显,安全性较好。

Objective To observe the clinical efficacy of optimized Bushen Shugan decoction in the treatment of chronic hepatitis B virus(HBV) carrying state and its effect on the level of programmed death-1(PD-1)in the serum of patients. Methods Eighty-six patients with chronic HBV carrying status were randomly divided into treatment group(n=44)and control group(n=42). Patients in the treatment group were treated with optimized Bushen Shugan decoction,and those in the control group were treated with placebo for 48 weeks. The changes of serum HBV DNA,Hepatitis Be antigen(HBeAg),Hepatitis B surface antigen(HBsAg)and PD-1 levels were measured before and after treatment,and the clinical efficacy and safety of optimized Bushen Shugan decoction were evaluated. Results During the experiment,1 case fell off and 3 cases were excluded from the scheme in the treatment group,2 cases fell off in the control group,40 cases in each group were finally included. After treatment,the total effective rate was 32.50%(13/40)in the treatment group and 10.00%(4/40)in the control group. The total effective rate in the treatment group was significantly higher than that in the control group(P<0.05). After treatment,the serum levels of HBV DNA,HBeAg and HBsAg in the treatment group were significantly lower than those before treatment(P<0.05),and the levels of serum HBV DNA,HBeAg and HBsAg in the treatment group were lower than those in the control group(P<0.05). After treatment,the proportions of HBeAg decreased>0.5 lg,1 lg and 2 lg COI in the treatment group were higher than those in the control group(P<0.05). The proportion of HBeAg seroconversion in the treatment group were higher than that in the control group,but the difference was not statistically significant(P>0.05). After treatment,the proportions of HBsAg decreased>0.5 lg and 1 lg COI in the treatment group were higher than those in the control group(P<0.05), and the proportion of HBsAg>2 lg COI in the treatment group was higher than that in the control group,but the difference was not statistically significant(P>0.05). After treatment,the level of serum PD-1 in the treatment group was significantly lower than that before treatment(P<0.05),and the level of serum PD-1 in the treatment group was lower than that in the control group(P<0.05). There were no significant abnormalities in the safety indicators of the two groups during the treatment. Conclusion Optimized Bushen Shugan decoction can reduce the serum levels of HBV DNA and virus markers to a certain extent,regulate immunity by reducing PD-1 level to inhibit HBV replication,with obvious curative effect and reasonable safety.