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目的探讨替比夫定(telbivudine,LDT)片联合健脾补肾方治疗慢性乙型肝炎(chronic hepatitis B,CHB)患者对乙型肝炎病毒(hepatitis B virus,HBV)特异性细胞毒性T淋巴细胞(cytotoxic T lymphocyte,CTL)及乙型肝炎e抗原(HBeAg)血清学转换的影响。方法采用随机数字表法将90例HBeAg阳性和人白细胞抗原(HLA)-A2阳性的CHB患者分为治疗组及对照组,每组45例,对照组单用LDT片治疗(600 mg口服,每日1次),治疗组在LDT片治疗基础上加用健脾补肾方颗粒剂,每日2次口服;两组疗程均为1年。比较治疗1年后两组HBV DNA阴转率、HBeAg血清转换率及HBV特异性CTL水平,并评价肝功能、耐药变异及不良反应。结果治疗1年后,治疗组HBV DNA阴转率及HBeAg血清学转换率[分别为88.89%(40/45)、40.00%(18/45)]均高于对照组[分别为68.89%(31/45)、20.00%(9/45)],差异有统计学意义(均P<0.05)。治疗组HBV特异性CTL水平为(0.78±0.09)%,明显高于治疗前的(0.36±0.07)%,亦高于对照组治疗1年后的(0.54±0.11)%,差异有统计学意义(P<0.01)。HBeAg血清学转换者(27例)HBV特异性CTL水平为(0.81±0.10)%,明显高于63例无HBeAg血清学转换者的(0.60±0.09)%,差异有统计学意义(P<0.01)。治疗组发生ALT恢复正常44例(97.78%),对照组为42例(93.33%),两组比较,差异无统计学意义(P>0.05)。两组治疗后总胆红素全部正常。治疗组rtM204I耐药变异1例(2.22%),对照组2例(4.44%),两组患者均未发现明显不良反应。结论 LDT片联合健脾补肾方治疗CHB能提高患者的HBV特异性CTL水平和HBeAg血清学转换率。
Objective To investigate the effect of telbivudine (LDT) combined with Jianpi Bushen Recipe on chronic hepatitis B (CHB) patients with hepatitis B virus (HBV) specific cytotoxic T lymphocytes cytotoxic T lymphocyte (CTL) and hepatitis B e antigen (HBeAg) seroconversion. Methods Ninety patients with positive HBeAg and HLA-A2 positive CHB were divided into treatment group and control group by random number table. Each group included 45 cases. In the control group, only LDT tablets (600 mg orally, each Day 1), the treatment group on the basis of LDT tablets plus spleen Bushen Fang granules, 2 times a day orally; two courses of treatment were 1 year. After 1 year of treatment, HBV DNA negative conversion rate, HBeAg seroconversion rate and HBV specific CTL level were compared between the two groups. The liver function, drug resistance mutation and adverse reactions were also evaluated. Results After 1 year of treatment, the rates of HBV DNA negative conversion and HBeAg seroconversion in the treatment group were 88.89% (40/45) and 40.00% (18/45), respectively, higher than those in the control group [68.89% (31 /45),20.00%(9/45), the difference was statistically significant (all P <0.05). The level of HBV-specific CTL in the treatment group was (0.78 ± 0.09)%, which was significantly higher than that before treatment (0.36 ± 0.07)%, which was also significantly higher than that of the control group (0.54 ± 0.11)% after 1 year (P <0.01). The level of HBV specific CTL in HBeAg seroconverters (27 cases) was significantly higher than that in 63 cases (0.60 ± 0.09%) without HBeAg seroconversion (0.81 ± 0.10%), the difference was statistically significant (P <0.01 ). There were 44 cases (97.78%) of ALT returned to normal in treatment group and 42 cases (93.33%) in control group, there was no significant difference between the two groups (P> 0.05). Total bilirubin was normal after treatment in both groups. In the treatment group, 1 case (2.22%) was resistant to rtM204I mutation and 2 cases (4.44%) in the control group. No significant adverse reaction was found in both groups. Conclusions LDT combined with Jianpi Bushen Recipe can improve HBV-specific CTL level and HBeAg seroconversion rate in CHB patients.