目的观察中医辨证分型论治联合恩替卡韦(ETV)治疗慢性乙型肝炎的临床疗效。方法采取前瞻性、随机、多中心临床研究方法,按3:1:1随机分组(A组为辨证论治联合ETV组;B组为固定处方联合ETV组;C组为单用ETV组),共236例完成48周的疗程。分别检测治疗前、治疗12周、治疗24周、治疗36周、治疗48周的HBV-M、HBV DNA,观察患者的中医证候、健康调查简表(SF-36)。结果 A组治疗48周HBV DNA低于检测下限的比率为94.29%(132/140),显著高于C组78%(39/50)(P<0.05)。A组治疗48周HBV DNA较基线下降≥2log10拷贝/ml的应答率为99.29%(139/140),均显著高于B组93.48%(43/46)及C组90.00%(45/50),差异均有统计学意义(P<0.05)。治疗48周,A组HBeAg低于检测下限的比率为37.50%(24/64),均高于B组26.67%(8/30)及C组15.00%(3/20)(P<0.05),差异有显著统计学意义。治疗48周,A组HBeAg血清学转换率为31.25%(20/64),与B组26.67%(8/30)及C组15.00%(3/20)比较,差异显著无统计学意义(P>0.05)。治疗48周,A组中医证候积分(5.46±3.52)均低于B组(7.33±3.80)及C组(8.46±2.92),差异均有显著统计学意义(P均<0.05)。治疗48周,A组总体生理健康均优于B组及C组,差异均有显著统计学意义(P均<0.05)。3组患者病毒学应答率、中医证候疗效、总体生理健康比较,均呈A组>B组>C组的趋势。结论辨证论治联合ETV治疗能显著提高HBV DNA低于检测下限的比率、HBeAg血清学转换率、改善中医证候、提高生活质量。辨证论治联合ETV治疗有理想的近期疗效,远期疗效需延长随访时间以进一步研究。 Objective To observe the clinical effect of traditional Chinese medicine syndrome differentiation and treatment combined with entecavir (ETV) on chronic hepatitis B. Methods A prospective, randomized, multicenter clinical study was conducted. Patients were randomized according to the ratio of 3: 1: 1 (group A was treated with syndrome differentiation and treatment combined with ETV group; group B was fixed prescription combined with ETV group; group C was treated with ETV alone) Cases completed 48 weeks of treatment. HBV-M and HBV DNA were measured before treatment, 12 weeks after treatment, 24 weeks after treatment, 36 weeks after treatment and 48 weeks after treatment. TCM syndromes and SF-36 questionnaires were observed. Results The ratio of HBV DNA below the limit of detection was 94.29% (132/140) in group A at 48 weeks, which was significantly higher than that in group C (78/39) (P <0.05). The response rate of HBV DNA in group A at 48 weeks after the treatment was 99.29% (139/140) lower than baseline (≥2 log10 copies / ml), significantly higher than 93.48% (43/46) in group B and 90.00% (45/50) in group C , The differences were statistically significant (P <0.05). After treatment for 48 weeks, the rate of HBeAg in group A was lower than the detection limit by 37.50% (24/64), which was higher than that in group B (26.67%, 8/30) and group C (15.00%, 3/20) (P <0.05) The difference was statistically significant. After 48 weeks of treatment, the seroconversion rate of HBeAg in group A was 31.25% (20/64), which was significantly lower than that in group B (26.67%, 8/30) and group C (15.00%, 3/20) (P > 0.05). After 48 weeks of treatment, the scores of TCM syndromes in group A (5.46 ± 3.52) were lower than those in group B (7.33 ± 3.80) and group C (8.46 ± 2.92) (all P <0.05). After 48 weeks of treatment, the overall physical health of group A was better than group B and group C (all P <0.05). The virological response rate, TCM syndrome curative effect and overall physical health of the three groups showed the trend of A group> B group> C group. Conclusion Syndrome differentiation combined with ETV treatment can significantly improve the HBV DNA lower than the detection limit ratio, HBeAg seroconversion rate, improve TCM syndromes and improve the quality of life. Syndrome differentiation combined with ETV treatment has an ideal short-term efficacy, long-term efficacy need to extend the follow-up time for further study.