中医辨证分型联合恩替卡韦治疗慢性乙型肝炎的临床研究

Clinical efficacy of traditional Chinese medicine combined with entecavir in chronic hepatitis B patients

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 efficacy of traditional Chinese medicine （TCM） combined with entecavir in patients with chronic hepatitis B. Methods According to randomized, multicenter clinical study and statistical methods, patients were divided into 3 groups （TCM differentiation treatment and entecavir of group A; TCM fixed treatment and entecavir of group B; entecavir monotherapy of group C） randomly. And HBV-M, HBV DNA, SF-36 were detected respectively. Results The negative rate of HBV DNA in group A （94.29%, 132/140） was higher than that of group C （78.00%, 39/50） （P 〈 0.05） at 48th week. The response rate of HBV DNA level declined 〉/2 log10 copies/ml from baseline of group A （99.29%, 139/140） were higher than that of group B （93.48%, 43/46） and group C （90.00%, 45/50） （both P 〈 0.05） at 48th week. The HBeAg negative rate of group A （37.50%, 24/64） were higher than group B （26.67%, 8/30） and group C （15.00%, 3/20） （both P 〈 0.05） at 48th week. The HBeAg serological conversion rate of group A （31.25%, 20/64） were higher than that of group B （26.67%, 8/30） and group C （15.00%, 3/20） （both P 〈 0.05） at 48th week. TCM symptoms curative effect of group A （5.46 ± 3.52） were lower than that of group B （7.33 ±3.80） and group C （8.46 ± 2.92） （both P 〈 0.05） at 48th week. The quality of life score （SF-36） of group A were better than that of group B and group C （both P 〈 0.05） at 48th week. The trend of virological response rate, TCM symptoms curative effect and quality of life score of three groups were group A 〉 group B 〉 group C. Conclusions TCM syndrome differentiation treatment and entecavir can significantly improve the negative rate of HBV DNA, HBeAg seroconversion rate, TCM symptoms and quality of life. TCM syndrome differentiation treatment and entecavir have a ideal short-term efficacy, while its long-term effects need further study to explore.