柴芍六君汤干预慢性乙型肝炎患者YMDD变异的临床研究

目的 观察柴芍六君汤、拉米夫定联合治疗慢性乙型肝炎患者YMDD变异的情况.方法 采用非随机同期对照试验,将405例慢性乙型肝炎患者分为治疗组和对照组,治疗组220例,对照组185例,对照组给予拉米夫定100 mg,每天1次,口服,治疗18个月.治疗组给予柴胡六君汤每日1剂,同时口服拉米夫定100 mg,每天1次,治疗18个月.观察患者临床症状、ALT复常率、HBeAg阴转率,HBeAg血清转换率,HBV DNA阴转率、治疗12个月及18个月的YMDD变异率.率的比较采用χ2检验,均数比较采用t检验或U检验,方差不齐者用秩和检验. 结果治疗3.6、12.18个月时,ALT复常率治疗组分别为69.5%、85.9%、90.5%,82.7%,对照组分别为50.3%、65.4%、78.4%,69.7%,两组比较,χ2值分别为15.70、23.50、11.50.9.50.JD值均<0.01,差异均有统计学意义.治疗组12、18个月HBV DNA阴转率、HBeAg阴转率、HBeAg血清转换率、YMDD变异率分别为77.7%、57.7%、25.5%、6.8%和86.8%、74.1%、33.2%、8.6%,对照组分别为54.6%、36.8%,13.O%,14.6%和69.2%、37.3%、19.5%、20.5%,两组比较,χ2值分别为24.38、17.70、9.88、6.54和18.67、55.60、9.62,11.78,P<0.01或P<0.05,差异有统计学意义. 结论柴芍六君汤联合拉米夫定治疗慢性乙型肝炎,能有效地改善肝功能,提高拉米夫定抑制HBV复制的作用,减少YMDD变异的发生.

Evaluation of Chai Shao Liu Jun Tang for the treatment of chronic hepatitis B

Objective To evaluate the effect of Chai Shao Liu Jun Tang in combination with Lamivudine for the treatment chronic hepatitis B (CHB) patients. Methods 405 CHB patients in Guangdong Provincial Hospital were randomly divided into 2 groups, 220 in the treated group, and 185 in the control group. The control group was treated with Lamivudine for 18 months. The treated group was treated with Lamivudine in combination with Chai Shao Liu Jun Tang for 18months. At the 3rd, 6th, 9th, 12th and 18th month during the treatment, the clinical symptoms, ALT normalization rate, HBeAg seroconversion rate, the proportion of patients with undetectable serum HBV DNA, and YMDD mutation rate were observed. Results ALT normalization rates at the 3rd, 6th, 12th, 18th month of the treatment group (69.5%, 85.9%, 90.5%, 82.7%) were higher than those in the control group (50.3%, 65.4%, 78.4%, 69.7%; P < 0.01). HBeAg seroconversion rate, rate of HBV DNA undetectable, and YMDD mutation rate at he 12th and 18th month are 77.7%, 57.7%, 25.5%, 6.8%; 86.8%, 74.1%, 33.2%, 8.6% in the treatment group, and 54.6%, 36.8%, 13.0%, 14.6%; 69.2%, 37.3%, 19.5%, 20.5% in the control group (P < 0.01, or P < 0.05). Conclusion Compared to lamivudine alone, Cai Shao Liu Ju Tang in combination with lamivudine is more effective and induces lessYMDD mutation rate in CHB patients.