鳖甲消癥丸联合拉米夫定治疗慢性乙型肝炎的疗效观察

目的观察鳖甲消癥丸联合拉米夫定治疗慢性乙型肝炎（CHB）的临床疗效及优势。方法收集轻中度CHB患者72例,随机分成2组。拉米夫定对照组30例,单以拉米夫定治疗;联合治疗组42例,在拉米夫定治疗基础上前24周连续加服鳖甲消癥丸2粒,2次/d。治疗前及治疗后的第12、24、48周检测并对比血清ALT、TBil、HBV DNA定量等指标变化,并对比临床症状体征变化,第24和48周评价总体疗效。结果 24周时联合治疗组症状学疗效及病毒完全应答率均显著优于对照组;治疗24周时联合治疗组HBV DNA定量显著低于对照组,治疗12及48周时差异无统计学意义;同组治疗后各时间点ALT、TBil与治疗前比较差异均有统计学意义（P〈0.05）,治疗的前24周两项指标变化显著,后24周两项指标变化不显著。结论鳖甲消癥丸可增进拉米夫定治疗的早期快速应答,从而提高临床疗效,甚至减少耐药的发生。

Clinical study of lamivudine and Biejia Xiaozheng pill combination therapy for chronic hepatitis B

Objective To investigate whether supplementation of Biejia Xiaozheng pill increased the therapeutic benefit of lamivudine （LAM） nuclcoside analogue drug treatment in patients with chronic hepatitis B virus （HBV） infection. Methods Between June 2009 and June 2012, adult patients （18 -60 years old） with mild to moderate chronic hepatitis B （CHB） were recruited for study according to find- ings of： serum HBV DNA ~〉 105 copies/ml, alanine aminotransferase （ALT） and asparatate aminotransferase （AST） increased 〈 10 times the upper limit of normal （ULN）, total bilirubin （TBil） 〉 5 times the ULN, and no previous treatment with antiviral and immunomodulatory agents. The 72 enrollees were randomly assigned to receive LAM alone for 24 weeks （control group, n --30） or LAM combined with Biejia Xiaozheng pill for 24 weeks followed by peresistant Biejia Xiaozheng pill （combination therapy group, n = 42）. The baseline levels of serum ALT, TBil, and HBV DNA were compared between the two groups at weeks 12, 24 and 48 after treatment initiation. The overall efficacy was evaluated at weeks 24 and 48, and classified as ： complete response, when ALT and TBil returned to normal level and HBV DNA was unde- tectable; partial response, when ALT and TBil showed ≥50% reduction and HBV DNA was reduced to ≥2log10 copies/ml; non - re- sponse ： ALT and TBil ≤50% reduction and HBV DNA was reduced to ≤2log10 copies/ml or increased. The sigifinficance of differences between the control and combination therapy groups was assessed by Chi - squared test or t - test. Results At week 24 of treatment, a sig- nificantly higher percentage of the combined treatment group than the control group had achieved complete response （80.95 vs. 56. 67% , P 〈 0.05 ） , but at week 48 the two groups showed similar percentages of complete response （ 83.33 vs. 80.00% , P 〉 0.05 ）. A similar trend of significant reduction in HBV DNA quantity was observed at 24 weeks of treatment （2.53 ＋ 0.61 vs. 3.12 ＋ 0.54, P 〈 0.01 ） and not at 48 weeks of treatment （2.44±0.85 vs. 2.56±0.94, P 〉 0.05 ）. ALT level was also significantly improved in the combination therapy group at 24 weeks compared to the control group （32.24±6.42 vs. 45.10±5.44 U/L, P 〈 0.01 ） but not at 48 weeks of treatment （P 〉 0.05 ）. However, the combination therapy group showed significantly improved TBil levels at both week 24 of treatment （ 12.66±3.41 vs. 15.42±5.76 p, mol/L, P〈0.01） and week48 of treatment （11.22±3.62 vs. 13.86±4.88 μmol/L, P〈0.01）. Conclusion Supple-mentation of Biejia Xiaozheng pill to the standard LAM therapy can enhance the early and rapid virological response rate, and may help to reduce the occurrence of LAM resistance.