中医化湿解毒法抗乙型肝炎病毒的临床研究

Clinical Research of Anti-Hepatitis B Virus(Anti-HBV) with Resolving Damp and Detoxification Principle in Chinese Medicine

目的观察化湿解毒清膏治疗乙型肝炎的病毒学及血清免疫学应答情况,探讨中医化湿解毒法抗乙肝病毒的临床疗效。方法把符合纳入标准的乙型肝炎患者,按1∶1比例随机分配进入相应组别。治疗组患者给予化湿解毒清膏,对照组给予拉米夫定片,总疗程52周。所有患者于疗程第12、24、52周及停药后24周分别检测乙肝病毒血清免疫标志物(HBVM)、乙肝病毒脱氧核糖核酸(HBVDNA)及肝功能丙氨酸氨基转移酶(ALT)。结果治疗52周,治疗组HBeAg/抗-HBe转换率明显好于对照组(0.383/0.191、χ2值6.77),差异具有统计学意义(P<0.01);停药24周,治疗组HBeAg/抗-HBe持久转换率、HBVDNA持久阴转率分别为96.8%和86.7%,对照组则为64.3%和58.06%,χ2值分别为8.81和6.2,差异均具有统计学意义(P<0.05或P<0.01)。结论化湿解毒清膏具有肯定的抗乙肝病毒作用,其抑制HBVDNA复制一年期间,效果相当于拉米夫定,而促HBeAg/抗HBe转换,以及减轻耐药复发、维持持久答应方面,效果明显好于拉米夫定。

Objective To observe the virological and serum immunological responses to hepatitis B in the treatment with huashi jiedu thick liquid and explore the clinical efficacy on anti-hepatitis B virus（HBV）with resolving damp and detoxification principle in Chinese medicine.Methods The patients in accordance with the inclusive criteria of hepatitis B were randomized into corresponding groups at 1∶1.In a treatment group,huashi jiedu thick liquid was applied.In a control group,lamivudine was administered.The treatment was 52 weeks totally.HBV serum immune markers（HBVM）,HBVDAN and alanine aminotransferase（ALT）were detected in the 12th,24th and 52nd weeks as well as in 24 weeks after medicine termination for all the patients separately.Results After 52 weeks treatment,in treatment group,HBeAg/anti-HBe conversion rate was apparently better than those in control group（0.383/0.191,χ2=6.77）,indicating statistical significance（P0.01）.In 24 weeks after medicine termination,the enduring conversion rates of HBeAg/Anti-HBe and HBVDNA were 96.8% and 86.7% respectively in treatment;there were 64.3% and 58.06% in control group;χ2 = 8.81,and 6.2 respectively,indicating statistical significance（P0.05 or P0.01）.Conclusion Huashi jiedu thick liquid has a definite action on anti-HBV and its effect on the suppression of HBVDNA duplication in one year is equal to that of lamivudine.In the aspects of promoting the conversion of HBeAg/Anti-HBe,alleviating the recurrence of medicinal endurance and maintaining enduring responses,the effects of this medicine are apparently better than lamivudine.