Objective: To explore the clinical curative effect evaluation in the treatment of chronic hepatitis B, in order to optimize clinical diagnosis and treatment scheme of chronic hepatitis B. Methods: The clinical curative effect of using Shuganjianpihuoxue Method combined with lamivudine (the treatment group) and placebo-particles combined with lamivudine (the control group)through the clinical randomized controlled trials and follow-up research according to evidence-based medicine, clinical epidemiology/DME methods. And the continuous treatment was for 72 weeks. Results: The liver function of the treatment group had remarkable improvement in the early(12 weeks),the Shuganjianpihuoxue Method could improve symptoms obviously;In the 24 weeks and the 48 weeks,the clinical cure rate of the treatment group was obviously higher than that of the control group. The virus nucleic acid complete response rate of the treatment group was significantly higher than those of the control group in the end. The scores of the QOL of both groups such as physical,psychological,social relations,environment had significantly improvement after treatment, but there was no significant difference between the treatment group and the control group. Conclusion: The Shuganjianpihuoxue Method combined with LAM (lamivudine) may be an antiviral optimization treatment strategies that is suitable for Chinese national conditions. The method is likely to slow the disease progression in patients with chronic hepatitis B,by improving the general curative effect and reducing the occurrence of drug resistance.%目的 探讨疏肝健脾活血法治疗慢性乙型肝炎的临床疗效评价,优化慢性乙型肝炎患者的临床诊疗方案.方法 采用循证医学、临床流行病学/DME方法,通过临床随机对照试验及随访研究,评价疏肝健脾活血颗粒+拉米夫定组与中药安慰剂颗粒+拉米夫定组连续治疗72周疗效.结果 治疗组在早期(12周)肝功能改善方面具有显著疗效,疏肝健脾活血法可显著改善患者症状,治疗24周及48周,治疗组临床痊愈率明显高于对照组,治疗结束时,治疗组病毒核酸完全应答率显著高于对照组,两组患者的生存质量在生理、心理、社会关系、环境等多个维度得分在治疗后均有显著提高,治疗组与对照组相比无显著差异.结论 疏肝健脾活血法联合拉米夫定治疗慢性乙型肝炎为适合我国国情的抗病毒优化治疗策略.通过此方案优化治疗,可提高我国乙型肝炎患者抗病毒治疗的总体疗效,减少耐药的发生,从而减缓疾病进展.
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