以解毒化瘀颗粒为主导中西医结合治疗乙型慢加急性肝衰竭的临床研究

A detoxification and stasis-resolving granules-dominated combination therapy in patients with hepatitis B acute-on-chronic liver failure

目的:探讨解毒化瘀颗粒治疗乙型慢加急性肝衰竭的临床疗效。方法:将符合纳入标准的乙型慢加急性肝衰竭患者60例随机分成两组,其中对照组30例,给予西医综合治疗方案;治疗组30例,在对照组的基础上加用中药解毒化瘀颗粒口服,疗程为8周,随访48周;观察两组患者治疗前、后的肝功能、凝血功能、血浆氨、HBV DNA以及整体疗效情况并作比较。结果:经治疗后,治疗组患者的肝功能、凝血功能的改善明显优于对照组(P<0.05),而血浆氨、HBV DNA的变化两组间差异无显著性意义(P>0.05);治疗组总有效率为80.0%,而对照组为53.3%(P<0.05);两组患者治疗后48周随访存活率差异具有统计学意义(P<0.05)。说明解毒化瘀颗粒对乙型慢加急性肝衰竭有肯定的疗效。结论:以解毒化瘀颗粒为主导的中西医结合治疗方案治疗乙型慢加急性肝衰竭优于西医综合治疗方案,值得进一步探讨,并有一定的推广应用价值。

Objective： To evaluate the efficacy of a Chinese-western combination therapy using the detoxification and stasisresolving granules in patients with hepatitis B acute-on-chronic liver failure. Methods： Sixty eligible patients were randomized in1∶ 1 ratio to receive conventional western medical therapy alone（ control group） or in combination with the detoxification and stasis-resolving granules（ test group） for 8 weeks. The duration of follow-up was 48 weeks. Overall outcomes and changes in liver function,coagulation function,plasma ammonia and HBV DNA from baseline were assessed and compared between both groups.Results： The combotherapy was associated with significantly improved liver function and coagulation function,compared with the monotherapy（ P〈0.05）. There were no significant differences in the changes in plasma ammonia or HBV DNA from baseline between both groups（ P〈0.05）. The overall response rate was 80. 0% in the test group,compared with 53. 3% in the control group（ P〉 0. 05）. The difference in survival at week 48 between both groups reached statistical significance（ P〈0.05）,suggesting a definitive efficacy of the detoxification and stasis-resolving granules in patients with hepatitis B acute-on-chronic liver failure. Conclusion： Further research is warranted to investigate the superior efficacy of the detoxification and stasis-resolving granules-dominated combination therapy over conventional western medical therapy alone. This combotherapy should be considered for frequent use in clinical practice.