Objective To investigate the effectiveness and safety of Xingpi Yiqi and Shugan Tongluo therapy in the treatment of hepatitis B liver failure. Methods 117 hospitalized patients with hepatitis B liver failure were divided into the experimental group and the control group according to the order of admission to the hospital, there were 58 cases in the experimental group and 59 cases in the control group. The control group was treated with western medicine method, symptomatic support, prevention of complications and the treatment of artificial liver;the treatment of the experimental group was on the basis of conventional therapy combined with traditional Chinese medicine ( Xingpi Yiqi, Shugan Tongluo method and Ganpi shuluo decoction) treatment. Results After 4 weeks of treatment, ALT, TBIL, TBA, PT of two groups were declined compared with before treatment, the result had statistical significance (P<0. 01), the PT and TBIL of experimental group was decreased more obvious than the control group(P<0. 01);The level of ALB and PTA in two groups were higher than before treatment, the difference was significant difference(P<0. 01), and the PTA of experimental group was higher than the control group, the difference was statistically significant(P<0. 05). After 8 weeks of treatment, the total effectiveness of treatment group was 87. 9% which was slightly higher than that was 83. 1% of control group, but there was no significance (P>0. 05) between two groups; The experimental group patients' HBV-DNA negative change rate (36. 2%) was higher than the control group' s rate (30. 5%), but there was no significant difference ( P>0. 05);The symptom scores of the two groups were decreased obvious compared with before treatment, the difference was significant difference(P<0. 01);The treatment group's symptoms scores after treatment was lower than the control group, the result had significant difference(P<0.01); The times of artificial liver in the group and the increased times of artificial liver than before entering the group,the experimental group was obvious less than that of the control group(P<0. 01). In all patients, 9 cases were death, death cases of the control group in the 2 weeks, 4 weeks and 8 weeks were higher than the experimental group, but there was no significant statistical significance(P>0. 05). There was no adverse event in the process of treatment observation. Conclusion The study verified the Xingpi Yiqi and Shugan Tongluo method ( Ganpi Shuluo decociton ) in treatment of liver failure with hepatitis B is effective and safe, it has certain advantages in promoting liver function recovery, improving coagulation function, alleviating the clinical symptoms and reduce the times of artificial liver compared with western medicine treatment.%目的 探讨醒脾益气、疏肝通络法治疗乙肝肝衰竭的有效性和安全性.方法 选取117例符合筛选标准的住院乙肝肝衰竭患者,按照入院的先后顺序将其分为试验组和对照组,其中试验组58例,对照组59例.对照组给予基础治疗、对症支持、并发症防治等西医综合方法并联合人工肝治疗;试验组在上述西医治疗基础上加用中医药(醒脾益气、疏肝通络法-肝脾疏络饮)治疗.结果 两组患者在治疗4周后丙氨酸氨基转移酶(alanine amino transferase,ALT)、总胆红素(total bilirubin,TBIL)、总胆叶酸(total bile acid,TBA)、凝血酶原时间(prothroubin time,PT)均较前下降,其中试验组的PT和TBIL下降较对照组更为明显,差异有显著统计学意义(P<0.01);两组患者PTA、ALB水平较治疗前均升高,其中试验组PTA升高较对照组明显,差异有统计学意义(P<0.05).治疗8周后试验组和对照组的总有效率比较,差异无统计学意义(P>0.05);试验组HBV-DNA阴转率(36.2%)虽高于对照组HBV-DNA阴转率(30.5%),但差异无统计学意义(P>0.05);试验组症状总积分低于对照组,差异有显著性统计学意义(P<0.01);入组后人工肝次数以及较入组前增加的人工肝次数试验组明显少于对照组(P<0.01).所有入组患者中共死亡9例,在2周内、4周内及8周内死亡例数对照组均高于试验组,但两组总死亡率比较无统计学意义(P>0.05).两组均未见不良事件.结论 醒脾益气、疏肝通络法(肝脾疏络饮)治疗乙肝肝衰竭是有效安全的,在促进肝功能恢复、改善凝血功能、缓解临床症状和减少人工肝次数上较西医治疗有一定优势.
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