中药内服、灌肠联合常规疗法治疗早中期乙型肝炎病毒相关慢加急性肝衰竭的临床观察

Clinical observation on oral administration and enema of traditional Chinese medicine combined with conventional therapy in treatment of hepatitis B virus associated acute- on- chronic liver failure at early and middle stages

目的观察利湿解毒方内服、通腑逐瘀方灌肠联合常规疗法治疗乙型肝炎病毒相关慢加急性肝衰竭(HBV-ACLF)的临床疗效。方法将139例HBV-ACLF患者随机分为治疗组(72例)和对照组(67例)。对照组采用内科综合治疗,治疗组在对照组治疗措施的基础上加用利湿解毒方口服、通腑逐瘀方灌肠。两组疗程均为8周,分别于治疗2周、4周、8周及疗程结束12周,观察生存率,比较肝功能[丙氨酸氨基转移酶(ALT)、总胆红素(TBil)、胆碱酯酶(CHE)]、凝血酶原活动度(PTA)、乙肝病毒定量(HBV-DNA)、终末期肝病模型(MELD)评分的变化情况。结果①治疗组总生存率及治疗2周、4周的生存率分别为65.3%、86.1%、95.2%,对照组分别为43.3%、67.2%、80.0%,组间差异有统计学意义(P<0.05)。②治疗前与治疗2周、治疗4周、治疗8周、疗程结束12周组内比较,两组血清ALT、TBil、CHE、PTA水平及MELD评分差异均有统计学意义(P<0.05);治疗4周、治疗8周后组间比较,血清ALT、TBil、CHE、PTA水平及MELD评分差异有统计学意义(P<0.05)。③治疗前与治疗2周、治疗4周、治疗8周、疗程结束12周组内比较,两组HBV-DNA水平降低(P<0.05);治疗8周后组间比较,治疗组HBV-DNA水平低于对照组(P<0.05)。结论利湿解毒方内服、通腑逐瘀方灌肠联合常规疗法治疗HBV-ACLF疗效满意,较常规疗法能更好地改善患者的肝功能、凝血功能,降低HBV-DNA水平,提高HBV-ACLF患者的短期生存率。

Objective To observe the clinical efficacy of Lishi Jiedu Formula(LSJD) for oral administration and Tongfu Zhuyu Formula(TFZY) for enema combined with conventional therapy in treating hepatitis B virus(HBV) associated acute-on-chronic liver failure(HBV-ACLF). Methods 139 patients with HBV-ACLF were randomly assigned into treatment group(72 patients) and control group(67 patients). The control group was treated with comprehensive medical treatment, while the treatment group was treated with LSJD and TFZY on the basis of the treatment measures of the control group. The two groups were treated for 8 weeks. Survival rate was observed, and liver function [alanine aminotransferase(ALT), total bilirubin(TBil) and cholinesterase(CHE)], prothrombin activity(PTA), hepatitis B virus-DNA(HBV-DNA), and score of model for end-stage liver disease(MELD) were compared at 2, 4 and 8 weeks of treatment and 12 weeks after treatment. Results ①The total survival rate and the 2-and 4-week survival rates were 65.3%, 86.1% and 95.2% respectively in the treatment group, and 43.3%, 67.2% and 80.0% respectively in the control group, with significant difference between the two groups(P<0.05).②There were significant differences in the levels of serum ALT, TBil, CHE and PTA and MELD scores in the groups at 2, 4 and 8 weeks of treatment and at 12 weeks after treatment compared to those before treatment(P<0.05);there were significant differences in the levels of serum ALT, TBil, CHE and PTA and MELD scores between the two groups at 4 and 8 weeks of treatment(P<0.05).③The level of HBV-DNA decreased in both groups at 2, 4 and 8 weeks of treatment and at 12 weeks after treatment compared to that before treatment(P<0.05);the level was lower in the treatment group than in the control group at 8 weeks of treatment(P<0.05). Conclusion LSJD for oral administration and TFZY for enema combined with conventional therapy shows satisfactory effect in treating HBV-ACLF. Compared with conventional therapy,it improves the liver function and coagulation function,reduces the level of HBV-DNA,and improves the short-term survival rate of patients with HBV-ACLF.