甘露消毒丹治疗乙肝病毒相关慢加急性肝衰竭湿热证疗效及FibroScan变化的临床观察

Clinical Observation of Ganlu Xiaodu Dan on Curative Effect and Changes of FibroScan in Patients with Damp-Heat Syndrome of HBV Associated with Acute-on-chronic Liver Failure

目的：探讨甘露消毒丹治疗乙肝病毒（HBV）相关慢加急性肝衰竭（HBV-ACLF）湿热证患者的临床疗效及FibroScan无创评估的应用价值。方法：选取HBV-ACLF湿热证患者108例,随机分为治疗组和对照组,各54例。两组患者均给予卧床休息、肠道营养支持、补充白蛋白或新鲜血浆、抗病毒等内科基础治疗,治疗组则在内科基础治疗前提下加用甘露消毒丹中药汤剂治疗。观察两组患者治疗前后主要中医证候（身目俱黄、小便短赤、脘腹胀满、神疲乏力、大便溏或黏滞不爽等）、肝功能生化指标[丙氨酸氨基转氨酶（ALT）,天冬氨酸氨基转氨酶（AST）,血清总胆红素（TBIL）,白蛋白（ALB）,凝血酶原活动度（PTA）]和FibroScan测量值的变化。结果：治疗组主要中医证候明显改善,疗效总有效率明显高于对照组（P〈0.05）;肝功能生化指标除对照组ALB治疗前后无显著性差异外,两组ALT,AST,TBIL治疗后均较本组治疗前明显降低（P〈0.05）,且治疗组各项指标的恢复程度均明显优于对照组（P〈0.05）;两组患者治疗后FibroScan测量值均较本组治疗前明显降低（P〈0.05）,且治疗组FibroScan测量值的降低幅度明显优于对照组（P〈0.05）。结论：甘露消毒丹联合内科基础治疗,不仅能明显提高HBV-ACLF湿热证患者的临床疗效,而且可显著改善FibroScan测量值。相比常规肝功能生化指标的有创检测,Fibroscan无创、即时、动态、综合的技术特点,为评估甘露消毒丹治疗HBV-ACLF湿热证的临床疗效提供了新手段,值得临床推广。

Objective： To investigate the clinical efficacy of Ganlu Xiaodu Dan in patients with dampheat syndrome of hepatitis B virus（HBV） associated with acute-on-chronic liver failure（HBV-ACLF） and the application value of noninvasive assessment by FibroScan. Method： A total of 108 patients with HBV-ACLF were selected and randomly divided into treatment group（54 cases） and control group（54 cases）. Both groups adopted the basic medical treatment including bed rest,enteral nutrition,supplementing albumin or fresh plasma,antiviral treatment and so on. On the basis of the basic medical treatment,the treatment group additionally received Ganlu Xiaodu Dan. The major traditional Chinese medicine（TCM） syndrome symptoms（yellow skin and eyes,scanty dark urine,abdominal fullness and distention,lack of energy,loose or sticky stool and so on）,liver function biochemical indexes [alanine aminotransferase（ALT）,aspartate aminotransferase（AST）,serum total bilirubin（TBIL）,albumin（ALB）,and prothrombin activityprothrombin time activity（PTA） ],and liver measurement of FibroScan（Kpa）,were observed in both groups before and after treatment. Result： In the aspect of TCM syndrome treatment efficacy,the total effective rate of the treatment group was significantly higher than that of the control group（P〈0. 05）. After treatment,both groups showed significant decrease in ALT,AST,TBIL and measurement of FibroScan,and the effect was more obvious in the treatment as compared with the control group（P〈0. 05）,but ALB had no significant difference after treatment. Conclusion： Based on the basic medical treatment,Ganlu Xiaodu Dan could not only enhance the curative effect in patients with HBV-ACLF significantly,but also improve the measurement value of the FibroScan markedly. As compared with the routine invasive tests of liver function biochemical index,Fibroscan provides a new method for evaluating the clinical efficacy of Ganlu Xiaodu Dan for treatment of HBV-ACLF,with real-time,dynamic,non-invasive and comprehensive technical characteristics,so it is worthy of clinical promotion.