新清开方联合醒脑鼻嗅剂防治乙肝后肝硬化合并轻微型肝性脑病的临床研究

Efficacy of Chinese medicine Xinqingkai prescription combined with Xingnao nasal olfactory agent for patients with posthepatitic cirrhosis and minimal hepatic encephalopathy

目的观察新清开方联合醒脑鼻嗅剂治疗乙肝后肝硬化合并轻微型肝性脑病(minimal hepatic encephalopathy,MHE)的临床疗效,为MHE的治疗提供新的思路和方法。方法将96例MHE患者按中心、随机数字表法分为中医药联合防治组和乳果糖口服对照组,其中中医药联合防治组48例,对照组48例。两组在抗病毒、保肝降酶及对症处理基础上,中医药联合防治组予以口服新清开方,并联合外用醒脑鼻嗅剂于每次服药前吸入;对照组予以乳果糖口服,30 d为一个疗程,观察治疗30 d后两组患者智力测试[数字连接试验A(NCT-A)、数字符号试验(DST)]、生化指标[丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、白蛋白(Alb)]、血氨、内毒素、肠道微生物数量、临床转归等的情况变化。结果最终完成试验共94例,其中中医药联合防治组48例,对照组46例。治疗30 d后,两组NCT-A水平均较治疗前明显降低,DST水平均明显升高,且中医药联合防治组改善情况明显优于对照组(P<0.05)。治疗后,两组肝功能、血氨、内毒素水平均较治疗前明显改善,中医药联合防治组均明显优于对照组(P<0.05)。肠道菌群调节方面,治疗后两组的双歧杆菌、乳酸杆菌和粪常球菌数量都较治疗前增加、大肠埃希菌数量较治疗前减少,中医药联合防治组在增加双歧杆菌及乳酸杆菌丰度、降低大肠埃希菌数量方面明显优于对照组(P<0.05)。两组临床转归情况比较,均未出现转为临床型肝性脑病患者,其中中医药联合防治组复常率(33.3%)明显高于对照组(10.9%)(P<0.05)。结论基于“肝肠脑轴”的新清开方联合外用醒脑鼻嗅剂能有效减轻乙肝后肝硬化合并MHE患者的神经精神学症状及体征,改善其肝功能、血氨、内毒素水平,调节肠道菌群,改善其临床转归,提高生活质量。

Objective To investigate the clinical efficacy of Chinese medicine Xinqingkai prescription combined with Xingnao nasal olfactory agent for patients with posthepatitic cirrhosis and minimal hepatic encephalopathy(MHE).Methods Ninety-six cirrhotic patients with MHE were randomly assigned into two groups with 48 cases in each group.The antiviral,liver-protecting and enzyme-reducing and symptomatic treatment were given to both groups;in addition,patients in TCM group received Xinqingkai prescription and Xingnao nasal olfactory agent for treatment,while patients in control group received oral lactulose.After 30 days of treatment,intelligence tests(NCT-A,DST)were performed,biochemical indexes(ALT,AST,Alb,serum ammonia,endotoxin)were measured,intestinal microbe quantity and clinical outcome of the two groups were observed.Results Ninety-four patients completed the study:48 in the TCM group and 46 in the control group.After 30 days of treatment,NCT-A levels were significantly decreased and DST levels increased in both groups compared with those before treatment,while the improvement in TCM group was more marked than that in the control group(P<0.05).After treatment,the levels of liver function,blood ammonia and endotoxin in both groups were significantly improved,while the improvement was significantly better in the TCM group than that in the control group(P<0.05).The intestinal flora regulation,the number of bifidobacterium,lactobacillus,autococcusfaecalis all increased and the number of E.coli decreased after treatment compared with those before treatment,which were better changed in TCM group than those in the control group(P<0.05).No patients had clinical hepatic encephalopathy after treatment in two groups,while the recovery rate in the TCM group(33.3%)was significantly higher than that in the control group(10.9%)(P<0.05).Conclusion On the basis of conventional treatment,Chinese medicine Xinqingkai prescription combined with Xingnao nasal olfactory agent can effectively reduce the neuropsychiatric symptoms and signs of patients with posthepatitic cirrhosis combined with MHE,improve the levels of liver function,reduce the blood ammonia and endotoxin,regulate the intestinal flora,ameliorate clinical recursion and enhance the quality of life of patients.