酪酸梭菌治疗轻微型肝性脑病的临床疗效

Clinical evaluation of Clostridium butyricum in the treatment of minimal hepatic encephalopathy

目的评价酪酸梭菌治疗轻微型肝性脑病的临床疗效。方法选取2018年1月至2019年1月就诊于兰州大学第一医院的90例乙肝肝硬化并发轻微肝性脑病患者,按随机对照试验设计原则将其分成试验组和对照组。试验组(n=45)患者接受基础治疗+酪酸梭菌胶囊治疗,对照组(n=45)患者接受基础治疗+安慰剂治疗,疗程均为3个月。分别收集并比较两组患者治疗前后血氨、数字符号试验(DST)、数字连接试验(NCT)、终末期肝病模型评分(MELD)、肝肾功能等指标的变化及药物相关的不良反应。结果试验组完成治疗者40例,1例因车祸死亡,3例退出试验,1例违背治疗方案。对照组完成治疗者41例,1例退出试验者,2例失访者,1例违背治疗方案。治疗前,两组患者血氨、DST、NCT、MELD、Child-Push评分差异无统计学意义(均P>0.05)。治疗后,两组患者上述指标水平均有所下降,且试验组患者上述指标水平的下降幅度大于对照组(均P<0.05)。试验组显性肝性脑病发生率(5%,2/40)低于对照组(12%,5/41),但差异无统计学意义(P>0.05)。治疗前后两组患者ALT、AST、尿素、肌酐水平差异均无统计学意义(均P>0.05),且治疗过程中两组患者均未出现药物不良反应。结论酪酸梭菌治疗乙肝肝硬化并发轻微肝性脑病疗效显著,是一种安全有效的治疗方法,值得临床推广。

Objective To evaluate the clinical efficacy of Clostridium butyricum in the treatment of patients with minimal hepatic encephalopathy.Methods From January 2018 to January 2019,90 patients with hepatitis B cirrhosis complicated with minimal hepatic encephalopathy were enrolled,and randomly divided into two groups.The observation group(n=45)received basic treatment+Clostridium butyricum capsule,while the control group(n=45)received basic treatment+placebo treatment,for 3 months.The changes of blood ammonia,digital sign test(DST),number connection test(NCT),the model of End-stage liver disease score(MELD),liver and kidney function and drug-related adverse reactions were observed and compared before and after treatment.Results In the observation group,40 cases completed the trial,1 case died in a car accident,3 cases withdrew from the trial,and 1 case violated the protocol;while in the control group,41 cases completed,1 case withdrew,2 cases lost to follow-up,and 1 case violated the protocol.Before treatment,there were no significant differences in blood ammonia,DST,NCT,MELD and Child-Push scores between the two groups(all P>0.05).After treatment,the above indicators decreased in both groups.Compared with the control group,the above indexes in the observation group decreased more significantly,and the differences were statistically significant(all P<0.05).The incidence of dominant hepatic encephalopathy in the observation group(5%,2/40)was lower than that in the control group(12%,5/41),but the difference was not statistical significant(P>0.05).Whether before or after treatment,there were no significant differences in ALT,AST,urea,creatinine between the groups(all P>0.05),and no adverse drug reactions occurred in the two groups during the treatment.Conclusion Clostridium butyricum capsule is a safe and effective method for the treatment of hepatitis B cirrhosis complicated with minimal hepatic encephalopathy.It is worthy of clinical promotion.