常规西药联合中药煎剂保留灌肠治疗轻微肝性脑病患者的Meta分析

Meta-analysis of conventional western medicine combined with traditional Chinese medicine decoction retention enema in the treatment of minimal hepatic encephalopathy

目的:系统评价常规西药联合中药煎剂保留灌肠治疗轻微肝性脑病(MHE)患者的有效性及安全性。方法:系统检索Medline、Embase、Cochrane Library、中国知网、万方数据库、中文科技期刊数据库及中国生物医学文献数据库,检索时限均从建库至2020年11月15日。根据Cochrane Handbook 5.1.0要求,按照纳入及排除标准进行文献筛选,对纳入的研究进行资料提取和质量评价,并应用RevMan 5.3软件进行数据分析,以及采用GRADEprofiler 3.6软件按照GRADE要求对Meta分析结局指标进行证据分级。结果:共检索到56篇文献,最终纳入13篇文献,共690例患者。Meta分析结果显示,在有效性方面,试验组在缩短数字连接实验A时间[MD=-12.03,95%CI(-21.70,-2.36),P=0.01]、提高数字符号实验得分[MD=1.09,95%CI(0.39,1.80),P=0.002]、降低血氨水平[MD=-14.78,95%CI(-21.89,-7.68),P<0.0001]、降低谷丙转氨酶水平[MD=-7.59,95%CI(-10.79,-4.40),P<0.00001]、降低谷草转氨酶水平[MD=-14.89,95%CI(-25.63,-4.16),P=0.007]、降低总胆红素水平[MD=-8.26,95%CI(-11.54,-4.97),P<0.00001]、提高白蛋白水平[MD=3.31,95%CI(-0.07,6.69),P=0.05]及改善中医证候疗效[RR=1.33,95%CI(1.13,1.57),P=0.0006]方面均优于对照组;在安全性方面,不良反应发生次数上两组差异无统计学意义[RR=0.99,95%CI(0.01,111.95),P=1.00]。GRADE证据分级结果显示,结局指标NCT A、血氨及不良反应为低等级,DST为中等级,ALT、AST、TBil、Alb及中医证候疗效均为极低等级。结论:常规西药联合中药煎剂保留灌肠对MHE患者在改善神经心理学测试结果、降低血氨、改善肝功方面可获益,但可能发生腹泻等不良反应。

Objective:To systematically evaluate the efficacy and safety of The combining use of conventional western medicine and traditional Chinese medicine(TCM)decoction retention enema compared with conventional western medicine in the treatment of minimal hepatic encephalopathy(MHE).Methods:Retrieval methods this study system Medline,Embase,the Cochrane Library,China National Knowledge Infrastructure(CNKI),Wanfang Digital Journal Full text Database,VIP Chinese Journal Database,and China Biomedical Literature Database,and the retrieval time was from November 15,2020.According to Cochrane Handbook 5.1.0,literature was screened according to the inclusion criteria,and data extraction and quality evaluation were conducted for the included studies.RevMan 5.3 was used for data analysis.GRADEprofiler 3.6 was used to grade the meta analysis outcome indicators according to the GRADE system.Results:A total of 56 articles was retrieved,and 13 articles were included,with a total of 690 patients.Meta-analysis results showed that in terms of effectiveness,the experimental group was superior to the control group in the number connection test A(NCT A)[MD=-12.03,95%CI(-21.70,-2.36),P=0.01],digit symbol test(DST)[MD=1.09,95%CI(0.39,1.80),P=0.002],blood ammonia[MD=-14.78,95%CI(-21.89,-7.68),P<0.0001)]alanine aminotransferase(ALT)[MD=-7.59,95%CI(-10.79,-4.40),P<0.00001],aspartate transaminase(AST)[MD=-14.89,95%CI(-25.63,-4.16),P=0.007],total bilirubin(TBIL)[MD=-8.26,95%CI(-11.54,-4.97),P<0.00001],albumin(ALB)[MD=3.31,95%CI(-0.07,6.69),P=0.05]and the efficacy of TCM syndromes[RR=1.33,95%CI(1.13,1.57),P=0.0006].In terms of safety,there was no statistically significant difference in the incidence of adverse reactions between the two groups[RR=0.99,95%CI(0.01,111.95),P=1.00].GRADE evidence showed that NCT A,blood ammonia,and adverse reactions were low grades,DST was medium grade,ALT,AST,TBIL,ALB,and the efficacy of TCM syndrome were all very low grade.Conclusion:The combining use of traditional Chinese medicine decoction retention enema and conventional therapy can benefit MHE patients in improving neuropsychological test results,reducing blood ammonia,improving liver function,but may occur diarrhea and other adverse reactions.Due to the low level of evidence,the relevant conclusions of this study still need to be confirmed by more high-quality studies.