大柴胡汤加减治疗脂肪肝随机对照试验Meta分析
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摘要
目的:评价大柴胡汤加减治疗脂肪肝的有效性与安全性。方法:检索数据库PubMed、Embase、Cochrane library、中国期刊全文数据库、万方数据库、维普数据库、中国生物医学文献数据库中收录的2018年10月前发表的关于大柴胡汤加减治疗脂肪肝随机对照试验(randomized controlled trials,RCTs)。由研究人员对文献进行筛选和数据提取,应用RevMan 5.3软件对临床疗效指标进行Meta分析,采用Cochrane风险偏倚评估工具进行偏倚风险评估和改良的Jadad量表进行质量评价。结果:共纳入7项RCT(494例患者),Meta分析结果显示:试验组大柴胡汤加减治疗脂肪肝与对照组西药常规疗法相比,临床疗效总有效率优于对照组(OR=2.64,95%CI:1.57～4.45,P=0.0002);治疗后丙氨酸氨基转移酶(ALT)优于对照组(MD=-17.76,95%CI:-20.00～-15.52,P<0.00001);治疗后总胆固醇(TC)优于对照组(MD=-0.38,95%CI:-0.63～-0.14,P=0.002);治疗后甘油三酯(TG)优于对照组(MD=-0.49,95%CI:-0.84～-0.14,P=0.007);所纳入的研究均未报道不良反应。结论:本研究表明大柴胡汤加减治疗脂肪肝临床疗效优于西药常规疗法,但由于所纳入的研究总体质量较低,研究的数量和样本量均较少,需进一步开展高质量的多中心、大样本、前瞻性、双盲等严格设计的RCT来验证其疗效与安全性。
Objective:To evaluate the clinical efficacy and safety of Dachaihu Decoction in the treatment of fatty liver disease(FLD). Methods:English and Chinese databases were searched from the inception of each database up to October 2018. Databases included PubMed,Embase,Cochrane library,China National Knowledge Infrastructure,WanFang Database,Chongqing VIP and Chinese Biomedical Database. The literatures of randomized controlled trials(RCTs)in treatment of FLD with Dachaihu Decoction were selected. Records were screened for eligible studies and data were extracted and synthesized using Review Manager Version 5.3. The methodological quality of the included studies was evaluated using the Cochrane risk of bias tool and modified Jadad scale. Results:Seven RCTs with 494 participants were included. The meta-analysis results showed that the clinical effective rate(OR=2.64,95% CI:1.57-4.45,P=0.0002),alanine aminotransferase(MD=-17.76,95% CI:-20.00--15.52,P<0.00001),total cholesterol(MD=-0.38,95% CI:-0.63--0.14,P=0.002),triglyceride(MD=-0.49,95% CI:-0.84--0.14,P=0.007)of Dachaihu Decoction group were better than those of Western medicine group. All studies did not report adverse reactions. Conclusion:Although a consistent result that Dachaihu Decoction might be more effective than western medicine conventional treatment in treating FLD in this study,further RCTs of higher quality,larger scale,more rationally designed and strictly executed are still required to identify the conclusion.
Objective:To evaluate the clinical efficacy and safety of Dachaihu Decoction in the treatment of fatty liver disease(FLD). Methods:English and Chinese databases were searched from the inception of each database up to October 2018. Databases included PubMed,Embase,Cochrane library,China National Knowledge Infrastructure,WanFang Database,Chongqing VIP and Chinese Biomedical Database. The literatures of randomized controlled trials(RCTs)in treatment of FLD with Dachaihu Decoction were selected. Records were screened for eligible studies and data were extracted and synthesized using Review Manager Version 5.3. The methodological quality of the included studies was evaluated using the Cochrane risk of bias tool and modified Jadad scale. Results:Seven RCTs with 494 participants were included. The meta-analysis results showed that the clinical effective rate(OR=2.64,95% CI:1.57-4.45,P=0.0002),alanine aminotransferase(MD=-17.76,95% CI:-20.00--15.52,P<0.00001),total cholesterol(MD=-0.38,95% CI:-0.63--0.14,P=0.002),triglyceride(MD=-0.49,95% CI:-0.84--0.14,P=0.007)of Dachaihu Decoction group were better than those of Western medicine group. All studies did not report adverse reactions. Conclusion:Although a consistent result that Dachaihu Decoction might be more effective than western medicine conventional treatment in treating FLD in this study,further RCTs of higher quality,larger scale,more rationally designed and strictly executed are still required to identify the conclusion.
引文
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[12]张旭剑,贾艳萍.大柴胡汤加味治疗脂肪肝52例观察[J].实用中医药杂志,2009,25(4):221-221.
[13]毛晓丽,周涵,陈慧敏.超声对大柴胡汤治疗脂肪肝76例的临床观察[J].内蒙古中医药,2013,32(30):105-105.
[14]王建国.大柴胡汤加减治疗脂肪肝36例[J].湖南中医药大学学报,2004,24(1):47-48.
[15]盛祥梅.超声对大柴胡汤治疗脂肪肝56例的临床观察[J].世界最新医学信息文摘,2016(A1):101.
[16]薛新庆.经方大柴胡汤治疗脂肪肝31例临床观察[J].世界最新医学信息文摘,2013(6):388-388.
[17]陈涤平,陈翠萍.改良大柴胡汤治疗脂肪肝40例[J].安徽中医药大学学报,2004,23(1):22-23.
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[19]李生香,戴光荣,侯帅,等.脂肪性肝病的影像学诊断方法应用进展[J].山东医药,2016,56(3):98-100.
[20] Dongiovanni P,Stender S,Pietrelli A,et al. Causal relationship of hepatic fat with liver damage and insulin resistance in nonalcoholic fatty liver[J]. Journal of Internal Medicine,2017,283(4):356-370.
[21]陈玉帅,王炳元,厉有名.非酒精性脂肪性肝病与酒精性肝病2016研究进展[J].中华肝脏病杂志,2017,25(3):181-186.
[22]马振增,陆伦根.胆固醇代谢与非酒精性脂肪性肝炎[J].中华肝脏病杂志,2016,24(8):623-627.
[23]戴红梅,蒋娟,邹勇波,等.血清学指标检验在脂肪肝患者临床诊断中的应用价值研究[J].现代生物医学进展,2015,15(3):493-495.
[24]杨一玖.基于数据挖掘的大柴胡汤证研究[D].北京:北京中医药大学,2017.
[25]李小菲,李静,王義雯,等.柴胡、柴胡和黄芩配伍对肝细胞损伤体外作用[J].吉林中医药,2016(2):176-180.
[26]李敏,王羲雯,李小菲,等.基于TLR4-NFκB的柴胡皂苷d-黄芩苷配伍抗CCl4损伤肝细胞的作用研究[J].中医药导报,2017(18):26-29.
[27]金英善,陈曼丽,陶俊.芍药化学成分和药理作用研究进展[J].中国药理学与毒理学杂志,2013,27(4):745-750.
[28]刘涛,徐秋玲,赵岩.大黄素抑制NAFLD大鼠肝脏TLR4信号表达的研究[J].中药新药与临床药理,2016,27(2):201-205.
[29]汉利,王新伟,单恒云,等.大柴胡汤加减方对肝功能和凝血机制的作用研究[J].世界中医药,2016,11(6):1063-1065.
[30]常一川,王凤荣.大柴胡汤干预高脂高胆固醇大鼠模型量效关系研究[J].辽宁中医药大学学报,2015(4):37-39.
[2]Zhu J Z,Zhou Q Y,Wang Y M,et al. Prevalence of fatty liver disease and the economy in China:A systematic review[J].World Journal of Gastroenterology,2015,21(18):5695-5706.
[3]Kim D,Touros A,Kim W R. Nonalcoholic Fatty Liver Disease and Metabolic Syndrome[J]. Clinics in Liver Disease,2018,22(1):133-140.
[4]Lee S W,Lee T Y,Yang S S,et al. The association of nonalcoholic fatty liver disease and metabolic syndrome in a Chinese population[J]. Hepatobiliary&Pancreatic Diseases International,2017,16(2):176-180.
[5]Tokita Y,Maejima Y,Shimomura K,et al. Non-alcoholic Fatty Liver Disease Is a Risk Factor for Type 2 Diabetes in Middle-aged Japanese Men and Women[J]. Internal Medicine,2017,56(7):763-771.
[6]Ma J,Hwang S J,Pedley A,et al. Bi-directional analysis between fatty liver and cardiovascular disease risk factors[J]. Journal of Hepatology,2017,66(2):390-397.
[7]Lonardo A,Sookoian S,Pirola C J,et al. Non-alcoholic fatty liver disease and risk of cardiovascular disease[J]. Metabolismclinical and Experimental,2015,65(8):1136-1150.
[8]Singh S,Osna N A,Kharbanda K K. Treatment options for alcoholic and non-alcoholic fatty liver disease:A review[J].World Journal of Gastroenterology,2017,23(36):6549-6570.
[9]潘雨亭,许方圆,于希忠,等.中药活性成分治疗非酒精性脂肪肝作用靶点的研究进展[J].中国中药杂志,2017,42(6):1109-1112.
[10]Li W,Wu Y,Ge W,et al. A herbal formula Erchen decoction for non-alcoholic fatty liver disease:A systematic review and meta-analysis of randomized controlled trials[J]. International Journal of Clinical and Experimental Medicine,2017,10(6):9110-9116.
[11]关崧,赵翠芳.化湿降浊活血法治疗2型糖尿病并发非酒精性脂肪肝疗效观察[J].陕西中医,2013,34(4):412-414.
[12]张旭剑,贾艳萍.大柴胡汤加味治疗脂肪肝52例观察[J].实用中医药杂志,2009,25(4):221-221.
[13]毛晓丽,周涵,陈慧敏.超声对大柴胡汤治疗脂肪肝76例的临床观察[J].内蒙古中医药,2013,32(30):105-105.
[14]王建国.大柴胡汤加减治疗脂肪肝36例[J].湖南中医药大学学报,2004,24(1):47-48.
[15]盛祥梅.超声对大柴胡汤治疗脂肪肝56例的临床观察[J].世界最新医学信息文摘,2016(A1):101.
[16]薛新庆.经方大柴胡汤治疗脂肪肝31例临床观察[J].世界最新医学信息文摘,2013(6):388-388.
[17]陈涤平,陈翠萍.改良大柴胡汤治疗脂肪肝40例[J].安徽中医药大学学报,2004,23(1):22-23.
[18] Higgins J. Cochrane handbook for systematic reviews of interventions Version 510 updated March 2011 The Cochrane Collaboration[J]. International Journal of Clinical Medicine,2011,5(2):S38.
[19]李生香,戴光荣,侯帅,等.脂肪性肝病的影像学诊断方法应用进展[J].山东医药,2016,56(3):98-100.
[20] Dongiovanni P,Stender S,Pietrelli A,et al. Causal relationship of hepatic fat with liver damage and insulin resistance in nonalcoholic fatty liver[J]. Journal of Internal Medicine,2017,283(4):356-370.
[21]陈玉帅,王炳元,厉有名.非酒精性脂肪性肝病与酒精性肝病2016研究进展[J].中华肝脏病杂志,2017,25(3):181-186.
[22]马振增,陆伦根.胆固醇代谢与非酒精性脂肪性肝炎[J].中华肝脏病杂志,2016,24(8):623-627.
[23]戴红梅,蒋娟,邹勇波,等.血清学指标检验在脂肪肝患者临床诊断中的应用价值研究[J].现代生物医学进展,2015,15(3):493-495.
[24]杨一玖.基于数据挖掘的大柴胡汤证研究[D].北京:北京中医药大学,2017.
[25]李小菲,李静,王義雯,等.柴胡、柴胡和黄芩配伍对肝细胞损伤体外作用[J].吉林中医药,2016(2):176-180.
[26]李敏,王羲雯,李小菲,等.基于TLR4-NFκB的柴胡皂苷d-黄芩苷配伍抗CCl4损伤肝细胞的作用研究[J].中医药导报,2017(18):26-29.
[27]金英善,陈曼丽,陶俊.芍药化学成分和药理作用研究进展[J].中国药理学与毒理学杂志,2013,27(4):745-750.
[28]刘涛,徐秋玲,赵岩.大黄素抑制NAFLD大鼠肝脏TLR4信号表达的研究[J].中药新药与临床药理,2016,27(2):201-205.
[29]汉利,王新伟,单恒云,等.大柴胡汤加减方对肝功能和凝血机制的作用研究[J].世界中医药,2016,11(6):1063-1065.
[30]常一川,王凤荣.大柴胡汤干预高脂高胆固醇大鼠模型量效关系研究[J].辽宁中医药大学学报,2015(4):37-39.