苓桂术甘汤的临床应用:1项系统性评价与Meta分析

Clinical application of Linggui Zhugan Decoction:A systematic review and Meta-analysis

目的 对经典名方苓桂术甘汤的临床应用证据进行系统性评价与Meta分析。方法 在知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献数据库(Sinomed)、PubMed、Web of Science与Ovid共7个平台检索自各数据库建库至2023年4月5日的苓桂术甘汤相关临床随机对照研究,对各病种研究中报告的结局指标进行Meta分析,Egger检验评估发表偏倚,应用剪补法后进行敏感性分析。结果 纳入47项研究,各病种病例共3933例。病种主要包括慢性心力衰竭、心律失常、非酒精性脂肪性肝病、2型糖尿病、血脂异常、肾脏病以及椎基底动脉供血不足。Meta分析显示,苓桂术甘汤具有改善慢性心力衰竭左室射血分数(MD=3.63,95%CI [1.72,5.54],P=0.000 2)、脑利钠肽(MD=-104.35,95%CI [-145.02,-63.67],P<0.000 1)、氨基末端脑利钠肽前体(MD=-140.60,95%CI [-213.40,-67.79],P=0.000 2)水平;降低24 h内房性早搏数量(MD=-288.36,95%CI [-323.21,-253.52],P<0.000 1)与室性早搏数量(MD=-262.53,95%CI [-301.23,-223.82],P<0.000 1);改善肝脏脂肪变性受控衰减参数(SMD=-0.71,95%CI [-1.01,-0.42],P<0.000 1)、肝脾CT比值(SMD=0.93,95%CI [0.62,1.24],P<0.000 1);控制2型糖尿病空腹血糖(MD=-1.05,95%CI [-1.96,-0.14],P=0.023 1)、餐后2 h血糖(MD=-1.39,95%CI [-1.98,-0.81],P<0.000 1)、糖化血红蛋白(MD=-0.86,95%CI [-1.35,-0.38],P=0.000 5)水平;改善冠心病三酰甘油(MD=-0.82,95%CI [-1.16,-0.47],P<0.000 1)、总胆固醇(MD=-1.79,95%CI [-2.61,-0.97],P<0.000 1)、低密度脂蛋白胆固醇(MD=-0.75,95%CI [-0.91,-0.59],P<0.000 1)、高密度脂蛋白胆固醇(MD=0.08,95%CI [0.05,0.11],P<0.000 1)水平;降低血尿素氮(MD=-6.32,95%CI [-8.14,-4.50],P<0.000 1)、血清肌酐(MD=-45.21,95%CI [-70.70,-19.32],P=0.000 5)水平以及提高基底动脉平均血流速度(MD=5.00,95%CI [4.21,5.79],P<0.000 1)的作用。结论 目前苓桂术甘汤临床应用证据涵盖慢性心力衰竭、心律失常、非酒精性脂肪性肝病、2型糖尿病、血脂异常、肾脏病以及椎基底动脉供血不足等疾病,对各病种相关结局指标均有所改善,临床应用多样;但相关研究的质量普遍有提高空间,仍需更高水平的循证医学证据。

Objective To conduct a systematic review and Meta-analysis concerning clinical application evidence of the classic prescription Linggui Zhugan Decoction(LGZGD,苓桂术甘汤).Methods The clinical randomized controlled studies related to LGZGD were searched via seven databases:CNKI,Wanfang,VIP,Sinomed,PubMed,Web of Science and Ovid from inception to April 5,2023.A Meta-analysis was performed on the outcome indicators reported in clinical research of each disease.Egger test was applied for publication bias,while sensitivity analyses was employed after using trim-and-fill method.Results A total of 47 clinical studies were included,with 3933 cases of various diseases.The main diseases included chronic heart failure,arrhythmia,non-alcoholic fatty liver disease(NAFLD),type 2 diabetes(T2DM),dyslipidemia,kidney disease and vertebrobasilar insufficiency(VBI).Metaanalysis showed that LGZGD could improve left ventricular ejection fraction(MD = 3.63,95% CI [1.72,5.54],P = 0.000 2),brain natriuretic peptide(MD =-104.35,95% CI [-145.02,-63.67],P<0.000 1) and N-terminal pro brain natriuretic peptide(MD =-140.60,95% CI [-213.40,-67.79],P = 0.000 2) of chronic heart failure;reduce the number of premature atrial beats within 24 h(MD =-288.36,95% CI [-323.21,-253.52],P<0.000 1),the number of premature ventricular beats within 24 h(MD =-262.53,95% CI [-301.23,-223.82],P<0.000 1);improve controlled attenuation parameter(SMD =-0.71,95% CI [-1.01,-0.42],P<0.000 1)and liver/spleen CT ratio(SMD = 0.93,95% CI [0.62,1.24],P<0.000 1) of NAFLD;control fasting blood glucose(MD =-1.05,95%CI [-1.96,-0.14],P = 0.023 1),2 h postprandial blood glucose(MD =-1.39,95% CI [-1.98,-0.81],P<0.000 1) and glycated hemoglobin A1c(MD =-0.86,95% CI [-1.35,-0.38],P = 0.000 5) of T2DM;regulate triglycerides(MD =-0.82,95% CI [-1.16,-0.47],P<0.000 1),total cholesterol(MD =-1.79,95% CI [-2.61,-0.97],P<0.000 1),low density lipoprotein cholesterol(MD =-0.75,95% CI [-0.91,-0.59],P<0.000 1) and high density lipoprotein cholesterol(MD = 0.08,95% CI [0.05,0.11],P<0.000 1) of coronary heart disease;reduce blood urea nitrogen(MD =-6.32,95% CI [-8.14,-4.50],P<0.000 1),serum creatinine(MD =-45.21,95% CI [-70.70,-19.32],P = 0.000 5) and improve mean velocity of vertebrobasilar insufficiency(MD = 5.00,95% CI [4.21,5.79],P<0.000 1).Conclusion Current clinical application of LGZGD mainly includes chronic heart failure,arrhythmia,NAFLD,T2DM,dyslipidemia,kidney disease,VBI,etc.LGZGD can improve the relevant outcome indicators of various diseases and its clinical application is diverse.However,research quality should be improved and high-quality evidence is still required.