| BackgroundDiabetes is an incurable chronic disease that causes functional disorders in human organs.Diabetic nephropathy(DN)is a serious chronic microvascular complication which seriously affects people's health and safety.In recent years,the increasing prevalence of diabetes leads to the increasing incidence of diabetic nephropathy.diabetes-related chronic kidney disease has become more common and the leading cause of chronic kidney disease now.In the field of Traditional Chinese Medicine,diabetic nephropathy belongs to the scope of relieving thirst.The proprietary Chinese medicine preparation liuwei dihuang pill(soup)and its prescription have certain advantages in the treatment and prevention of diabetic nephropathy complications and the improvement of clinical symptoms of diabetic nephropathy,and the price is affordable,especially in the rural grassroots,liuwei dihuang pill(soup)and its prescription are more popular with the majority of patients.ObjectiveThe clinical efficacy and safety of liuwei dihuang pill(decoction)and its prescription for the treatment of diabetic nephropathy were comprehensively evaluated and analyzed by means of Meta analysis.MethodsRetrieval database:Wanfang,CNKI,VIP,CBM,The Cochrane Library,Pubmed database,Embase,the search time is from the establishment of each database to January2020.Find random and controlled trials published at home and abroad about the efficacy and safety of Liuwei Dihuang Wan(Tang)and its Modified Formula in the treatment of diabetic nephropathy,according to the inclusion and exclusion criteria,screen out documents that meet the criteria,and collect relevant information on the included literature Methodological quality evaluation;using the software Review Manager 5.2 Meta analysis method provided by the Cochrane Collaboration Network to perform qualitative and quantitative analysis on the data that meet the inclusion criteria,and to explain and discuss the analysis results and qualitative aspects.ResultsA total of 764 related documents were retrieved,and finally 16 were included,including 14 in Chinese and 2 in English.Of the 16 studies included,9 studies reported clinical comprehensive efficacy,combined OR value and 95%confidence interval:OR=4.79,95%CI[3.2,7.18],the results showed that the treatment group Liuweidihuangwan(tang)Compared with the control group,diabetic nephropathy and its modified formula were significantly more effective,and the difference was statistically significant(P<0.00001);9 studies reported urine microalbumin excretion,I~2=73%,combined MD value and 95%The confidence interval is:MD=-34.14,95%CI[-40.36,-27.92],the results show that Liuweidihuangwan(Tang)and its modified formula in treating diabetic nephropathy are significantly more effective than the control group in reducing urine microalbumin excretion,The difference was statistically significant(P<0.00001);4 studies reported 24-hour urine protein quantification,the results showed that Liuwei Dihuang Wan(decoction)and its modified formula had a significant advantage in improving 24-hour urine protein quantification compared with the control group.The difference was statistically significant(SMD=-0.66,95%CI[-0.89,-0.44],P<0.00001);4 studies reported serum cystatin levels,Meta analysis I~2=94%,combined effect size Analysis shows that Liuwei Dihuang Wan(Tang)and its modified formula are lowering serum cystatin levels compared with the control group There are significant differences in the face,and the results are statistically significant(MD=-0.54,95%CI[-0.64,-0.43],P<0.00001);4 studies have reported urine?2-MG Meta analysis I~2=97%,effect The combined analysis of the results showed that Liuweidihuangwan(Tang)and its modified formula had a significant difference in reducing?2-MG level compared with the control group,and the results were statistically significant(SMD=-0.83,95%CI[-1.03,-0.62],P<0.00001);8 studies reported blood creatinine values,the results showed that Liuweidihuangwan(decoction)and its addition and subtraction formula were significantly different from the control group in reducing blood creatinine levels,the results were statistically Significance(MD=-16.14,95%CI[-29.18,-3.1],P=0.02);7 studies reported urea nitrogen value,I~2=82%,the results showed that Liuweidihuangwan(soup)and its addition and subtraction formula Reducing urea nitrogen is comparable to the control group(MD=-0.31,95%CI[-0.93,0.3],P=0.31);8independent studies have reported fasting blood glucose,Meta analysis I~2=60%,effect size The combined analysis showed that Liuweidihuangwan(Tang)and its modified formula had a significant advantage over the control group in reducing fasting blood glucose,and the difference was statistically significant(MD=-0.42,95%CI[-0.67,-0.16],P=0.01);4studies reported 2 hours postprandial blood glucose,Meta analysis I~2=35%,the combined effect volume suggested that Liuweidihuangwan(soup)and its addition and subtraction formulas decreased after meals compared with the control group There was a significant difference in blood glucose at 2 hours(MD=-0.57,95%CI[-0.83,-0.32],P<0.0001);5independent studies reported glycated hemoglobin,Meta analysis I~2=92%,the results of the combined effect There was no significant difference in improvement of glycated hemoglobin between Liuwei Dihuang Pills(Tang)and its modified formula(MD=-0.74,95%CI[-1.72,0.24],P=0.14);four studies reported Cholesterol,I~2=0%,combined effect size analysis MD value and 95%confidence interval is(MD=-0.05,95%CI[-0.17,0.07])prompts treatment group Liuweidihuangwan(decoction)and its addition and subtraction comparison The control group was equivalent in reducing total cholesterol in diabetic nephropathy;4 studies reported triglyceride,I~2=86%,the combined MD value and 95%confidence interval were(MD=-0.11,95%CI[-0.51,0.28]),the results of the treatment group Liuwei Dihuang Wan(decoction)and its modified formula for diabetic nephropathy are equivalent in reducing triglyceride;5 studies have reported TCM symptoms To improve the situation,the combined MD value and 95%confidence interval of the three independent studies are:(MD=-6.82,95%CI[-7.87,-5.77]),the results show that the treatment group Liuweidihuangwan(soup)and its plus The treatment of diabetic nephropathy with reduced prescription has obvious advantages over the control group in the improvement of TCM symptoms,the difference is statistically significant(P<0.00001);of the 16 studies included,8 studies reported adverse reactions,in addition to serious adverse reactions,8 The study described that adverse events are controllable,so Liuwei Dihuang Wan(Tang)and its addition and subtraction are relatively safe.The methodological quality of the included literature is low,and the risk of selection bias,implementation bias,and measurement bias is high.ConclusionLiuwei Dihuang Pills(Tang)and Jiajianfang have obvious curative effectiveness on diabetic nephropathy,with relatively high safety,and can effectively reduce the urinary albumin excretion rate,24-hour urine protein,FPG,P2hPG,Scr,serum cystatin,The microglobulin level is better than the control group,and it has no significant difference in reducing BUN,HbAlc,TC,TG levels compared with the control group;it can significantly improve the clinical symptoms and provide a clinical basis for the treatment of diabetic nephropathy,it is worth further discussion.Due to the heterogeneity and methodological defects of the original documents included,and the randomized controlled trials of the related literatures of Dihuang Wan(Tang)are few,with obvious limitations,we still need to improve the design plan in further clinical trials to improve Methodological quality,rigorously designed multi-center,reasonable sample size,randomized double-blind,distributed hidden randomized controlled trials for further systematic evaluation.Minimize bias and further optimize the level of evidence for Liuweidihuangwan(Tang)and its modified formula to treat diabetic nephropathy,providing a stronger basis for the clinical application of Liuweidihuangwan(Tang)and its modified formula. |
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