| Objective: To systematically evaluate the efficacy and safety of Jisheng Shenqi Pill and its additive and subtractive formula combined with western medicine in the treatment of diabetic nephropathy through Meta-analysis,and to summarize the medication pattern of Jisheng Shenqi Pill additive and subtractive formula in the treatment of diabetic nephropathy through data mining,so as to guide the clinical use of diabetic nephropathy.Methods:1.The databases such as China Knowledge Network(CNKI),Vipshop Chinese Journal Database,Wanfang Data Service Platform,Cochrane,Pub Med,etc.were searched by computer,and the Chinese search terms were "Jisheng Kidney Qi Pills","diabetic nephropathy",etc;The English search terms were "diabetic nephropathy","Jisheng-Shenqi Pill","clinical observation experiment",etc.The search period was limited to December 31,2022,when the database was created.The retrieved literature was screened with the established inclusion criteria,duplicate and redundant literature was eliminated using relevant software,and the literature that met the inclusion criteria was organized in a uniform manner using Excel sheets,and then systematic Meta-analysis was performed using Revman 5.4,and various graphs such as forest plots were drawn,and sensitivity analysis and subgroup analysis were performed when necessary to better judge the efficacy and If necessary,sensitivity analysis and subgroup analysis were performed to better evaluate the efficacy and safety.2.The databases such as China Knowledge Network(CNKI),Vipshop Chinese Journal Database,Wanfang Data Service Platform,Cochrane,Pub Med,etc.were searched by computer,and the Chinese search terms were "Jisheng Kidney Qi Pills","diabetic nephropathy",etc;The English search terms were "diabetic nephropathy","Jisheng-Shenqi Pill","clinical observation experiment",etc.The search period was limited to December 31,2022,when the database was created.The retrieved literature was screened with established inclusion criteria,duplicate and redundant literature was eliminated using relevant software,and those meeting the inclusion criteria were organized in a uniform manner using Excel sheets for data,and then the core drugs were explored using SPSS Modeler 18.0 in conjunction with Cytoscape3.9.1 software,and RStudio 4.2.1 was used for Apriori algorithm for association rule analysis and RStudio4.2.1 for clustering and drug dose analysis of core drugs.thereby better improve the research content and guide clinical practice.Results:1.Meta-analysis: A total of 20 papers meeting the criteria were searched and screened for a total of 1589 patients,including 804 cases in the study group and 785 cases in the control group,between2003 and 2022.The maximum number of cases in a single group was 60 cases and the minimum was 18 cases.The following results were obtained after Meta-analysis:(1)Total clinical efficiency: 20 papers with 1589 cases meeting the criteria were included,and the test results were: RR = 1.28,95% CI = [1.22,1.35],Z = 9.83,P < 0.00001.(2)Fasting blood glucose: 11 papers with 967 cases meeting the criteria were included,and the test result was MD =-1.46,95% CI = [-1.84,-1.07],Z = 11.29,P < 0.00001.(3)Postprandial 2-hour glucose: 7 papers with 606 cases meeting the criteria were included and the test result was: MD=-0.87 95% CI=[-1.06,-0.68],Z = 9.05,P<0.00001.(4)Glycosylated hemoglobin: 7 papers with 432 cases meeting the criteria were included,and the test result was MD =-1.35,95% CI = [-2.08,-0.63],Z = 3.64,P = 0.0003 < 0.05.(5)Serum creatinine: 8 papers with 704 cases meeting the criteria were included,and the test result was: SMD =-3.67,95% CI = [-5.04,-2.31],Z = 5.27,P < 0.00001.(6)Blood urea nitrogen: 8 papers with 536 cases meeting the criteria were included,and the test result was: SMD=-2.58,95% CI=[-3.84,-1.32],Z=4.02,P < 0.0001.(7)Urinary albumin excretion rates: 7 papers with 525 cases meeting the criteria were included,and the test result was: SMD=-2.14,95% CI=[-3.09,-1.19],Z=4.44,P<0.00001.(8)24-hour urinary protein quantity: 7 papers with 609 cases meeting the criteria were included,and the test result was: SMD =-1.65,95% CI [-2.43,-0.68],Z = 4.12,P < 0.0001.(9)Creatinine Clearance: 7 papers with 204 cases meeting the criteria were included,and the test results were MD=9.72,95% CI= [6.19,13.25],Z=5.40,P< 0.00001.(10)Triglycerides: 4 papers with 416 cases meeting the criteria were included and the test result was: MD=-0.81,95% CI= [-1.50,-0.12],Z=2.30,P=0.02<0.05.2.Data Mining:A total of 67 cases were included through data mining,and 67 prescriptions involving82 herbs were extracted to obtain the following results:(1)The top 4 symptoms involved were: spleen and kidney yang deficiency(32 times,47.76%),yin and yang deficiency(7 times,10.45%),yang deficiency and blood stasis(7 times,10.45%),and qi deficiency and blood stasis(6 times,8.96%).(2)The top 4 herbal medicines involved in efficacy were: deficiency tonics(256 times,27.56%),diuretics(181 times,19.48%),blood activators(123 times,13.24%),and warmers(109 times,11.73%).(3)The top ranking in the nature and taste of the herbs involved are:(1)drug nature: warm(296,31.86%),cold(278,29.92%),and flat(238,25.62%)dominate,with a cumulative percentage of 87.4%;(2)drug taste: sweet(660,42.58%),pungent(299,19.29%),and bitter(238,15.35%)dominate,with a cumulative percentage of 77.22%;(3)drug meridian: kidney meridian(664,25.74%),liver meridian(502,19.46%),and spleen meridian(409,15.85%)were dominant,with a cumulative percentage of 61.05%.(4)Core drugs: In addition to the Jisheng Kidney Qi Pill formula,the core drugs include Astragalus,Salvia,Radix Angelicae Sinensis,Yimoucao,Rhubarb,Fructus Lycii,Radix et Rhizoma,Golden Cherry,Gorgonzola.Glycyrrhiza glabra,poria.(5)Core drug rule association analysis: filtered with support >95% and confidence >90%,108 core association rules were obtained,all with a lift greater than 1,suggesting that the drug associations were all strong.(6)Dosimetric analysis:Minimal fluctuations in dosage:Goji berries,Astragalus,Hyssop,Amomom;Dosage fluctuates within 10g:Plantago ovata,Rhubarb,Radix Angelicae Sinensis,Poria,Radix et Rhizoma,Glycyrrhiza glabra,Peony bark,Cinnamon,Cornu Cervi Pantotrichum,Radix Rehmanniae Praeparata,Fructus Yimou,Poria;Fluctuations greater than 10g:Salvia miltiorrhiza,cinnamon stick,golden cherry,gorgonian,yam,zedoary.Conclusion: 1.The total clinical effectiveness of Jisheng Shenqi Wan and its additive formula in the treatment of diabetic nephropathy was better than that of the control group.The mechanism is related to regulating patients’ glucose and lipid metabolism,reducing urinary protein excretion and protecting glomerular filtration function.2.The RCT literature is highly heterogeneous and may be biased.3.The herbs used in Jisheng Shenqi Wan plus or minus formula for the treatment of diabetic nephropathy are mostly warm,cold and flat in nature,sweet,pungent and bitter in taste,and are mostly attributed to the kidney,liver and spleen meridians,and are mostly used together with qi tonics,blood invigorating herbs,dampifying herbs and astringent herbs.It completes the deficiencies of Meta-analysis and also guides the direction of clinical addition and subtraction of Chinese herbs for the treatment of diabetic nephropathy. |
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