| Objective:1.Meta-analysis:Reviewing the clinical therapeutic effect of the treatment of adult primary nephrotic syndrome based on combined treatment of traditional Chinese medicine and western medicine through Meta-analysis will provide basis for clinical treatment and research.2.Clinical research:Discuss whether the clinical symptoms of spleen-kidney yang deficiency patients could be improved by warming reinforcing spleen-kidney through using shipi drink combined with jishengshenqi pill and whether the adverse reaction from western medicine can be released.It will provide the effective clinical basis for exploring the treatment of primary nephrotic syndrome through traditional Chinese medicine.Method:1.Meta-analysis:Retrieve all the handy databases,including PubMed,CNKI,VIP and Wanfang Data,collect the literatures about clinical randomized comparison trial issued officially from the date that the database was created to Dec.2017.Adopt the Evaluation Standard of quality of Cochrane Handbook 5.1 to evaluate the risk of bias of the included studies from overall point of view.All the data are obtained through the Meta-analysis for more than 3 of the randomized comparison trials with the identical therapeutic effect index by using Review Manage 5.3 and plotting the forest map.Exclude two of the research with the highest weight,re-analyze,compare the stability of the two results and evaluate the stability of Meta-analysis based on the resistency of the results.Including the results of Meta-analysis based on more than five of the above studies,use funnel plot to analyze the publication bias.2.Clinical research:Picking 70 outpatients or inpatients who according with primary nephrotic syndrome and spleen-kidney yang deficiency and registered in No.211 hospital of PL A from 1st Jan.2016 to 31st Dec.2017,separated as treated group and control group randomly.Giving the general treatment and standard glucocorticoid therapy to the control group whereas giving the treated group the same as the control group plus Shipi Drink combined with Jishengshenqi Pill add and subtract.The whole course of treatment is 8 weeks.Evaluate the validity and safety of the combined traditional Chinese medicine and western medicine by observing clinic symptome and sign,TCM syndrome,blood and urine biochemical criterion,glucocorticoid related adverse reaction,blood routine examination,liver function and ECG etc.safety index.The data were entered and analyzed through SPSS 22.0,a statistical software.The measured data are recorded as average ±standard deviation(x±s)by using t test in groups.The enumeration data are tested by χ2 test.Result:1.Meta-analysis:Retrieve 4696 literatures from the mentioned databases,and choose 33 for Meta-analysis.The risk of bias of the 33 papers are quite high.Meta-analysis shows as follows:compared with the control group,the clinical therapeutical effect of the treated group are improved apparently,OR=4.47,95%CI is 3.59～5.56,p<0.00001;24·hour urinary protein quantity was reduced apparently,SMD=-1.06,95%CI is-1.32～-0.80,p<0.00001;plasma albumin went up evidently,SMD=1.14,95%CI is 0.94～1.34,p<0.00001;TCM syndrome score was reduced apparently,SMD=-0.39,95%CI is-0.66～-0.12,p=0.005;the risk of adverse reaction was low,RR=0.44,95%CI is 0.26～0.73,p=0.002.The funnel plot is asymmetric,which means publication bias exists.2.Clinical research:Before the treatment,there is no apparent differences(p<0.05)among the blood and urine biochemical index of 24hUPQ,Alb,TC,TG,SCr and BUN etc.between the two groups.After the treatment,the improvement of some of the index are better(p<0.05)than the control group,which including the comprehensive clinical effects,24hUPQ,Alb,TC and TG,however,there is no apparent differences of SCr and BUN(p>0.05).For the treated group,TCM score is reduced apparently(p<0.05),the incidence rate of the glucocorticoid related adverse reactions of infection and blood glucose increasing and so on are reduced apparently(p<0.05).There are no apparent variations between the two groups of blood routine examination,liver function and ECG after the treatment.Conclusion:1.Meta-analysis:it showed that,under the identical situation,treating the primary nephrotic syndrome for adults by using the combined treatment of traditional Chinese medicine and western medicine has better comprehensive clinical effect and safety.Roughly evaluate the funnel plot,there is publication bias among the 33 studies included.2.Clinical research:The curative effect of treating spleen-kidney yang deficiency type primary nephrotic syndrome for adults with shipi drink combined with jishengshenqi pill and standard glucocorticoid therapy regimen are exact.It would improve the clinical symptom of the patients,reduce urine protein,increase plasma albumin,adjust blood fat and reduce the glucocorticoid related adverse reaction.It is safe and effective. |
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