A Retrospective Study Of Haikun Shenxi Capsules In The Treatment Of Diabetic Nephropathy Based On Propensity Score Matching Method

Objective:to evaluate the efficacy and the safety of Haikunshenxi capsule in the treatment of diabetic kidney disease(DKD)based on the systematically review and t he propensity score matching method.Also to explore the pathological hypothesis of t he "micro Zhengjia" and the therapy of "Huajiexiaozheng".Methods:(1)Systematic review:"Five major electronic database were retrieved(Chinese database:China National Knowledge Internet(CNKI),WanFang Data,VIP,C hina Biology Medicine disc(CBMdisc),English database includes:Medline),the retrie val date was from the beginning of the database to August 2017;②Based on the pre set inclusion and exclusion criteria,documents screening,data extraction were conducte d by two researchers separately;③Methodological quality of randomized controlled tri als of Haikunshenxi capsule in the treatment of DKD was evaluated based on the Coc hrane’s risk assessment tool.This process was also conducted by two researchers separ ately;④The qualitative analysis was made for the basic characteristics of the RCT liter ature,methodological quality,observation index;Meta analysis was used to make the quantitative analysis of renal function and urinary protein related indexes;(2)Propens ity score matching study:①The clinical data cases was obtained from the Hospital I nformation System(HIS)and Laboratory Information System(LIS),the retrieval infor mation was about those Diabetic nephropathy patients who were hospitalized with nep hrotic endocrinology from 2012 to 2017;②The incomplete information case was delet ed,and the related information of the project name was standardized for establishing t he database by SPSS;③The covariates for SCr,BUN and FIB respectively was select ed by Logistic regression model;④The covariates of the two groups was dealt by pr opensity score matching method(caliper value 0.2,the proportion of 1:1)to get the matching samples for analyzing.Results:(1):Systematic review:Haikunshenxi capsule for improving DKD patient s Scr(MD=-52.92 umol/L,95%CI=[-61.25,-44.58],I2=0%),BUN(MD=-1.66mmol/L 95%CI=[-2.52,-0.80],I2=0%),24hUTP(MD=-14.84mg 95%＝[-21.42,-8.26],I2=0%an d mAlb(MD=-1.8mg,95%=[-2.42,-1.19],12=0%)treatment efficacy is better than wes tern medicine conventional control group;(2)Propensity score matching study:observe d 89 cases of FIB,7 were successfully matched to the sample.The distribution of va riables was uneven among Shenkang Injection group(p=0.001)and Jinshuibao capsule group(p=0.002)before matching,and balanced after matching.The analysis results af ter matching showed that,Before and after the treatment,the FIB difference of Haiku nshenxi group was-0.88±0.52,the control group was 0.19±1.02.The difference is stati stically significant(p=0.03).Conclusions:(1)Through systematic review,Haikunshenxi capsule has the long-te rm intervention to patients with DKD,which could improve their SCr,BUN,24hUTP,mAlb level effectively,the potency is definitely;The "real-world study" of Haikunshe nxi capsule which was based on the propensity score matching method shows that,Ha ikunshenxi capsule doesn’t have the obvious improvement on kidney function of patien is with DKD in short-term,but it could effectively improve their FIB level;(2)Throu gh the evaluation of the therapeutic effect on the treatment of DKD by Haikunshenxi capsule,it is proved that the "micro Zhengjia" pathological hypothesis and the therapy of "Huajiexiaozheng" method have practical significance for clinical treatment of DK D.