| Background:Uric acid nephropathy(UAN),also known as hy peruricemic nephropathy and gout nephropathy,refers to the renal damage caused by the deposition of uric acid crystals in the distal tubule or collecting duct due to excessive production or reduced excretion of blood uric acid.According to its pathological changes and clinical manifestations,it can be divided into three types:acute uric acid nephropathy,chronic uric acid nephropathy and uric acid stones[1].Hyperuricemia(HUA)is closely related to gout.Some studies have shown[2]that more than 40%of gout patients can develop chronic kidney disease,and nearly 50%of patients will lead to decreased glomerular filtration rate.Autopsy found that 79%-99%of gout patients have uric acid nephropathy[3].In recent years,with the improvement of national living conditions and dietary level,big data shows that there are nearly 120 million HUA patients in China[4].This data is 10 times of the prevalence of HUA in China 10 years ago.The occurrence and development of acute and chronic renal failure is closely related to the level of serum uric acid,which is the wind vane of its prognosis[5].Therefore,it is of great significance to strengthen the prevention and treatment of hyperuricemia and uric acid nephropathy.The treatment and pathogenesis of uric acid nephropathy has not been unified,and its treatment methods are diverse.Therefore,this study objectively evaluated the treatment effect of Western medicine,traditional Chinese medicine and integrated traditional Chinese and Western Medicine on this disease through meta-analysis,and expanded the sample size to study the treatment scheme of uric acid nephropathy,in order to provide evidence-based medicine basis for clinical diagnosis and treatment of uric acid nephropathy.Objectives:Objective and accurate analysis and evaluation of traditional Chinese medicine in the clinical treatment of uric acid nephropathy on the efficacy and safety of the problem,for the future in clinical practice in the treatment of reliable system evaluation evidence.Methods:In order to avoid the repeatability and reporting bias,this study was registered on prospero platform before literature retrieval.After registration,a comprehensive search of commonly used Chinese and English databases was conducted,including:(1)Chinese databases:CNKI,VIP,Wanfang and CBM;(2)English databases:pubMed,EMBASE and Cochrane Library According to the search strategy formulated at the time of registration in prospero platform,we searched the randomized controlled clinical trial(RCT)of traditional Chinese medicine in the treatment of uric acid nephropathy.The retrieved articles were imported into Noteexpress,and then the final included studies were determined by careful screening combined with the inclusion and exclusion criteria.The final included studies were evaluated according to the Cochrane risk bias assessment tool,and the indicators and data needed for statistical analysis were extracted.Revman5.3 software was used to analyze the outcome indicators of this study,and the corresponding results were explained and discussed in detail in scientific methodology,medicine and ethics.Finally,the results of this paper,that is,whether traditional Chinese medicine treatment of uric acid nephropathy has curative effect,what is the level of curative effect,how to alleviate the specific indicators,and make a detailed and reliable decision evidence for the future clinical practiceResults:The study was finally included in 74 literatures,all of which were Chinese literature,from January 2010 to December 2020.5507 patients were included,including 2759 in the experimental group and 2748 in the control group,male:female?3:1.Meta analysis results showed that the total effective rate of treatment of urinary acid nephropathy by traditional Chinese medicine or combination of traditional Chinese and Western medicine was better than that of Western medicine alone[RR=1.30,95%CI(1.26,1.33),z=17.28,P<0.00001],all 74 studies included in the study reported the results of blood uric acid(SUA).The combined results showed that the reduction of SUA level in the experimental group was better than that of the control group[MD=-38.81,95%CI(-49.01,-28.62),z=7.46,P<0.00001],but the heterogeneity was large(I2=96%),so subgroup analysis was carried out according to different intervention measures in the treatment group.The results showed that the efficacy of reducing SUA with Chinese medicine alone was not significantly different from that of the control group(MD=-7.2,95%CI(-18.42,4.01),z=1.26,p=0.21].The therapeutic effect of Chinese medicine combined with western medicine in reducing SUA was significantly different from that of control group(MD=-45.71.95%CI(-56.16,-35.26)5 z=8.57,p<0.00001).There are 70 studies reported the serum creatinine(SCr).According to the analysis results of different subgroups of positive drugs in each control group,it is shown that when the positive drugs in the control group are allopurinol,phenobromomalone and fenbustam,the therapeutic group has better effect on reducing SCr than the control group,while the control group has no significant difference in the effect of reducing the SCr when the control group is positive drug losartan potassium.18 studies reported TCM syndrome score,but the heterogeneity was serious(I2=96%),and subgroup analysis was conducted according to the reference standards.Eight TCM syndrome scores were analyzed according to the guiding principles of clinical research on new Chinese medicine in 2002.The results showed that the efficacy of the exp-erimental group in reducing the symptoms of patients was significantly different from that of the control group[MD=-1.23,95%CI(-2.25,-2.0),z=2.34,p=0.02];5 articles refer to the diagnosis,differentiation and classification of uric acid nephropathy and evaluation of efficacy(Trial Scheme)issued by nephrotic branch of Chinese Academy of traditional Chinese medicine in 2008.The results of the combination showed that the efficacy of the experimental group in improving the symptoms of the patients was significantly different from that of the control group[MD=-2.35,95%CI(-3.88,-0.81),z=2.99,p=0.003];5 articles were not marked with origin or reference standards or two reference standards were used in combination.The results showed that the efficacy of the experimental group in reducing clinical symptoms was significantly different from that of the control group(MD=-1.35,95%CI(-2.37,-0.32),z=2.58,p=0.01].There were 48 studies reported 24-UTP.The results of subgroup analysis showed that when the control group was allopurinol,fenbustam and losartan potassium,the treatment group had better efficacy in reducing 24-UTP than the control group,while the control group was benbromomalone,the treatment group had no significant difference in the efficacy of reducing 24-UTP compared with the control group.63 reports on the results of BUN showed that the heterogeneity among the studies was serious(I2=94%),the efficacy of reducing BUN in the experimental group was better than that of the control group.Twenty reports of the results of?2-microglobulin(?2-MG)in urine were reported.The results showed that the heterogeneity among the studies was serious(I2=94%),the efficacy of reducing urinary ?2-MG in the experimental group was better than that of the control group(MD=-0.29,95%CI(-0.36,-0.22),z=7.62,p<0.00001).There were 16 reports on the results of ?2-MG in blood.The results showed that the heterogeneity among the studies was serious(I2=95%),the efficacy of reducing blood ?2-MG in the experimental group was better than that of the control group(MD=-1.06,95%CI(-1.38,-0.75),z=6.63,p<0.00001).There were 6 reports on the results of glomerular filtration rate(eGFR).The results showed that there was no heterogeneity among the studies(I 2=0%),the efficacy of the experimental group to improve eGFR was better than that of the control group(MD=8.45,95%CI(6.47,10.44),Z=8.34,p<0.00001).Six reports were made on the results of serum Cystatin-C(Cys-C).The results showed that the heterogeneity among the studies was serious(I2=78%),the efficacy of reducing Cys-C in the experimental group was better than that of the control group(MD=-0.19,95%CI(-0.34,-0.04),z=2.43,p=0.02].There were 30 studies reported the number of adverse reactions,the results of the combination showed that the homogeneity was better(I2=22%),the efficacy of the experimental group in reducing adverse reactions was better than that of the control group.Conclusion:The total effective rate of traditional Chinese medicine or integrated traditional Chinese and Western medicine in the treatment of uric acid nephropathy is better than that of Western medicine alone.In the aspect of reducing blood uric acid,the effect of integrated traditional Chinese and Western medicine is better than that of Western medicine alone,but there is no significant difference between traditional Chinese medicine and Western medicine alone in reducing blood uric acid.Compared with western medicine alone,it has better effect in reducing 24-UTP,SCr,BUN,urine/blood ?2-MG,Cys-C and improving eGFR.However,when the positive drug of the control group was losartan potassium,there was no significant difference in the efficacy of reducing SCr between the treatment group and the control group.When the positive drug of the control group was benbromarone,there was no significant difference in the reduction of 24-UTP between the treatment group and the control group.Traditional Chinese medicine can reduce TCM syndrome score,improve clinical symptoms,and the treatment of traditional Chinese medicine is relatively safe.However,in the course of the study,we found that most of the included literatures were heterogeneous,and the method of RCT design was also defective.Therefore,we still need to carry out large sample,multi center,double-blind design of high-quality randomized controlled trials to further the conclusion of this study. |
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