| Objective：Diabetic kidney disease (DKD) which is a severe andfrequent complication of both type 1 and type 2 diabetes mellitus, is the singlemost common and increasing cause of end-stage renal disease (ESRD) in bothdeveloping and developed countries. Sulodexide one of the members of theheparin substances becomes one of the hot new drugs for the treatment ofDKD. The positive effects and few adverse events were found on delaying theprogression of DKD in many trails but the effectiveness and safety ofsulodexide for DKD needs to be reviewed systematically. This review wasconducted in order to assess the benefits and harms of sulodexide fordelayting the progression of kidney disease in diabetic patients.Methods：We searched the Cochrane Library, Medline (1980 to mostrecent), Embase (1950 to most recent) and Cnki. When necessary, manualsearching was used for abstract and/or original text of possible articles.Pharmaceutical companies were also contacted. All randomized controlledtrials (RCTs) or quasi-RCTs comparing treatment of DKD with sulodexideagainst placebo, no treatment and other drug were included with noconsideration of dose, administration and duration. Two authors extracted dataand assessed the trial quality according to recommendation from Cochranecolloquium independently. Revman 5.1 software was used for data analysis.Outcomes, urinary albumin excretion rate (UAER), proteinuria, creatinine(Cr), creatinine clearance (Ccr), fasting plasma glucose, glycosylatedhemoglobin (HbA1c), cholesterol, triglyceride (TG), and fibrinogen were measured. We collected adverse effects information from the trials. Theresults of statistical analyses were expressed as relative risk (RR) fordichotomous outcomes and weighted mean difference (WMD) for continuousoutcomes, with 95% confidence intervals (CI).Results: Initially, 112 articles were found, including 68 English papers,43 Chinese papers and 1 non-English papers. After elementary screening, 28papers remained and 10 papers were included. Because there were no enoughincluded trials, outcomes UAER, proteinuria, cholesterol, TG, ATIII andfibrinogen showed significant favour of sulodexide as compared withplacebo/no treatment in every single study before combination analysis.While after combination analysis there be significant in UAER, proteinuria,cholesterol, TG, and fibrinogen while no significant in Cr, Ccr, fasting plasmaglucose, HbA1c. The trend of more events of bleeding were found insulodexide groups did not reach significant difference.Conclusions: The results of meta-analysis implied that, sulodexide havepositive effect on UAER, proteinuria, cholesterol, TG, ATIII and fibrinogen.The results presented in this review must be interpreted with extreme cautiongiven the limited quality of studies and small numbers of trials evaluated forany one comparison. Studies with high quality and enough sample size thatmeasures robust clinical end-points (e.g. time to ESRD and death) andconcerns use of ACEI and ARB should be conducted and will be of greatworth. |
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