Systematic Review and Trial Sequential Analysis of Efficacy and Safety of Salvianolate Combined with Western Medicine on Diabetes Mellitus and Associated Chronic Microvascular Complications
- VernacularTitle:系统评价及序贯分析丹参多酚酸盐对糖尿病及慢性微血管并发症患者临床指标的影响
- Author:
Yuanyuan YUE
1
;
Yanshuo SHI
1
;
Yuehong YUE
1
;
Yingguang SUN
1
Author Information
- Publication Type:Journal Article
- Keywords: Salvianolate; Diabetic kidney disease; Diabetic peripheral neuropathy; Meta-analysis; Trial sequential analysis
- From: World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(5):1297-1311
- CountryChina
- Language:Chinese
- Abstract: Objective To systematically evaluate the CIinical indexes of western medicine combined with salvianolate in patients affected with diabetes and chronic microvascular complications.Methods Relevant RCTs in China National Knowledge(CNKI),Wanfang Date,Chinese Scientific Journal Database(VIP),PubMed and other databases were searched by computer,and the search time was limited from the foundation of each database to December,2023.Rev Man 5.3 and Stata 15.0 software were used for meta analysis,and TSA 0.9.5.10 Beta software was used for trial sequential analysis(TSA).Results A total of 33 RCTs(2690 patients)were finally involved.The meta-analysis results showed that compared with western medicine,combined with alvianolate could significantly improve the Clinical total effective rate,decrease fasting and postprandial blood glucose,improve vascellum endothelial function{ET-1[MD=-82.46,95%CI(-122.25,-42.67),P<0.05]、NO[MD=11.50,95%CI(7.22,15.78),P<0.05]},lower oxidative stress{SOD[MD=13.18,95%CI(10.26,16.11),P<0.05]、MDA[SMD=-1.43,95%CI(-1.94,-0.92),P<0.05]、Hcy[MD=-6.85,95%CI(-10.58,-3.12),P<0.05]},reduce inflammatory markers{hs-CRP[MD=-3.77,95%CI(-4.90,-2.64),P<0.05]、sICAM-1[MD=-212.59,95%CI(-289.48,-135.70),P<0.05]、IL-6[MD=-14.14,95%CI(-17.73,-10.54),P<0.05]},improve renal function{Scr[MD=-18.69,95%CI(-28.34,-9.03),P<0.05]、BUN[MD=-1.30,95%CI(-1.92,-0.67),P<0.05]、UAER[MD=-37.75,95%CI(-49.40,-26.10),P<0.05].There was no statistical difference in the incidence of adverse reactions between the two groups(P>0.05).TSA further affirmed salvianolate had beneficial effect on serum ET-1、SOD、IL-6、Scr and BUN.Conclusion Compared with the conventional therapy of western medicine,the combined medication of salvianolate and chemical medicine achieves much better Clinical effects on diabetes and chronic microvascular complications.Considering the limitations of the included studies,more large sample and high-quality randomized controlled trials are needed to prove our conclusions.
