摘要
目的系统评价丹参多酚酸盐对糖尿病及慢性微血管并发症包括糖尿病肾病及糖尿病周围神经病变患者的临床指标的影响。方法计算机检索中国知网、万方、维普、Embase、PubMed等数据库中的随机对照试验(RCT s),检索时限自建库至2023年12月。采用Rev Man 5.3软件、Stata 15.0进行Meta分析,采用TSA 0.9.5.10 Beta软件进行序贯分析。结果总共纳入33篇文献,共计2690例患者。Meta分析结果显示,与常规西医治疗相比,联合丹参多酚酸盐能够提高糖尿病肾病及周围神经病变患者的临床总有效率、改善空腹血糖及餐后2 h血糖、提高血管内皮功能{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]}、降低氧化应激反应{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]}及炎性因子{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]}、改善肾功能{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]。在不良反应发生率方面,两组差异无统计学意义(P>0.05)。试验序贯分析表明丹参多酚酸盐对患者血清ET-1、SOD、IL-6、Scr、BUN指标具有有利影响。结论丹参多酚酸盐联合西医治疗糖尿病及微血管并发症对于临床指标的改善具有积极的作用,考虑纳入的文献存在一些局限性,仍需要更多大样本、高质量研究进一步验证本结论。
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 MD=effective rate,decrease fasting and postprandial blood glucose,improve vascellum endothelial function{ET-1[-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.
作者
岳圆圆
石岩硕
岳月红
孙颖光
YUE Yuanyuan;SHI Yanshuo;YUE Yuehong;SUN Yingguang(Hebei General Hospital,Hebei Key Laboratory of Clinical Pharmacy,Shijiazhuang 050000,China)
出处
《世界科学技术-中医药现代化》
北大核心
2025年第5期1297-1311,共15页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
河北省中医药管理局科研计划项目(2019141):利用传统经典名方治疗慢性疾病的循证药学研究,负责人:孙颖光。
