文献检索，用中文搜 PubMed

BACKGROUND

Salvianolate, a compound mainly composed of salvia magnesium acetate, is extracted from the Chinese herb . Because of its biological activity, easy quality control and certain efficacy, salvianolate is widely used in treating ischemic cardiocerebral vascular disease, liver damage, renal injury, diabetes, and its complications. Particularly, it has potential protective effects on diabetic nephropathy (DN).

OBJECTIVE

This meta-analysis aimed to evaluate the efficacy and safety of salvianolate when combined with western medicine in patients affected with DN.

METHODS

We searched Pubmed, Web of Science, the Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Data knowledge service platform (Wanfang Data), Chinese Scientific Journal Database (VIP), and China Biology Medicine Disc (SinoMed) for randomized controlled trials (RCTs) of salvianolate in combination with western medicine on DN, including results from the foundation of each database until November 30, 2019. Two reviewers independently performed literature screening, data extraction, and quality evaluation. This meta-analysis was carried out using RevMan5.3 software.

RESULTS

From the 12 RCTs, 1,030 patients from China were involved. Compared with single-use western medicine, the combination of salvianolate and western medicine for the treatment of DN could reduce levels of serum creatinine (Scr) [MD=-16.53, 95% CI (-28.79, -4.27), =0.008], blood urea nitrogen (BUN) [MD=-1.40, 95% CI (-2.17, -0.62), =0.0004], urinary albumin excretion rate (UARE) [SMD=-1.84, 95% CI (-2.70, -0.98), < 0.0001], 24-hour urinary protein (24h Upro) [MD=-0.37, 95% CI (-0.47, -0.26), < 0.00001], albumin-to-creatinine ratio (ACR) [SMD=-1.43, 95% CI (-2.64, -0.23), =0.02], hypersensitive C-reactive protein (hs-CRP) [MD=-5.69, 95% CI (-7.09, -4.29), < 0.00001], interleukin-6 (IL-6) [MD=-12.53, 95% CI (-18.55, -6.52), < 0.0001], malondialdehyde (MDA) [SMD=-2.05, 95% CI (-3.67, -0.43), =0.01], as well as improve clinical efficacy [RR=1.21, 95% CI (1.12,1.31), < 0.00001], and increase superoxide dismutase (SOD) levels [SMD=1.12, 95% CI (0.86,1.38), < 0.00001]. No increase in the occurrence of serious adverse events were observed in the treatment group compared with the control group.

CONCLUSION

This study indicated that salvianolate combined with western medicine contributes to protecting renal function, inhibiting inflammation, and exhibiting anti-oxidative properties, thereby improving clinical efficacy. Thus, salvianolate can be considered as a potential complementary therapy for DN patients. However, due to the low quality of methodology and small sample sizes, more rigorous and larger trials are essential to validate our results.

BACKGROUND

OBJECTIVE

This meta-analysis aimed to evaluate the efficacy and safety of salvianolate when combined with western medicine in patients affected with DN.

METHODS

RESULTS

CONCLUSION

背景

丹参多酚酸盐是一种主要由丹参乙酸镁组成的化合物，从中药材中提取。由于其生物活性、易于质量控制和一定的疗效，丹参多酚酸盐广泛应用于治疗缺血性心脑血管疾病、肝损伤、肾损伤、糖尿病及其并发症。特别是，它对糖尿病肾病（DN）具有潜在的保护作用。

目的

本荟萃分析旨在评估丹参多酚酸盐联合西药治疗DN患者的疗效和安全性。

方法

我们检索了PubMed、Web of Science、Cochrane图书馆、中国知网（CNKI）、万方数据知识服务平台（万方数据）、维普中文科技期刊数据库（VIP）和中国生物医学文献数据库（SinoMed），以查找丹参多酚酸盐联合西药治疗DN的随机对照试验（RCT），包括各数据库建库至2019年11月30日的结果。两名评价员独立进行文献筛选、数据提取和质量评估。本荟萃分析使用RevMan5.3软件进行。

结果

12项RCT共纳入来自中国的1030例患者。与单用西药相比，丹参多酚酸盐联合西药治疗DN可降低血清肌酐（Scr）水平[MD=-16.53，95%CI（-28.79，-4.27），P=0.008]、血尿素氮（BUN）水平[MD=-1.40，95%CI（-2.17，-0.62），P=0.0004]、尿白蛋白排泄率（UARE）[SMD=-1.84，95%CI（-2.70，-0.98），P<0.0001]、24小时尿蛋白（24h Upro）水平[MD=-0.37，95%CI（-0.47，-0.26），P<0.00001]、白蛋白与肌酐比值（ACR）[SMD=-1.43，95%CI（-2.64，-0.23），P=0.02]、超敏C反应蛋白（hs-CRP）水平[MD=-5.69，95%CI（-7.09，-4.29），P<0.00001]、白细胞介素-6（IL-6）水平[MD=-12.53，95%CI（-18.55，-6.52），P<0.0001]、丙二醛（MDA）水平[SMD=-2.05，95%CI（-3.67，-0.43），P=0.01]，提高临床疗效[RR=1.21，95%CI（1.12，1.31），P<0.00001]，并提高超氧化物歧化酶（SOD）水平[SMD=1.12，95%CI（0.86，1.38），P<0.00001]。治疗组与对照组相比，严重不良事件发生率未增加。