First Branch of Nephrology Department, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Medicine (Baltimore). 2024 Feb 23;103(8):e35853. doi: 10.1097/MD.0000000000035853.
In China, Salvia miltiorrhiza and ligustrazine (SML) injection are widely used as adjunctive therapy for patients with diabetic kidney disease (DKD). However, different studies have reported conflicting results. Therefore, a systematic review and meta-analysis are necessary to assess the efficacy and safety of SML injection for the treatment of DKD.
We searched 6 electronic literature databases comparing randomized controlled trials (RCTs) of angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB), SML injection in combination with ACEIs/ARBs that were conducted from inception until September 5, 2023. Two reviewers extracted data and independently assessed the risk of bias. Using the Cochrane Risk of Bias Tool for Risk Assessment. Mean differences (MD) were combined with random-effects models and the corresponding 95% confidence intervals (CI) were reported. Review Manager 5.4 software was used for meta-analysis. Stata 17.0 software was used for sensitivity analysis and Egger test.
The combined results show that the use of SML injection along with ACEI/ARB led to better outcomes than the use of controls in terms of enhancing recovery: renal function: Serum creatinine (MD = -14.69, 95% CI (-19.38, -10.00)), Blood urea nitrogen (MD = -1.23, 95% CI (-1.72, -0.74)), Urinary β2-microglobulin (MD = -4.58, 95% CI (-7.72, -1.44)); urinary protein: Urinary albumin excretion rate (MD = -45.74, 95% CI (-58.92, -32.56)), Urine albumin-creatinine ratio (MD = -11.93, 95% CI (-13.89, -9.96)), 24-h urine proteinuria (MD = -0.59, 95% CI (-0.86, -0.32)), Urine microalbumin (MD = -13.50, 95% CI (-20.18, -6.83)). Additionally, adjuvant therapy with SML injection enhanced results in blood glucose, blood pressure, lipids, and inflammatory responses, and no significant variations in adverse events were discovered between the 2 groups.
In patients with DKD, combining SML injection with ACEI/ARB improves renal function, renal proteinuria, hyperglycemia, blood pressure, dyslipidemia, and inflammatory response.
在中国，丹参注射液和川芎嗪（SML）广泛用作糖尿病肾病（DKD）患者的辅助治疗药物。然而，不同的研究报告结果相互矛盾。因此，有必要进行系统评价和荟萃分析，以评估 SML 注射治疗 DKD 的疗效和安全性。
我们检索了 6 个电子文献数据库，比较了从成立到 2023 年 9 月 5 日进行的血管紧张素转换酶抑制剂（ACEI）/血管紧张素受体阻滞剂（ARB）与 SML 联合治疗的随机对照试验（RCT）。两位审阅者提取数据并独立评估偏倚风险。使用 Cochrane 风险偏倚工具进行风险评估。使用随机效应模型合并均值差（MD），并报告相应的 95%置信区间（CI）。使用 Review Manager 5.4 软件进行荟萃分析。使用 Stata 17.0 软件进行敏感性分析和 Egger 检验。
联合结果表明，与对照组相比，使用 SML 注射联合 ACEI/ARB 可改善以下结果：恢复肾功能：血清肌酐（MD=-14.69，95%CI（-19.38，-10.00））、血尿素氮（MD=-1.23，95%CI（-1.72，-0.74））、尿β2-微球蛋白（MD=-4.58，95%CI（-7.72，-1.44））；尿蛋白：尿白蛋白排泄率（MD=-45.74，95%CI（-58.92，-32.56））、尿白蛋白/肌酐比值（MD=-11.93，95%CI（-13.89，-9.96））、24 小时尿蛋白（MD=-0.59，95%CI（-0.86，-0.32））、尿微量白蛋白（MD=-13.50，95%CI（-20.18，-6.83））。此外，SML 注射辅助治疗可改善血糖、血压、血脂和炎症反应，且两组间不良事件无显著差异。
在 DKD 患者中，SML 注射联合 ACEI/ARB 可改善肾功能、肾脏蛋白尿、高血糖、血压、血脂异常和炎症反应。
