Wei Mao-Ying, Jiang Yi-Jia, Tang Yi-Ting, Wang Chu-Ran, Yin Dan, Li Ai-Jing, Guo Jing-Yi, Gong Yan-Bing
Department of Nephrology and Endocrinology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.
Graduate College, Beijing University of Chinese Medicine, Beijing 100029, China.
World J Diabetes. 2025 May 15;16(5):100980. doi: 10.4239/wjd.v16.i5.100980.
Diabetic kidney disease (DKD), a common microvascular complication of diabetes mellitus, is the primary cause of end-stage renal disease. Tongxinluo capsule (TXLC), a traditional Chinese medicinal compound, is widely utilized in China for treating DKD.
To analyze the effectiveness and safety of TXLC for treating DKD.
Eight electronic literature databases were retrieved to obtain randomized controlled trials (RCTs) of TXLC for DKD. RevMan 5.3 software was used for data analysis. Evidence quality was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation System. Publication bias was detected using Stata 16.0 software.
Twenty-two RCTs involving 1941 patients with DKD were identified. Compared with conventional treatment, TXLC combination therapy significantly improved the primary outcomes, including 24-hour urine proteinuria, urine microalbumin, and urinary albumin excretion rate. Regarding secondary outcomes, TXLC combination therapy significantly reduced serum creatinine, blood urea nitrogen, β2-microglobulin, and cystatin C levels; however, it had no significant effect on creatinine clearance rate. In terms of additional outcomes, TXLC combination therapy significantly reduced total cholesterol, triglycerides, low-density lipoprotein cholesterol, fibrinogen, plasma viscosity, whole blood low shear viscosity, whole blood high shear viscosity, and endothelin-1 levels, while increasing nitric oxide levels. However, the addition of TXLC treatment did not significantly affect fasting plasma glucose, 2-hour postprandial blood glucose, glycosylated hemoglobin, high-density lipoprotein cholesterol, or C-reactive protein levels. The safety of TXLC in DKD remains uncertain due to limited adverse event reporting.
TXLC may benefit individuals with DKD by improving various health parameters, such as urinary protein levels, renal function, blood lipids, hemorheology, and vascular endothelial function. However, TXLC did not improve all studied outcomes.
糖尿病肾病（DKD）是糖尿病常见的微血管并发症，是终末期肾病的主要原因。通心络胶囊（TXLC）是一种中药复方制剂，在中国被广泛用于治疗DKD。
分析通心络胶囊治疗DKD的有效性和安全性。
检索八个电子文献数据库，以获取通心络胶囊治疗DKD的随机对照试验（RCT）。使用RevMan 5.3软件进行数据分析。采用推荐分级、评估、制定与评价系统对证据质量进行评估。使用Stata 16.0软件检测发表偏倚。
共纳入22项RCT，涉及1941例DKD患者。与传统治疗相比，通心络胶囊联合治疗显著改善了主要结局，包括24小时尿蛋白、尿微量白蛋白和尿白蛋白排泄率。在次要结局方面，通心络胶囊联合治疗显著降低了血清肌酐、血尿素氮、β2-微球蛋白和胱抑素C水平；然而，对肌酐清除率没有显著影响。在其他结局方面，通心络胶囊联合治疗显著降低了总胆固醇、甘油三酯、低密度脂蛋白胆固醇、纤维蛋白原、血浆粘度、全血低切粘度、全血高切粘度和内皮素-1水平，同时提高了一氧化氮水平。然而，加用通心络胶囊治疗对空腹血糖、餐后2小时血糖、糖化血红蛋白、高密度脂蛋白胆固醇或C反应蛋白水平没有显著影响。由于不良事件报告有限，通心络胶囊在DKD中的安全性仍不确定。
通心络胶囊可能通过改善尿蛋白水平、肾功能、血脂、血液流变学和血管内皮功能等多种健康参数，使DKD患者受益。然而，通心络胶囊并未改善所有研究结局。
