Li Aijing, Wei Maoying, Wu Chan, Yin Dan, Tang Yiting, Jiang Yijia, Wang Churan, Guo Jingyi, Sun Anning, Gu Xin, Gong Yanbing
Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Beijing University of Chinese Medicine, Beijing, China.
Front Pharmacol. 2025 Jul 18;16:1543275. doi: 10.3389/fphar.2025.1543275. eCollection 2025.
This systematic review and network meta-analysis aimed to evaluate the comparative effectiveness of traditional Chinese medicine injections (TCMIs) combined with angiotensin-converting enzyme inhibitors or angiotensin Ⅱ receptor blockers for diabetic nephropathy (DN).
Ten databases were searched. Primary endpoint indicators were urinary albumin excretion rate (UAER) and serum creatinine (Scr). Secondary endpoint indicators were blood urea nitrogen (BUN), urinary β-microglobulin, total cholesterol, triglyceride, systolic blood pressure, and total effective rate. Cochrane risk of bias tool (version 2.0) was used to evaluate the quality of the studies. The GRADE method was used to assess the whole network. Finally, Stata 16.0 software was used to perform network meta-analysis.
A total of 99 randomised controlled trials and ten TCMIs were included for analysis. Based on the surface under the cumulative ranking curve values, it was observed that the efficacy of the combination group was better than that of the control group. For the primary endpoints, the Shuxuetong and Shenkang injections were excellent in reducing UAER and Scr, respectively. The Danshen injection was the most effective for the total effective rate and BUN; the Shuxuetong, Yinxingdamo, Danshen-Chuanxiongqin, and Shuxuening injections were the most effective for total cholesterol, β-microglobulin, triglyceride, and systolic blood pressure, respectively. In terms of dual indicators, for UAER and Scr, the Danshen injection may be the most effective treatment. In addition, no significant adverse reactions were reported in the relevant studies on the Huangqi and Gegensu injections, whereas the Yinxingdamo, Danshen-Chuanxiongqin, Shenkang, Shuxuetong, and Kudiezi injections demonstrated varying degrees of adverse reactions.
In this study, it is indicated that when combined with ACEI/ARB, the Shuxuetong, Shenkang, Danshen, Danshen-Chuanxiongqin, Yinxingdamo, and Shuxuening injections may confer advantages in improving DN indicators. However, due to limitations in the methodological quality of the included studies (especially deficiencies in randomisation and blinding) and the critical lack of reporting on key information regarding TCMI components, the reliability of these findings is compromised.
本系统评价和网状Meta分析旨在评估中药注射剂(TCMIs)联合血管紧张素转换酶抑制剂或血管紧张素Ⅱ受体阻滞剂治疗糖尿病肾病(DN)的相对疗效。
检索了10个数据库。主要终点指标为尿白蛋白排泄率(UAER)和血清肌酐(Scr)。次要终点指标为血尿素氮(BUN)、尿β-微球蛋白、总胆固醇、甘油三酯、收缩压和总有效率。采用Cochrane偏倚风险工具(2.0版)评估研究质量。采用GRADE方法评估整个网络。最后,使用Stata 16.0软件进行网状Meta分析。
共纳入99项随机对照试验和10种中药注射剂进行分析。根据累积排名曲线下面积值,观察到联合组的疗效优于对照组。对于主要终点,舒血宁注射液和肾康注射液分别在降低UAER和Scr方面表现出色。丹参注射液对总有效率和BUN最有效;舒血宁注射液、银杏达莫注射液、丹参川芎嗪注射液和疏血通注射液分别对总胆固醇、β-微球蛋白、甘油三酯和收缩压最有效。在双重指标方面,对于UAER和Scr,丹参注射液可能是最有效的治疗方法。此外,黄芪注射液和葛根素注射液的相关研究未报告明显不良反应,而银杏达莫注射液、丹参川芎嗪注射液、肾康注射液、舒血宁注射液和苦碟子注射液表现出不同程度的不良反应。
本研究表明,与ACEI/ARB联合使用时,舒血宁注射液、肾康注射液、丹参注射液、丹参川芎嗪注射液、银杏达莫注射液和疏血通注射液在改善DN指标方面可能具有优势。然而,由于纳入研究的方法学质量存在局限性(尤其是随机化和盲法方面的缺陷)以及中药注射剂成分关键信息报告严重不足,这些研究结果的可靠性受到影响。