天津中医药大学学报2026，Vol.45Issue(3)：327-338,12.DOI:10.11656/j.issn.1673-9043.2026.03.10
舒血宁注射液治疗糖尿病周围神经病变临床疗效和安全性的系统评价
Systematic evaluation of the clinical efficacy and safety of Shuxuening Injection for diabetic peripheral neuropathy
摘要
Abstract
[Objective]To systematically evaluate the clinical efficacy and safety of Shuxuening Injection for diabetic peripheral neuropathy(DPN).[Methods]Chinese databases(CNKI,Wanfang,VIP,CBM)and English databases(PubMed,Embase,Web of Science,Cochrane Library)were searched for randomized controlled trials(RCTs)on Shuxuening Injection for DPN.The search period spanned from the inception of each database to May 1,2024.The Cochrane Risk of Bias tool(ROB2)was used to assess the methodological quality of the included studies.Meta-analysis was performed using Review Manager 5.4 and Stata 15.The quality of evidence for outcome measures was graded using GRADEpro software.[Results]A total of 28 RCTs involving 2 355 patients were included(1 199 in the Shuxuening group and 1 156 in the control group).The methodological quality of most included studies was rated as having"some concerns."Meta-analysis results showed that,compared with the control group,the Shuxuening Injection group demonstrated superior outcomes in terms of overall clinical response rate(RR=1.35,95%CI[1.29,1.42],P<0.000 01),median nerve sensory conduction velocity(MD=3.62,95%CI[3.12,4.12],P<0.000 01),median nerve motor conduction velocity(MD=6.07,95%CI[4.94,7.20],P<0.000 01),peroneal nerve sensory conduction velocity(MD=4.21,95%CI[2.87,5.55],P<0.000 01),and peroneal nerve motor conduction velocity(MD=5.32,95%CI[4.46,6.19],P<0.000 01).There was no statistically significant difference in the incidence of adverse reactions between the two groups(P>0.05).The GRADE evidence profile indicated that the quality of evidence for the outcomes ranged from very low to moderate.[Conclusion]Shuxuening Injection shows advantages in improving the overall clinical response rate and enhancing the conduction velocity of the median and peroneal nerves in the treatment of DPN,with a comparable safety profile.However,further verification through more high-quality studies is warranted.关键词
舒血宁注射液/糖尿病周围神经病变/随机对照试验/系统评价/Meta分析Key words
Shuxuening Injection/diabetic peripheral neuropathy/randomized controlled trial/systematic review/Meta-analysis分类
医药卫生引用本文复制引用
闫幸,刘洋,唐湘,刘耀远,宋雯婷,张雅姿,庞稳泰,杨丰文..舒血宁注射液治疗糖尿病周围神经病变临床疗效和安全性的系统评价[J].天津中医药大学学报,2026,45(3):327-338,12.基金项目
现代中药创制全国重点实验室青苗基金项目(CBCM2023204) （CBCM2023204）
中国科协青年人才托举工程项目(2024-QNRC1-02). （2024-QNRC1-02）
