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| Systematic evaluation of the clinical efficacy and safety of Shuxuening Injection for diabetic peripheral neuropathy |
| Hits 126 Download times 25 Received:September 17, 2025 |
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| DOI
10.11656/j.issn.1673-9043.2026.03.10 |
| Key Words
Shuxuening Injection;diabetic peripheral neuropathy;randomized controlled trial;systematic review;Meta-analysis |
| Author Name | Affiliation | E-mail | | YAN Xing | Tianjin University of Traditional Chinese Medicine, Evidence-Based Medicine Center, Tianjin 301617, China | | | LIU Yang | Tianjin University of Traditional Chinese Medicine, Evidence-Based Medicine Center, Tianjin 301617, China | | | TANG Xiang | Department of Gastroenterology, the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | LIU Yaoyuan | Tianjin University of Traditional Chinese Medicine, Evidence-Based Medicine Center, Tianjin 301617, China | | | SONG Wenting | Tianjin University of Traditional Chinese Medicine, Evidence-Based Medicine Center, Tianjin 301617, China | | | ZHANG Yazi | Tianjin University of Traditional Chinese Medicine, Evidence-Based Medicine Center, Tianjin 301617, China | | | PANG Wentai | Tianjin University of Traditional Chinese Medicine, Evidence-Based Medicine Center, Tianjin 301617, China | pwttcm@tjutcm.edu.cn | | YANG Fengwen | Tianjin University of Traditional Chinese Medicine, Evidence-Based Medicine Center, Tianjin 301617, China | 13682027022@163.com |
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| Abstract
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| [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. |
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