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

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

摘要:

[目的] 系统分析舒血宁注射液治疗糖尿病周围神经病的临床疗效和安全性。[方法] 检索中国数据库知网、万方、维普、中国生物医学数据库；英文数据库Pubmed、Embase、Web of science、the Cochrane Library。纳入舒血宁注射液治疗糖尿病周围神经病变的随机对照试验（RCT），检索时间为数据库建立到2024年5月1日。使用Cochrane偏倚风险评估工具（ROB2）对纳入文章进行文献质量评价，使用Review Manager5.4、Stata15进行Meta分析，使用GRADEpro软件对结局指标的证据进行证据质量分级。[结果] 共纳入28项随机对照试验，总样本数量为2 355例，其中试验组样本量为1 199例，对照组样本量为1 156例，纳入研究的方法学质量评价多为“有一定风险”。Meta分析结果显示，与对照组相比，舒血宁注射液组临床疗效（RR=1.35，95%CI[1.29，1.42]，P<0.000 01）、正中神经-感觉传导速度（MD=3.62，95%CI[3.12，4.12]，P<0.000 01）、正中神经-运动传导速度（MD=6.07，95%CI[4.94，7.20]，P<0.000 01）、腓总神经-感觉传导速度（MD=4.21，95%CI[2.87，5.55]，P<0.000 01）、腓总神经-运动传导速度（MD=5.32，95%CI[4.46，6.19]，P<0.000 01）方面均优于对照组，舒血宁注射液组和对照组的不良反应比较，差异无统计学意义（P>0.05）。GRADE证据系统显示结局指标证据分级为极低级至中级。[结论] 舒血宁注射液治疗糖尿病周围神经病变在临床有效率，改善正中神经，腓总神经传导速度方面均有优势，需更多高质量研究进一步验证。

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.