Li Xia, Li Bo, Wang Tian-Yuan, Wang Hong, Li Qiang
Department of Spleen and Stomach Diseases of Traditional Chinese Medicine, China-Japan Friendship Hospital Beijing 100029, China.
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Beijing 100010, China Beijing Institute of Traditional Chinese Medicine Beijing 100010, China Beijing Evidence-based Chinese Medicine Center Beijing 100010, China.
Zhongguo Zhong Yao Za Zhi. 2022 Jun;47(11):3088-3094. doi: 10.19540/j.cnki.cjcmm.20220303.501.
The present study evaluated the efficacy and safety of Shuxuetong Injection in the treatment of diabetic peripheral neuropathy(DPN). PubMed, Cochrane Library, EMbase, CNKI, VIP, SinoMed, and Wanfang were searched for randomized controlled trials(RCTs) of Shuxuetong Injection in the treatment of DPN from database inception to July 18, 2021. Literature screening was carried out according to the inclusion and exclusion criteria, and the required information was extracted. Cochrane risk-of-bias tool was used to evaluate the quality of the included trials, and RevMan 5.3 was used for Meta-analysis. Finally, six articles were included, involving 507 patients. The overall quality of included RCTs was not high. As revealed by Meta-analysis results, in terms of DPN score, one trial showed a significant difference in the experimental group before and after treatment, and the symptom of the experimental group was significantly improved compared with that in the control group after treatment. After treatment, a significant difference in DPN scores of the experimental group and the control group was observed(P<0.05), and the symptom improvement of the experimental group was significantly better than that of the control group. In terms of sensory nerve conduction velocity(SCV), the experimental group was superior to the control group in improving conduction velocities(MD_(median SCV)=4.45, 95%CI[2.79, 6.10], P<0.000 01; MD_(peroneal SCV)=6.70, 95%CI[5.64, 7.75], P<0.000 01; MD_(posterior tibial SCV)=4.03, 95%CI[0.56, 7.49], P=0.02). In terms of motor nerve conduction velocity(MCV), compared with the conditions before treatment, the conduction velocities of median nerve, peroneal nerve, and posterior tibial nerve in both groups increased after treatment(P<0.01). The experimental group was superior to the control group in improving MCV after treatment(P<0.05). In terms of average blood glucose change, there is no statistical significance of the improvement of average blood glucose between experimental group and the control group(MD=-0.15, 95%CI[-0.82, 0.51], P=0.65). In terms of overall response rate, the curative effect of the experimental group in the treatment of DPN was superior to that of the control group(RR=1.23, 95%CI[1.11, 1.37], P=0.000 1). In terms of adverse events, no obvious adverse events were reported in the included RCTs. In light of existing data and indexes, the clinical efficacy of Shuxuetong Injection combined with western medicine in the treatment of DPN may be superior to that of conventional western medicine. It can improve the clinical symptoms, SCV, MCV, and average blood glucose of DPN, with good safety. However, existing clinical trials are few and the quality is low. It is recommended to further verify the above conclusions with internationally recognized outcome indicators.
本研究评估了舒血宁注射液治疗糖尿病周围神经病变(DPN)的疗效和安全性。检索了PubMed、Cochrane图书馆、EMbase、中国知网、维普资讯、中国生物医学文献数据库和万方数据库,以查找从建库至2021年7月18日期间舒血宁注射液治疗DPN的随机对照试验(RCT)。根据纳入和排除标准进行文献筛选,并提取所需信息。使用Cochrane偏倚风险工具评估纳入试验的质量,并使用RevMan 5.3进行Meta分析。最终纳入6篇文章,涉及507例患者。纳入的RCT总体质量不高。Meta分析结果显示,在DPN评分方面,一项试验显示试验组治疗前后有显著差异,且试验组治疗后的症状与对照组相比有显著改善。治疗后,试验组和对照组的DPN评分有显著差异(P<0.05),试验组的症状改善明显优于对照组。在感觉神经传导速度(SCV)方面,试验组在改善传导速度方面优于对照组(MD_(正中神经SCV)=4.45,95%CI[2.79,6.10],P<0.000 01;MD_(腓总神经SCV)=6.70,95%CI[5.64,7.75],P<0.000 01;MD_(胫后神经SCV)=4.03,95%CI[0.56,7.49],P=0.02)。在运动神经传导速度(MCV)方面,与治疗前相比,两组的正中神经、腓总神经和胫后神经传导速度在治疗后均增加(P<小于0.01)。试验组治疗后在改善MCV方面优于对照组(P<0.05)。在平均血糖变化方面,试验组和对照组在平均血糖改善方面无统计学意义(MD=-0.15,95%CI[-0.82,0.51],P=0.65)。在总有效率方面,试验组治疗DPN的疗效优于对照组(RR=1.23,95%CI[1.11,1.37],P=0.000 1)。在不良事件方面,纳入的RCT中未报告明显不良事件。根据现有数据和指标,舒血宁注射液联合西药治疗DPN的临床疗效可能优于传统西药。它可以改善DPN的临床症状、SCV、MCV和平均血糖,安全性良好。然而,现有临床试验较少且质量较低。建议用国际认可的结局指标进一步验证上述结论。