目的：探讨丹红注射液联合甲钴胺治疗糖尿病周围神经病变（DPN）的疗效与安全性。方法：检索并选取国内公开发表的有关丹红注射液联合甲钴胺治疗DPN 的随机临床对照试验文献，运用Meta 分析进行统计分析。结果：共有14 项研究符合纳入标准，包括1019 例DPN 患者。但方法学质量评价显示纳入研究质量不高，均为C 级。Meta 分析显示：与对照组比较，丹红注射液联合甲钴胺治疗DPN 的临床综合疗效[OR=4.01, 95%CI（2.90，5.53）]较优，可改善周围神经传导速度，包括正中神经运动神经[WMD=3.81，95%CI（3.29，4.34）]，正中神经感觉神经[WMD=3.94，95%CI（3.32，4.55）]，腓神经运动神经[WMD=3.71，95%CI（3.21，4.21）]，腓神经感觉神经[WMD=6.13，95%CI（5.59，6.68）]，改善血浆黏度[WMD=-0.50，95%CI（-0.58，-0.42）]。结论：丹红注射液联合甲钴胺治疗DPN 临床疗效及在改善周围神经传导速度、血液黏度方面优于对照组。安全性方面未发现严重不良反应及毒副作用，所报道的3 例不良反应症状分别为皮疹、胸闷、头晕。

The study was aimed to evaluate the efficacy and safety of Danhong injection combined with Mecobalamin in DPN treatment. Domestic published literatures of randomized controlled clinical trials in DPN treatment by Danhong injection combined with Mecobalamin were searched and selected. Meta analysis was used in the statistical analysis. The results showed that a total of 14 studies met the inclusion criteria. And 1019 patients of DPN were included. Compared with control group, the results of meta analysis showed that the clinical comprehensive curative effect was superior in DPN treatment by Danhong injection combined with Mecobalamin [OR=4.01, 95%CI (2.90-5.53)], the conduction velocity of peripheral nerves, including motor nerve in median nerves [WMD=3.81, 95%CI (3.29, 4.34)], sensory nerve in median nerves [WMD=3.94, 95%CI (3.32, 4.55)], motor nerve in peroneal nerves [WMD=3.71, 95%CI (3.21, 4.21)], sensory nerve in peroneal nerves [WMD=6.13, 95%CI (5.59, 6.68)] were improved, as well as plasma viscosity [WMD=-0.50, 95%CI (-0.58, -0.42)]. It was concluded that Danhong injection combined with Mecobalamin in DPN treatment was more effective than the control group, especial on the improvement of conduction velocity of peripheral nerves and plasma viscosity. There was no serious adverse event in the above trails. The symptoms of 3 cases of adverse events founded were rash, chest tightness and dizziness respectively.