Objective  To observe the efficacy of external application of Yiqi Tongluo Plaster combined with fumigation of Yiqi Tongluo Recipe in the treatment of patients with diabetic peripheral neuropathy (DPN) differentiated as syndrome of qi deficiency and blood stasis.

  Methods  Totally 118 patients with DPN in Yangzhou City Hospital of Traditional Chinese Medicine from January 2018 to December 2019 were randomly divided into control group and observation group, with 59 cases in each group. Both groups were conducted with conventional treatment, the control group was treated with additional intravenous dripping of α-lipoic acid, and the observation group was treated with external application of Yiqi Tongluo Plaster combined with fumigation of Yiqi Tongluo Recipe on the basis of the control group. After 4 weeks of continuous treatment, indexes of blood glucose, blood lipid and renal function, peripheral nerve conduction velocity, the Toronto Clinical Scoring System (TCSS), score of syndrome of qi deficiency and blood stasis, and clinical efficacy were compared between the two groups.

  Results  After treatment, levels of the blood glucose, blood lipid and renal function indexes, TCSS score and score of syndrome of qi deficiency blood stasis in the observation group were significantly lower than those in the control group, while the motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of tibial nerve and common peroneal nerve as well as the total effective rate were significantly higher than those in the control group (P < 0.05 or P < 0.01). No serious adverse reactions occurred during the treatment in both groups.

  Conclusion  External application of Yiqi Tongluo Plaster combined with fumigation of Yiqi Tongluo Recipe is effective in the treatment of patients with DPN differentiated as syndrome of qi deficiency and blood stasis, which can improve indexes of blood glucose, blood lipid and renal function and nerve conduction velocity.