Pakistan Journal of Pharmaceutical Sciences

Abstract: Background: Type 2 diabetes mellitus (T2DM) has become a global public health crisis with a steady upward prevalence, and China alone has over 100 million adult T2DM patients. Long-term persistent hyperglycemia damages microvasculature and peripheral nerves, leading to disabling complications such as diabetic foot (DF) and diabetic peripheral neuropathy (DPN). These complications severely reduce patients’ quality of life and increase medical burdens, thus creating an urgent need for effective adjunctive therapeutic interventions. Objectives: To evaluate the efficacy and safety of alprostadil injection in treating type 2 diabetes-related DF or DPN. Methods: A prospective randomized controlled trial was conducted involving 120 eligible patients (62 with DF, 58 with DPN) recruited from our hospital between 2018 and 2021. Inclusion criteria included confirmed T2DM diagnosis and meeting diagnostic criteria for DF/DPN; exclusion criteria included severe organ dysfunction. Patients were randomly divided into control group (n=60, receiving standard care including blood glucose control and symptom management) and observation group (n=60, standard care plus 40?g alprostadil intravenous infusion daily for 14–21 days). Outcomes included total efficacy rate, lipid profiles (TC, TG, LDL-C, HDL-C), and adverse events. Results: Clinical outcomes showed significant advantages in the observation group: total efficacy rate was 93.33% (56/60) versus 76.67% (46/60) in the control group (P=0.011). Lipid profiles improved more remarkably in the observation group: TC decreased by (1.24±0.32) mmol/L, TG by (0.86±0.21) mmol/L, LDL-C by (0.92±0.25) mmol/L, and HDL-C increased by (0.35±0.10) mmol/L (all P<0.05). Adverse event rate was 3.33% (2/60) in the observation group, much lower than 18.83% (11/60) in the control group (P=0.008). Conclusion: Alprostadil injection as an adjunctive therapy for T2DM-related DF or DPN exhibits significant efficacy and good safety. It not only enhances the overall therapeutic response but also effectively improves lipid metabolism disorders, with a low incidence of adverse events.