Clinical efficacy of different doses of lipo-prostaglandin E1 in the treatment of painful diabetic peripheral neuropathy

J Diabetes Complications. 2015 Nov-Dec;29(8):1283-6. doi: 10.1016/j.jdiacomp.2015.08.001. Epub 2015 Aug 7.

Abstract

Objective: To observe the clinical efficacy of different doses of alprostadil (lipo-prostaglandin E1, lipo-PGE1) in the treatment of painful diabetic peripheral neuropathy (DPN).

Methods: Sixty patients with painful DPN were equally and randomly assigned into three groups. Two groups received different doses of lipo-PGE1 by intravenous drip injection (A group: low-dose lipo-PGE1; B group: high-dose lipo-PGE1) following intravenous bolus injection of mecobalamin (MeCbl, 0.5mg once daily (QD)); the third group received MeCbl alone (C group). All patients received optimized treatment to lower blood glucose, blood pressure, and blood lipids to target levels. The efficacy of lipo-PGE1 in the three groups of patients was observed after 3weeks of treatment.

Results: The overall response rate was 90% in the B group, significantly higher than that in the A and C groups (80% and 55%, respectively; P<0.05). During the observation period, there was no incidence of serious adverse reactions (e.g., acute heart failure, sudden drop in blood pressure, or malignant arrhythmias) in any of the three groups.

Conclusions: High-dose lipo-PGE1 has better efficacy than low-dose lipo-PGE1 or MeCbl alone in the treatment of painful DPN.

Keywords: Diabetes mellitus; Diabetic peripheral neuropathy; Dose; Lipo-prostaglandin E1; Mecobalamin.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Alprostadil / administration & dosage*
  • Alprostadil / adverse effects
  • Alprostadil / therapeutic use
  • Analgesics, Non-Narcotic / administration & dosage*
  • Analgesics, Non-Narcotic / adverse effects
  • Analgesics, Non-Narcotic / therapeutic use
  • Diabetes Mellitus, Type 2 / complications*
  • Diabetic Neuropathies / blood
  • Diabetic Neuropathies / drug therapy*
  • Diabetic Neuropathies / metabolism
  • Diabetic Neuropathies / physiopathology
  • Dose-Response Relationship, Drug
  • Female
  • Glycated Hemoglobin / analysis
  • Humans
  • Infusions, Intravenous
  • Injections, Intravenous
  • Leg
  • Male
  • Middle Aged
  • Motor Neurons / drug effects
  • Motor Neurons / metabolism
  • Neural Conduction / drug effects
  • Neuralgia / etiology
  • Neuralgia / prevention & control*
  • Pain Measurement
  • Sensory Receptor Cells / drug effects
  • Sensory Receptor Cells / metabolism
  • Vasodilator Agents / administration & dosage*
  • Vasodilator Agents / adverse effects
  • Vasodilator Agents / therapeutic use
  • Vitamin B 12 / administration & dosage
  • Vitamin B 12 / adverse effects
  • Vitamin B 12 / analogs & derivatives
  • Vitamin B 12 / therapeutic use
  • Vitamin B Complex / administration & dosage
  • Vitamin B Complex / adverse effects
  • Vitamin B Complex / therapeutic use

Substances

  • Analgesics, Non-Narcotic
  • Glycated Hemoglobin A
  • Vasodilator Agents
  • hemoglobin A1c protein, human
  • Vitamin B Complex
  • mecobalamin
  • Alprostadil
  • Vitamin B 12