Clinical efficacy of different doses of lipo-prostaglandin E1 in the treatment of painful diabetic peripheral neuropathy.
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.
Department of Endocrinology, The First Affiliated Hospital of Zhejiang University School of Medicine, 79# Qingchun Road, Hangzhou, Zhejiang Province, PR China 310003; Lin'an People's Hospital, 548# Yijin Road, Jincheng Town, Lin'an, Hangzhou, Zhejiang Province, PR China 311300.
Lihua
L
Hong
Lin'an People's Hospital, 548# Yijin Road, Jincheng Town, Lin'an, Hangzhou, Zhejiang Province, PR China 311300.
Jian
J
Zhang
Department of Endocrinology, The First Affiliated Hospital of Zhejiang University School of Medicine, 79# Qingchun Road, Hangzhou, Zhejiang Province, PR China 310003. Electronic address: shenjglaoshi@163.com.
Jianguo
J
Shen
D000368:Aged; D000527:Alprostadil / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D003929:Diabetic Neuropathies / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D007866:Leg; D008297:Male; D008875:Middle Aged; D009046:Motor Neurons / Q000187:drug effects / Q000378:metabolism; D009431:Neural Conduction / Q000187:drug effects; D009437:Neuralgia / Q000209:etiology / Q000517:prevention & control*; D010147:Pain Measurement; D011984:Sensory Receptor Cells / Q000187:drug effects / Q000378:metabolism; D014665:Vasodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D014805:Vitamin B 12 / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D014803:Vitamin B Complex / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
D000527:Alprostadil; D018712:Analgesics, Non-Narcotic; D006442:Glycated Hemoglobin; D014665:Vasodilator Agents; D014805:Vitamin B 12; D014803:Vitamin B Complex; C517652:hemoglobin A1c protein, human; C019476:mecobalamin
Diabetes mellitus; Diabetic peripheral neuropathy; Dose; Lipo-prostaglandin E1; Mecobalamin