Efficacy and safety of 2-hour urokinase regime in acute pulmonary embolism: a randomized controlled trial.
BACKGROUND
Urokinase (UK) 2 200 U/kg.h for 12 hours infusion(UK-12 h)is an ACCP recommended regimen in treating acute pulmonary embolism (PE). It is unclear whether this dose and time can be reduced further. We compared the efficacy and safety of 20, 000 U/kg for 2 hours (UK-2 h) with the UK-12 h regime in selected PE patients.


METHODS
A randomized trial involving 129 patients was conducted. Patients with acute PE were randomly assigned to receive either UK-12 h (n = 70), or UK-2 h (n = 59). The efficacy was determined by the improvement of right heart dysfunction and perfusion defect at 24 h and 14 d post UK treatment. The bleeding incidence, death rate and PE recurrence were also evaluated.


RESULTS
Similarly significant improvements in right heart dysfunction and lung perfusion defects were observed in both groups. Overall bleeding incidents were low in both groups. Major bleeding directly associated with UK infusion occurred in one patient in the UK-2 h group and one in the UK-12 h group. Mortality rates were low, with one reported fatal recurrent in the UK-12 h group and none in the UK-2 h group. When the rate of bleeding, death and PE recurrence were compared separately in the hemodynamic instability and the massive anatomic obstruction subgroups, no significant difference was found.


CONCLUSIONS
The UK-2 h regimen exhibits similar efficacy and safety as the UK-12 h regimen for acute PE.
Wang
Chen
C
Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, PR China. cyh-birm@263.net
Zhai
Zhenguo
Z
Yang
Yuanhua
Y
Yuan
Yadong
Y
Cheng
Zhaozhong
Z
Liang
Lirong
L
Dai
Huaping
H
Huang
Kewu
K
Lu
Weixuan
W
Zhang
Zhonghe
Z
Cheng
Xiansheng
X
Shen
Ying H
YH
D002681:China; D004305:Dose-Response Relationship, Drug; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D011655:Pulmonary Embolism / Q000175:diagnosis* / Q000188:drug therapy*; D016896:Treatment Outcome; D014568:Urokinase-Type Plasminogen Activator / Q000008:administration & dosage*
D005343:Fibrinolytic Agents; D014568:Urokinase-Type Plasminogen Activator