Skip to main content
. 2008 Jan 23;2008(1):CD003653. doi: 10.1002/14651858.CD003653.pub3

Yang 2004.

Methods Single‐site study (Korea) 
 Open label 
 Method of randomization: NR 
 Concealment of allocation : NR 
 Duration of treatment: 1 hour 
 Follow‐up: 1 hour
Participants 40 patients with acute pulmonary edema and high blood pressure (SBP >160)
Inclusion Criteria:
Systolic pressure > 160 and a diastolic pressure > 100 mmHg accompanied by cardiovascular abnormalities and acute pulmonary edema
Exclusion Criteria: 
 Not stated
* Baseline characteristics for the two randomized groups: 
 Nitroprusside:(NTP) n = 20 
 Nicardipine (NIC) n= 20
Age (years) ± sd 
 NTP:60 ± 14 
 NIC: 59±12
BP: (mm Hg) 
 NTP:195/115; ± 27/20 
 NIC:196/114 ± 14/13
Interventions Nitroprusside infusion at a starting dose of 1 mcg /kg x min., for 1 hour 
 Nicardipine infusion at a starting dose of 3 mcg /kg per min for 1 hour 
 The dose regimen was titrated to maintain the BP at 80% of the initial mean arterial pressure.
‐mean dose given of NTP was 1.5‐mean dose given was 1.5±0.4 mcg/kg x min 
 ‐mean dose given of NIC was 3.5±0.5mcg/kg per min
Co‐interventions: NR
Outcomes Outcomes obtained from this trial: 
 Total SAE: Not reported (NR) 
 Mortality: NR 
 Total Non‐fatal cardiovascular events: NR 
 Individual cardiovascular events: NR 
 Withdrawals due to adverse events: NR 
 Despite the author's statement that patients were to be remove from the study if they experience an excessive drop in BP , developed arrhythmia or respiratory difficulty , or became unresponsive or lost of consciousness, there is no report of these withdrawals.
Blood pressure: 
 Data was obtained from table 2 page 121. The calculated weighted mean BP change was: 
 Nitroprusside: SBP‐41.25± 24; : DBP‐26.5±12 
 Nicardipine: SBP‐49± 23; : DBP‐30±12
Standard deviation of the change was not reported but imputed from end point
Heart rate: 
 Data was obtained from table 2 page 121. The calculated weighted mean HR change was: 
 Nitroprusside: 2±16 
 Nicardipine: ‐1.5±20
Standard deviation of the change was not reported but imputed from end point
Notes Funding: NR
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear

Glossary: 
 AEOD=acute end organ damage 
 NTP=sodium Nitroprusside 
 NR=Not reported 
 LVEF=left ventricular ejection fraction 
 SBP =systolic blood pressure 
 MAP=mean arterial pressure 
 DBP=diastolic blood pressure 
 HR=heart rate 
 CO=cardiac output