Skip to main content
. 2009 Oct 7;2009(4):CD008154. doi: 10.1002/14651858.CD008154

Li 2004.

Methods Randomised clinical trial.
Participants Country: China. 
 Number randomised: initially 31, post randomisation drop outs 0, final number of study participants 31. 
 Mean age: 50.2 years. 
 Females: 5 (16.1%). 
 Cirrhotic livers: 27 (87.1%). 
 Steatotic livers: not stated.
Inclusion criteria: 
 1. Elective hepatic resection. 
 2. Portal triad clamping. 
 3. Diagnosis of primary hepatocellular carcinoma.
Interventions Participants were randomly assigned to two groups:
Intervention group 1: administered 10000 IU of ulinastatin during the operation, and twice a day with combination of vitamin K1 and glucose for 5 consecutive days after the operation (n = 16). 
 Intervention group 2: administered gantaile (a Chinese herbal medicine used as a 'common liver protectant') the dose for which was not given, vitamin K1, and glucose (n = 15).
Outcomes The outcomes reported were mortality, liver decompensation, wound infection, intra‐abdominal infection, hospital stay, blood loss, markers of liver function, and enzyme markers of liver injury.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk Quote: "sealed envelope".
Blinding? 
 All outcomes High risk Comment: trial not double blinded.
Incomplete outcome data addressed? 
 outcomes 2‐4 weeks Low risk Comment: no post randomisation drop‐outs.
Free of selective reporting? Low risk Comment: all important outcomes reported.
Free from baseline imbalance? Low risk Comment: no baseline imbalance in important characteristics.
Free from academic bias? Low risk Comment: no previous published studies of the same comparison by the trial authors.