Objective 　To assess the efficacy and safety of human urinary kallidinogenase injection (HUK) in treating patients with acute ischemic stroke.
Methods 　Through adopting Cochrane systematic review methods, the relevant materials were retrieved by electronically and manually searching databases and claimed from pharmaceutical factories, so as to collect the randomized controlled trials (RCTs) about HUK for the patients with acute ischemic stroke, which were searched by the end of October 2010. The quality of each trial was assessed by two reviewers independently, and meta-analysis was conducted by using RevMan 5.0.2 software.
Results 　Twenty-four trials involving 2 433 patients were included, of which 2 were multi-center placebo controlled trials, and the other 22 were all non-placebo trials. Only 2 trials (459 cases) reported the death or dependence at the end of 3-month follow-up. In those trials, HUK reduced death or dependency comparing to the control group (RR=0.69, 95%CI 0.55 to 0.86). Twenty trials (2 117 patients) reported the proportion of patients with marked neurological improvement after finishing the 7 to 21 days treatment. Meta-analysis showed the HUK group had more neurological improvement than the control group, with significant differences (RR=1.56, 95%CI 1.44 to 1.70). Fifteen trials reported adverse events, of which the transient hypotension was commonly seen (1.5%-5.1%). Non-fatal intracerebral hemorrhage was detected in 7 patients in 3 trials, but the difference between the HUK group (6 patients, 1.2%) and the control group (1 patient, 0.4%) was not significant (RR=1.82, 95%CI 0.34 to 9.61). Deaths occurred in both HUK group (2 patients, 0.4%) and the control group (1 patient, 1.1%) in 2 trials, without significant differences (RR=0.6, 95%CI 0.09 to 3.92). No trial assessed quality of life.
Conclusion 　Available evidence suggests that HUK injection reduces neurological impairment after acute ischemic stroke and improves long-term outcomes, though a few patients suffer from transient hypotension. Further high-quality, large-scale RCTs are needed to confirm these results.

Citation： ZHANG Canfei,TAO Wendan,LIU Ming,WANG Deren. Efficacy and Safety of Human Urinary Kallidinogenase Injection for Acute Ischemic Stroke: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2012, 12(5): 570-576. doi: 10.7507/1672-2531.20120092 Copy