Objective: To assess the efficacy and safety of human urinary kallidinogenase injection (HUK) in treating patients with acute ischemic stroke.
Methods: We searched the Chinese Stroke Trials Register, the Cochrane Stroke Group Trials Register, CENTRAL, Medline, EMBASE, the China Biological Medicine Database(CBM), and the China National Knowledge Infrastructure (CNKI), which were all last searched October 2010.
Randomized controlled trials (RCTs) about HUK for patients with acute ischemic stroke were included. The quality of each trial was assessed using the Cochrane Reviewers’ Handbook 5.0.2.
Results: Twenty-four trials involving 2433 patients were included. Only two trials reported death or dependence at the end of three months follow up. In those trials, HUK reduced death or dependency comparing to the control group (relative ratio (RR) = 0.69, 95% CI 0.55 to 0.86). Twenty trials (2117 patients) reported the proportion of patients with marked neurological improvement after treatment. Meta analysis showed the HUK-treated group had more neurological improvement than did the control group (RR = 1.56, 95% CI 1.44 to 1.70). Fifteen trials reported adverse events, of which transient hypotension was most common (1.5%–5.1%). Non-fatal intracerebral hemorrhage was detected in seven patients, but the difference between the treatment and control groups was not significant (RR = 1.82, 95% CI 0.34 to 9.61). Deaths occurred in both the HUK group (0.4%) and the control group (1.1%), with no significant difference for this outcome (RR = 0.6, 95% CI 0.09 to 3.92). No trial assessed quality of life.
Conclusions: Available evidence suggests that HUK injection reduces neurological impairment after acute ischemic stroke and improves long-term outcomes, though a few patients suffered from transient hypotension. Further high-quality, large scale randomized trials are needed to confirm these results.