Abstract
Objective To evaluate the treatment efficacy and safety of troxerutin and cerebroprotein hydrolysate injection(TCHI) in patients with traumatic brain injury. Methods A total of 360 patients with traumatic brain injury were admitted to neurosurgery departments at 10 medical centers (mainly led by Beijing Hospital of Health Ministry) and enrolled into this prospective, multi-center, placebo-controlled, clinical trial from June 2013 to July 2014. Through stratified random sampling, patients were randomized into the TCHI (n=240) group and placebo group (n=120). TCHI(40 mg/ml, 2ml/d, iv) or placebo had been intravenously administered for 14 days starting from patient admission. The parameters were compared between the two groups that included Glasgow coma scale (GCS), Glasgow outcome scale (GOS), level of consciousness, language and motor functions, Karnofsky performance status scale (KPS) and incidence rate of adverse events. Results The study was successfully conducted in 321 out of the 360 cases, which included 213 patients in the TCHI group and 108 patients in the placebo group. The treatment lasted 14 days in both groups. The GCS in TCHI group (14.1±2.0) was significantly higher than that in placebo group (13.4±2.3) (P=0.007), and the ratio of consciousness in TCHI group was remarkably higher than that in placebo group (81.8% vs. 70.0%) (P=0.036). At the 30-day follow-up, the rate of good outcomes assessed by GOS (82.3% vs. 58.1%), rate of normal verbal functional (86.1% vs 61.9%), rate of normal function in upper/lower limb (88.9%/90.4% vs. 78.1%/81.9%) and KPS score(91.3 vs. 89.1) (P<0.05). No serious adverse effects were noted in either group. Conclusion TCHI could be helpful for shortening the coma period and improving the patient's life quality as well as long-term outcome. Key words: Craniocerebral trauma; Multicenter study; Randomized controlled trial; Troxerutin and cerebroprotein hydrolysate injection
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