Clinical trial of edaravone combined with cattle encephalon glycoside and ignotin in the treatment of severe traumatic brain injury
10.13699/j.cnki.1001-6821.2016.14.004
- VernacularTitle:依达拉奉联合脑苷肌肽治疗重症颅脑损伤的临床研究
- Author:
Qi-Han CHEN
1
;
Dan LIN
;
Gang DENG
;
Jian ZHOU
;
Jiang-Biao GONG
Author Information
1. 杭州市桐庐县第一人民医院 神经外科
- Keywords:
edaravone;
cattle encephalon glycoside and ignotin;
severe traumatic brain injury;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2016;32(14):1261-1264
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of edaravone combined with cattle encephalon glycoside and ignotin in the treatment of severe traumatic brain injury .Methods A total of 74 cases with severe traumatic brain injury were divided into control group ( n =37 ) and treatment group ( n =37 ) .Control group was given cattle encephalon glycoside and ignotin injection 10 mL, intravenous infusion, qd.Treat-ment group was received edaravone 30 mg, intravenous infusion , qd, on the basis of control group .Two groups were treated for two cycles with 28 d per cycle.The clinical efficacy , brain ede-ma area, the scores of acute physiology and chronic health evaluation Ⅱ(APACHE-Ⅱ), glasgow coma scale(GCS) and activities of daily living scale (ADL), levels of glial fibrillary acidic protein (GFAP), S100 calcium -binding protein( S100β) , heme oxygenase 1 ( HO -1 ) , matrix metalloproteinase -9 ( MMP -9 ) , hematocrit ( HCT ) and erythrocyte sedimentation rate ( ESR ) and incidence of adverse drug reactions were compared in two groups . Results After treatment, the total effective rate in treatment group was 94.59%(35/37), which was significantly higher than that in control group [ 81.08%( 30/37 ) , P<0.05 ] .There was no significant difference of the HCT in control group after and before treatment [(44.30 ±5.19)%vs (46.03 ±5.50)%, P>0.05], and the level of HCT in treatment group after treatment was significantly lower than that before treatment [ ( 40.15 ±4.44 )% vs (46.15 ±5.47)%, P<0.05].After treatment, the main observation indexes in treatment and control group: brain edema area were ( 12.46 ±1.42 ) , ( 18.46 ±1.96 ) cm2; APACHE -Ⅱ score were ( 10.19 ±1.13 ) , ( 13.57 ± 1.52 ) point;serum GFAP were ( 6.54 ±0.67 ) , ( 13.77 ±1.42 ) ng? L-1; serum S100 βwere ( 0.07 ±0.01 ) , (0.09 ±0.01) μg? L-1; serum HO -1 were (4.73 ±0.49), (11.74 ±1.25)μg? L-1; serum MMP -9 were (137.67 ±15.53), (167.65 ±17.53)g? mL-1 and ESR were (3.01 ±0.33), (3.88 ±0.48)mm? h -1, also those indexes in treatment group after treatment were significantly lower than those in control group (P<0.05).After treat-ment , among the treatment and control group , the scores of GCS were ( 15.33 ±1.62 ) , ( 9.63 ±0.98 ) point and scores of ADL were (57.24 ±6.01), (46.35 ±4.72) point, and those indexes in treatment group after treatment were significantly higher than those in control group ( P<0.05 ) .The adverse drug reactions were based on abnormal liver function, nausea, vomiting and rash for two groups.Also, the incidences of adverse drug reactions in treatment and control group were 8.11%, 18.92%, respectively , without significant difference ( P > 0.05 ) . Conclusion Edaravone combined with cattle encephalon glycoside and ignotin have a definitive clinical efficacy and safety for the treatment of severe traumatic brain injury .
