Clinical trial of citicoline sodium tablets combined with edaravone injection in the treatment of cerebral ischemic stroke
10.13699/j.cnki.1001-6821.2019.07.003
- VernacularTitle:胞磷胆碱钠片联合依达拉奉注射液治疗缺血性脑卒中的临床研究
- Author:
Yan-Ying QI
1
;
Xiu-Fang FENG
;
Jun-Hui SUN
;
Lin QIU
;
Fan YANG
Author Information
1. 唐山工人医院 综合康复科
- Keywords:
citicoline sodium tablet;
edaravone injection;
cerebral ischemic stroke;
safety evaluation
- From:
The Chinese Journal of Clinical Pharmacology
2019;35(7):610-613
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of citicoline sodium tablets combined with edaravone injection in the treatment of cerebral ischemic stroke. Methods A total of 100 patients with cerebral ischemic stroke were randomly divided into control group (n = 48 cases) and treatment group (n = 52 cases) . Control group was given edaravone injection 30 mg per time, bid, intravenous drip. Treatment group received citicoline sodium tablets 0. 2 g per time, tid, orally, on the basis of control group. Two groups were treated for 14 days. The clinical efficacy, the levels of serum calmodulin (CAM) , growth differentiation factor 15 (GDF-15) and pentraxin-3 (PTX-3) , the scores of national institutes of health stroke scale (NIHSS) and modified Barthel index (MBI) , and adverse drug reactions were compared between twogroups. Results After treatment, the total effective rates of treatment and control groups were 88. 46％ (46 cases/52 cases) and 70. 82％ (34 cases/48 cases) with significant difference (P < 0. 05) . After treatment, the main indexes of treatment and control groups were compared: CAM were (102. 45 ± 14. 59) and (136. 58 ± 14. 55) mg ·m L-1, GDF-15 were (443. 59 ± 49. 34) and (567. 36 ± 55. 20) pg·m L-1, PTX-3 were (0. 40 ± 0. 05) and (0. 56 ± 0. 08) ng·m L-1, NIHSS scores were (9. 19 ± 1. 67) and (11. 13 ± 1. 65) , MBI scores were (58. 37 ± 3. 17) and (49. 75 ± 3. 43) , the differences were statistically significant (all P < 0. 05) . The adverse drug reactions of treatment group were gastrointestinal discomfort and fever, which in control group were fever and elevated blood pressure. The total incidences of adverse drug reactions in treatment and control groups were 5. 77％ and 4. 17％ without significant difference (P> 0. 05) . Conclusion Citicoline sodium tablets combined with edaravone injection have a definitive clinical efficacy in the treatment of cerebral ischemic stroke, which can effectively reduce the levels of serum CAM, GDF-15 and PTX-3, improve the nerve function, without increasing the incidences of adverse drug reactions.
