Clinical trial of dantrolone sodium capsules in the thrombolytic therapy of acute stroke
10.13699/j.cnki.1001-6821.2019.07.002
- VernacularTitle:丹曲林钠胶囊用于急性脑卒中溶栓治疗的临床研究
- Author:
Hai-Yun LIANG
1
;
Liang WANG
;
Nan-Yao CHEN
;
Shu-Xiang WU
Author Information
1. 海口市第四人民医院 神经内科
- Keywords:
dantrolone sodium capsule;
low molecular weight heparins calcium injection;
aspirinenteric-coated tablet;
stroke;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2019;35(7):607-609,636
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of dantrolone sodium capsules in thethrombolytic therapy of acute stroke.Methods One hundred and thirty-six patients with acute stroke were randomly divided into control and treatment groups with 68 cases per group. Control group was given routine thrombolytic therapy + low molecular weight heparin calcium 0. 4 m L per, q12 h, subcutaneous injection for 10 days + aspirin 100 mg per time, qd, orally for 3 months.Treatment group was given dantraline sodium capsules 25 mg per time, qd, orally for 3 months after thrombolytic therapy, on the basis of control group. The clinical efficacy, American institutes of health stroke scale (NIHSS) scores and adverse drug reactions were compared between two groups. Results After treatment, the total effective rates of treatment and control groups were 77. 94％ (53 cases/68 cases) and 54. 41％ (37 cases/68 cases) with significant difference (P < 0. 05) . The NIHSS scores of treatment and control groups were (16. 07 ± 1. 18) and (18. 27 ± 1. 21) at 7 days after thrombolytic therapy, and those were (12. 15 ± 1. 06) and (16. 84 ± 1. 10) at 3 months after thrombolytictherapy. The differences were statistically significant between two groups (all P < 0. 05) . The adverse drug reactions of control group were gastrointestinal reaction, hematuria, sleepiness and asymptomatic cerebral hemorrhage, which in treatment group were gastrointestinal reaction, lethargy, fatigue, dizziness, asymptomatic cerebral hemorrhage and hematuria. The total incidences of adverse drug reactions in treatment and control groups were 17. 65％ and 13. 24％without significant difference (P> 0. 05) . Conclusion Dantraline sodium capsule is effective in thrombolytic therapy for acute stroke, without increasing the incidence of adverse drug reactions.
