丁苯酞注射液治疗进展性脑梗死的临床研究

Clinical trial of butylphthalide injection in the treatment of patients with progressive cerebral infarction

目的观察丁苯酞注射液对进展性脑梗死患者神经功能及血浆纤维蛋白原的影响。方法将78例进展性脑梗死患者随机分为对照组39例和试验组39例。对照组第1天口服氯吡格雷300 mg,+阿司匹林100 mg,每天1次,第2~14天口服氯吡格雷75 mg,+阿司匹林100 mg,每天1次;试验组在对照组的基础上,给予丁苯酞氯化钠注射液100 m L,每天2次,间隔时间≥6 h,静脉滴注。2组患者均治疗2周。比较2组患者的临床疗效、血浆纤维蛋白原(Fib)、D-二聚体(D-D)、血小板计数、平均血小板体积(MPV)、内皮素^(-1)(ET^(-1))、一氧化氮(NO)、血管内皮生长因子(VEGF)值,记录美国国立卫生研究院卒中量表(NIHSS)评分和Barthel指数(BI)评分及药物不良反应的发生情况。结果治疗后,对照组的改善率为74.36%(29例/39例),试验组为92.31%(36例/39例),差异有统计学意义(P<0.05)。治疗后,试验组与对照组Fib分别为(2.75±1.04)和(3.58±1.20)g·L^(-1),D-D分别为(0.71±0.34)和(0.98±0.39)mg·L^(-1),血小板计数分别为(157.42±10.28)×109/L和(165.35±11.47)×109/L,MPV分别为(10.41±1.21)和(11.98±1.35)f L,ET^(-1)分别为(61.24±9.84)和(70.26±10.07)ng·m L^(-1),VEGF分别为(143.69±25.87)和(210.03±28.68)ng·m L^(-1),NO分别为(65.34±13.27)和(53.26±12.45)U·m L^(-1),NIHSS分别为(4.19±2.05)和(6.41±2.26)分,BI评分分别为(46.15±5.97)和(40.82±5.34)分,差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要为恶心、呕吐、皮疹及头部不适,药物不良反应发生率为15.38%;对照组的药物不良反应主要为恶心、呕吐及发热,药物不良反应发生率为12.82%,差异无统计学意义(P>0.05)。结论丁苯酞注射液对进展性脑梗死的疗效确切,能改善神经缺损和血管内皮功能,降低血浆纤维蛋白原含量,且安全性高。

Objective To observe the effect of butylphthalide injection on neurological function and plasma fibrinogenin in patients with progre- ssive cerebral infarction. Methods Seventy -eight patients with progre- ssive cerebral infarction were randomly divided into control group （ n = 39） and treatment group （ n = 39 ）. Control group was orally given clopidogrel 300 mg ＋ aspirin 100 mg on first day, qd, and orally given clopidogrel 75 mg＋ aspirin 100 mg on 2 - 14 d, qd. On the basis of control group, treatment group was treated with butylphthalide and sodium chloride injection 100 mL, bid, interval time I〉 6 h, intravenous drip. All the patients were treated for 2 weeks. The clinical effect, thelevels of plasma fibrinogen （ Fib）, D - dimer （ D - D）, platelet count （ PC）, mean platelet volume （ MPV）, endothe- lin - 1 （ ET - 1 ）, nitric oxide（ NO）, vascular endothelial growth factor （ VEGF）, the National institute of health stroke scale （ NIHSS）, Barthel index （BI） score, and the incidence of adverse drug reactions in two grousp were compared. Results After treatment, the improved rates in control group and treatment group were 74. 36% （29 cases/39 eases）, 92. 31% （36 cases/39eases）, with significant difference （P 〈 0. 05 ）. After treatment, the levels of Fib in treatment group and control group were（2.75 ±1.04） and（3.58 ±1.20） g· L-1, the D - D were（0.71 ±0.34） and （0. 98± 0. 39） mg· L-l, the PC were （ 157.42± 10. 28 ） × 109/L and （ 165.35 ± 11.47 ） × 109/L, the MPV were （ 10. 41 ± 1.21 ） and（ 11.98 ± 1.35） fL, the ET - 1 were （61.24 ±9. 84） and （70. 26 ± 10. 07 ） ng · mL- 1, the VEGF were（ 143.69± 25.87 ） and （ 210. 03± 28.68 ） ng·mL-1, the NO were （ 65.34 ± 13.27 ） and （ 53.26 ± 12. 45 ） U· mL-1, the NIHSS were4. 19 ±2.05 and 6.41±2.26, the BI scores were 46. 15 ±5.97 and 40.82 ±5.34, all with significant difference （ all P 〈 0. 05 ）. The adverse drug reactions were nausea, vomiting, rash and head discomfort in treatment group, with the incidence of 15.38%. The adverse drug reactions were nausea, vomiting and fever in con- trol group, with the incidence of 12. 82%. There was no difference in the incidence of adverse drug reactions between the two groups （P 〉 0. 05 ）. Conclusion The clinical effect of butylphthalide is great in the treatment of progressive cerebral infarction patients, and can improve the nerve defect and vascular endothelial function, reduce the content of fibrinogen in plasma with high safety.