丁苯酞治疗高危性短暂性脑缺血发作的临床疗效与安全性

Clinical efficacy and safety of butylphthalide in the treatment of patient with transient ischemic attack

目的观察丁苯酞治疗高危性短暂性脑缺血发作的临床疗效及安全性。方法 91例高危性短暂性脑缺血发作患者随机分为对照组45例与试验组46例,对照组静脉滴注奥扎格雷钠80 mg+0.9%Na Cl 150 m L,每天2次;试验组静脉滴注丁苯酞25 mg,每天2次。2组均2周为1个疗程,共治疗2个疗程。观察2组的临床疗效、治疗前后血清三酰甘油及纤维蛋白原水平、治疗前后颈动脉内膜中层厚度、斑块面积和不良反应发生情况。结果治疗后,试验组临床总有效率为86.96%(40/46),显著高于对照组的66.67%(30/45,P<0.05)。治疗后,2组血清三酰甘油及纤维蛋白原水平均显著低于治疗前(P<0.05);2组治疗后颈动脉内膜中层厚度及斑块面积无明显变化(P>0.05)。2组治疗过程中均未见明显的不良反应发生,试验组2例患者用药后转氨酶水平轻微上升,停药后1个月恢复至正常水平。结论丁苯酞治疗高危性短暂性脑缺血发作临床疗效显著,安全性高。

Objective To observe the clinical efficacy and safety of butylphthalide in the treatment of patient with transient ischemic attack.Methods Ninety-one cases with transient ischemic attack were randomly divided into control group（ n = 45） and treatment group（ n = 46）.Patients in the control group were administered of ozagrel sodium 80 mg＋ 0. 9% Na Cl 150 m L,ivgtt,bid; patients in treatment group administered of butylphthalide 25 mg,ivgtt,bid,two weeks a cycle. After 2cycles treatment,the clinical efficacy of the two groups,the levels of serum fibrinogen（ FIB） and triglyceride（ TG） before and after treatment,the carotid intima-media thickness（ c IMT） and the area of the carotid artery,the area of the soft plaque and the incidence of adverse reactions were compared. Results Total clinical efficacy were 86. 96%（ 40 /46）and 66. 67%（ 30 /45） respectively with statistical difference（ P〈0. 05）.The serum levels of TG and FIB were significantly decreased after treatment in both the control and treatment group（ P〈0. 05）. The serum levels of TG and FIB were significant lower than control group after treatment（ P〈0. 05）. Carotid artery IMT and plaque area in two groups had no significant changes of the two groups（ P〉0. 05）. No significant adverse reaction in two groups occurred,only two patients with medicationncrease in transaminase,after 1 month,the aminotransferase levels recovery to normal. Conclusion Significant clinical efficacy and safety was found for butylphthalide in the treatment of transient ischemic attack.