丁苯酞注射液联合阿托伐他汀片治疗脑梗死患者的临床研究

Clinical trial of butylphthalide injection combined with atorvastatin tablets in the treatment of patients with cerebral infarction

目的观察丁苯酞注射液联合阿托伐他汀片治疗脑梗死患者的临床疗效和安全性。方法将100例脑梗死患者随机分为对照组48例和试验组52例。对照组口服阿司匹林肠溶片200 mg+阿托伐他汀10 mg,静脉滴注银杏达莫注射液20 mL,每天1次;试验组在对照组的基础上给予丁苯酞注射液100 mL,静脉滴注,每天2次。2组患者均治疗20 d。比较2组患者的低密度脂蛋白胆固醇、空腹血糖、餐后2 h血糖、纤维蛋白原、血小板计数、美国国立卫生研究院卒中量表(NIHSS)评分、Barthel指数和药物不良反应发生情况。结果治疗后,试验组的总有效率为92.31%(45例/52例),对照组为75.00%(36例/48例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的餐后2 h血糖分别为(7.30±0.61),(7.05±0.48)mmol·L^(-1),纤维蛋白原分别为(3.55±0.14),(3.45±0.11)g·L^(-1),低密度脂蛋白胆固醇分别为(2.67±0.42),(3.13±0.41)mmol·L^(-1),空腹血糖分别为(4.69±0.31),(5.12±0.50)mmol·L^(-1),血小板计数分别为(211.14±7.71)×109/L,(221.23±7.81)×109/L,差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的NIHSS分别为(8.28±2.36),(13.50±4.24)分,Barthel指数为(73.67±11.32),(57.91±9.87)分,差异均有统计学意义(均P<0.05)。试验组和对照组的药物不良反应发生率分别为9.62%(5例/52例),6.25%(3例/48例),差异无统计学意义(P>0.05)。结论丁苯酞注射液联合阿托伐他汀片治疗脑梗死患者是安全有效的。

Objective To observe the clinical efficacy and safety of bu- tylphthalide injection combined with atorvastatin tablets in the treatment of patients with cerebral infarction. Methods A total of 100 patients with cerebral infarction were randomly divided into control group （n = 48 cases） and treatment group （n = 52 cases）. Control group was treated with aspirin enteric - coated tablets 200 mg ± atorvastatin 10 mg, orally, Ginkgo leaf extract and dipyridamole injection 20 mL intravenous drip, qd. Treatment group was treated with butylphthalide injection 100 mL on the basis of control group, intravenous drip, 2 times a day. All patients were treated for 20 d. The levels of low density lipoprotein （LDL）, fasting blood glucose, 2 h postprandial blood glucose, fibrino- gen, platelet count, National Institute of Health stroke scale （NIHSS）,Barthel index and adverse drug reactions were compared between the two groups. Results After treatment, the total effective rates of treatment group and control group were 92. 31% （45 cases/52 cases） , 75.00% （36 cases/48 cases） , with significant difference （ P 〈 0. 05 ）. After treatment, the 2 h postprandial blood glucose in treatment group and control group were （7.30 s0.61）, （7.05 ±0.48）mmol . L-1, fibrinogen were （3.55 ±0.14）, （3.45 ±0.11） g. L-1, low density lipoprotein were （2.67 ±0.42）, （3.13 ±0.41） mmol . L-1,fasting blood glucose were （4.69 ±0. 31 ）, （5.12 ±0.50） mmol . L-l, platelet count were （211.14 ±7.71 ） x 109/L, （221.23 ±7.81 ） x 109/L, all with significant difference （all P 〈0. 05）. Alter treatment, the NIHSS scores of treatment group and control group were 8.28 s 2.36, 13.50 s 4.24, Barthel index were 73.67 ± 11.32, 57.91 ± 9. 87, all with significant difference （all P 〈 0. 05 ）. The incidence of adverse drug reactions in treatment group and control group were 9.62% （5 cases/52 cases ） and 6.25% （ 3 cases/48 cases ）, with no significant difference （ P 〈 0. 05 ）. Conclusion Butylphthalide combined with atorvastatin calcium tablets in the treatment of patients with cerebral infarction had significant clinical effect, with high safety.