The Efficacy And Safety Of Dl-3-n-butylphthalide Injection On Acute Cerebral Infarction

Objectives:To assess the efficacy and safety of dl-3-n-butylphthalide injection in treatment of acute cerebral infarction.Methods:41 patients with acute cerebral infarction were followed up in a double-blind, randomized, multidoses, and parallel controlled study. The Xiang-dan Injection 20ml/d was used for all the cases as basic treatment for 14 days and dl-3-n-butylphthalide, as the test drug, was used for 10 days for groups except the controls. The 41 cases were randomly divided into control group, low-dose (of dl-3-n-butylphthalide) group, middle-dose (of dl-3-n-butylphthalide) group and high-dose (of dl-3-n-butylphthalide) group. NIHSS, Barthel index and Rankin scales were get as major index to evaluate therapeutic affection on the 11th day after treatment and those get on the 21st day after treatment as secondary therapeutic effect index. EKG, blood clotting, liver function, creatase examination and the routines of blood, urine and stool were used to evaluate medical safety.Results:1. 41 patients include 7 patients in the control group, 10 patients in low-dose group excluding 1 patient; 11 patients in middle-dose group; 13 patients in high-dose group excluding 2 patients.2. There was no significant difference in patients' characteristics, history and initial symptoms, NIHSS and Barthel index between control, low-dose, high-dose and middle-dose groups.3. The scores of NIHSS, Barthel index and Rankin score with dl-3-n-butylphthalide on the 11th day or on 21st day after treatment had statistically greatly improved than those before curing(p＜0.05), so did with the control.4. There were statistic differences in NIHSS, Barthel index and Rankin score between control group and dl-3-n-butylphthalide group on the 11th day or on 21st day after treatment, but there wasn't difference among dl-3-n-butylphthalide groups.5. Their hepatic and renal functions, blood and urine routine test, EKG (electrokardiogram,electrocardiogram) and blood clotting were all in normal state before curing. There were 10 patients, 1 in the control group and 9 in the test groups, showing adverse events and those were uncommon hepatic function, skin rash, hypodynamia, dyskinesia, hypolekocytosis, and heart rate negative acceleration. Only the hypodynamia case was judged as having possible some relationship with the test drug. The total 3 cases, showing skin rash, hypodynamia or dyskinesia, were withdrawn from the test and others recovered normal.Conclusion: dl-3-n-butylphthalide could greatly improve acute cerebral infarction patient's neurological symptoms, at the same time, the side effect is acceptable. In another words, dl-3-n-butylphthalide is a safe and effective drug for patient with acute cerebral infarction.