| Background: Stroke, a brain attack,is the leading cause of disability and the third leading cause of death.It has became the first factor of cripple and death in China’s urban and rural population.The acute cerebral infarction accounted for 80% of all stroke patients.How to reduce mortality and disability of patients with stroke is a hot topic at present.Neuroprotective drugs have been an important way for early treatments of ischemic stroke in the last thirty years.So,our scientists have been looking for a drug to protect the ischemic penumbra,which be able to block the cerebral ischemic injury mechanisms from multi-link. In the 1990 s,the famous nerve pharmacologist ping did a series of in-depth research on butylphthalide,and found that its effectiveness of brain protection. 1n 2001,the soft capsule Butylphthalide(NBP) officially available I,II,III clinical trials were carried out in succession. It’s main roles includes remodeling the microcirculation of areas,restraining the apoptosis of nerve cells,protecting mitochondrial cells,seavenging free radicals,inhibiting platelet aggregation and thrombosis and reducing the inflammatory response.Butylphthalide could block multiple pathological links in ischemic brain damage, reduce ischemia penumbra brain tissue volume,and improve the acute ischemic cerebral apoplexy nerve functional defects to improve the ability and quality of life of the patients.Based on clinical needs,CSPC developed Butylphthalide injection to overcome the inconvenience of soft capsule for stroke patients with dysphagia and to improve its bioavailability. I, II, III, clinical trials has been completed, the research is a part of IV clinical trials, is to evaluate the efficacy and safety of dl-3-n-butylphthaltide injection in the real world treatment of acute cerebral infarction.Purpose: To observe the clinical efficacy and the occurrance of serious adverse events about Butylphthalide Injection to treat acute cerebral infarction within 72 hours, and to analysis the prognostic factors.Methods: From June 2012 to June 2013 in our hospital,86 patients of cerebral infarction were selected and randomly divided into experimental group and control group.With same normal basic treatment between the two groups,the treatment group was intravenous injected with Butylphthalide Injection 25mg(100ml),twice a day for 14 days.The neural function deficits and the clinical curative effects on the 0,8,15,90 days after the treatment were observed,and the efficacy measures were Barthel index score and the modified Rankin scale(m Rs) at day 1 and 90.Results:1 The NIHSS change in two groups before and after treatment:The NIHSS score after treatment in both groups were statistically different than before. Moreover, the treatment group significantly decreased The NIHSS score(P﹤0.05).2 Comparison of the incidence of adverse events the control one and the treatment one is nondifference.3 hyperglycemia,dyslipidemia and NHISS score before therapy are respective predictive indexes of curative effect.Conclusion:1 The Butylphthalide injection improve the acute ischemic cerebral apoplexy nerve functional defects to improve the ability and quality of life of the patients.2 The Butylphthalide injection is safe.3 Curative effect are affected by hyperglycemia,dyslipidemia and NHISS score before cure. |
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