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

Objectives: Cerebrovascular disease is a common and frequently-occurring disease of the nervous system. It has became the first factor ofcripple and death in China’s urban and rural population.The morbidity hasincreased year by year,bringing heavy burden on the family and society.Stroke includes ischemic stroke and hemorrhagic stroke, the acute cerebralinfarction accounted for70%-80%of all stroke patients. The treatment ofacute cerebral infarction influences the prognosis directly, so it has attractedmore and more attention. At present,the corresponding processing andtreatment include stroke unit, arterial and venous thrombolysis, arterialembolectomy, anti-platelet aggregation, anticoagulant, neuroprotective,surgery and so on, some of them are clinically proved to be efficacious butsome remains controversial.However, these therapies are not play a well role in protection of theischemic penumbra. To this end, our scientists have been looking for a drug toprotect the ischemic penumbra, which be able to block the cerebral ischemicinjury mechanisms from multi-link. In1978, Yang Jun-Shan extracted n-butylphthalide from celery seed. In1980, Yang Jinghua synthetized n-butylphthalide by chemical methods; In the1990s, the famous nervepharmacologist Ping did a series of in-depth research on butyl phthalide, andfound that its effectiveness of brain protection. In2001, the soft capsuleButylphthalide (NBP) officially available, I, Ⅱ, Ⅲclinical trials were carriedout in succession, confirmed its efficiency up to73.2%in the treatment ofacute ischemic stroke. It can block multiple pathological aspects of braindamage caused by ischemic stroke, with a strong anti-cerebral ischemia. It canalso significantly reduce the infarct size of focal cerebral ischemia, cerebraledema, improve brain energy metabolism, ischemic areas microcirculation and cerebral blood flow; meanwhile, it can inhibit neuronal apoptosis and play arole in anti-thrombotic and anti-platelet aggregation, so as to improve andmaximize the purpose of restoring nerve function.Based on clinical needs, CSPC developed Butylphthalide injection. Ⅰ,Ⅱ, Ⅲ, clinical trials has been completed, the purpose of ourresearch is toevaluate the efficacy and safety of dl-3-n-butylphthalide injection in the realworld treatment of acute cerebral infarction.Methods:100patients with acute cerebral infarction were followed up ina Randomized and parallel controlled study．Under the premise of basictreatment,60patients were given the test drug ButylphthalideIn injection(Butylphthalide50mg/d). Observed the100cases of patients for3months.Rankin scales were get as major index to evaluate therapeutic affection in the3months after treatment and NIHSS get on the7th and14th day aftertreatment as secondary therapeutic effect index．ECG, blood clotting, liverfunction, kidney function, blood glucose, and the routines of blood, urine andstool were used to evaluate medical safety.Results:1100patients include40patients in the control group，no Patients wereexcluded.2There was no significant difference in patients’characteristics，historyand initial symptoms, NIHSS and Rankin scales between control andtreatment group.3Comparing the score at different periods within the group of the controlone and the treatment one，that is NIHSS comparison between0th day and7thdays,0th day and14th days,7th days and14th days，the results show that it isof statistically significant difference (P <0.05). Comparing the Rankin scorebetween0day and3-month, the results show that there is a statisticallysignificant difference (P<0.01). Accompanied by the duration of the extension,neurological symptoms of the control group and the treatment group were allimproved. Comparing the scores of NIHSS on the7th day,14th day and theRankin score in the3months between dl-3-n-butylphthalide and the control, the results show that there is also a statistically significant difference (P<0.01).This show that dl-3-n-butylphthalide can significantly improve the ratings andhave a positive effect on acute cerebral infarction.4Their hepatic and renal functions,blood and urine routine test,ECG(electrocardiogram)and blood clotting were all in normal state beforecuring．There were7patients，3in the control group and4in the test groups,showing adverse events and those were uncommon hepatic function,hypodynamia, dyskinesia, and heart rate negative acceleration．Only thedecrease in heart rate case was judged as having possible some relationshipwith the test drug．The total7cases recovered normal．Comparing theincidence of adverse events between the two groups, p is0.669, with nostatistically significant.Conclusion: The Butylphthalide injection is a safe, effective and long-term benefit new drug in the real world treatment of acute ischemic stroke.