Effects And Safety Of Danhong Injection In Patients With Acute Cerebral Infarction

Objectives:Danhong injection (Z20026866, pharmaceutical company of Buchang) is a kind of traditional Chinese medicine injection formula, which is mainly composed of the active components from salvia miltiorrhiza and safflower. Pharmacological experiment researches proved that it had great effects of anticoagulating, anti-platelet aggregation and could improve blood circulation of human body, from which it was widely used for treating heart and cerebral vascular diseases due to vascular occlusion. This study is to evaluate its clinical effects in treatment of ACI as long as the key point of improving nerve function defect symptoms and life ability, and observe the safety of clinical application as well.Materials and Methods:A whole number of87patients had been taken into group, all of which were admitted in neurological departments of our hospital due to ACI. All the patients conformed to the diagnostic criteria in "the various cerebrovascular disease diagnosis points" from Chinese medical association of the fourth national cerebrovascular disease conference, with cerebral CT or MRI diagnosis of cerebral infarction in super acute or acute phase. After admission, we detailed the medical history and other basic information and did nerve function defect score of NIHSS (National institutes of Health stroke scale) and Daily life ability scale score of ADL (Activity of Daily Living scale). By own comparison of before-and-after treatment, we would apply Danhong injection (20ml) by intravenous drip path to patients for continuous treatment lasting14days and follow-up observation for3months to evaluate the clinical effects. We selected the total effective rate, NIHSS score and ADL score for clinical efficacy evaluation index, and changes of fasting plasma Homocysteine(Hcy) and Fibrinogen(FIB) level for laboratory evaluation index. According to the level of Hey on admission,87ACI patients were divided into high Hey level group (HHcy group) and normal Hey group (NHcy group) for an aim to do comparative analysis on clinical characters after collecting the common and clinical data of patients, like lifestyle, medical history, basic information, blood lipid level and FIB level, etc. All the patients should do regular routine laboratory tests before treatment (generally the2th day after hospital) and the14th day for safety monitoring indexes such as blood routine, urine routine, stool routine, blood coagulation function, liver function and biochemical lab test(including kidney function), ECG, radiological examination if necessary.Results:1.87cases of ACI patients completed the test, which were composed of56male cases and31female cases with an range of31-77y. The average age was56.18±11.3years old. With radiological diagnosis of craniocerebral CT or MRI for acute cerebral infarction, it included36cases of basal ganglia region infarction,22cases of brain stem infarction,7cases of occipital lobe infarction,5cases of frontal lobe infarction,3cases of temporal lobe infarction,4cases of cerebellar infarction and10cases of multiple infarctions. Of these patients,49cases accompanied with hypertension,30patients with diabetes mellitus,24cases with heart disease,34cases combined hyperlipidemia,20cases with other system diseases.2.According to Hey level after admission, patients were divided into44cases of HHcy group and43cases of NHcy group. It was found that HHcy group had more patients than NHcy group in comparing these indexes of men, smoking history, drinking history and TIA history before onset, and the average age was much younger than that of NHcy group. The plasma Hey level and LDL-C level of HHcy group were higher than that of NHcy group(p<0.05); The NIHSS score and ADL score of the two groups on admission into hospital had no significant difference(p>0.05), but the occurrence of disease progression in patients were more than NHcy group(p<0.05).3.The clinical effect:All patients completed the study with no dropouts. The total effective rate of HHcy group was93.2%, which was slightly higher than that of NHcy group with88.4%. However, the difference was not statistically significant(p>0.05).4.NIHSS and ADL score(x±s):The NIHSS score of HHcy group and NHcy group after treatment for14days were both significantly lower than before treatment (p<0.001), and the NIHSS score of HHcy group decreased by a bigger extent than NHcy group with a statistically significant difference(p<0.05); The ADL score of both groups after treatment increased significantly compared with that before treatment(p<0.001), but the increased rate of HHcy group is greater than NHcy group, and the difference was statistically significant(p<0.01).5.FIB and Hcy levels(x±s):The fasting plasma Hcy level and FIB level decreased significantly at the14th day of treatment than before treatment, and the differences were all statistically significant(p<0.001).6.Safety observation:During the treatment process, the incidence of adverse reactions was3.4%. All adverse reactions were easy for tolerance with mild degree and no serious adverse reactions occurred, like airway spasm, anaphylactic shock and gastrointestinal bleeding.Conclusions:1.Patients of ACI with a high level of homocysteine are more common in young men and might be associated with smoking, drinking, TIA and LDL-C level. It may have something to do with the state that patients are susceptible to disease progression, but the degree of nerve function defect after onset is not affected. Clinical treatment with appropriate interventions should be given when necessary.2.Danhong injection can significantly improve the clinical symptoms in ACI patients, reduce the neural function defect scale and simultaneously improve the ability of the patient’s daily life, aiming to reduce the short-term morbidity and improve prognosis. Moreover, Danhong injection might show a better effect in reducing the neurological deficit and improving the prognosis of the treatment for ACI patients with high homocysteine level, but it still needs much further studies.3.Danhong injection can also reduce recurrence risk of cerebrovascular disease significantly by lowering the level of plasma Hcy and FIB. It can change blood high condensation state through playing the role of anticoagulant and anti-thrombotic effects to prevent the recurrence and progression of ACI.4. It showed a low incidence of adverse reactions in the process of clinical application, and it was easy for patients to tolerate as a mild degree.