摘要
BACKGROUND： Within 3 hours after ischemic stroke, thrombolysis can improve prognosis of patients; however, cerebral edema and cerebral hemorrhage induced by vascular recanalization at an early phase can influence on therapeutic effect of thrombolysis; therefore, thrombolysis is combined with neuroprotective agent for recently clinical treatment. OBJECTIVE： To evaluate the neuroprotective effect of shenfu injection on patients with ischemic stroke after arterial thrombolysis and compare with the controls. DESIGN ： Case-controlled study.SETTING ： Department of Medical Image, Second Hospital of Hebei Medical University.PARTICIPANTS ： A total of 45 patients with acute stroke were selected from Emergency Department or Neurological Department of the Second Hospital of Hebei Medical University from August 2005 to May 2006. All patients were met the diagnosis criteria published by the Fourth National Stroke Conference and had middle cerebral arterial embolism with angiography. Attacked course was less than 6 hours. Patients did not have a history of stroke. Scores of the National Institutes of Health Stroke Scale （NIHSS） were not less than 4 points and patients were aged from 18 to 80 years. All subjects consented of the whole therapeutic process. METHODS ： ① Intermittent perfusion was used to treat intra-arterial thrombolysis. Thirty patients with vascular recanalization or partially vascular recanalization （18 males and 12 females） were randomly divided into treatment group and control group with 15 in each group. There was no significant difference of baseline data between the two groups. After recanalization, patients in treatment group were given 20 mL shenfu injection, which consisted of ginseng saponin and aconitine （Ya＇an Sanjiu Pharmaceutical Company, batch number： 041013, 10 mL/ampoule） and slowly injected into vein for longer than 5 minutes. And then, patients were intravenously dripped with 50 mL shenfu injection and 50 g/L 250 mL glucose solution once a day for 2 courses. Fourteen days were regarded as a course. Patients in control group were treated with the same volume of glucose solution （50 g/L）, and other processes in this group were as the same as those in treatment group. ② NIHSS scores before thrombolysis and at 24 hours after thrombolysis： Patients were scored as the follows： level of consciousness, staring, sight, facial paralysis, upper limb movement, lower limb movement, incoordination, sense, language, dysarthria and neglect. Total scbres ranged from 0 to 42, and the more the scores were, the more obvious the symptom was. ③ Patients were checked with head CT examination at 24 hours after thrombolysis. ④ Modified Rankin scores at 3 months after thrombolysis： Total scores ranged from 0 to 6. 0： symptomless; 6： death; 0- 2： well; 3-6： poor. ⑤ Adverse events and side effects were checked after thrombolysis. MAIN OUTCOME MEASURES： ① Comparison of NIHSS scores between the two groups before and after thrombolysis; ② comparison of modified Rankin scores at 3 months after thrombolysis; ③ comparison of adverse events and side effects. RESULTS ： Among 45 patients with ischemic stroke, 30 ones with vascular recanalization were involved in the final analysis. ① Comparison of NIHSS scores before and after thrombolysis： After thrombolysis, NIHSS scores were 5 in treatment group and 8 in control group, which were lower than those before thrombolysis （12, 13; U =2.054, 1.652; P 〈 0.05）. At 24 hours after thrombolysis, NIHSS score was 5 in treatment group, which was lower than that in control group （8, U=2.157, P〈 0.05）. ② Comparison of modified Rankin scores at 3 months after thrombolysis： Rankin scores which were regarded as well accounted for 93% （14/15） in treatment group, which was higher than those in control group （53%, 8/15, P〈 0.05）. ③ Comparison of adverse events and side effects： Patients in treatment group did not have cerebral hemorrhage and whole-body hemorrhage with head CT examination; meanwhile, all patients were living at 24 hours after thrombolysis. Among 2 patients with cerebral hemorrhage, 1 case were dead in control group with head CT examination at 24 hours after thrombolysis. CONCLUSION： Intra-arterial thrombolysis combined with shenfu injection plays a neuroprotective role in ischemic stroke; additionally, it is safe for patients.
BACKGROUND： Within 3 hours after ischemic stroke, thrombolysis can improve prognosis of patients; however, cerebral edema and cerebral hemorrhage induced by vascular recanalization at an early phase can influence on therapeutic effect of thrombolysis; therefore, thrombolysis is combined with neuroprotective agent for recently clinical treatment. OBJECTIVE： To evaluate the neuroprotective effect of shenfu injection on patients with ischemic stroke after arterial thrombolysis and compare with the controls. DESIGN ： Case-controlled study.SETTING ： Department of Medical Image, Second Hospital of Hebei Medical University.PARTICIPANTS ： A total of 45 patients with acute stroke were selected from Emergency Department or Neurological Department of the Second Hospital of Hebei Medical University from August 2005 to May 2006. All patients were met the diagnosis criteria published by the Fourth National Stroke Conference and had middle cerebral arterial embolism with angiography. Attacked course was less than 6 hours. Patients did not have a history of stroke. Scores of the National Institutes of Health Stroke Scale （NIHSS） were not less than 4 points and patients were aged from 18 to 80 years. All subjects consented of the whole therapeutic process. METHODS ： ① Intermittent perfusion was used to treat intra-arterial thrombolysis. Thirty patients with vascular recanalization or partially vascular recanalization （18 males and 12 females） were randomly divided into treatment group and control group with 15 in each group. There was no significant difference of baseline data between the two groups. After recanalization, patients in treatment group were given 20 mL shenfu injection, which consisted of ginseng saponin and aconitine （Ya＇an Sanjiu Pharmaceutical Company, batch number： 041013, 10 mL/ampoule） and slowly injected into vein for longer than 5 minutes. And then, patients were intravenously dripped with 50 mL shenfu injection and 50 g/L 250 mL glucose solution once a day for 2 courses. Fourteen days were regarded as a course. Patients in control group were treated with the same volume of glucose solution （50 g/L）, and other processes in this group were as the same as those in treatment group. ② NIHSS scores before thrombolysis and at 24 hours after thrombolysis： Patients were scored as the follows： level of consciousness, staring, sight, facial paralysis, upper limb movement, lower limb movement, incoordination, sense, language, dysarthria and neglect. Total scbres ranged from 0 to 42, and the more the scores were, the more obvious the symptom was. ③ Patients were checked with head CT examination at 24 hours after thrombolysis. ④ Modified Rankin scores at 3 months after thrombolysis： Total scores ranged from 0 to 6. 0： symptomless; 6： death; 0- 2： well; 3-6： poor. ⑤ Adverse events and side effects were checked after thrombolysis. MAIN OUTCOME MEASURES： ① Comparison of NIHSS scores between the two groups before and after thrombolysis; ② comparison of modified Rankin scores at 3 months after thrombolysis; ③ comparison of adverse events and side effects. RESULTS ： Among 45 patients with ischemic stroke, 30 ones with vascular recanalization were involved in the final analysis. ① Comparison of NIHSS scores before and after thrombolysis： After thrombolysis, NIHSS scores were 5 in treatment group and 8 in control group, which were lower than those before thrombolysis （12, 13; U =2.054, 1.652; P 〈 0.05）. At 24 hours after thrombolysis, NIHSS score was 5 in treatment group, which was lower than that in control group （8, U=2.157, P〈 0.05）. ② Comparison of modified Rankin scores at 3 months after thrombolysis： Rankin scores which were regarded as well accounted for 93% （14/15） in treatment group, which was higher than those in control group （53%, 8/15, P〈 0.05）. ③ Comparison of adverse events and side effects： Patients in treatment group did not have cerebral hemorrhage and whole-body hemorrhage with head CT examination; meanwhile, all patients were living at 24 hours after thrombolysis. Among 2 patients with cerebral hemorrhage, 1 case were dead in control group with head CT examination at 24 hours after thrombolysis. CONCLUSION： Intra-arterial thrombolysis combined with shenfu injection plays a neuroprotective role in ischemic stroke; additionally, it is safe for patients.
