Safety and Feasibility of Recombinant Factor VIIa for Acute Intracerebral Hemorrhage Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial [Effect of multiple paralleled acupuncture needles stimulation of scalp points on hemodynamics and blood flow energy of the common carotid artery in stroke patients]. [Effect of scalp acupuncture on the expression of NF-kappaB mRNA, COX-2 mRNA and their proteins in rats with acute cerebral ischemia-reperfusion injury]. [Clinical observation on effect of acupuncture on nervous functions of the patient after operation of. hypertensive cerebral hemorrhage]. Recombinant activated factor VII for acute intracerebral hemorrhage. [Effect of scalp acupuncture on inflammatory response in rats with acute cerebral ischemia-reperfusion injury].
Background and Purpose — Hematoma growth occurs in 38 % of intracerebral hemorrhage ( ICH ) patients scanned by computed tomography ( CT ) within 3 hours of onset . Activated recombinant factor VII ( rFVIIa ) promotes hemostasis at sites of vascular injury and may minimize hematoma growth after ICH . Methods — In this r and omized , double-blind , placebo-controlled , dose-escalation trial , 48 subjects with ICH diagnosed within 3 hours of onset were treated with placebo ( n=12 ) or rFVIIa ( 10 , 20 , 40 , 80 , 120 , or 160 & mgr;g/kg ; n=6 per group ) . The primary endpoint was the frequency of adverse events ( AEs ) . Safety assessment s included serial electrocardiography ( ECG ) , troponin I and coagulation testing , lower extremity Doppler ultrasonography , and calculation of edema : ICH volume ratios . Results — Mean age was 61 years ( range , 30 to 93 ) and 57 % were male . At admission , mean National Institutes of Health Stroke Scale ( NIHSS ) score was 14 ( range , 1 to 26 ) , median Glasgow Coma Scale score was 14 ( range , 6 to 15 ) , and mean ICH volume was 21 mL ( range , 1 to 151 ) . Mean time from onset to treatment was 181 minutes ( range , 120 to 265 ) . Twelve serious AEs occurred , including 5 deaths ( mortality 11 % ) . Six AEs were considered possibly treatment-related , including rash , vomiting , fever , ECG T-wave inversion , and 2 cases of deep vein thrombosis ( placebo and 20-&mgr;g/kg groups ) . No myocardial ischemia , consumption coagulopathy , or dose-related increase in edema : ICH volume occurred . Conclusion — This small phase II trial evaluated a wide range of rFVIIa doses in acute ICH and raised no major safety concerns . Larger studies are justified to determine whether rFVIIa can safely and effectively limit ICH growth BACKGROUND Spontaneous supratentorial intracerebral haemorrhage accounts for 20 % of all stroke-related sudden neurological deficits , has the highest morbidity and mortality of all stroke , and the role of surgery remains controversial . We undertook a prospect i ve r and omised trial to compare early surgery with initial conservative treatment for patients with intracerebral haemorrhage .  METHODS A parallel-group trial design was used . Early surgery combined haematoma evacuation ( within 24 h of r and omisation ) with medical treatment . Initial conservative treatment used medical treatment , although later evacuation was allowed if necessary . We used the eight-point Glasgow outcome scale obtained by postal question naires sent directly to patients at 6 months follow-up as the primary outcome measure . We divided the patients into good and poor prognosis groups on the basis of their clinical status at r and omisation . For the good prognosis group , a favourable outcome was defined as good recovery or moderate disability on the Glasgow outcome scale . For the poor prognosis group , a favourable outcome also included the upper level of severe disability . Analysis was by intention to treat . FINDINGS 1033 patients from 83 centres in 27 countries were r and omised to early surgery ( 503 ) or initial conservative treatment  ( 530 ) . At 6 months , 51 patients were lost to follow-up , and 17 were alive with unknown status . Of 468 patients r and omised to early surgery , 122 ( 26 % ) had a favourable outcome compared with 118 ( 24 % ) of 496 r and omised to initial conservative treatment ( odds ratio 0.89 [ 95 % CI 0.66 - 1.19 ] , p=0.414 ) ; absolute benefit 2.3 % ( -3.2 to 7.7 ) , relative benefit 10 % ( -13 to 33 ) . INTERPRETATION Patients with spontaneous supratentorial intracerebral haemorrhage in neurosurgical units show no overall benefit from early surgery when compared with initial conservative treatment OBJECTIVE To observe the changes of carotid hemodynamic and hydraulic power indices after paralleled scalp-point acupuncture therapy in post-stroke patients . METHODS Twenty post-stroke volunteer patients were enlisted in the present study . Aseptic filiform needles were inserted into Baihui ( GV 20 ) , bilateral Motor Area ( MS 8) , etc . with the needles retained for 5 min . The treatment was given one time . Hemodynamic indices : mean velocity of blood flow ( Vmean ) , maximum velocity ( Vmax ) , minimum velocity ( Vmin ) , mean blood flow ( Qmean ) , maximum blood flow ( Qmax ) , minimum blood flow ( Qmin ) , natural impedance ( Zc ) , peripheral resistance ( Rc ) , dynamic resistance ( Dr ) , and critical pressure ( Pc ) before and after the treatment were detected with KF-3000 Brain Circulation Analyzer . The hydraulic power indices : stable potential energy ( Ws ) , oscillation potential energy ( Wo ) , total potential energy ( Wc ) , stable kinetic energy ( Ks ) , success kinetic energy ( Ko ) , total kinetic energy ( Kc ) , stable total energy ( Ts ) , oscillation total energy ( To ) , total energy ( Tc ) , To/Tc , Kc/Tc , Wo/Wc and Ks/Kc were obtained through calculation . RESULTS After the therapy , Vmin , Vmean , Qmin and Qmean increased significantly ( P<0.001 ) , while Rc decreased evidently ( P<0.001 ) . Ws , Ks , Ts , Wc , Kc , Tc and Kc/Tc increased obviously ( P<0.001 , P<0.05 ) , and Ks/Kc declined significantly ( P<0.01 ) . The rest indices had no significant changes after the treatment . CONCLUSION Multiple paralleled scalp acupuncture needles stimulation can effectively raise the blood flow volume of the common caroitid artery , leading to an increase of the energy supply of the cerebral blood circulation , but has no apparent influence on the total oscillatory energy/total energy in stroke patients OBJECTIVE To explore the possible mechanism of scalp acupuncture ( SA ) in relieving cerebral ischemia reperfusion ( CI-R ) injury . METHODS Seventy male SD rats were r and omized into sham-operation ( sham , n = 10 ) , model ( n = 30 ) and SA ( n = 30 ) groups . The later 2 groups were further divided into 24 h , 48 h and 72 h subgroups respectively , with 10 cases in each . CI-R model was established by middle cerebral artery occlusion ( MCAO ) and reperfusion . Electroacupuncture ( 2 mA , 2 Hz/100 Hz ) was applied to " Dingnie Houxiexian " ( MS 7 ) and " Dingnie Qianxiexian " ( MS 6 ) for 30 min , once every 24 h. Changes of the animal behavior were observed by using neurological severity score ( NSS ) , nuclear factor-kappa B ( NF-kappaB ) and cyclooxygenase ( COX-2 ) contents and their mRNA expression were detected with enzyme-linked immunosorbent assay ( ELISA ) and polymerase chain reaction ( PCR ) techniques respectively . RESULTS Following modeling , the NSS at 24 h , 48 h and 72 h after MCAO increased significantly , while compared with model group , NSS of SA group at the 3 time-points decreased considerably ( P < 0.05 , P < 0.01 ) , suggesting an improvement of the neurological functions after SA treatment . In comparison with sham group , NF-kappaB mRNA and COX-2 mRNA , and NF-kappaB and COX-2 protein expression of model group in the infa rct ed cerebral tissue were significantly upregulated at the 3 time-points ( P < 0.01 ) except NF-KB mRNA at 72 h ( no significant change ) , while compared with the 3 time-points of model group , NF-kappaB mRNA and COX-2 mRNA , and NF-KB and COX-2 protein expression of SA group were downregulated obviously ( P < 0.01 ) except COX-2 mRNA at 72 h. CONCLUSION Scalp acupuncture can suppress cerebral ischemia-induced upregulation of NF-kappaB mRNA and COX-2 mRNA , and NF-kappaB and COX-2 protein expression , which may contribute to its effect in promoting neurofunctional rehabilitation of CI-R rats by reducing cytokines-mediated inflammatory reaction OBJECTIVE To probe the best therapy for the patient after operation of hypertensive cerebral hemorrhage . METHODS One hundred cases were r and omly divided into a treatment group and a control group , 50 cases in each group . The control group were treated by routine western medicine ( Mannitol , Nifedipine and Caftriaxone sodium and so On ) , and the treatment group by the medication of the control group plus acupuncture 9 days after operation . Acupuncture was given at Neiguan ( PC 6 ) , Shuigou ( GV 26 ) , Sanyinjiso ( SP 6 ) , Jiquan ( HT 1 ) and Weizhong ( BL 40 ) and so on , combined with scalp acupuncture , with " restoring consciousness and inducing consciousness " needling method , for 10 days . The nervous function defect was assessed by Chinese Stroke Scale and the criteria for assessment of therapeutic effects . RESULTS Acupuncture could improve significantly nervous function defect . The total effective rate was 86.000 in the treatment group and 14.0 % in the control group with a significant difference between the two groups ( P < 0.01 ) . CONCLUSION The therapeutic effect of the treatment group is better than that of the control group . Acupuncture combined with western medicine has cooperation for treatment of hypertensive intracerebral hemorrhage with a better therapeutic effect BACKGROUND Intracerebral hemorrhage is the least treatable form of stroke and is associated with high mortality . Among patients who undergo computed tomography ( CT ) within three hours after the onset of intracerebral hemorrhage , one third have an increase in the volume of the hematoma related to subsequent bleeding . We sought to determine whether recombinant activated factor VII ( rFVIIa ) can reduce hematoma growth after intracerebral hemorrhage . METHODS We r and omly assigned 399 patients with intracerebral hemorrhage diagnosed by CT within three hours after onset to receive placebo ( 96 patients ) or 40 microg of rFVIIa per kilogram of body weight ( 108 patients ) , 80 microg per kilogram ( 92 patients ) , or 160 microg per kilogram ( 103 patients ) within one hour after the baseline scan . The primary outcome measure was the percent change in the volume of the intracerebral hemorrhage at 24 hours . Clinical outcomes were assessed at 90 days . RESULTS Hematoma volume increased more in the placebo group than in the rFVIIa groups . The mean increase was 29 percent in the placebo group , as compared with 16 percent , 14 percent , and 11 percent in the groups given 40 microg , 80 microg , and 160 microg of rFVIIa per kilogram , respectively ( P=0.01 for the comparison of the three rFVIIa groups with the placebo group ) . Growth in the volume of intracerebral hemorrhage was reduced by 3.3 ml , 4.5 ml , and 5.8 ml in the three treatment groups , as compared with that in the placebo group ( P=0.01 ) . Sixty-nine percent of placebo-treated patients died or were severely disabled ( as defined by a modified Rankin Scale score of 4 to 6 ) , as compared with 55 percent , 49 percent , and 54 percent of the patients who were given 40 , 80 , and 160 microg of rFVIIa , respectively ( P=0.004 for the comparison of the three rFVIIa groups with the placebo group ) . Mortality at 90 days was 29 percent for patients who received placebo , as compared with 18 percent in the three rFVIIa groups combined ( P=0.02 ) . Serious thromboembolic adverse events , mainly myocardial or cerebral infa rct ion , occurred in 7 percent of rFVIIa-treated patients , as compared with 2 percent of those given placebo ( P=0.12 ) . CONCLUSIONS Treatment with rFVIIa within four hours after the onset of intracerebral hemorrhage limits the growth of the hematoma , reduces mortality , and improves functional outcomes at 90 days , despite a small increase in the frequency of thromboembolic adverse events OBJECTIVE To explore the mechanism of scalp acupuncture ( SA ) in treating cerebral ischemia . METHODS Sixty SD rats with middle cerebral artery occlusion ( MCAO ) were r and omized into untreated group and SA-treated group , with another group of 10 SD rats without artery occlusion as sham-operated control . Neurological severity score ( NSS ) , hemetoxylin and eosin ( HE ) staining and enzyme-linked immunosorbent assay were applied to observing the changes of neurofunctional defect , inflammatory infiltration in cerebral tissue and content of tumor necrosis factor-alpha ( TNF-alpha ) , interleukin-1beta ( IL-1beta ) and IL-10 at 24 , 48 and 72 h after ischemia-reperfusion . RESULTS There existed significant difference in NSS between SA-treated group and untreated group ( P<0.01 ) , especially at 72 h after ischemia-reperfusion . The HE staining results of ischemic cerebral tissue showed an apparent reduction of inflamed lesions in SA-treated group as compared with the untreated group ( P<0.01 ) , especially at 72 h after ischemia-reperfusion . The content of TNF-alpha and IL-1beta at each phase point after ischemia-reperfusion in SA-treated was decreased as compared with that in the untreated group , and there were differences between SA-treated group and untreated group at 72 h after ischemia-reperfusion ( P<0.01 ) . An apparent increase was observed in IL-10 between SA-treated group and untreated group at each phase point after ischemia-reperfusion , and there were significant differences between SA-treated group and untreated group at 48 and 72 h after ischemia-reperfusion ( P<0.05 , P<0.01 ) . CONCLUSION Scalp acupuncture can improve neurofunctional rehabilitation , suppress leukocyte infiltration , decrease the content of TNF-alpha and IL-1beta within a certain range and enhance IL-10 expression so as to suppress cytokines-mediated inflammatory reaction and attenuate cerebral ischemia-reperfusion injury
OBJECTIVES Scalp acupuncture ( SA ) is a commonly used therapeutic approach for primary intracerebral hemorrhage ( ICH ) in Traditional Chinese Medicine ( TCM ) , but the efficacy and safety of SA therapy are still undetermined .
The aim of this study is to systematic ally evaluate the efficacy and safety of SA therapy for the treatment of acute hypertensive ICH .