BACKGROUND: Thrombolysis therapy is not suitable for the elderly patients with acute ischemic stroke who delayed to be diagnosed for more than 3 hours, but traditional medicine is also not very ideal. OBJECTIVE: To observe the clinical therapeutic effect of modified hemodilution combined therapy applied in elderly patients with acute cerebral thrombosis and analyze the mechanism of this therapeutic method. DESIGN: 1∶1 paired grouping according to gender and controlled observation. SETTING: Department of Internal Medicine, Chengzhanyuan District, First Hospital Affiliated to Zhejiang University. PARTICIPANTS: Totally 90 elderly patients with acute ischemic stroke who received the treatment in the Cadre Ward and Mental Ward, Department of Internal Medicine, Chengzhanyuan District, First Hospital Affiliated to Zhejiang University from March 1996 to June 2004 were recruited. They all met the diagnosis criteria revised by the Fourth Academic Conference of National Cerebrovascular Diseases in 1995 and were diagnosed as acute ischemic stroke by skull CT. They were informed of therapeutic plan and detected items. According to 1∶1 paired principle in gender, 90 enrolled patients were assigned into treated group (n=45) and control group (n=45). There were 39 male and 6 female in the treatment group, and they were aged (76±6)years, ranging from 71 to 84 years, and hospitalized at the 14th to 76th hours after onset. There were 39 male and 6 female in the control group, and they were aged (76±6)years , ranging from 70 to 82 years, and hospitalized at the 16th to 72th hours after onset. METHODS: Therapeutic method: Patients of treated group received modified hemodilution combined therapy. 200 mL whole blood of patients was exchanged with 500 mL dextran-40 (including 20 mL danshen parenteral solution and 32 mg heparin) at the beginning of therapy; From the 2nd day, compound huangqi tea bag (Huangqi mainly, including danshen, honghua, chuanxiong, shishao and a little acetyl salicylic acid) was made, twice a day, 1 bag once. At the same time, the above-mentioned dextran-40 liquid of 500 mL was intravenously injected, once a day, 14 days in total; On the 6th day after therapy, the above-mentioned aseptic autoblood stored in refrigerator at 4 ℃ was transfused back into the patients following pre-treatment of high-concentration oxygenation and ultraviolet irradiation by light quantum instrument. Patients of control group were intravenously injected of 0.4 g venoruton(Traditional Chinese medicine compound parenteral solution for promoting blood circulation and removing blood stasis ) and 50 g/L glucose of 500 mL, 75 mg acetosal was taken orally, once a day, 14 days in total. ② Measurement and observation of index: Blood coagulation index, change of platelet aggregation rate and change of hemorrheology of patients in two groups were monitored before and after therapy. The level of blood lipid of patients in two groups was measured with American Beckman automatic biochemistry analyzer. Blood flow rate of middle cerebral artery of resting electrocardiogram were measured with American HP SONOS 2500 sonoscope. Neuro-dysfunction score revised in the national conference (1995) was used to evaluate the recovery of neurological function of the patients in two groups at the 3rd, 5th, 7th and 14th days after therapy. ③Therapeutic effect and adverse effect were observed at the same time. MAIN OUTCOME MEASURES: ① Changes of coagulation index, blood lipid level and hemorheology; ② Blood flow rate of middle cerebral artery and NDS of patients with acute ischemic stroke in two groups; ③Adverse effect of drug. RESULTS: Totally 90 patients were enrolled in the experiment. One patient from treated group died of hyperosmolar nonketotic diabetic coma of complicated diabetes mellitus. One patient from control group died of severe pulmonary infection. The rest 88 patients entered the stage of result analysis. ① Change of coagulation index and platelet aggregation rate: prothrombin time (PT), activated partial thromboplastin time (APTT) and thrombin time (TT) of patients after therapy were significantly longer than those before therapy in the treated group and those after therapy in control group [After therapy in treated group: (18.4±1.9), (41.8±2.1), (19.7±1.7) s, Before therapy in treated group: (13.4±1.3), (35.8±1.3), (12.5±0.9) s, After therapy in control group: (16.9±1.5), (39.1±1.1), (11.9±2.1) s, P < 0.05];Concentration of fibrinogen (Fbg) after therapy was significantly lower than that before therapy in the treated group and that after therapy in control group[After therapy in treated group: (3.4±0.4) g/L; Before therapy in treated group: (4.3±0.7) g/L; After therapy in control group:(4.0±0.6) g/L; P < 0.05]. Platelet aggregation rate decreased from (37.92 ±0.85)% before therapy to (26.42±1.01)% after therapy (P < 0.01). ②Change of blood lipid level: Levels of total cholesterol (TC), triacylglycerol(TG) and low density lipoprotein cholesterol (LDL-C) of patients after therapy were significantly lower than those before therapy in treated group and those after therapy in control group [After therapy in treated group: (5.2±0.9), (1.9±0.9), (2.08±1.1) mmol/L, before therapy in treated group:(5.9±1.2), (2.8±0.9), (3.94±0.5) mmol/L, After therapy in control group: (6.0±1.1), (2.6±0.8), (3.84±0.9) mmol/L,P < 0.05]. ③ Change of hemorheology index: Hematocrit of patients of treated group was significantly lower after therapy than before therapy [Before therapy: (43.84±4.55)%;After therapy: (40.48±4.02)%;P < 0.05]. ④ Blood flow rate of middle cerebral artery of patients of treated group was significantly lower before therapy than after therapy [(90±1.2),(97±2.1) cm/s,P < 0.01]. ⑤ NDS of patients in treated group was significantly lower than of control group 14 days after therapy. The total effective rate after therapy was significantly higher in the treated group than in the control group (93%,78%, P < 0.05). ⑥There was no obvious adverse effect. CONCLUSION: Modified hemodilution combined therapy can improve hemorheology, decrease hematocrit, increase blood flow rate of middle cerebral artery, so as to improve the impaired clinical neurological function of elderly patients with acute cerebral thrombosis through anticoagulation and antiplatelet aggregative activity as well as regulating blood lipid. BACKGROUND: Thrombolysis therapy is not suitable for the elderly patients with acute ischemic stroke who delayed to be diagnosed for more than 3 hours, but traditional medicine is also not very ideal. OBJECTIVE: To observe the clinical therapeutic effect of modified hemodilution combined therapy applied in elderly patients with acute cerebral thrombosis and analyze the mechanism of this therapeutic method. DESIGN: 1:1 paired grouping according to gender and controlled observation. SETTING: Department of Internal Medicine, Chengzhanyuan District, First Hospital Affiliated to Zhejiang University. PARTICIPANTS: Totally 90 elderly patients with acute ischemic stroke who received the treatment in the Cadre Ward and Mental Ward, Department of Internal Medicine, Chengzhanyuan District, First Hospital Affiliated to Zhejiang University from March 1996 to June 2004 were recruited. They all met the diagnosis criteria revised by the Fourth Academic Conference of National Cerebrovascular Diseases in 1995 and were diagnosed as acute ischemic stroke by skull CT. They were informed of therapeutic plan and detected items. According to 1: 1 paired principle in gender, 90 enrolled patients were assigned into treated group (n = 45) and control group ( There were 39 male and 6 female in the treatment group, and they were aged (76 ± 6) years, ranging from 71 to 84 years, and hospitalized at the 14th to 76th hours after onset. There were 39 male and 6 female in the control group, and they were aged (76 ± 6) years, ranging from 70 to 82 years, and hospitalized at the 16th to 72th hours after onset. METHODS: Therapeutic method: Patients of treated group received modified hemodilution combined therapy. 200 mL whole blood of patients was exchanged with 500 mL dextran-40 (including 20 mL danshen parenteral solution and 32 mg heparin) at the beginning of therapy; From the 2nd day, compound huangqi tea bag (Huangqi mainly, including danshen, honghua, chuanxiong, shishao and a little acetyl s alicylic acid) was made, twice a day, 1 bag once. At the same time, the above-mentioned dextran-40 liquid of 500 mL was intravenously injected, once a day, 14 days in total; On the 6th day after therapy, the above-mentioned aseptic autoblood stored in refrigerator at 4 ° C was transfused back into the patient following pre-treatment of high-concentration oxygenation and ultraviolet irradiation by light quantum instrument. Patients of control group were intravenously injected of 0.4 g venoruton (Traditional Chinese medicine Compound parenteral solution for promoting blood circulation and removing blood stasis) and 50 g / L glucose of 500 mL, 75 mg acetosal was taken orally, once a day, 14 days in total. ② Measurement and observation of index: Blood coagulation index, change of platelet aggregation rate and change of hemorrheology of patients in two groups were monitored before and after therapy. The level of blood lipid of patients in two groups was measured with American Beckman automatic b iochemistry analyzer. Blood flow rate of middle cerebral artery of resting electrocardiogram were measured with American HP SONOS 2500 sonoscope. Neuro-dysfunction score revised in the national conference (1995) was used to evaluate the recovery of neurological function of the patients in two groups at the 3rd, 5th, 7th and 14th days after therapy. ③ Therapeutic effect and adverse effect were observed at the same time. MAIN OUTCOME MEASURES: ① Changes of coagulation index, blood lipid level and hemorheology; ② Blood flow rate of middle cerebral artery and NDS of patients with acute ischemic stroke in two groups; ③Adverse effect of drug. RESULTS: Totally 90 patients were enrolled in the experiment. One patient from treated group died of hyperosmolar nonketotic diabetic coma of complicated diabetes mellitus. One patient from control group died of severe The rest 88 patients entered the stage of result analysis. ① Change of coagulation index and platelet aggr egation rate:prothrombin time (PT), activated partial thromboplastin time (APTT) and thrombin time (TT) of patients after therapy were significantly longer than those before therapy in the treated group and those after therapy in control group [After therapy in treated group: (18.4 ± 1.9, 41.8 ± 2.1, 19.7 ± 1.7 s, Before therapy in treated group: (13.4 ± 1.3), (35.8 ± 1.3), (12.5 ± 0.9) s, ± 1.5), (39.1 ± 1.1), (11.9 ± 2.1) s, P <0.05]; Concentration of fibrinogen (Fbg) after therapy was significantly lower than that before therapy in the treated group and that after therapy in control group [After (3.4 ± 0.4) g / L; Before therapy in treated group: (4.3 ± 0.7) g / L; After therapy in control group: (4.0 ± 0.6) g / L; Levels of total cholesterol (TC), triacylglycerol (TG) and low density lipopro (TG) decreased from (37.92 ± 0.85)% before therapy to (26.42 ± 1.01)% after therapy tein cholesterol (LDL-C) of patients after therapy were significantly lower than those before therapy in treated group and those after therapy in control group [after therapy in treated group: (5.2 ± 0.9), (1.9 ± 0.9), (2.08 ± 1.1) mmol / L before therapy in treated group: (5.9 ± 1.2), (2.8 ± 0.9), (3.94 ± 0.5) mmol / L, , (3.84 ± 0.9) mmol / L, P <0.05]. ③ Change of hemorheology index: Hematocrit of patients of treated group was significantly lower after therapy than before therapy [Before therapy: (43.84 ± 4.55)%; 40.48 ± 4.02)%; P <0.05] .④ Blood flow rate of middle cerebral artery of patients of treated group was significantly lower than therapy than after therapy [(90 ± 1.2), (97 ± 2.1) cm / s, P < 0.01]. ⑤ NDS of patients in treated group was significantly lower than of control group for 14 days after therapy. The total effective rate after therapy was significantly higher in the treated group than in the control group (93%, 78% P <0.05) ⑥There was no obvious advance effect. CONCLUSION: Modified hemodilution combined therapy can improve hemorheology, decreased hematocrit, increase blood flow rate of middle cerebral artery, so as to improve the impaired clinical neurological function of elderly patients with acute cerebral thrombosis through anticoagulation and antiplatelet aggregative activity as well as regulating blood lipid