OBJECTIVE: To observe the clinical efficacy of Safflower Injection (Al) in treating and preventing the vascular crisis after free flap transplantation. METHODS:Sixty patients undergoing free flap transplantation were randomly assigned to the treatment group and control group according to the visiting sequence, thirty in each. Free flap transplantation was performed on all patients, and medication was given 0. 5 h before flap vascular anastomosis, 1-7 days after surgery. Twenty mL Al was intravenously dripped to patients in the treatment group after adding in 250 mL 5% glucose injection, while Dextran-40 was intravenously dripped to patients in the control group. The medication was conducted once per day. The hemorheology and four indices of blood coagulation [prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (APTT), fibrinogen (FIB)] were compared between the two groups before operation (TO), during operation (T1), 24 h after operation (T2), three days after operation (T3), and seven days after operation (T4). Meanwhile, flaps were observed and adverse reaction recorded. The clinical efficacy and safety were compared. RESULTS: Better result was obtained in the treatment group when compared their clinical efficacy (86. 67% vs 60. 00%, P<0.05). The whole blood high and low viscosity, plasma viscosity, red blood cell (RBC) volume, RBC aggregation index all decreased, and RBC deformed index increased in the two groups at T4, showing statistical difference when compared with those at T3 (P<0.05, P<0.01). There was no statistical significance in the four indices of blood coagulation when compared with any time point in the same group (P>0.05). There was no statistical significance in hemorheology and the four indices of blood coagulation between the two groups at the same time point (P>0.05). The adverse reaction rate in the treatment group was lower than that in the control group, showing statistical difference (13.33% vs 30.00%, P<0.05). CONCLUSIONS: AI could effectively prevent and treat the vascular crisis after free flap transplantation. It had less adverse reaction and good safety. It was better than Dextran-40. It was a safe and effective drug to prevent the vascular crisis.
RCT Entities:
OBJECTIVE: To observe the clinical efficacy of Safflower Injection (Al) in treating and preventing the vascular crisis after free flap transplantation. METHODS: Sixty patients undergoing free flap transplantation were randomly assigned to the treatment group and control group according to the visiting sequence, thirty in each. Free flap transplantation was performed on all patients, and medication was given 0. 5 h before flap vascular anastomosis, 1-7 days after surgery. Twenty mL Al was intravenously dripped to patients in the treatment group after adding in 250 mL 5% glucose injection, while Dextran-40 was intravenously dripped to patients in the control group. The medication was conducted once per day. The hemorheology and four indices of blood coagulation [prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (APTT), fibrinogen (FIB)] were compared between the two groups before operation (TO), during operation (T1), 24 h after operation (T2), three days after operation (T3), and seven days after operation (T4). Meanwhile, flaps were observed and adverse reaction recorded. The clinical efficacy and safety were compared. RESULTS: Better result was obtained in the treatment group when compared their clinical efficacy (86. 67% vs 60. 00%, P<0.05). The whole blood high and low viscosity, plasma viscosity, red blood cell (RBC) volume, RBC aggregation index all decreased, and RBC deformed index increased in the two groups at T4, showing statistical difference when compared with those at T3 (P<0.05, P<0.01). There was no statistical significance in the four indices of blood coagulation when compared with any time point in the same group (P>0.05). There was no statistical significance in hemorheology and the four indices of blood coagulation between the two groups at the same time point (P>0.05). The adverse reaction rate in the treatment group was lower than that in the control group, showing statistical difference (13.33% vs 30.00%, P<0.05). CONCLUSIONS: AI could effectively prevent and treat the vascular crisis after free flap transplantation. It had less adverse reaction and good safety. It was better than Dextran-40. It was a safe and effective drug to prevent the vascular crisis.