红花注射液防治游离皮瓣移植术后血管危象的临床研究

Clinical Study of Safflower Injection in Treating and Preventing the Vascular Crisis after Free Flap Transplantation

目的观察红花注射液防治游离皮瓣移植术后血管危象的临床疗效。方法游离皮瓣组织移植的60例患者按照入院顺序分为治疗组和对照组,每组30例。两组均行游离皮瓣移植术,并于皮瓣血管吻合前0.5h及术后1～7天给药,治疗组给予红花注射液20mL加入5%葡萄糖250mL中静脉滴注,对照组给予低分子右旋糖酐注射液500mL静脉滴注,均每天1次。比较两组术前(T0)、术中(T1)、术后24h(T2)、3天(T3)、7天(T4)血液流变学及凝血四项[凝血酶原时间(PT)、国际标准化比值(INR)、活化部分凝血活酶时间(APTT)、纤维蛋白原(FIB)]指标;同时行皮瓣大体观察及不良反应记录,进行临床疗效与安全性比较。结果两组临床疗效比较,治疗组优良率高于对照组(86.67%vs60.00%),差异有统计学意义(P<0.05)。两组T4时全血高、低切黏度、血浆黏度、RBC压积、RBC聚集指数均降低,RBC变形指数均升高,与本组T3时比较,差异均有统计学意义(P<0.05,P<0.01)。两组凝血四项各时间点比较,差异均无统计学意义(P>0.05)。相同时间点两组间血液流变学与凝血四项各指标比较,差异均无统计学意义(P>0.05)。治疗组不良反应率低于对照组(13.33%vs30.00%),差异有统计学意义(P<0.05)。结论红花注射液能够有效防治游离皮瓣移植术后血管危象,不良反应少,安全性好,优于低分子右旋糖酐,为一种安全有效防止血管危象的药物。

Objective To observe the clinical efficacy of Safflower Injection （AI） 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 AI was intravenously dripped to patients in the treatment group after adding in 250 mL 5% glucose injection, while Dextram-40 was intravenously dripped to patients in the control group. The medication was conducted once per day. The hemorrheology 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 （T0）, 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%, P0.05）. 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 （P0.05, P0.01）. There was no statistical significance in the four indices of blood coagulation when compared with any time point in the same group （P0.05）. There was no statistical significance in hemorrheology and the four indices of blood coagulation between the two groups at the same time point （P0.05）. The adverse reaction rate in the treatment group was lower than that in the control group, showing statistical difference （13.33% vs 30.00%, P0.05）. 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 Dextram-40. It was a safe and effective drug to prevent the vascular crisis.