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目的评价新型羟乙基淀粉(HES)制剂在烧伤患者休克期液体复苏中的应用疗效及安全性。方法选择笔者单位收治的烧伤休克期需液体复苏患者66例,按表格随机化方法分成HES组(33例)和血浆组(33例)。两组患者伤后48 h内给予的液体中胶体成分仅为HES(130／0．4, 60 g／L)或血浆,伤后3-7 d两组均替换成白蛋白作为胶体成分[5 d共给予白蛋白各(111±4)、(105±5)g],本试验全过程两组所给予的营养支持、抗感染等措施相同。监测患者伤后24 h内的心率、血压、中心静脉压、尿量,并记录伤后第1、2个24 h的胶体输入量、进出量比,于伤后指定时相点检测血清总蛋白、白蛋白、血红蛋白、凝血酶原时间、纤维蛋白原、血小板计数及某些肝、肾功能指标,观察患者有无变态反应发生及出血情况。结果两组患者伤后心率、血压、中心静脉压、尿量及第1、2个24 h的胶体输入量、进出量比差异无统计学意义(P>0．05)．患者伤后1、3、7、14 d的血红蛋白及1、3、14 d的凝血酶原时间、纤维蛋白原、血小板计数组间比较,差异亦无统计学意义(P>0．05);HES组在伤后1、3 d的血清总蛋白和白蛋白各为(31±3)、(30±3)只／L和(20．4±3．6)、(18．4±2．3) g/L,均明显低于血浆组的(45±4)、(39±3)g/L和(24.5±4．3)、(21．3±3．9)g／L(P<0.02);伤后7 d两组血清白蛋白水平较接近(P>0．05),但HES组血清总蛋白(40±4)g／L仍明显低于血浆组的(45±4)g／L(P<0．01)。两组患者肝功能指标变化基本一致,肾功能无异常改变,均未见明显的出血倾向。HES组无变态反应发生,血浆组有4例出现荨麻疹。结论新型HES130／0．4可部分代替血浆用于烧伤患者休克期的液体复苏治疗,但要注意在一定时相点及时补充血浆蛋白。
Objective To evaluate the efficacy and safety of a novel hydroxyethyl starch (HES) preparation for shock resuscitation in burn patients. Methods Sixty-six patients with fluid resuscitation in burn shock stage were selected and divided into HES group (33 cases) and plasma group (33 cases) according to the table randomized method. The two groups of patients were given HES (130 / 0.4, 60 g / L) or plasma only within 48 hours after injury, and albumin was replaced by albumin as colloidal component in groups 3-7 d after injury [5 d were (111 ± 4), (105 ± 5) g, respectively. The nutritional support and anti-infective measures were the same in both groups during the whole experiment. The heart rate, blood pressure, central venous pressure and urine output were monitored within 24 hours after injury. The amount of colloid input, the ratio of intake and excretion at 1, 2 and 24 hours after injury were recorded, and the serum total protein , Albumin, hemoglobin, prothrombin time, fibrinogen, platelet count and some liver and kidney function indicators were observed in patients with or without allergic reactions and bleeding. Results There were no significant differences in heart rate, blood pressure, central venous pressure, urine output and colloid input at the first and second 24 h after operation in both groups (P> 0.05). There were no significant differences in hemoglobin at 1, 3, 7 and 14 days after injury and prothrombin time, fibrinogen and platelet count at 1, 3 and 14 days (P> 0.05). The total protein and albumin in HES group were (31 ± 3), (30 ± 3) / L and (20.4 ± 3.6), (18.4 ± 2) 3 and g / L, respectively, were significantly lower than those in the plasma group (45 ± 4, 39 ± 3 and 24.5 ± 4.3, and (21.3 ± 3.9) g / L, respectively (P <0.05). However, the serum total protein (40 ± 4) g / L in HES group was still significantly lower than that in plasma group (45 ± 4) g / L (P <0.01). Two groups of patients with changes in liver function was basically the same, no abnormal changes in renal function, no obvious bleeding tendency. No allergic reaction occurred in the HES group, and 4 cases of urticaria in the plasma group. Conclusion The new HES130 / 0.4 may partially replace the plasma for shock resuscitation in burn patients, but pay attention to the timely replenishment of plasma proteins at certain time points.