新型羟乙基淀粉应用于烧伤休克期液体复苏的疗效及安全性评价

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。

Evaluation of effectiveness and safety of a new hydroxyethyl starch used in resuscitation of burn shock

OBJECTIVE: To evaluate the effectiveness and safety of hydroxyethyl starch (HES 130/ 0.4, 60 g/L) in resuscitation during shock stage of burns. METHODS: Sixty-six burn patients who were admitted to hospital within 2 hours after burn injury requring fluid resuscitation were enrolled into this study, and they were randomized into HES( n = 33, with HES as a component of fluid resuscitation) and plasma (P, n = 33, with plasma as a component of fluid resuscitation) groups. HES or plasm was given as colloid within 48 postburn hours (PBH), and only albumin [( 111 +/- 4) , ( 105 +/- 5 ) g for each group] were given to the patients during 3 to 7 postburn days (PBD). Heart rate, blood pressure, central venous pressure (CVP) , urine output per hour were measured, gain/loss of body fluid during the first and second 24 PBH were recorded, serum total protein, albumin, hemoglobin( Hb) , prothrombin time (PT) , fibrinogen; platelet ( PLT) , as well as liver and renal function, allergy and bleeding tendency were determined and observed at corresponding time-points. RESULTS: There were no obvious differences in heart rate, blood pressure, CVP and urine output per hour within 24 PBH between the two groups (P > 0.05). Also there was no difference in gain/loss of body fluid during the first and second 24 PBH. The content of hemoglobin on 1 ,3, 7,14 PBD ,and the PT, the content of fibrinogen, the number of PLT on 1,3,14 PBD also exhibited no difference between the two groups (P > 0.05). The serum contents of total protein and albumin in HES group were [(31 +/- 3) g/L, (30 +/- 3)g/L ] on 1 PBD, and [(20.4 +/- 3.6) g/L, (18.4 +/-2.3) g/L] on 3 PBD, which were obviously lower than those in P group [(45 +/- 4) g/L, (39 +/- 3) g/L on 1 PBD, and 1 (24.5 +/- 4.3) g/L, (21.3 +/- 3.9) g/L) on 3 PBD, (P <0. 01). Though the serum content of albumin on 7 PBD was similar in the two groups (P > 0.05), the serum total protein in HES group (40 +/- 4) g/L was markedly lower than that in P group [(45 +/- 4) g/L, P < 0.01] . Within 7 PBD, no abnormal bleeding was found in the two groups, and the liver function and renal function were similar. There were 4 cases showing allergic reaction in plasma group while none in HES group. CONCLUSION: New type of HES can partially substitute plasma and be used in fluid resuscitation for burn patients. However, plasma protein replenishment should still be emphasized.