国产与进口羟乙基淀粉溶液的临床疗效与不良反应比较

目的评价国产羟乙基淀粉溶液的临床疗效和不良反应。方法选择124例创伤及大、中手术患者,64例(A组)给予国产羟乙基淀粉溶液治疗,60例(B组)输入进口羟乙基淀粉溶液,观察并比较用药前、后生命体征变化及对血常规,肝、肾功能,血流动力学,凝血功能的影响。结果不同时相点上P、R、SBP、DBP指标变化前后比较及组间比较均无临床意义(P>0.05)。ITT和PP人群中,A、B组的疗效积分均≥12分,总有效率≥98%(P>0.05),2组药物对血常规、肝肾功能、血流动力学及凝血功能的影响相同(P>0.05),未发现不良反应。结论国产与进口羟乙基淀粉溶液作用一致,为一有效的血浆代用品。

Differences between domestic and imported hydroxyethyl starch in clinical effects and adverse drug reactions

AIM To evaluate and observe the clinical effects and adverse drug reactions of domestic hydroxyethyl starch.METHODS All of 124 patients with trauma and major surgery,64 patients(group A) were treated with domestic hydroxyethyl starch;60 patients,as the control groups(group B),were treated with imported hydroxyethyl starch solution.The life physical signs,blood routine,haemodynamics,acid-base changes,coagulation variables,liver functions and renal functions were compared before and after administration.RESULTS On the all different time points,the comparisons with pulses,respiration,systolic and diastolic blood pressures of all patients between groups and within group showed no significant difference(P>0.05).Efficacy was over 98% and accumulated points was not less than 12 in A,B groups of intention-to-treat(ITT) and per-protocol population(PP) patients(P>0.05).The blood routine,liver and renal functions,haemodynamics and coagulation functions showed no significant changes between A and B groups.No adverse drug reaction was found in the period of study.CONCLUSION Domestic hydroxyethyl starch is also an effective and safe artificial colloid for plasma volume substitution for imported hydroxyethyl starch.