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目的:观察注射用尖吻蝮蛇血凝酶( HCA )在骨科手术中的用药安全性。方法入选骨科手术患者200例,手术开始前和手术中用HCA辅助止血患者100例为试验组,不用任何止血药物患者100例为对照组(成年组56例,老年组44例)。用重复测量资料的方差分析,比较4组在手术前1~6天和手术后1~3天的血常规、肝肾功能、凝血功能指标。结果检测时间(术前和术后)对总胆红素外其他指标的主效应均有统计学意义( P<0.05)。分组(对照和试验)对除总蛋白、白蛋白外其他指标的主效应均无统计学意义( P>0.05)。年龄分层(成年和老年)对红细胞计数、血红蛋白、血小板计数、总蛋白、白蛋白、血肌酸酐、血尿素、凝血酶原时间的主效应均有统计学意义( P<0.05)。结论骨科手术开始前或手术中用HCA对血常规、肝功能、肾功能及凝血功能无明显影响,老年与成年患者相比安全性差异无统计学意义。“,”Objective To evaluate the safety of hemocoagulage agkistro-don(HCA) in orthopaedic surgical patients .Methods A total of 200 hospitalized patients undergoing orthopaedic surgery in our hospital were assigned to two groups: the trial group ( 100 cases: adult group 56 and senile group 44 ) and the control group ( 100 cases: adult group 56 and senile group 44 ).The patients in the trial group were administered with HCA during or just before the surgery.The patients in the control group didn′t use any hemostatic.Then, the blood routine test , coagulation function ,hepatic and renal function within 6 days before the surgery and within 3 days after surgery were compared by ANOVA for repeated mea-surement.Results There was statistically significant difference on time effect in all indicators except for total bilirubin ( TBIL ).There was no statistically significant difference of group effect in all indicators except for total protein ( TP ) and albumin ( ALB ).And there was statistically significant difference on age effect in red blood cell (RBC), hemoglobin (Hb), platelet(PLT), TP, ALB, creatinine(Cr),UREA and prothrom-bin time ( PT).No interaction effect was found in time & group , time &age & group.Conclusion Using HCA during or just before the ortho-paedic surgery shows no significant influence on the blood routine test , liver function , renal function and coagulation function.The application ofHCA during or just before the orthopaedic surgery is safe , and there is no significant difference between the adult group and the senile group in drug safety of HCA.