尖吻蝮蛇血凝酶在甲状腺手术局部应用的临床研究

Clinical outcomes of locally applying haemocoagulase Agkistrodon to patients undergoing thyroidectomy

目的:探究尖吻蝮蛇血凝酶(HCA)在甲状腺手术中局部应用的止血效果。方法:随机选择我院2016年1月～2017年12月行单侧甲状腺次全切除手术的患者60例。按随机数字表法分为研究组(尖吻蝮蛇血凝酶组)和对照组(生理盐水组)各30例。研究组注射用尖吻蝮蛇血凝酶(辽宁锦州奥鸿药业有限公司) 2 k U加入10 mL的0. 9%氯化钠液中局部浸润在手术创面上;对照组使用10 mL生理盐水浸润在手术创面上。两组患者术后均复查凝血功能及行双下肢静脉超声。记录两组患者手术持续时间,术后第1天、第2天引流管引流量,术后引流管拔除时间以及患者术前与术后24 h凝血酶原时间(PT)、活化部分凝血酶原时间(APTT)和纤维蛋白原(FIB)的变化。记录两组患者术后过敏性反应及静脉血栓等术后并发症的例数,统计各组患者的住院天数等。结果:在两组手术时间基本一致的情况下,研究组术后引流管引流量少于对照组,引流管拔除时间提前,住院时间也短于对照组,差异具有统计学意义(P<0. 05)。两组患者术后24 h PT、APTT和FIB较术前比较,差异均无统计学意义,且过敏性反应及血栓形成等术后并发症差异亦无统计学意义(P>0. 05)。结论:注射用尖吻蝮蛇血凝酶术中局部浸润能减少甲状腺术后引流管引流量,提前拔除颈部引流管,且不增加血栓形成等手术风险,能够安全有效地用于甲状腺手术。

Objective:To assess the clinical outcomes of locally applying haemocoagulase Agkistrodon to patients undergoing thyroidectomy.Methods:Sixty patients undergoing unilateral subtotal thyroidectomy were included in our hospital from January 2016 to December 2017,and equally randomized into study group and control group as random digital table.2 kU of haemocoagulase Agkistrodon was initially dissolved in 10 mL 0.9%sodium chloride and topically applied to the surgical wounds in patients in the study group,and normal saline was used in patients in the control group.Patients in the two groups received B-mode ultrasonic examination of lower extremities and blood coagulation test following surgery.Data recorded in the two groups included operative time,postoperative drainage volume I the 1st and 2nd day,time to remove the drainage tube after surgery,changes of prothrombin time(PT),active partial thrombin time(APTT)and fibrinogen(FIB)24 h before and after surgery,incidences of allergic reaction,venous thrombosis and other complications as well as the days of hospital stay.Results:Patients in the study group had significantly lower drainage volume,earlier removal of the drainage tube and reduced hospital stay considering the operative time being approximately equal in the two groups(P<0.05).The difference was insignificant regarding PT,APTT and FIB measured in 24 h after surgery.No added risks,including allergic response,thrombopoiesis and other complications were observed following operation(P>0.05).Conclusion:Local application of haemocoagulase Agkistrodon may lead to reduced drainage volume and earlier removal of the drainage tube,yet will not increase the risks of thrombopoiesis,which suggests that this agent can be safe and effective for patients undergoing thyrodectomy.