注射用尖吻蝮蛇血凝酶在单节段腰椎PLIF手术中应用的安全性和有效性观察

The evaluation of the efficacy and safety of Hemocoagulase Agkistrodon in patients with lumbar disc herniation undergoing single segment PLIF surgery

目的观察注射用尖吻蝮蛇血凝酶在单节段腰椎PLIF手术中局部应用的安全性和有效性。方法选择2015年9月至2016年8月本院收治的因腰椎间盘突出症接受单节段腰椎PLIF手术的患者90例,按就诊顺序编码,分为血凝酶A组、血凝酶B组和非血凝酶C组,每组30例。所有患者均在俯卧位插管全麻下行单节段腰椎PLIF手术。A组术中使用1 U/mL浸泡的纱布对出血部位进行填塞止血;B组使用0.5 U/mL浸泡过的纱布进行填塞止血;C组作为对照组术中使用相同的浸泡过0.9%氯化钠溶液的纱布进行填塞止血。A组和B组术后第1天给予注射用尖吻蝮蛇血凝酶2 U静脉注射,C组给予相同剂量的0.9%氯化钠溶液。观察并记录手术时间、术中出血量、术后伤口引流量、凝血功能及术后并发症,记录所有患者引流管留置时间、住院时长及输血量。结果所有入选患者均顺利完成手术,伤口均一期愈合出院,住院期间未发生感染及血栓形成等并发症。3组患者在凝血功能方面的指标比较包括凝血酶原时间(PT)、凝血酶时间(TT)、活化部分凝血活酶时间(APTT)、纤维蛋白原定量(FIB)以及D-2聚体等术前术后比较,差异无统计学意义。实验A组和实验B组手术时间、术中出血量、术后24 h引流量、术后总引流量、引流管留置时间及住院时长比较差异无统计学意义,实验A组和实验B组与对照组比较差异均有统计学意义(P<0.05)。所有患者出院时下肢血管超声检查未发现动脉或静脉血栓形成。结论腰椎PLIF手术术中局部应用和术后给予注射尖吻蝮蛇血凝酶可以有效减少术中及术后失血量,有助于患者术后早期恢复,缩短住院时长及减少手术输血量,且无过敏及增加伤口感染和血栓形成风险,可以作为脊柱后路手术中一种理想的术中局部辅助止血药物应用。

Objective To evaluate the efficacy and safety of Hemocoagulase Agkistrodon in patients with Lumbar disc herniation undergoing single segment PLIF surgery.Methods 90 patients from September 2015 to August 2016 with Lumbar disc herniation undergoing single segment PLIF surgery who met with inclusion/exclusion criteria were enrolled into the study,and then were assigned averagely and randomly to group A(hemocoagulase agkistrodon,1 U/mL,30 cases),group B(hemocoagulase agkistrodon,0.5 U/mL,30 cases)and control group C(no hemocoagulase agkistrodon,30 cases)by their outpatient ID.In group A,the bleeding site was filled with 1 U/mL soaked gauze,the group B used 0.5 U/mL soaked gauze and the control group used the soaked gauze without hemocoagulase agkistrodon.2 U hemocoagulase agkistrodon for injection intravenously in the first day of group A and B after operation,the same dose saline was given for the control group.Wound drainage was placed at the end of operation.Operation time,amount of bleeding during surgery and drain out post operation,coagulation function and the relative complication were recorded.Indwelling time of drainage,length of hospital stay and blood transfusion were also recorded.Results All surgeries were completed smoothly and wounds were healed one stage and no complication such as infection and thrombosis occurred during the period of hospitalization.In the in‐dex of blood coagulation function between 3 groups including prothrombin time(PT),thrombin time(TT),activated partial thromboplastin time(APTT),fibrinogen(FIB)and D-2 dimer,preoperative and postoperative,the difference was not statistically significant.When group A compared with group B,the operation time,intraoperative bleeding volume,postoperative drainage volume,postoperative 24 h total drainage volume,drainage time and hospitalization time,there was no significant difference.Whereas when they were compared with the control group,there was significant difference of.None of the patients were found to have arterial or venous thrombosis on discharge.Conclusion Local application of hemocoagulase agkistrodon during the PLIF surgery and given injection of hemocoagulase agkistrodon after operation can significantly reduce bleeding of intraoperative and postoperative blood loss,contribute to the early recovery of patients,shorten the hospitalization time and reduce postoperative blood transfusion,and no allergy and increase wound infection and thrombosis with risk.Hemocoagulase agkistrodon can be used as a the ideal auxiliary intraoperative topical application of hemostatic drugs in posterior spinal surgery.