尖吻蝮蛇血凝酶在乳腺癌手术创面的止血作用

摘要

目的 评价尖吻蝮蛇血凝酶对乳腺癌手术患者的止血作用及安全性.方法 采用前瞻、随机、盲法、对照的研究设计,共纳入符合入排标准并获得知情同意的乳腺癌患者60例,随机分为研究组和对照组,每组各30例;研究组于术前20 min静脉注射尖吻蝮蛇血凝酶2U,术后4和24 h再次注射2U,对照组对应时间给予生理盐水;观察记录术中出血量、术后1～3d创面引流量及创面总引流量;同时观察凝血功能变化和安全性,以及临床结局指标.结果 研究组术中出血量(95.0±48.3)g较对照组(144.8±105.4)g显著减少(t=-2.07,P=0.044);研究组术后创面总引流量(166.7±71.2)g显著少于对照组(2514±166.3)g(t=-2.29,P=0.029);凝血功能指标两组比较差异无统计学意义.两组患者未出现血栓等并发症;住院时间两组比较差异无统计学意义[(15.92±2.32)d比(15.00±3.53)d,t=-1.057,P=0.297].未出现研究药物相关的不良事件.结论 尖吻蝮蛇血凝酶对乳腺癌手术创面的止血作用较好,未增加血栓形成的风险,有较好的安全性.%Objective To evaluate the hemostatic effect of hemocoagulase agkistrodon on surgical wound in breast cancer surgery.Methods Totally 60 patients undergoing breast cancer surgery were enrolled in this prospective,randomized,double-blinded,and controlled study.All the patients met the inclusion and exclusion criteria and signed the informed consent.Hemocoagulase agkistrodon (2 U) was injected 20 minutes before surgery and 4 and 24 hours after surgery in the intervention group (n =30),whereas normal saline was used instead in the control group (n =30).The volume of intraoperative bleeding,wound drainage volume 1-3 days after surgery,and total drainage volume were recorded.Meanwhile,the change of blood coagulation function,treatment safety,and clinical outcomes were observed.Results The intra-operative hemorrhage volume of the intervention group [(95.0 ±48.3) g] was significantly lower than that of the control group [(144.8 ± 105.4) g] (t =-2.07,P =0.044).The volume of total drainage of the intervention group [(166.7 ±71.2) g] was significantly lower than that of the control group [(251.4 ± 166.3) g] (t =-2.29,P =0.029).The hemoagglutination indicators were similar in the two groups and no complication such as thrombosis occurred.The length of hospital stay of the intervention group [(15.00 ± 3.53) d] was similar to that of the control group [(15.92 ±2.32) d] (t =-1.057,P =0.297).No research drug-related adverse event was occurred in our study.Conclusion Hemocoagulase agkistrodon has good hemostatic effect for patients undergoing breast cancer surgery without increasing the risk of thrombosis.