Lu Xu, Yang Xin, Zhu Mingwei, Hua Bin, Niu Xiaojuan, Xiao Wenzheng, Wei Junmin
Department of General Surgery,Beijing Hospital,Beijing 100730,China.
Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2017 Apr 20;39(2):183-187. doi: 10.3881/j.issn.1000-503X.2017.02.004.
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.
目的 评价尖吻蝮蛇血凝酶对乳腺癌手术创面的止血效果。方法 本前瞻性、随机、双盲、对照研究共纳入60例行乳腺癌手术的患者。所有患者均符合纳入及排除标准并签署知情同意书。干预组(n=30)于手术前20分钟及术后4小时、24小时注射尖吻蝮蛇血凝酶(2 U),而对照组(n=30)则使用生理盐水替代。记录术中出血量、术后1~3天的伤口引流量及总引流量。同时,观察凝血功能变化、治疗安全性及临床结局。结果 干预组的术中出血量[(95.0±48.3)g]显著低于对照组[(144.8±105.4)g](t=-2.07,P=0.044)。干预组的总引流量[(166.7±71.2)g]显著低于对照组[(251.4±166.3)g](t=-2.29,P=0.029)。两组的血凝指标相似,未发生血栓形成等并发症。干预组的住院时间[(15.00±3.53)d]与对照组[(15.92±2.32)d]相似(t=-1.057,P=0.297)。本研究未发生与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患者具有良好的止血效果,且不增加血栓形成风险。