尖吻蝮蛇血凝酶对甲状腺手术创面的止血作用研究

The hemostatic effects and safety of hemocoagulase agkistrodon on patients undergoing thyroidectomy

目的评价尖吻蝮蛇血凝酶对甲状腺切除患者的止血作用及安全性。方法采用前瞻、随机、盲法、对照研究设计，满足方案入选标准并获得知情同意的甲状腺疾病患者共60例，分为研究组（30例）于术前20min静脉注射尖吻蝮蛇血凝酶2u，术后4h再次注射2u，对照组（30例）给予生理盐水；观察记录术中出血量和术后24h创面引流量；同时观察凝血功能变化和安全性。结果研究组术中出血量（40．6±19．5）g与对照组（54．1±22．3）g相比减少（t=2．496，P=0．015）；研究组术后24h创面引流量（56．4±24．8）g少于对照组（73．0±31，5）g（t=2．268，P=0．027）；凝血功能指标两组问差异无统计学意义。2组患者均未出现血栓等并发症。本研究中未出现研究药物相关的不良事件。结论尖吻蝮蛇血凝酶对甲状腺切除手术创面有较好的止血作用，并且未增加血栓形成的风险，有较好的安全性。

Objective To evaluate the hemostatic effects of hemocoagulase agkistrodon on patients undergoing thyroid operation and to analyze its influence on thrombosis and its safety. Methods It was a prospective, randomized, single-blind and controlled study, in which 60 patients were enrolled. 2 U hemocoagulasc agkistrodon was injected 20 minutes before and 4 hours after operation in the study group, while normal saline was used in the control group. The volume of intraoperative bleeding and 24 hours drainage after operation was recorded. Results Intra-operative hemorrhage of the study group （ 40. 6 ± 19.5） g was obviously lower than the control group （54.1 ±22. 3） g（t =2. 496,P =0. 015）. The volume of 24 hours drainage after operation was （56. 4 ±24. 8） g in the study group and （73. 0 ±31.5） g in the control group（t =2. 268 ,P =0. 027）. The hemoagglutination indices were similar in the two groups and no complications such as thrombus occurred in the study group. No adverse event occurred in this study. Conclusions Hemocoagulase agkistrodon has good hemostatic effects and safety for patients undergoing thyroid operation, without increasing the risk of thrombosis.