注射用矛头蝮蛇血凝酶预防围手术期出血安全性的真实世界数据分析

An evaluation of the safety of hemocoagulase atrox for injection in preventing bleeding events in perioperative patients:a real-world data analysis

目的采用真实世界数据的分析方法,评估注射用矛头蝮蛇血凝酶预防围手术期出血的安全性。方法研究数据来源于全病种的临床医疗真实数据库(溯直)。提取2015年1月至2019年12月围手术期使用矛头蝮蛇血凝酶预防出血患者的真实数据,分析患者的人口学特征、凝血指标变化及不良反应发生情况。结果共纳入11 025例患者。其中60岁以下的患者为7587例,占68.82%,60~75岁患者为2635例,占23.90%,75岁以上患者为801例,占7.27%,2例患者年龄不详。围术期使用矛头蝮蛇血凝酶的患者以男性为主,共计7021例,占63.68%。矛头蝮蛇血凝酶在围手术期预防出血的严重不良反应发生率为零,即未发现患者发生过敏性休克、过敏性事件和围手术期血栓事件。手术和药物的应用对4项凝血指标有轻度影响,但临床意义有限。结论矛头蝮蛇血凝酶在围手术期预防出血的安全性较好,未出现过敏性休克事件和血栓事件,使用矛头蝮蛇血凝酶对凝血功能影响不大。

Objective The study aimed to evaluate the safety of hemocoagulase atrox for injection in preventing blceding events in perioperative patients of all age groups by analyzing real-world data and generating evidence to guide rational drug use in clinical practice.Methods The analytical data were obtained from the SuValue,a large electronic medical records database.The researchers extracted real clinical data of the past 5 years(2015—2019),which mainly targeted perioperative use of hemocoagulase atrox for injection to prevent bleeding events.The data included demographic information and medical records.Descriptive statistical methods were used to summarize the demographic characteristics of patients who used hemocoagulase atrox for injection during the perioperative period,and described the safety events(anaphylactic shock,thrombosis)that may have occurred over the use of hemocoagulase atrox for injection during the perioperative period.Results A total of11 025 patients were included.Among them,7587 patients(68.82%)were under 60 years of age,2635 patients(23.90%)were 60-75 years of age,and 801 patients(7.27%)were over 75 years old.Most users during perioperative period were males,a total of 7021 patients,accounting for 63.68%;female population were relatively small,accounting for 36.25%.The incidence of severe adverse evens of hemocoagulase atrox for injection was 0.No anaphylactic shock or allergic event was found in the included perioperative patients.No thrombosis was found in the oberved patients,either.Hemocoagulase atrox for Injection had mild effects on the four indicators of coagulation,but the clinical significance is limited.Conclusion The study found that hemocoagulase atrox for injection was safe in preventing bleeding events during perioperative period as no anaphylactic shock or allergic event,and no thrombotic events were observed.No overall incidence of severe adverse reactions was found and hemocoagulase atrox for injection had little effect on coagulation function.