新型可吸收骨蜡在外科手术中控制骨损伤出血效果及安全性研究  

Study on the effect and safety of new type of absorbable bone wax in controlling bleeding of bone injury in surgical operation

作　　者：王翔宇 李远[2] 马艳 Wang Xiangyu;Li Yuan;Ma Yan(Operating Room,Fuwai Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100037,China;Department of Orthopaedic Oncology,Beijing Jishuitan Hospital,Beijing 100035,China)

机构地区：[1]中国医学科学院阜外医院手术室,北京100037 [2]北京积水潭医院骨肿瘤科,北京100035

出　　处：《中国医学装备》2025年第3期73-77,共5页China Medical Equipment

摘　　要：目的:探究新型可吸收骨蜡与传统不可吸收骨蜡在外科手术中的止血效果及安全性。方法:本研究为前瞻性、阳性平行对照、单盲、非劣效、多中心临床试验,选取2022年7月至2023年10月在中国医学科学院阜外医院、北京积水潭医院诊疗的141例骨科及心外科手术患者,其中心外科手术64例,骨科手术77例,采用区组随机法将所有患者分为可吸收骨蜡组(70例)和不可吸收骨蜡组(71)例。比较两组止血成功率(3min内)、术后伤口愈合情况、器械使用(满意度和粘附性)评价、术后并发症发生率和严重不良事件。结果:可吸收骨蜡组止血成功率(3min内)为98.57%(69/70),不可吸收骨蜡组为100.00%(71/71),差异无统计学意义(P>0.05)。两组患者出院前、术后1个月及术后3个月的伤口愈合情况比较,差异无统计学意义(P>0.05)。两组器械使用评价中,可吸收骨蜡组70例患者中66例(占94.29%)满意度评价为优级,57例(占81.43%)粘附性评价为优级;不可吸收骨蜡组71例患者中62例(占87.32%)满意度评价为优级,48例(占67.61%)粘附性评价为优级,可吸收骨蜡组评价好于不可吸收骨蜡组,但两组比较差异无统计学意义(P>0.05)。两组术后并发症发生率比较,差异无统计学意义(P>0.05);可吸收骨蜡组严重不良事件发生率为2.86%,不可吸收骨蜡组为4.23%,两组比较差异无统计学意义(P>0.05)。结论:可吸收骨蜡具有与传统不可吸收骨蜡同等的止血效果及安全性,且可吸收骨蜡组的器械使用评价更好。Objective:To study and explore the hemostatic effect and safety of new type of absorbable bone wax and conventional non-absorbable bone wax in surgery.Methods:A total of 141 patients from orthopedic department and cardiac surgery department,who underwent surgery at Beijing Jishuitan Hospital,and Fuwai Hospital of the Chinese Academy of Medical Sciences from July 2022 to October 2023,were selected.Patients were allocated via block randomization into the absorbable bone wax group(70 cases)and the non-absorbable bone wax group(71 cases).The success rates of hemostasis(within 3min),postoperative wound healing conditions,evaluation of using apparatuses(satisfaction and adhesion),incidence of postoperative complication and the severe adverse events of two groups were compared.Results:The success rates of hemostasis(within 3 minutes)of the absorbable bone wax group and the non-absorbable bone wax group were respectively 98.57%(69/70)and 100.00%(71/71),and the difference was not statistically significant(P>0.05).The differences of wound healing conditions before discharge,at 1st month and 3rd month after surgery between two groups were not significant(P>0.05).In the evaluation of using apparatuses,the satisfaction evaluation of 66 cases(94.29%)of 70 patients in the absorbable bone wax group was superior grade,and the adhesion of 57 cases(81.43%)was superior grade.The satisfaction evaluation of 62 cases(87.32%)of 71 patients in the non-absorbable bone wax group was superior grade,and the adhesion of 48 cases(67.61%)was superior grade.The differences of them between two groups were not statistically significant(P>0.05).There was no significant in the postoperative complication between two groups(P>0.05).The incidence of severe adverse events was 2.86%in the absorbable bone wax group,and it was 4.23%in the non-absorbable bone wax group,there was no statistically significant difference in that between two groups(P>0.05).Conclusion:The absorbable bone wax has the same hemostatic effect and safety with conventional non-absorba

关 键 词：可吸收骨蜡 可降解材料 止血 骨肿瘤 安全性 可用抗凝药 

分 类 号：R683[医药卫生—骨科学]