可吸收骨止血材料用于骨损伤创面临床止血有效性和安全性研究

作者	单位	邮编
张党锋^*	西安交通大学第一附属医院骨科，陕西西安，710061	710061
王泽刚^*	北京大学第三医院骨科，北京，100191	100191
徐宝艳	陕西佰傲再生医学有限公司，陕西西安，710038	710038
张银刚	西安交通大学第一附属医院骨科，陕西西安，710061	710061
戴星	西安交通大学第一附属医院骨科，陕西西安，710061	710061
赵聪	陕西佰傲再生医学有限公司，陕西西安，710038	710038
石莉	陕西佰傲再生医学有限公司，陕西西安，710038	710038
黄婷	陕西佰傲再生医学有限公司，陕西西安，710038	710038
堵斌	陕西佰傲再生医学有限公司，陕西西安，710038	710038
张勇杰	陕西佰傲再生医学有限公司，陕西西安，710038	710038
龚熹	北京大学第三医院骨科，北京，100191	100191

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中文摘要:

目的研究可吸收骨止血材料用于受试者骨损伤创面的止血有效性和安全性。方法将2022年3月至2023年8月就诊于西安交通大学第一附属医院、深圳市第二人民医院、西安市红会医院、北京大学第三医院、北京大学深圳医院、空军军医大学第三附属医院、西安交通大学口腔医院、陕西省人民医院、厦门大学附属第一医院共9家临床研究机构的230例截骨、钻骨或切骨等机械性损伤导致的骨质出血的受试者随机分为可吸收骨止血材料试验组和强生骨蜡（Bone Wax）对照组。试验组共114例，其中男46例，女68例，年龄19 ～ 80岁，平均年龄为（53.33±15.85）岁；对照组共116例，其中男49例，女67例，年龄19 ～ 78岁，平均年龄为（52.10±15.70）岁。本研究主要评价指标为受试者3 min内止血有效率；次要评价指标为受试者切口愈合时间和血红蛋白变化情况；安全性评价指标为受试者术中材料使用不良事件发生率。结果试验组与对照组受试者的3 min止血有效率分别为99.12%和99.14%，两组受试者主要评价指标组间差异均无统计学意义（P＞0.05）。试验组受试者术后12、30、90 d血红蛋白数值变化正常率分别为42.86%、83.16%和89.52%，对照组受试者术后12、30、90 d血红蛋白数值变化正常率分别为45.95%、81.52%和87.38%；试验组受试者术后12、30、90 d的切口愈合率分别为55.20%、93.86%和97.37%，对照组受试者术后12、30、90 d切口愈合率分别为53.90%、91.23%和98.25%。两组受试者各项次要评价指标评价相比较，差异无统计学意义（P＞0.05）。试验组和对照组受试者术后不良反应发生率分别为9.65%和7.76%，两组受试者不良反应发生率比较，差异无统计学意义（P＞0.05）。结论骨损伤术中使用可吸收骨止血材料产品封闭骨截面止血，临床止血效果良好，且未增加并发症的风险，值得临床推广应用。

英文摘要:

Objective To evaluate the efficacy and safety of absorbable bone hemostatic materials (ABHM) after bone injury.Methods A total of 230 patients who presented with haemostasis due to bone bleeding caused by mechanical injury, such as osteotomy, bone drilling or bone cutting, and who were admitted to nine different hospitals between February 2022 and August 2023, were analysed. The patients were randomly divided into a study group and a control group, receiving ABHM and bone wax, respectively. The study group comprised 114 patients, including 46 males and 68 females, with an average age of (53.33±15.85) years, while the control group comprised 116 patients, including 49 males and 67 females, with an average age of (52.10±15.70) years. The primary evaluation indicator was the effective rate of hemostasis within 3 min. The secondary evaluation indicators were the wound healing time and the changes of hemoglobin. The safety evaluation indicator was the incidence of adverse events.Results The effective hemostasis rate was 99.12% in the study group and 99.14% in the control group, there was no significant difference in the main efficacy evaluation indicator between the two groups (P>0.05). The haemoglobin change rates at 12, 30 and 90 d after surgery were 42.86%, 83.16% and 89.52% respectively in the study group, and 45.95%, 81.52% and 87.38% respectively in the bone wax control group. Wound healing times at 12, 30 and 90 d after surgery were 55.20%, 93.86% and 97.37% respectively in the study group, and 53.90%, 91.23% and 98.25% respectively in the bone wax control group. There was no statistical difference in any of the secondary efficacy evaluation indicators between the two groups (all P>0.05). Adverse reactions that were definitely or possibly related to the study materials occurred in 11 cases (9.65%) in the study group and 9 cases (7.76%) in the control group. However, the difference was not statistically significant (P>0.05).Conclusion ABHM is effective and safe for occluding vascular openings in damaged bone via mechanical tamponade. There was also no increased risk of complications. It is worthy of clinical application and promotion.

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