复合大孔聚多糖可吸收止血材料在甲状腺创面止血的临床评价

Clinical study on absorbable macroporous polysaccharide compound hemostatics as topical hemostatic agents for intraoperative bleeding during thyroid surgery

目的:评价复合大孔聚多糖可吸收止血材料在甲状腺创面的临床止血效果及安全性。方法:采用前瞻性、随机、对照、非劣效性设计,纳入从2019年8月至2020年6月行甲状腺外科手术患者。合格患者将随机分组(2∶1)。除术中应用局部止血材料(试验组:复合大孔聚多糖可吸收止血材料,对照组:复合微孔多聚糖止血粉)不同,其余操作方式均相同。术中录像并分析疗效。随访收集包括不良事件、实验室检查等安全性指标。结果:37例患者纳入分析,试验组(n=25)和对照组(n=12)基线特征均衡,5 min止血有效率均达100%,止血时间分别为(91.04±72.07)s和(75.83±53.98)s。2组均数差为15.21 s(95%CI上限为54.91 s,P<0.05),试验组止血疗效非劣效于对照组,且2组止血时间无统计学差异(P>0.05)。2组实验室检查指标(凝血功能和血常规)和不良事件发生率[试验组20%(5/25);对照组16.67%(2/12)]均无统计学差异(P>0.05),安全性指标相当。结论:复合大孔聚多糖可吸收止血材料在甲状腺切除手术创面止血的有效性和安全性非劣效于对照组,两者均可达到满意的局部止血效果。

OBJECTIVE To evaluate the safety and efficacy of absorbable macroporous polysaccharide compound hemostatics as topical hemostatic agents for intraoperative bleeding during thyroid surgery.METHODS For this prospective, randomized, controlled, non-inferior clinical study, from August 2019 to June 2020,37 patients undergoing thyroidectomy were recruited and randomized in a 2:1 ratio to received either absorbable macroporous polysaccharide compound hemostatics(experimental group)or compound microporous polysaccharide haemostatic powder(control group).Final hemostatic operative outcomes were accurately recorded.The safety indicators included adverse events and laboratory tests.RESULTS Demographic and baseline characteristics were comparable between experimental group(n=25)and control group(n=12).Rates of hemostasis within 5 min were 100% in both groups.Hemostasis took 91.04±72.07 seconds in experimental group and 75.83±53.98 seconds in control group with a mean difference of 15.21 seconds(upper limit of 95%CI 54.91,P<0.05).It hinted at a non-inferiority of experimental group to control group.Hemostatic time, coagulation function, routine blood test and adverse events were comparable between two groups(P>0.05).CONCLUSION Absorbable macroporous polysaccharide compounds possess excellent profiles of biocompatibility and hemostatic effectiveness as a local hemostatic.They are non-inferior to microporous polysaccharide haemostatic powder for intraoperative bleeding during thyroid surgery.