可降解止血粉在慢性鼻窦炎内镜手术中的应用:前瞻性、随机、对照、单盲临床试验

目的评估可降解止血粉应用于鼻内镜手术的有效性及舒适度。方法前瞻性纳入2015年10月至2019年7月期间就诊于首都医科大学附属北京同仁医院的慢性鼻窦炎患者21例,患者均为双侧病变,其中男17例,女4例,年龄18~65岁,平均42岁。所有患者均接受鼻内镜手术治疗,采用同一患者左右侧鼻腔随机对照试验,若试验侧鼻腔应用可降解止血粉,则对照侧鼻腔应用可降解止血绵。患者术前CT平均评分为6.25分。术后第1、7、14、30天完成左右侧鼻腔鼻出血以及鼻塞、流涕、疼痛视觉模拟量表(VAS)评分。评估患者术后鼻内镜评分。应用SPSS 22和Graphpad prism 8.0 软件进行统计学分析。患者试验侧和对照侧之间采用配对t检验或非参数检验。P<0.05为差异有统计学意义。结果患者在术后第1、7、14、30天,止血粉侧和对照侧鼻腔的出血评分、鼻部症状总评分差异无统计学意义(t值分别为1.341、0.552、0.631、0.158,P值均>0.05;t值分别为0.944、1.471、1.612、2.251,P值均>0.05);各鼻部症状评分差异无统计学意义(P值均>0.05)。术后第1、7、14天,止血粉侧的材料降解评分分别为(1.33±0.21)、(0.38±0.18)、0分;低于对照侧的(2.00±0.00)、(1.95±0.22)、(1.80±0.13)分,差异有统计学意义(P值均<0.01)。术后第1、7、14和30天,患者止血粉侧鼻腔的鼻内镜评分(水肿、结痂、分泌物、瘢痕、息肉)均低于对照侧(t=3.07、7.00、6.41、2.69,P值均<0.05)。结论慢性鼻窦炎患者行内镜鼻窦手术后,止血粉与可降解止血绵的止血效果相当。术后14 d止血粉降解和清除程度优于可降解止血绵,对黏膜伤口愈合没有影响。

The efficacy of hemostatic powder for chronic rhinosinusitis in endoscopic sinus surgery:a prospective,randomised,controlled and single blinded clinical trial

Objective To study the efficacy and patient comfort of absorbable hemostatic powder after endoscopic sinus surgery(ESS).Methods A total of 21(17 males,4 females)patients with an average age of 42(ranging from 18 to 65)underwent bilateral ESS for chronic rhinosinusitis(CRS)in Beiing Tongren Hospital,Capital Medical University between October 2015 and July 2019 were enrolled to compare the effect of absorbable hemostasis powder with Nasopore using an intrapatient control design.A randomized controlled trial was conducted in the left and right nasal cavities of the same patient.If hemostatic powder was applied in the experiment nasal cavity,the Nasopore was applied in the control nasal cavity.The mean preoperative sinus computed tomography(CT)score was 6.25.All patients competed for symptom diaries using a visual analog scale(VAS,score out of 10)at baseline,through 1,7,14 and 30 days.Outcomes including bleeding,facial pain,nasal obstruction,nasal discharges using VAS were recorded separately for both sides.Postoperative endoscopic scores were also investigated.SPSS 22 and Graphpad prism 8.0 statistical softwares were used for the analysis.Paired t-test or nonparametric test was used between the test side and the control side.The difference was statistically significant(P<0.05).Results The bleeding score and total nasal symptom VAS scores at postoperative days(POD)1,7,14 and 30 were not significantly different(t=1.341,0.552,0.631,0.158,all P>0.05;t=0.944,1.471,1.612,2.251,all P>0.05).There was no significant difference between absorbable hemostasis powder and Nasopore side on POD 1,7,14 and 30 in terms of each nasal symptom VAS scores(all P>0.05).0n POD 1,7 and 14,the packing material degeneration scores of the absorbable hemostasis powder side were significantly lower than those of the Nasopore side(1.33+0.21)vs(2.00+0.00),(038+0.18)vs(1.95±0.22),0 vs(1.80+0.13),allP<0.01].There were significant differences between absorbable hemostasis powder and Nasopore side on POD 1,7,14 and 30 in terms of endoscopic scores(edema,crusting,discharges,scar,polyps and material degeneration,1=3.07,7.00,6.41,2.69,all P<0.05).Conclusions The absorbable hemostasis powder and N asopore has similar postoperative hemostasis effect.The absorbable hemostasis powder is rapidly cleared and without negative effects on mucosal wound healing 14 days postoperatively.