[Studies on efficacy of a bioabsorbable steroid-eluting sinus stent in the frontal sinus opening of chronic rhinosinusitis with nasal polyps]

Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2021 Aug 7;56(8):824-829. doi: 10.3760/cma.j.cn115330-20200809-00655.
[Article in Chinese]

Abstract

Objective: To assess the efficacy of a bioabsorbable steroid-eluting sinus stent in improving surgical outcomes when placed in the frontal sinus ostium (FSO) following full endoscopic sinus surgery (ESS) in patients with whole group chronic rhinosinusitis with nasal polyps (CRSwNP). Methods: Patients with whole group CRSwNP who had similar lesions on bilateral sinus between September 2019 and March 2020 in Department of Otorhinolaryngology Head and Neck Surgery, Shanghai Changhai Hospital were chosen. Patients with CRSwNP who underwent extended ESS were randomly assigned to receive a steroid-eluting sinus stent in one FSO whereas the contralateral side received surgery alone. Endoscopic evaluations recorded at 30, 90 days postoperative were graded by an independent assessment panel to assess the need for interventions in the FSO. Semi-quantitative data with CT and endoscopic score were performed by rank sum test. The need for postoperative intervention and the patency rate of FSO were analyzed using the McNemar test. Results: Thirty-one patients with whole group CRSwNP met all eligible criteria, including 17 males and 14 females, with the age of (44.5±11.8) years(x¯±s). Stents were successfully placed in one FSO of all patients. At 30 days post-ESS, the assessment panel reported that steroid-eluting stents reduced the need for postoperative interventions by 41.0% (χ2=5.314,P=0.021), the need for oral steroid interventions by 40.0% (χ2=4.133,P=0.042) and the need for surgical interventions by 74.8% (χ2=4.292,P=0.038) compared to control sinuses with no stents. Clinical surgeons also reported greater diameter of FSO compared to control sinuses at 30 days post-ESS (74.2% vs 48.4%, χ2=4.351, P=0.037). These results at 90 days post-ESS were consistent with those at 30 days post-ESS. Conclusion: Bioabsorbable steroid-eluting sinus stents in the FSO can reduce polyp formation, adhesion, and the need for postoperative interventions in FSO of CRSwNP patients and improve the early postoperative outcomes.

目的: 评估在全组慢性鼻窦炎伴鼻息肉(CRSwNP)患者额窦口植入缓释糖皮质激素支架(简称支架)对扩大性内镜鼻窦手术(ESS)后额窦术区创面恢复的疗效。 方法: 选取2019年9月至2020年3月在上海长海医院耳鼻咽喉头颈外科就诊的双侧病变程度相近的全组CRSwNP患者,采用自身对照设计,扩大性ESS后采用随机数据表法在一侧额窦术区植入支架,另一侧作为对照,术后第30、90天鼻内镜观察支架植入组与对照组额窦术区创面恢复情况。独立评估小组按照评估标准对鼻内镜检查结果进行评分,评估两组的治疗效果及额窦术区是否需要术后干预。CT及内镜评分半定量资料采用秩和检验,术后干预率、额窦口通畅度比例以计量资料统计,用配对四格表进行χ2检验。 结果: 共31例全组CRSwNP患者纳入研究,其中男性17例,女性14例,年龄(44.5±11.8)岁(x¯±s)。所有患者的一侧额窦口均成功植入支架。术后第30天鼻内镜检查结果显示:支架植入组需要术后干预的比例相比对照组降低了41.0%(χ2=5.314,P=0.021),其中口服糖皮质激素干预比例下降了40.0%(χ2=4.133,P=0.042),手术干预比例下降了74.8%(χ2=4.292,P=0.038);支架植入组较对照组具有更高的额窦口通畅比例(74.2%比48.4%,χ2=4.351,P=0.037)。术后第90天的结果与第30天一致。 结论: 缓释糖皮质激素的生物可降解支架在额窦术区的植入能有效降低术后再干预的可能,提高术后额窦口的通畅性。.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Absorbable Implants
  • Adult
  • China
  • Chronic Disease
  • Endoscopy
  • Female
  • Frontal Sinus* / surgery
  • Humans
  • Male
  • Middle Aged
  • Nasal Polyps* / complications
  • Paranasal Sinuses*
  • Rhinitis* / complications
  • Stents
  • Steroids
  • Treatment Outcome

Substances

  • Steroids