Zhou H Q, Tan L, Liu P Q, Xu Y
Department of Otolaryngology Head and Neck Surgery, Renmin Hospital of Wuhan University, Research Institute of Otolaryngology Head and Neck Surgery, Renmin Hospital of Wuhan University, Hubei Province Key Laboratory of Allergy and Immunology, Wuhan 430060, China.
Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2025 Jun 7;60(6):638-645. doi: 10.3760/cma.j.cn115330-20250425-00252.
To assess the optimal timing and short-term clinical efficacy of sinus drug-eluting stent placement in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The minimum sample size was calculated using G-power 3.1.9.7 software. From March 2021 and May 2023, a total of 114 eligible patients with CRSwNP were recruited in this study at the Department of Otolaryngology Head and Neck Surgery, Renmin Hospital of Wuhan University. The patients were randomly assigned to three groups: the control group, the intraoperative stent group, and the postoperative stent group. In the intraoperative stent group, drug-eluting stents were implanted during endoscopic sinus surgery (ESS), while patients in the postoperative stent group received drug-eluting stent 2 weeks after ESS, following routine debridement of the surgical cavity. Bilateral ethmoid sinus stenting was performed for both stent groups, while the control group only underwent ESS with standard postoperative cavity debridement. All subjects were followed up at 2, 4, 8, and 12 weeks postoperatively. Nasal symptom Visual Analog Scale (VAS) scores and endoscopic evaluations of the ethmoid cavity-assessing obstruction, crusting, polypoid mucosal changes, epithelialization of ethmoid cavity, need for intervention, and complications such as middle turbinate lateralization and adhesions-were collected to evaluate the treatment efficacy of three groups. Statistical analyses were performed using GraphPad Prism 9. Analysis of variance (ANOVA) was applied to analyze continuous variables among the three groups, and chi-square tests were used for categorical variables. Among 114 CRSwNP patients, 21 lost follow-up patients and 7 postoperative oral corticosteroid intervention patients were excluded. Finally, 86 patients were included in the analysis, including 45 males and 41 females, aged 18-65 years. The cohort comprised 29 in the control group, 29 in the intraoperative stent group, and 28 in the postoperative stent group. Successful bilateral ethmoid sinus stent implantation was achieved in both stent groups. At 4 weeks postoperatively, compared with the control group, both stent groups showed significant improvements in nasal congestion and rhinorrhea scores (<0.05). At 8 weeks, the postoperative group continued to demonstrate superior outcomes in these two symptoms (both <0.05), while the intraoperative group only showed significant improvement in nasal congestion (<0.05). No significant differences were observed in facial pressure, olfactory loss, or nasal dryness scores among the three groups (all >0.05). Endoscopic evaluation revealed that both stent groups had significant improvements in ethmoid sinus obstruction scores at 4 weeks compared with the control group, with the postoperative group maintaining this advantage at 8 weeks (<0.05). At 2 weeks, the intraoperative stent group had higher crusting scores than other groups (<0.05). At 2 weeks after stent implantation, the postoperative stent group had significantly lower crusting scores than the intraoperative stent group (<0.001). The intraoperative group had a significantly lower incidence of ethmoid sinus edema and polypoid changes at 4 weeks compared with the control group (<0.05), while the postoperative group showed reduced rates of these pathological changes at 4, 8, and 12 weeks (all <0.05). The postoperative stent group had significantly higher rates of ethmoid sinus mucosal epithelialization at 8 and 12 weeks postoperatively compared with the control group. The intraoperative stent group required fewer interventions than the control group at both 8 and 12 weeks, while the postoperative stent group maintained lower interventions rates at all follow-up points after implantation (all <0.05). Additionally, the incidence of complications was significantly lower in both stent groups compared with the control group (<0.05). Overall, stent implantation at different time points showed similar efficacy, with the postoperative group demonstrating more stable outcomes and less crusting/coagulation formation compared with the intraoperative group. The implantation of corticosteroid sinus stents in the ethmoid sinuses effectively controls postoperative inflammation, promotes mucosal epithelialization, and reduces postoperative intervention rates. Stent implantation two weeks after surgery is feasible. Adjusting the timing of stent placement can minimize crust formation and maximize the corticosteroid effect, thereby facilitating a benign course of the surgical site.
评估鼻窦药物洗脱支架置入术治疗慢性鼻-鼻窦炎伴鼻息肉(CRSwNP)患者的最佳时机及短期临床疗效。使用G-power 3.1.9.7软件计算最小样本量。2021年3月至2023年5月,武汉大学人民医院耳鼻咽喉头颈外科共招募了114例符合条件的CRSwNP患者。患者被随机分为三组:对照组、术中支架组和术后支架组。术中支架组在内镜鼻窦手术(ESS)期间植入药物洗脱支架,而术后支架组在ESS术后2周,在术腔常规清创后接受药物洗脱支架植入。两个支架组均进行双侧筛窦支架置入,而对照组仅接受ESS及标准的术后术腔清创。所有受试者在术后2、4、8和12周进行随访。收集鼻症状视觉模拟量表(VAS)评分以及筛窦腔的内镜评估结果,评估阻塞、结痂、息肉样黏膜改变、筛窦腔上皮化、干预需求以及中鼻甲外移和粘连等并发症,以评估三组的治疗效果。使用GraphPad Prism 9进行统计分析。应用方差分析(ANOVA)分析三组间的连续变量,使用卡方检验分析分类变量。在114例CRSwNP患者中,21例失访患者和7例术后口服糖皮质激素干预患者被排除。最终,86例患者纳入分析,其中男性45例,女性41例,年龄18 - 65岁。队列包括对照组29例、术中支架组29例和术后支架组28例。两个支架组均成功完成双侧筛窦支架植入。术后4周,与对照组相比,两个支架组的鼻塞和流涕评分均有显著改善(<0.05)。8周时,术后组在这两个症状方面继续显示出更好的结果(均<0.05),而术中组仅在鼻塞方面有显著改善(<0.05)。三组在面部压痛、嗅觉减退或鼻干评分方面均未观察到显著差异(均>0.05)。内镜评估显示,与对照组相比,两个支架组在术后4周时筛窦阻塞评分均有显著改善,术后组在8周时保持这一优势(<0.05)。术后2周,术中支架组的结痂评分高于其他组(<0.05)。支架植入术后2周,术后支架组的结痂评分显著低于术中支架组(<0.001)。与对照组相比,术中组在术后4周时筛窦水肿和息肉样改变的发生率显著降低(<0.05),而术后组在术后4、8和12周时这些病理改变的发生率均降低(均<0.05)。术后支架组在术后8周和12周时筛窦黏膜上皮化率显著高于对照组。术中支架组在8周和12周时的干预需求均少于对照组,而术后支架组在植入后的所有随访点均保持较低的干预率(均<0.05)。此外,两个支架组的并发症发生率均显著低于对照组(<0.05)。总体而言,不同时间点的支架植入显示出相似的疗效,与术中组相比,术后组的结果更稳定,结痂/凝血形成更少。在筛窦中植入糖皮质激素鼻窦支架可有效控制术后炎症,促进黏膜上皮化,并降低术后干预率。术后两周植入支架是可行的。调整支架置入时机可减少结痂形成并最大化糖皮质激素效果,从而促进手术部位的良性转归。