生物可吸收类固醇释放植入物用于额窦开口的随机对照试验。
Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening.
作者信息
Smith Timothy L, Singh Ameet, Luong Amber, Ow Randall A, Shotts Steven D, Sautter Nathan B, Han Joseph K, Stambaugh James, Raman Aarthi
机构信息
Department of Otolaryngology-Head and Neck Surgery, Oregon Health Sciences University, Portland, Oregon, U.S.A.
Department of Surgery and Neurosurgery, George Washington Medical Faculty Associates, Washington, DC, U.S.A.
出版信息
Laryngoscope. 2016 Dec;126(12):2659-2664. doi: 10.1002/lary.26140. Epub 2016 Jul 1.
OBJECTIVES/HYPOTHESIS: To assess safety and efficacy of a steroid-releasing implant in improving surgical outcomes when placed in the frontal sinus opening (FSO) following endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS).
STUDY DESIGN
Prospective, multicenter, randomized, blinded trial using an intrapatient control design.
METHODS
Eighty adult (≥ 18 years) CRS patients who underwent successful bilateral frontal sinusotomy were randomized to receive a steroid-releasing implant in one FSO, whereas the contralateral control side received no implant. All patients received standard postoperative care. Endoscopic evaluations recorded at 30-days postendoscopic sinus surgery (ESS) were graded real time by clinical investigators and by an independent, blinded sinus surgeon to assess the need for postoperative interventions in the FSO.
RESULTS
Implants were successfully placed in all 80 frontal sinuses, resulting in 100% implant delivery success. At 30-days post-ESS, steroid-releasing implants provided a statistically significant (P = 0.0070) reduction in the need for postoperative interventions compared to surgery alone by an independent reviewer, representing 38% relative reduction. Clinical investigators reported statistically significant reduction in this measure at 30 days (P < 0.0001) and 90 days (P = 0.0129). Clinical investigators also reported a 55.6% reduction in the need for oral steroid interventions (P = 0.0015), 75% reduction in the need for surgical interventions (P = 0.0225), 16.7% reduction in inflammation score, 54.3% reduction in restenosis rate (P = 0.0002), and 32.2% greater diameter of FSO (P < 0.0001) on treated sides compared to control at 30 days. No implant-related adverse events were reported.
CONCLUSION
This study demonstrates the efficacy of steroid-releasing implants in improving outcomes of frontal sinus surgery.
LEVEL OF EVIDENCE
1b. Laryngoscope, 126:2659-2664, 2016.
目的/假设：评估在慢性鼻-鼻窦炎（CRS）患者接受鼻内镜鼻窦手术（ESS）后，将类固醇释放植入物置于额窦开口（FSO）时，其改善手术效果的安全性和有效性。
研究设计
采用患者自身对照设计的前瞻性、多中心、随机、双盲试验。
方法
80例成年（≥18岁）成功接受双侧额窦切开术的CRS患者被随机分配，一侧FSO植入类固醇释放植入物，对侧作为对照不植入。所有患者均接受标准的术后护理。鼻内镜鼻窦手术（ESS）后30天进行的内镜评估由临床研究人员和一名独立的、不知情的鼻窦外科医生实时评分，以评估FSO术后干预的必要性。
结果
所有80个额窦均成功植入植入物，植入成功率达100%。ESS术后30天，与单纯手术相比，独立评审者发现类固醇释放植入物使术后干预的必要性显著降低（P = 0.0070），相对降低了38%。临床研究人员报告，在30天（P < 0.0001）和90天（P = 0.0129）时，该指标有统计学意义的降低。临床研究人员还报告，与对照侧相比，治疗侧在30天时口服类固醇干预的必要性降低了55.6%（P = 0.0015），手术干预的必要性降低了75%（P = 0.0225），炎症评分降低了16.7%，再狭窄率降低了54.3%（P = 0.0002），FSO直径增大了32.2%（P < 0.0001）。未报告与植入物相关的不良事件。
结论
本研究证明了类固醇释放植入物在改善额窦手术效果方面的有效性。
证据级别
1b。《喉镜》，2016年，第126卷，第2659 - 2664页。
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