Ottaviano Giancarlo, Blandamura Stella, Fasanaro Elena, Favaretto Niccolo', Andrea Lovato, Giacomelli Luciano, Bartolini Andrea, Staffieri Claudia, Marchese-Ragona Rosario, Marioni Gino, Staffieri Alberto
Department of Neurosciences DNS, Otolaryngology Section, Padova University, Padova, Italy.
Department of Medicine DIMED, Padova University, Padova, Italy.
Am J Otolaryngol. 2015 Sep-Oct;36(5):625-31. doi: 10.1016/j.amjoto.2015.02.014. Epub 2015 Mar 3.
The aim of the present prospective, randomized, double-blind, and placebo-controlled investigation (approved by the Ethical Committee of Padova University Hospital [Italy]) was to assess the effect of a nasal gel containing a combination of silver sucrose octasulfate and potassium sucrose octasulfate (Silsos gel® [SG]) in wound healing after endoscopic sinus surgery (ESS) for chronic rhinosinusitis in terms of: nasal symptoms (SNOT22), endoscopic appearance of the sinonasal mucosa (Lund-Kennedy score), nasal air flow (anterior active rhinomanometry), evidence of mucosal inflammatory processes (nasal cytology and histology), and microbiological growth.
Thirty-four patients with chronic rhinosinusitis were randomized on a 1:1 ratio to receive after ESS either SG or placebo (contained only the excipients [carbopol and propylene glycol] in the same concentrations as in SG).
RESULTS/CONCLUSIONS: Judging from the present prospective investigation on patients who underwent ESS for chronic rhinosinusitis, treatment with SG seems to enable a significantly faster improvement in specific symptoms (assessed on the validated SNOT22 scale) than placebo. Patients treated with SG also had a quicker improvement in the endoscopic appearance of their nasal mucosa after ESS than patients treated with placebo. These endoscopic improvements in the SG group were also confirmed at the long-term follow-up, while the same did not apply to the placebo-treated group.
本前瞻性、随机、双盲、安慰剂对照研究（已获意大利帕多瓦大学医院伦理委员会批准）旨在评估含八硫酸蔗糖银和八硫酸蔗糖钾组合的鼻用凝胶（Silsos凝胶®[SG]）对慢性鼻窦炎内镜鼻窦手术（ESS）后伤口愈合的影响，具体涉及：鼻部症状（SNOT22）、鼻窦黏膜的内镜表现（Lund-Kennedy评分）、鼻气流（前鼻主动测压法）、黏膜炎症过程的证据（鼻细胞学和组织学）以及微生物生长情况。
34例慢性鼻窦炎患者按1:1比例随机分组，ESS术后分别接受SG或安慰剂治疗（安慰剂仅含有与SG相同浓度的辅料[卡波姆和丙二醇]）。
结果/结论：从本次对接受ESS治疗的慢性鼻窦炎患者的前瞻性研究来看，与安慰剂相比，SG治疗似乎能使特定症状（根据经过验证的SNOT22量表评估）改善得明显更快。ESS术后，接受SG治疗的患者鼻黏膜的内镜表现也比接受安慰剂治疗的患者改善得更快。SG组的这些内镜改善情况在长期随访中也得到了证实，而安慰剂治疗组则未出现同样情况。
