背景:功能性鼻内镜鼻窦手术是治疗药物治疗失败后慢性鼻窦炎伴鼻息肉(CRSwNP)的主要选择。不幸的是,一些患者术后恢复仍不理想。据报道,鼻息肉组织中炎性细胞浸润的类型可用于复发预测。因为它是侵入性的和耗时的,在现有技术条件下,这种技术很难在临床上推广。而在临床治疗过程中,我们注意到不同中医证型患者术后复发率存在差异。
方法:这是非随机的,单中心,前瞻性队列研究在四川省成都市开始,中华人民共和国,2021年1月。总共200名参与者将从被诊断为CRSwNP并准备进行功能性内窥镜鼻窦手术的患者中招募。我们收集术前数据,包括一般信息,病史,中医证候,主观症状的视觉模拟量表(VAS),Lund-Kennedy内窥镜评分,鼻窦计算机断层扫描(CT)扫描的Lund-Mackay评分。我们通过手术后的多次计划随访获得VAS评分和主观症状的Lund-Kennedy评分。随访1年后,复发率将被计算,并对疗效进行评估。同时,病人的病理切片将被整理,和炎性细胞浸润将被分析。进行统计学分析,评价CRSwNP复发与中医证型及组织炎症细胞浸润类型的相关性。然后我们将建立CRSwNP复发的预测模型。调查数据的分析包括描述性和推断性统计方法。
结论:这是首次探讨CRSwNP复发与中医证型及组织炎症细胞浸润类型相关性的前瞻性队列研究。通过这项研究,我们希望发现一个新的和简单的,有效,和无创性方法快速预测CRSwNP术后复发率,为中医应用干预时机提供参考,从而实现定制化的诊断和治疗,将手术事件的风险降至最低,延迟CRSwNP术后复发。
背景:PROSPEROChiCTR2100041646.
BACKGROUND: Functional endoscopic sinus surgery is a principal option for treating chronic rhinosinusitis with nasal polyps (CRSwNP) after medication failures. Unfortunately, some patients still have unsatisfactory postoperative recovery. The type of inflammatory cell infiltration in nasal polyp tissue has been reported available for recurrence prediction. As it is invasive and time-consuming, this technique is hard to promote clinically under the existing technical conditions. And during the course of clinical treatment, we have noted that differences in the postoperative recurrence rate of patients present among different traditional Chinese medicine syndrome types.
METHODS: This is a non-randomized, single-center, and prospective cohort study started in Chengdu Sichuan Province, People\'s Republic of
China, in January 2021. A total of 200 participants will be recruited from patients who are diagnosed with CRSwNP and prepared for functional endoscopic sinus surgery. We collect preoperative data which includes general information, medical history, TCM syndromes, visual analogue scale (VAS) of subjective symptoms, Lund-Kennedy endoscopic score, and Lund-Mackay score of computed tomography (CT) scanning of sinuses. We acquire the VAS score and Lund-Kennedy score of subjective symptoms through multiple planned follow-up after surgery. After 1 year of follow-up, the recurrence rate will be calculated, and the curative effect will be assessed. Meanwhile, the patients\' pathological sections will be sorted out, and inflammatory cell infiltration will be analyzed. Statistical analysis will be carried out to evaluate the correlation among CRSwNP recurrence and TCM syndrome types and tissue inflammatory cell infiltration types. Then we will establish a predictive model for CRSwNP recurrence. Analyses of survey data include descriptive and inferential statistical approaches.
CONCLUSIONS: This is the first prospective cohort study on investigating the correlation of CRSwNP recurrence with TCM syndrome types and tissue inflammatory cell infiltration types. Through this study, we hope to discover a new and simple, effective, and noninvasive way to predict the recurrence rate rapidly after CRSwNP and provide reference for the intervention timing of traditional Chinese medicine application, thereby achieving customized diagnosis and treatment, minimizing risks of surgical events, and delaying postoperative recurrence of CRSwNP.
BACKGROUND: PROSPERO ChiCTR2100041646.