Chen Jiani, Wang Huan, Zhang Chen, Shi Le, Zhang Qianqian, Song Xiaole, Wang Dehui, Hu Li, Yu Hongmeng, Sun Xicai
ENT Institute and Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai, China.
Research Units of New Technologies of Endoscopic Surgery in Skull Base Tumor (2018RU003), Chinese Academy of Medical Sciences, Beijing, China.
Clin Transl Allergy. 2023 Jun;13(6):e12269. doi: 10.1002/clt2.12269.
To compare the safety and efficacy between endoscopic sinus surgery and different biologics in treating chronic rhinosinusitis with nasal polyps in adults by reviewing the existing clinical trials.
Data extraction and risk of bias assessment were conducted by 2 independent reviewers according to the PRISMA recommendations and any disagreement was resolved by a third investigator. Outcomes were measured through a random-effects model. We searched Embase, Web of Science, MEDLINE, Cochrane, and other relevant sources from its inception to April 30, 2022. We included randomized controlled trials(RCTs) involving endoscopic sinus surgery (ESS) or biologics in treating adult patients with chronic rhinosinusitis with nasal polyps. Studies involving other miscellaneous diseases, non-RCT design, and insufficient participants or follow-up were excluded.
In this systematic review, five RCTs and 1748 patients were included. All the biologics, as well as ESS, could significantly improve key nasal outcomes in CRSwNP both at 6 months and 1 year. Dupilumab exhibited better efficacy than ESS in improving SNOT-22 scores at one year. However, ESS showed superiority over three biologics in improving nasal congestion scores (NCS) at two various time points, except for better efficacy of Dupilumab at 1 year. For the loss of smell scores, a greater improvement was observed in the Dupilumab cohort compared with other biologics and even ESS counterparts. Safety analysis showed no significant difference between the ESS cohort and biologic treatment.
In summary, ESS showed comparable improvement in quality of life and symptoms to Omalizumab, Mepolizumab, and Benralizumab. Dupilumab seems to be more effective than ESS in selected items, whereas head-to-head trials and real-world studies are urgent to compare their efficacy. Our findings also showed that biologics could be applied as alternative or adjuvant therapy for uncontrolled severe CRSwNP.
通过回顾现有临床试验，比较成人慢性鼻-鼻窦炎伴鼻息肉患者内镜鼻窦手术与不同生物制剂治疗的安全性和有效性。
两名独立评审员根据PRISMA建议进行数据提取和偏倚风险评估，任何分歧由第三名研究人员解决。通过随机效应模型测量结果。我们检索了Embase、Web of Science、MEDLINE、Cochrane以及其他相关来源，检索时间从其创建至2022年4月30日。我们纳入了涉及内镜鼻窦手术（ESS）或生物制剂治疗成人慢性鼻-鼻窦炎伴鼻息肉患者的随机对照试验（RCT）。排除涉及其他杂病、非RCT设计以及参与者或随访不足的研究。
在本系统评价中，纳入了5项RCT和1748例患者。所有生物制剂以及ESS在6个月和1年时均能显著改善慢性鼻-鼻窦炎伴鼻息肉患者的关键鼻部结局。度普利尤单抗在改善1年时的SNOT-22评分方面比ESS疗效更好。然而，除度普利尤单抗在1年时疗效更佳外，ESS在两个不同时间点改善鼻充血评分（NCS）方面优于三种生物制剂。对于嗅觉丧失评分，与其他生物制剂甚至ESS组相比，度普利尤单抗组有更大改善。安全性分析显示ESS组与生物制剂治疗之间无显著差异。
总之，ESS在生活质量和症状改善方面与奥马珠单抗、美泊利单抗和贝那利珠单抗相当。度普利尤单抗在某些特定项目上似乎比ESS更有效，然而迫切需要进行头对头试验和真实世界研究来比较它们的疗效。我们的研究结果还表明，生物制剂可作为未控制的重度慢性鼻-鼻窦炎伴鼻息肉的替代或辅助治疗。
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