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度普利尤单抗注射液治疗慢性鼻窦炎伴鼻息肉疗效的Meta分析

Efficacy and safety of Dupilumab in chronic rhinosinusitis with nasal polyps: Systematic review and Meta-analysis

摘要目的:系统评价度普利尤单抗注射液(Dupilumab)治疗慢性鼻窦炎伴鼻息肉(chronic rhinosinusitis with nasal polyps,CRSwNP)患者的疗效。方法:由于Dupilumab适应证在国内暂未获批用于CRSwNP患者,故未检索中文文献,在计算机上直接检索Pubmed、Medline、Embase、Ovid Medline、Cochrane Library、Web of Science数据库,并同时手工检索相关会议论文集、出版物、会议摘要及临床试验网站等,检索年限自建库至2022年10月,筛选Dupiliumab治疗CRSwNP的随机对照试验(randomized controlled trial,RCT)研究,对符合纳入标准的文献采用Rev Man5.4软件进行Meta分析。结果:纳入3项RCT研究,共639例参与者。Dupilumab与安慰剂组比较,总鼻息肉评分(total nasal polyp score,TNPS)(WMD=-2.07,95% CI:-2.35~-1.80)、鼻塞评分(nasal congestion score,NCS)(WMD=-0.91,95% CI:-1.04~-0.77)、鼻腔鼻窦结局测试-22(sino-nasal outcome test,SNOT-22)(WMD=-20.92,95% CI:-23.90~-17.94)、总鼻症状评分(total symptom score,TNSS)(WMD=-2.68,95% CI:-3.01~-2.35)和Lund-Mackay CT评分(WMD=-7.38,95% CI:-8.06~-6.45)改善有显著差异。此外,两组一般不良事件(RR=0.86,95% CI:0.75~0.98)的发生风险无明显差异,但严重不良事件(RR=0.40,95% CI:0.23~0.70)Dupilumab组发生的风险明显低于安慰剂组。 结论:Dupilumab治疗中重度CRSwNP成人患者,显著改善了鼻息肉评分、临床症状和生活质量,取得较好疗效。Dupilumab发生严重不良事件风险小于安慰剂组,而一般不良事件发生风险与安慰剂组无显著差别,Dupilumab耐受性良好。今后需要进一步高水平的研究来评估CRSwNP轻症患者的临床疗效及与常规治疗方法的费用情况比较。

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abstractsObjective:To systematically evaluate the efficacy of Dupilumab in the treatment of patients with chronic rhinosinusitis with nasal polyps(CRSwNP).Methods:Since the indication of Dupiliumab in China is only moderate-to-severe atopic dermatitis, which is not approved for CRSwNP, Chinese literature was not included, Pubmed, Medline, Embase, Ovid Medline, Cochrane library, Web of Science databases were searched. We also searched the relevant conference proceedings, publications and conference abstracts, and clinical trial websites artificially. Randomized controlled trials of Dupiliumab for the treatment of CRSwNP were screened from the year of database construction to October 2022, and Meta-analysis was performed on the literature that met the inclusion criteria with Rev Man 5.4 software.Results:A total of 3 randomized controlled studies(RCT) with a total of 639 participants were included. When dupleixumab was compared with placebo, nasal polyp scores(MD=?2.07, 95%CI: ?2.35-?1.80), nasal congestion scores(MD=?0.91, 95%CI: ?1.04-?0.77), SNOT22(MD=?20.92, 95%CI: ?23.90-?17.94), total nasal symptom score(MD=?2.68, 95%CI: ?3.01-?2.35) and Lund-Mackay CT scores(MD=?7.38, 95%CI: ?8.06-?6.45) were significantly different. In addition, there was no significant difference in the risk of adverse events(RR=0.86, 95%CI: 0.75-0.98) between the two groups; and the risk of serious adverse events(RR=0.40, 95%CI: 0.23-0.70) was significantly lower in the Dupilumab group than in the placebo group.Conclusions:In this Meta-analysis study, Dupilumab was found to significantly improve nasal polyp scores, clinical symptoms, and quality of life on adult patients with moderate-to-severe CRSwNP with better efficacy. The risk of serious adverse events was less with Dupilumab than with placebo, while the risk of common adverse events was not significantly different from placebo, and Dupilumab was well tolerated Dupilumab was well tolerated; further high-level studies are needed to assess the clinical efficacy and cost of CRSwNP in patients with mild disease compared with conventional treatments.

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