小剂量奥马珠单抗在嗜酸粒细胞增多的难治性鼻窦炎患者扩大鼻窦开放术后的应用初探

Application and exploration of small dose omalizumab in patients with recurrent eosinophilic sinusitis after extended sinus surgery

目的:探讨奥马珠单抗在嗜酸粒细胞增多的难治性鼻窦炎患者鼻窦扩大开放术后的近期应用疗效。方法:收集2020年1月至2022年6月就诊于湖南省人民医院且符合嗜酸粒细胞性慢性鼻窦炎诊断标准、经多次手术病情仍然未控制的患者共24例,其中男13例,女11例,年龄(46.43±13.74)岁。将患者随机分为试验组(12例)与对照组(12例),均进行扩大鼻窦开放术,试验组术后使用奥马珠单抗(150 mg/月),对照组未使用奥马珠单抗。观察两组内及组间患者4个月后的主客观症状评分变化情况,包括视觉模拟量表(VAS)评分、鼻腔鼻窦结局测试(SNOT)-22评分、Lund-Mackay评分及Lund-Kennedy评分等。使用SPSS 24.0软件进行统计学分析。结果:将术后1个月设为基线,两组患者的基线临床特点无显著差别。试验组用药4个月后与基线相比,鼻塞、流涕、嗅觉VAS评分、SNOT-22评分、Lund-Kennedy评分均显著降低[(3.11±1.05)分比(6.44±1.13)分,(2.00±0.87)分比(6.55±1.33)分,(2.22±0.67)分比(7.00±1.22)分,(4.44±0.88)分比(15.22±1.20)分,(1.67±1.00)分比(7.44±0.88)分, P值均<0.001]。对照组自身前后比较,各症状评分在术后1~2个月下降,但随着时间延长,评分逐渐呈现增长趋势。试验组与对照组对比,基线后4个月时,鼻塞、流涕、嗅觉VAS、SNOT-22、Lund-Kennedy评分更低,差异有统计学意义[(3.11±1.05)分比(7.11±1.17)分,(2.00±0.87)分比(7.67±1.41)分,(2.22±0.67)分比(7.56±0.88)分,(4.44±0.88)分比(15.33±2.34)分,(1.67±1.00)分比(9.00±1.41)分, P值均<0.001]。试验组停药后2个月复查,患者鼻塞、流涕、嗅觉VAS评分、SNOT-22评分、Lund-Kennedy评分较停药前稍升高,但差异无统计学意义[(3.44±1.33)分比(3.11±1.05)分,(2.22±1.09)分比(2.00±0.86)分,(2.55±0.88)分比(2.22±0.66)分,(4.77±0.97)分比(4.44±0.88)分,(2.11±1.05)分比(1.67±1.00)分, P值均>0.05]。 结论:针对嗜酸粒细胞增多的难治性鼻窦炎患者,采用扩大鼻窦开放术联合术后应用小剂量奥马珠单抗,可有效控制术腔黏膜炎性反应,促进黏膜上皮化进程,在疾病早期转归关键阶段发挥重要作用。

Objective To explore the short-term efficacy of small dose omalizumab in refractory sinusitis with eosinophilia after extended sinus surgery.Methods A total of 24 patients who met the diagnostic criteria for eosinophilic chronic rhinosinusitis and remained poorly controlled after multiple surgical treatments were included in this study.These patients were admitted to Hunan People′s Hospital between January 2020 and June 2022,and comprised 13 males and 11 females with an average age of(46.43±13.74)years.The patients were randomly divided into experimental group(12 cases)and control group(12 cases),both of which underwent extended sinus opening surgery.The experimental group received a small dose of omalizumab(150 mg/month)for 4 months,while no omalizumab was applied in the control group.All patients were followed up monthly,subjective and objective symptom scores were collected and compared between groups,which included visual analogue scale(VAS)score,sino-nasal outcome test(SNOT)-22 score,Lund-Mackay score,and Lund-Kennedy score.Statistical analysis was performed using SPSS 24.0 software.Results The baseline was set at 1 month after surgery.There was no significant difference in baseline clinical characteristics between the two groups.After 4 months of treatment with omalizumab,the experimental group showed significant improvements in VAS scores for nasal obstruction,rhinorrhea,hyposmia,SNOT‐22 score,and Lund-Kennedy score(3.11±1.05 vs 6.44±1.13,2.00±0.87 vs 6.55±1.33,2.22±0.67 vs 7.00±1.22,4.44±0.88 vs 15.22±1.20,1.67±1.00 vs 7.44±0.88,respectively,all P<0.001).Compared to the control group at 4 months after baseline,the experimental group had significantly lower scores for nasal obstruction,rhinorrhea,hyposmia,SNOT-22,and Lund-Kennedy(3.11±1.05 vs 7.11±1.17,2.00±0.87 vs 7.67±1.41,2.22±0.67 vs 7.56±0.88,4.44±0.88 vs 15.33±2.34,1.67±1.00 vs 9.00±1.41,respectively,all P<0.001).During a 2-month follow-up period after drug withdrawal,the VAS,SNOT-22,and Lund-Kennedy scores of the experimental group were slightly higher than those before drug withdrawal but showed no significant difference(3.44±1.33 vs 3.11±1.05,2.22±1.09 vs 2.00±0.86,2.55±0.88 vs 2.22±0.66,4.77±0.97 vs 4.44±0.88,2.11±1.05 vs 1.67±1.00,respectively,all P>0.05).Conclusion For patients of refractory sinusitis with eosinophilia,a combination of extended sinus surgery and postoperative small dosage of omalizumab can effectively control mucous inflammation,promote mucosal epithelization,and play an important role in the critical early stage of disease recovery.