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摘要: 目的 比较奥马珠单抗联合冲击免疫治疗(RIT)与糖皮质激素联合RIT在剂量递增阶段的临床安全性。方法 回顾性研究88例行RIT治疗的变应性鼻炎患者的临床资料，包括性别、年龄、治疗前总VAS评分、血中EOS%、血清总IgE、局部及全身不良反应。88例中奥马珠单抗联合RIT(试验组)57例，激素/抗过敏药联合RIT(对照组)31例，比较2组在剂量递增阶段的治疗安全性。结果 试验组在剂量递增阶段住院期间、出院第1针、出院第2针均未出现Ⅰ级全身不良反应；出现Ⅱ级全身不良反应分别为4例(7.1%)，2例(3.6%)，0例(0)；未出现局部瘙痒及硬结症状。对照组在住院期间、出院第1针、出院第2针的Ⅰ级全身不良反应分别为1例(3.4%)、2例(6.9%)、1例(3.4%)；出现Ⅱ级全身不良反应分别为5例(17.2%)、1例(3.4%)、0例(0)；在住院期间8例患者出现局部注射部位瘙痒(其中5例为轻度瘙痒，3例为中度瘙痒)，4例(13.8%)患者出现局部硬结。结论 奥马珠单抗联合RIT不仅缩短了特异性免疫治疗剂量递增阶段的疗程，还增加了剂量递增阶段住院期间及出院后第1、2针的安全性，提高了患者的依从性。Abstract: Objective To observe the safety of omalizumab and glucocorticoid in the dose-increasing phase of rush allergen immunotherapy(RIT).Method The clinical data of 88 patients with allergic rhinitis treated with RIT were retrospectively studied, including gender, age, pre-treatment total VAS score, blood EOS%, serum total IgE, local and systemic adverse reactions. Of all patients, fifty-seven were treated with omalizumab combined with RIT(experimental group) and thirty-one were treated with hormone/antiallergic drugs combined with RIT(control group). The safety of the two groups was compared in the dose-increasing phase.Result There was no grade Ⅰ systemic adverse reactions during the whole process in the experimental group, while Grade Ⅱ systemic adverse reactions were 4 cases(7.1%) during the period of hospitalization, 2 cases(3.6%) after the first injection after discharge, zero(0) after the second injection after discharge. No local pruritus and induration were observed. During the period of hospitalization, the first and second injection after discharge, control group had grade Ⅰ level systemic adverse reactions were 1 case(3.4%), 2 cases(6.9%), 1 case(3.4%) at different time point, respectively. Grade Ⅱ systemic adverse reactions were 5 cases(17.2%), 1 case(3.4%), zero(0) at different time point, respectively. Local injection site itching was observed in 8 patients(5 cases were mild and 3 cases were moderate) and 4 cases(13.8%) had induration during hospitalization.Conclusion Omalizumab combined with RIT not only shortens the duration of dose-increasing phase of specific immunotherapy, but also increases the safety of the dose-increasing phase during hospitalization, the first and second injection after discharge and improves patient compliance.
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Key words:
- rhinitis, allergic /
- omalizumab /
- glucocorticoid /
- rush allergen immunotherapy /
- security
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表 1 快速脱敏治疗方案
试验组 对照组 容量/mL 总量SQ-U 注射时间 容量/mL 总量SQ-U 注射时间 第1天 奥马珠单抗 150 mg - 0.1 10 9AM - - - 0.1 100 11AM - - - 0.1 1 000 3PM 第2天 0.1 10 10AM 0.2 2 000 9AM 0.1 100 11AM 0.4 4 000 11AM 0.1 1 000 3PM 0.6 6 000 3PM 第3天 0.2 2 000 10AM 0.8 8 000 9AM 0.4 4 000 3PM 0.1 10 000 11AM - - - 0.2 20 000 3PM 第4天 0.1 10 000 10AM 0.3 30 000 9AM 0.2 20 000 3PM 0.4 40 000 3PM 第5天 0.4 40 000 10AM 0.5 50 000 9AM 0.6 60 000 3PM 0.6 60 000 3PM 第6天 - - - 1.0 100 000 9AM 出院后2周 0.5 50 000 间隔30 min 1.0 100 000 - 0.5 50 000 - - - - 出院后6周 1.0 100 000 - 1.0 100 000 - 
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表 2 2组患者的基本资料对比
x±s 参数 试验组 对照组 P 男：女 37：20 15：16 0.3221 年龄/岁 16.00±12.00 18.74±8.37 0.3208 治疗前症状总评分 7.44±2.32 5.65±2.02 0.0006 治疗前总VAS评分 6.32±2.00 7.10±1.89 0.0829 哮喘病史/例(%) 5(8.77) 3(9.68) 0.9886 血中EOS% 6.66±4.26 5.20±3.02 0.1001 血清总IgE/(kU·L-1) 487.80±558.39 867.10±1112.36 0.0676 血清特异性尘螨IgE/(kUA·L-1) 52.85±49.85 16.50±10.82 0.0011 血清特异性尘螨IgE>100 kUA/L者均以100 kUA/L计算。
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表 3 2组患者不良反应的比较
例(%) 不良反应 试验组(56例) 对照组(29例) 住院期间 出院第1针 出院第2针 住院期间 出院第1针 出院第2针 硬结 0(0) 0(0) 0(0) 4(13.8) 0(0) 0(0) 瘙痒程度 轻度 0(0) 0(0) 0(0) 5(17.2) 0(0) 0(0) 中度 0(0) 0(0) 0(0) 3(10.3) 0(0) 0(0) 重度 0(0) 0(0) 0(0) 0(0) 0(0) 0(0) 全身不良反应 Ⅰ级 0(0) 0(0) 0(0) 1(3.4) 2(6.9) 1(3.4) Ⅱ级 4(7.1) 2(3.6) 0(0) 5(17.2) 1(3.4) 0(0) Ⅲ级 0(0) 0(0) 0(0) 0(0) 0(0) 0(0) Ⅳ级 0(0) 0(0) 0(0) 0(0) 0(0) 0(0)
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| 引用本文: |
高培, 余文婷, 周玥, 等. 奥马珠单抗联合RIT与糖皮质激素联合RIT的安全性比较[J]. 临床耳鼻咽喉头颈外科杂志, 2020, 34(7): 610-614. doi: 10.13201/j.issn.2096-7993.2020.07.008
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| Citation: |
GAO Pei, YU Wenting, ZHOU Yue, et al. Safety comparison of omalizumab and glucocorticoid in rush allergen immunotherapy[J]. J Clin Otorhinolaryngol Head Neck Surg, 2020, 34(7): 610-614. doi: 10.13201/j.issn.2096-7993.2020.07.008
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