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抗IgE单克隆抗体治疗重度持续性哮喘患者的临床病程及副作用

Clinical course and side effects of anti-IgE monoclonal antibody in patients with severe persistent asthma.

作者信息

Yalcin Arzu Didem, Bisgin Atil, Cetinkaya Ramazan, Yildirim Mustafa, Gorczynski Reginald M

机构信息

Allergy and Clinical Immunology Unit, Department of Internal Medicine, Antalya Education and Research Hospital, Antalya, Turkey.

出版信息

Clin Lab. 2013;59(1-2):71-7. doi: 10.7754/clin.lab.2012.120406.

DOI:10.7754/clin.lab.2012.120406
PMID:23505909
Abstract

BACKGROUND

Omalizumab, a recombinant humanized monoclonal antibody to IgE, is recommended as a new option for the treatment of severe persistent allergic asthma. The purpose of this study is to assess the effects omalizumab treatment on life quality and its side effects in severe persistent asthma patients.

METHODS

In this study, we evaluated 19 severe persistent asthma patients who received therapy with omalizumab for 8 months. Omalizumab was administered every 2 weeks at doses between 150 to 375 mg. Symptoms and severity of allergic reactions were recorded before and after being on omalizumab. IgE levels, mean platelet volume (MPV), platelet levels, pulmonary function test, and asthma control test were evaluated in all patients before and 8 months after the treatment. Local and systemic side effects of omalizumab were evaluated. Stool parasites were examined in the 4th and 8th month after initiation of treatment to investigate any parasitosis.

RESULTS

The patients had severe persistent asthma for periods ranging from 3 to 8 years, and they were diagnosed with allergic asthma for 7 - 28 years. Thrombocytopenia developed in a male patient after the 22nd dose of the drug was given. When the platelet count fell down to 55000, the omalizumab treatment was suspended. During the therapy period, one patient had parasitosis (giardiasis), one patient had severe side effects, one patient had dyspnea two hours after the injection, and one patient had a dyspnea attack 2 hours after the injection. The changes in MPV levels were not statistically significant. There was also a significant decrease in IgE levels after the treatment.

CONCLUSIONS

Monitoring of complete blood cell count is very important when using this drug. Though we did not see anaphylaxis in any patients, we believe that the patients should be monitored at least for 3 hours after the omalizumab injection.

摘要

背景

奥马珠单抗是一种重组人源化抗IgE单克隆抗体,被推荐作为治疗重度持续性过敏性哮喘的新选择。本研究旨在评估奥马珠单抗治疗对重度持续性哮喘患者生活质量的影响及其副作用。

方法

在本研究中,我们评估了19例接受奥马珠单抗治疗8个月的重度持续性哮喘患者。奥马珠单抗每2周给药一次,剂量为150至375毫克。记录使用奥马珠单抗前后的过敏反应症状和严重程度。在所有患者治疗前和治疗8个月后评估IgE水平、平均血小板体积(MPV)、血小板水平、肺功能测试和哮喘控制测试。评估奥马珠单抗的局部和全身副作用。在治疗开始后的第4个月和第8个月检查粪便寄生虫,以调查是否存在寄生虫病。

结果

患者重度持续性哮喘病史为3至8年,过敏性哮喘诊断时间为7至28年。一名男性患者在第22剂药物给药后出现血小板减少。当血小板计数降至55000时,暂停奥马珠单抗治疗。在治疗期间,一名患者发生寄生虫病(贾第虫病),一名患者出现严重副作用,一名患者在注射后2小时出现呼吸困难,一名患者在注射后2小时出现哮喘发作。MPV水平的变化无统计学意义。治疗后IgE水平也有显著下降。

结论

使用该药物时监测全血细胞计数非常重要。虽然我们在任何患者中均未观察到过敏反应,但我们认为在奥马珠单抗注射后至少应监测患者3小时。

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