陈余雪.新型冠状病毒肺炎期间风湿病患者应用生物制剂的安全性评估[J].内科急危重症杂志,2021,27(2):117-120
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| DOI：10.11768/nkjwzzzz20210207 |
| 中文关键词: 新型冠状病毒肺炎 SARS-CoV-2 生物制剂 风湿免疫性疾病 |
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| 摘要点击次数: 1991 |
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| 中文摘要: |
| 目的：评估风湿病患者在新型冠状病毒肺炎（COVID-19）疫情期间应用生物制剂（包括依那西普、阿达木单抗、托法替布、巴瑞替尼、托珠单抗）的安全性，为风湿病患者在疫情爆发期间能否使用生物制剂提供临床指导。方法：通过电话随访和自制问卷的方式，对1 154名在COVID-19疫情爆发（即2019年12月）前有生物制剂使用记录的湖北省风湿病患者进行随访调查，收集患者的临床资料，包括性别、年龄、疾病诊断、病程、合并症、用药史、有无疾病复发、COVID-19暴露史、是否感染COVID-19等。结果：排除疫情期间不在湖北居住（2019年12月~2020年 4月）、失访或死亡（死因非COVID-19），及停用生物制剂超过该药物五个半衰期以上的患者，湖北省共计有999例患者纳入研究。所有使用生物制剂患者均未感染COVID-19，仅1例患者在停用巴瑞替尼1个月后感染COVID-19。相较于疫情期间停用生物制剂的患者而言，使用巴瑞替尼的风湿病患者复发率较低。其他生物制剂组如托珠单抗、依那西普、阿达木单抗中，停药组和用药组的激素及抗风湿类药物（DMARDs）使用率、疾病复发率比较差异无显著统计学意义。结论：疫情期间风湿病患者使用生物制剂并不会增加感染SARS-CoV-2的风险，可持续使用生物制剂或靶向抑制剂，以降低疾病复发率及感染风险。 |
| 英文摘要: |
| Objective: To evaluate the safety of background use of biological agents (etanercept, adalimumab, tofacitinib, tocilizumab, and baricitinib) in patients with rheumatic disease during the COVID-19 epidemic, aiming to provide real-world evidence for the management guidelines in patients with rheumatic diseases during the pandemic. Methods: A total of 1154 patients with rheumatic diseases who had used biological agents before the epidemic (December 2019) were recruited. Demographic and clinical data, including gender, age, diagnosis, duration, symptoms, signs, recent exposure history, comorbidities and medication history were collected through a telephone follow-up. Results: We excluded patients who were not living in Hubei during the outbreak, lost follow-up, or died (not because of COVID-19). Those who had withdrawal time of bDMARDs or tsDMARDs over five half time were also excluded. A total of 999 patients were enrolled from 1154 rheumatic patients who were using or had used biological target therapy in Hubei, China. All patients were not infected with COVID-19. Only 1 patient died of COVID-19 infection one month after the withdrawal of baricitinib. As compared with the with drawal group, the recurrence rate of rheumatic disease was significantly lower in patients treated with baricitinib, but not in those treated with tocilizumab, etanercept, or adalimumab. Conclusion: Rheumatic patients treated with background biological therapies (bDMARDs or tsDMARDs) do not seem to be at increased risk of SARS-CoV-2 infections. We suggest to continue all biological therapies as usual, since medicines interruption could lead to recurrence of disease, which may in turn cause higher infectious risk, including COVID-19. |
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