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生物治疗期间的不良事件——聚焦皮肤副作用

[Adverse events during biological therapy -- focusing on dermatological side-effects].

作者信息

Nagy Gabriella, Lukács Katalin, Sziray Agnes, Fazekas Katalin, Florián Agnes, Tamási László, Károlyi Zsuzsánna

机构信息

Miskolci Semmelweis Ignác Egészségügyi Központ Nonprofit Kft. Miskolc Csabai kapu 9-11. 3526.

出版信息

Orv Hetil. 2011 Feb 6;152(6):212-20. doi: 10.1556/OH.2011.28987.

DOI:10.1556/OH.2011.28987
PMID:21278026
Abstract

UNLABELLED

Biological response modifiers, especially tumour necrosis factor inhibitors have been proved to be very effective in the treatment of various immune mediated rheumatological, gastroenterological and dermatological diseases in the last 15 years. With their increasing use, the incidence of their adverse effects are more precisely defined. The aim of this cohort study was to analyse the adverse effects occurred within the study period in patients receiving biological therapy for rheumatological and dermatological autoimmune diseases.

METHODS

324 patients within a 3 years study period were treated with biological response modifiers (adalimumab: 92, etanercept: 107, infliximab: 125). The primary diagnoses were rheumotoid arthritis (n = 174), ankylosing spondylitis (n = 60), psoriatic arthritis (n = 11), and psoriasis vulgaris (79).

RESULTS

Hypersensitive reactions were observed in 11 of the patients (3.4%), 7 of which were serious and needed treatment termination. Infections constituted the majority of side effects, which were localised to skin in 10 (3.1%) and to respiratory tract in 9 (2.8%). However, most of these were mild or moderate reactions. Malignant skin tumour developed in 1 case (0.3%) only. Drug induced inflammatory disorders occurred in some cases: onset of new psoriasis was observed in 1 and flares of the existing disease were detected in additional three. Lichenoid exanthema developed in one. (n = 5, 1.5%)

CONCLUSION

The use of TNF-α blockers may provoke a broad spectrum of dermatological side effects. Our results suggest that the majority of these are infectious and inflammatory disorders, the latter may relatively often appear as drug induced psoriasis. The occurrence of malignancies was very low in our series.

摘要

未标注

在过去15年中,生物反应调节剂,尤其是肿瘤坏死因子抑制剂已被证明在治疗各种免疫介导的风湿性、胃肠病学和皮肤病学疾病方面非常有效。随着它们的使用越来越多,其不良反应的发生率得到了更精确的界定。这项队列研究的目的是分析在研究期间接受生物疗法治疗风湿性和皮肤病自身免疫性疾病的患者中发生的不良反应。

方法

在3年的研究期间,324例患者接受了生物反应调节剂治疗(阿达木单抗:92例,依那西普:107例,英夫利昔单抗:125例)。主要诊断为类风湿性关节炎(n = 174)、强直性脊柱炎(n = 60)、银屑病关节炎(n = 11)和寻常型银屑病(79例)。

结果

11例患者(3.4%)出现过敏反应,其中7例严重,需要终止治疗。感染是副作用的主要组成部分,其中10例(3.1%)局限于皮肤,9例(2.8%)局限于呼吸道。然而,这些大多是轻度或中度反应。仅1例(0.3%)发生恶性皮肤肿瘤。某些情况下出现药物性炎症性疾病:1例出现新发银屑病,另外3例检测到现有疾病发作。1例出现苔藓样疹(n = 5,1.5%)。

结论

使用TNF-α阻滞剂可能引发广泛的皮肤副作用。我们的结果表明,其中大多数是感染性和炎症性疾病,后者可能相对经常表现为药物性银屑病。在我们的系列中,恶性肿瘤的发生率非常低。

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