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对化妆品皮肤不良反应的报告能否得到改善?一项采用结构化方案的前瞻性临床研究。

Can the reporting of adverse skin reactions to cosmetics be improved? A prospective clinical study using a structured protocol.

作者信息

Berne Berit, Tammela Monica, Färm Gunilla, Inerot Annica, Lindberg Magnus

机构信息

Department of Medical Sciences, Section of Dermatology and Venereology, University Hospital, S-751 85 Uppsala, Sweden.

出版信息

Contact Dermatitis. 2008 Apr;58(4):223-7. doi: 10.1111/j.1600-0536.2007.01309.x.

DOI:10.1111/j.1600-0536.2007.01309.x
PMID:18353030
Abstract

BACKGROUND

The use of cosmetics is rising, and adverse reactions to these products are increasing. In Sweden, the Medical Products Agency (MPA) keeps a voluntary reporting system for such adverse reactions. However, the reporting is sparse, consisting almost only of cases with test-proven allergic contact dermatitis, thus under-reporting the more common irritant reactions.

OBJECTIVE

The aim of the study was to try to improve the reporting system.

PATIENTS AND METHODS

Dermatologists at 3 dermatology departments used a structured protocol during the clinical investigation of 151 consecutive patients reporting skin reactions to cosmetics. The protocol included symptoms, signs, affected body site, suspected products, and final diagnosis after patch testing. Based on clinical data and patch test results, a causality assessment for each product was made according to a protocol used at the MPA.

RESULTS

Allergic contact dermatitis was found in 28% of the patients, and irritant reactions were equally common at 27%.

CONCLUSIONS

Using this structured protocol, the cases of irritant dermatitis were also reported, and it is recommended that such a protocol is used as a standard to improve the reporting of adverse reactions to skin care products.

摘要

背景

化妆品的使用日益增加,对这些产品的不良反应也在增多。在瑞典,医疗产品管理局(MPA)设有此类不良反应的自愿报告系统。然而,报告数量稀少,几乎仅包括经检测证实的过敏性接触性皮炎病例,因此对更常见的刺激性反应报告不足。

目的

本研究旨在尝试改进报告系统。

患者与方法

3个皮肤科的皮肤科医生在对151例连续报告对化妆品有皮肤反应的患者进行临床调查时,使用了结构化方案。该方案包括症状、体征、受累身体部位、可疑产品以及斑贴试验后的最终诊断。根据临床数据和斑贴试验结果,按照MPA使用的方案对每种产品进行因果关系评估。

结果

28%的患者被发现患有过敏性接触性皮炎,刺激性反应同样常见,占27%。

结论

使用这种结构化方案,刺激性皮炎病例也得到了报告,建议将此类方案用作标准,以改进对护肤品不良反应的报告。

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