Caumes E, Le Maitre M, Garnier J-M, Bricaire F, Crickx B
Service des Maladies Infectieuses et Tropicales, Hôpital Pitié-Salpêtrière, Université Pierre et Marie Curie, 47-83, boulevard de l'hôpital, 75013 Paris.
Ann Dermatol Venereol. 2006 Oct;133(10):755-60. doi: 10.1016/s0151-9638(06)71038-9.
We prospectively studied the prevalence and the clinical forms of adverse cutaneous reactions associated with the main antiseptics used in France, the incidence of which is not well known.
Patients were included by 773 French dermatologists from May to June 2003. The 8 first consecutive adult patients for whom ambulatory treatment with a cutaneous antiseptic was prescribed were included. Patients were evaluated at inclusion and after treatment, either in person or by telephone. All reported adverse cutaneous reactions were validated by two independent experts.
3,403 patients (61% women, 39% men; mean age: 47) were included. Antiseptics were indicated for ambulatory surgery (45%), technical procedures (33%), and in combination with other treatments for various dermatoses, wounds and burns (12%). The 6 most widely used treatments (96% of prescriptions) were hexamidine (37%), chlorhexidine-benzalkonium (28%), chlorhexidine-alcohol (16.5%), aqueous chlorhexidine (7%), polyvidone iodine (6%) and hexamidine-chlorhexidine (1.8%). The antiseptic was prescribed for application by dabbing (57%) or spraying (40%), twice daily for a mean 10 days (3-30 days). A transient burning sensation was noticed by 4 to 7% of the patients, without any significant difference between antiseptics. Twelve adverse events were reported: contact dermatitis in 9 patients, persistent burning sensation in 2 and yellow discoloration of the skin in one. This latter case, caused by the colour of the antiseptic, cannot be considered as an adverse event. Furthermore one patient with contact dermatitis should have not been included because he had a history of cutaneous reaction related to the use of the same antiseptic. Therefore only 10 cutaneous reactions were eventually taken into account (overall prevalence=2.9 per thousand, ranging from 0% to 0.5% according to the antiseptic). There was no significant difference in terms either of the antiseptic used or the site of the treated lesion. A history of contact dermatitis was associated with a significant risk of adverse reaction (OR=7.2; CI 95: 2.0-26.4; p=0.007). The median time from onset of treatment to appearance of contact dermatitis was 4 days (0-90 days). The condition resolved following discontinuation of treatment; spontaneously in 5 patients and with dermocorticoid therapy in 5 others.
The results of this study give a precise idea of how the antiseptics are used by French dermatologists in clinical practice in outpatients and how often their use is complicated by the occurrence of adverse cutaneous reactions. The low rate of such reactions (2.9 per thousand) in our study is thus in contrast with the impression given by the large number of publications related to this complication. It also tempers the high rates of sensitisation to various antiseptics found in selected at-risk patients. The most common adverse event observed was contact dermatitis and a history of this condition conferred a significant risk of cutaneous reaction.
Although cutaneous antiseptics are well tolerated with a low prevalence of adverse reactions, generally mild, they should nevertheless be prescribed with caution in patients with a history of contact dermatitis.
我们对法国使用的主要防腐剂相关皮肤不良反应的患病率和临床形式进行了前瞻性研究，其发生率尚不明确。
2003年5月至6月，773名法国皮肤科医生纳入了患者。纳入连续8例首次接受皮肤防腐剂门诊治疗的成年患者。在纳入时和治疗后对患者进行当面或电话评估。所有报告的皮肤不良反应均由两名独立专家进行验证。
共纳入3403例患者（61%为女性，39%为男性；平均年龄47岁）。防腐剂用于门诊手术（45%）、技术操作（33%），以及与其他治疗联合用于各种皮肤病、伤口和烧伤（12%）。6种最常用的防腐剂（占处方的96%）为己脒定（37%）、氯己定 - 苯扎氯铵（28%）、氯己定 - 酒精（16.5%）、水性氯己定（7%）、聚维酮碘（6%）和己脒定 - 氯己定（1.8%）。防腐剂的给药方式为涂抹（57%）或喷雾（40%），每日两次，平均使用10天（3 - 30天）。4%至7%的患者出现短暂烧灼感，不同防腐剂之间无显著差异。报告了12例不良事件：9例患者发生接触性皮炎，2例患者持续有烧灼感，1例患者皮肤发黄。后一例由防腐剂颜色引起，不能视为不良事件。此外，有1例接触性皮炎患者因有使用同一防腐剂的皮肤反应史，本不应纳入。因此最终仅考虑10例皮肤反应（总体患病率为千分之2.9，根据防腐剂不同，患病率在0%至0.5%之间）。所使用的防腐剂或治疗病变部位方面均无显著差异。有接触性皮炎病史与不良反应风险显著相关（比值比=7.2；95%置信区间：2.0 - 26.4；p = 0.007）。从治疗开始到出现接触性皮炎的中位时间为4天（0 - 90天）。停药后病情缓解；5例患者自行缓解，5例患者接受了糖皮质激素治疗。
本研究结果明确了法国皮肤科医生在门诊临床实践中如何使用防腐剂，以及其使用因皮肤不良反应的发生而复杂化的频率。我们研究中此类反应的低发生率（千分之2.9）与大量关于该并发症的出版物所给人的印象形成对比。这也缓和了在选定的高危患者中发现的对各种防腐剂的高致敏率。观察到的最常见不良事件是接触性皮炎，有此病史会显著增加皮肤反应风险。
尽管皮肤防腐剂耐受性良好，不良反应患病率低，且一般症状较轻，但对于有接触性皮炎病史的患者仍应谨慎使用。
