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滑石粉与氧化锌乳膏预防婴儿刺激性接触性皮炎的对比研究

Comparative Study between Talcum and Zinc Oxide Cream for the Prevention of Irritant Contact Diaper Dermatitis in Infants.

作者信息

Chaithirayanon Suthida

出版信息

J Med Assoc Thai. 2016 Nov;99 Suppl 8:S1-S6.

PMID:29901362
Abstract

BACKGROUND

Baby powder which consists of talcum powder (magnesium silicate) as an active ingredient has been popularly used for prevention of irritant contact diaper dermatitis for a long time because it has water absorbent and friction-decreased properties. There are some case reports of its side effects of pulmonary complication from massive inhalation and the risk of ovarian tumors in adult. However the clinical research on the effectiveness of talcum powder for the prevention of diaper dermatitis has not been investigated.

OBJECTIVE

To compare the effectiveness between talcum powder with topical zinc oxide cream for the prevention of irritant diaper dermatitis.

MATERIALS AND METHOD

Fifty Thai infants at the age of 6-12 months old were randomized. Either topical talcum powder or zinc oxide cream was topically applied to their skin before changing new diapers. The follow-up were conducted at week 0, 2 and 8 to evaluate an occurrence of diaper dermatitis and to collect the median time-to-event data (the duration of disease occurrence). The clinical severity was assessed by using diaper dermatitis severity scoring scale and the side effects were recorded.

RESULTS

The average age of the infants was 8.8 months old. The incidence of irritant contact diaper dermatitis from the talcum group was 4 per 1,000 persons-day (95% confidence interval, 95% CI: 2-7) while the incidence of diaper dermatitis from the zinc oxide group was 2 per 1,000 persons-day (95% CI: 1-5). The median time-to-event outcome of diaper dermatitis for the talcum group was 19 days (interquartile range, IQR: 7-29) which was earlier than that of zinc oxide group, which was 39 days (IQR: 30-59). This showed statistically significant difference (p = 0.03, Log rank test). The average of disease duration of the talcum group (mean + SD) was 2.7+0.5 days whereas that of the zinc oxide group was 3.7+3.3 days. There is no significant difference between the two groups (p = 0.34). Most of the severity of the disease found in both groups is mild. The risk evaluation of diaper dermatitis at week 8, determined by using Cox proportional hazard analysis showed that the talcum group had 5.3 times greater risk than the zinc oxide group (hazard ratio, HR; 5.3, 95% confidence interval, CI: 1.4-20.0), with significant group difference (p = 0.01). There was no adverse effect detected on both groups.

CONCLUSION

Topical zinc oxide cream was better than talcum powder for the prevention of irritant contact diaper dermatitis.

摘要

背景

由滑石粉(硅酸镁)作为活性成分组成的婴儿爽身粉,因其具有吸水和减少摩擦的特性,长期以来一直被广泛用于预防刺激性接触性尿布皮炎。有一些病例报告指出其大量吸入会引发肺部并发症以及成年后患卵巢肿瘤的风险。然而,关于滑石粉预防尿布皮炎有效性的临床研究尚未开展。

目的

比较滑石粉与外用氧化锌乳膏预防刺激性尿布皮炎的有效性。

材料与方法

将50名6至12个月大的泰国婴儿随机分组。在更换新尿布前,分别将外用滑石粉或氧化锌乳膏涂抹于他们的皮肤上。在第0、2和8周进行随访,以评估尿布皮炎的发生情况并收集事件发生的中位时间数据(疾病发生的持续时间)。使用尿布皮炎严重程度评分量表评估临床严重程度,并记录副作用。

结果

婴儿的平均年龄为8.8个月。滑石粉组刺激性接触性尿布皮炎的发病率为每1000人日4例(95%置信区间,95%CI:2 - 7),而氧化锌组尿布皮炎的发病率为每1000人日2例(95%CI:1 - 5)。滑石粉组尿布皮炎事件发生的中位时间为19天(四分位间距,IQR:7 - 29),早于氧化锌组的39天(IQR:30 - 59)。这显示出统计学上的显著差异(p = 0.03,对数秩检验)。滑石粉组疾病持续时间的平均值(均值 + 标准差)为2.7 + 0.5天,而氧化锌组为3.7 + 3.3天。两组之间无显著差异(p = 0.34)。两组中发现的大多数疾病严重程度为轻度。使用Cox比例风险分析确定的第8周尿布皮炎风险评估显示,滑石粉组的风险比氧化锌组高5.3倍(风险比,HR;5.3,95%置信区间,CI:1.4 - 20.0),组间差异显著(p = 0.01)。两组均未检测到不良反应。

结论

外用氧化锌乳膏在预防刺激性接触性尿布皮炎方面优于滑石粉。

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