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用于湿疹的润肤剂和保湿剂。

Emollients and moisturisers for eczema.

作者信息

van Zuuren Esther J, Fedorowicz Zbys, Christensen Robin, Lavrijsen Adriana, Arents Bernd WM

机构信息

Department of Dermatology, Leiden University Medical Center, PO Box 9600, B1-Q, Leiden, Netherlands, 2300 RC.

Bahrain Branch, Cochrane, Box 25438, Awali, Bahrain.

出版信息

Cochrane Database Syst Rev. 2017 Feb 6;2(2):CD012119. doi: 10.1002/14651858.CD012119.pub2.

Abstract

BACKGROUND

Eczema is a chronic skin disease characterised by dry skin, intense itching, inflammatory skin lesions, and a considerable impact on quality of life. Moisturisation is an integral part of treatment, but it is unclear if moisturisers are effective.

OBJECTIVES

To assess the effects of moisturisers for eczema.

SEARCH METHODS

We searched the following databases to December 2015: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, the GREAT database. We searched five trials registers and checked references of included and excluded studies for further relevant trials.

SELECTION CRITERIA

Randomised controlled trials in people with eczema.

DATA COLLECTION AND ANALYSIS

We used standard Cochrane methodological procedures.

MAIN RESULTS

We included 77 studies (6603 participants, mean age: 18.6 years, mean duration: 6.7 weeks). We assessed 36 studies as at a high risk of bias, 34 at unclear risk, and seven at low risk. Twenty-four studies assessed our primary outcome 'participant-assessed disease severity', 13 assessed 'satisfaction', and 41 assessed 'adverse events'. Secondary outcomes included investigator-assessed disease severity (addressed in 65 studies), skin barrier function (29), flare prevention (16), quality of life (10), and corticosteroid use (eight). Adverse events reporting was limited (smarting, stinging, pruritus, erythema, folliculitis).Six studies evaluated moisturiser versus no moisturiser. 'Participant-assessed disease severity' and 'satisfaction' were not assessed. Moisturiser use yielded lower SCORAD than no moisturiser (three studies, 276 participants, mean difference (MD) -2.42, 95% confidence interval (CI) -4.55 to -0.28), but the minimal important difference (MID) (8.7) was unmet. There were fewer flares with moisturisers (two studies, 87 participants, RR 0.40, 95% CI 0.23 to 0.70), time to flare was prolonged (median: 180 versus 30 days), and less topical corticosteroids were needed (two studies, 222 participants, MD -9.30 g, 95% CI -15.3 to -3.27). There was no statistically significant difference in adverse events (one study, 173 participants, risk ratio (RR) 15.34, 95% CI 0.90 to 261.64). Evidence for these outcomes was low quality.With Atopiclair (three studies), 174/232 participants experienced improvement in participant-assessed disease severity versus 27/158 allocated to vehicle (RR 4.51, 95% CI 2.19 to 9.29). Atopiclair decreased itching (four studies, 396 participants, MD -2.65, 95% CI -4.21 to -1.09) and achieved more frequent satisfaction (two studies, 248 participants, RR 2.14, 95% CI 1.58 to 2.89), fewer flares (three studies, 397 participants, RR 0.18, 95% CI 0.11 to 0.31), and lower EASI (four studies, 426 participants, MD -4.0, 95% CI -5.42 to -2.57), but MID (6.6) was unmet. The number of participants reporting adverse events was not statistically different (four studies, 430 participants, RR 1.03, 95% CI 0.79 to 1.33). Evidence for these outcomes was moderate quality.Participants reported skin improvement more frequently with urea-containing cream than placebo (one study, 129 participants, RR 1.28, 95% CI 1.06 to 1.53; low-quality evidence), with equal satisfaction between the two groups (one study, 38 participants, low-quality evidence). Urea-containing cream improved dryness (investigator-assessed) more frequently (one study, 128 participants, RR 1.40, 95% CI 1.14 to 1.71; moderate-quality evidence) with fewer flares (one study, 44 participants, RR 0.47, 95% CI 0.24 to 0.92; low-quality evidence), but more participants in this group reported adverse events (one study, 129 participants, RR 1.65, 95% CI 1.16 to 2.34; moderate-quality evidence).Three studies assessed glycerol-containing moisturiser versus vehicle or placebo. More participants in the glycerol group noticed skin improvement (one study, 134 participants, RR 1.22, 95% CI 1.01 to 1.48; moderate-quality evidence), and this group saw improved investigator-assessed SCORAD (one study, 249 participants, MD -2.20, 95% CI -3.44 to -0.96; high-quality evidence), but MID was unmet. Participant satisfaction was not addressed. The number of participants reporting adverse events was not statistically significant (two studies, 385 participants, RR 0.90, 95% CI 0.68 to 1.19; moderate-quality evidence).Four studies investigated oat-containing moisturisers versus no treatment or vehicle. No significant differences between groups were reported for participant-assessed disease severity (one study, 50 participants, RR 1.11, 95% CI 0.84 to 1.46; low-quality evidence), satisfaction (one study, 50 participants, RR 1.06, 95% CI 0.74 to 1.52; very low-quality evidence), and investigator-assessed disease severity (three studies, 272 participants, standardised mean difference (SMD) -0.23, 95% CI -0.66 to 0.21; low-quality evidence). In the oat group, there were fewer flares (one study, 43 participants, RR 0.31, 95% CI 0.12 to 0.7; low-quality evidence) and less topical corticosteroids needed (two studies, 222 participants, MD -9.30g, 95% CI 15.3 to -3.27; low-quality evidence), but more adverse events were reported (one study, 173 participants; Peto odds ratio (OR) 7.26, 95% CI 1.76 to 29.92; low-quality evidence).All moisturisers above were compared to placebo, vehicle, or no moisturiser. Participants considered moisturisers more effective in reducing eczema (five studies, 572 participants, RR 2.46, 95% CI 1.16 to 5.23; low-quality evidence) and itch (seven studies, 749 participants, SMD -1.10, 95% CI -1.83 to -0.38) than control. Participants in both treatment arms reported comparable satisfaction (three studies, 296 participants, RR 1.35, 95% CI 0.77 to 2.26; low-quality evidence). Moisturisers led to lower investigator-assessed disease severity (12 studies, 1281 participants, SMD -1.04, 95% CI -1.57 to -0.51; high-quality evidence) and fewer flares (six studies, 607 participants, RR 0.33, 95% CI 0.17 to 0.62; moderate-quality evidence), but there was no difference in adverse events (10 studies, 1275 participants, RR 1.03, 95% CI 0.82 to 1.30; moderate-quality evidence).Topical active treatment combined with moisturiser was more effective than active treatment alone in reducing investigator-assessed disease severity (three studies, 192 participants, SMD -0.87, 95% CI -1.17 to -0.57; moderate-quality evidence) and flares (one study, 105 participants, RR 0.43, 95% CI 0.20 to 0.93), and was preferred by participants (both low-quality evidence). There was no statistically significant difference in number of adverse events (one study, 125 participants, RR 0.39, 95% CI 0.13 to 1.19; very low-quality evidence). Participant-assessed disease severity was not addressed.

AUTHORS' CONCLUSIONS: Most moisturisers showed some beneficial effects, producing better results when used with active treatment, prolonging time to flare, and reducing the number of flares and amount of topical corticosteroids needed to achieve similar reductions in eczema severity. We did not find reliable evidence that one moisturiser is better than another.

摘要

背景

湿疹是一种慢性皮肤病,其特征为皮肤干燥、剧烈瘙痒、炎症性皮肤损伤,对生活质量有相当大的影响。保湿是治疗的一个组成部分,但保湿剂是否有效尚不清楚。

目的

评估保湿剂对湿疹的疗效。

检索方法

我们检索了以下数据库至2015年12月:Cochrane皮肤专科注册库、CENTRAL、MEDLINE、Embase、LILACS、GREAT数据库。我们检索了五个试验注册库,并检查了纳入和排除研究的参考文献以寻找更多相关试验。

入选标准

针对湿疹患者的随机对照试验。

数据收集与分析

我们采用标准的Cochrane方法学程序。

主要结果

我们纳入了77项研究(6603名参与者,平均年龄:18.6岁,平均病程:6.7周)。我们评估36项研究存在高偏倚风险,34项风险不明,7项低风险。24项研究评估了我们的主要结局“参与者评估的疾病严重程度”,13项评估了“满意度”,41项评估了“不良事件”。次要结局包括研究者评估的疾病严重程度(65项研究涉及)、皮肤屏障功能(29项)、预防皮疹发作(16项)、生活质量(10项)和皮质类固醇使用情况(8项)。不良事件报告有限(刺痛、灼痛、瘙痒、红斑、毛囊炎)。

六项研究比较了保湿剂与不使用保湿剂的情况。未评估“参与者评估的疾病严重程度”和“满意度”。使用保湿剂的SCORAD低于不使用保湿剂(三项研究,276名参与者,平均差值(MD)-2.42,95%置信区间(CI)-4.55至-0.28),但未达到最小重要差异(MID)(8.7)。使用保湿剂时皮疹发作较少(两项研究,87名参与者,RR 0.40,95%CI 0.23至0.70),发作时间延长(中位数:180天对30天),且需要的外用皮质类固醇较少(两项研究,222名参与者,MD -9.30g,95%CI -15.3至-3.27)。不良事件无统计学显著差异(一项研究,173名参与者,风险比(RR)15.34,95%CI 0.90至261.64)。这些结局的证据质量低。

使用Atopiclair(三项研究)时,174/232名参与者的参与者评估疾病严重程度有所改善,而分配到赋形剂组的27/158名参与者有改善(RR 4.51,95%CI 2.19至9.29)。Atopiclair减轻了瘙痒(四项研究,396名参与者,MD -2.65,95%CI -4.21至-1.09),更频繁地获得了满意度(两项研究,248名参与者,RR 2.14,95%CI 1.58至2.89),皮疹发作较少(三项研究,397名参与者,RR 0.18,95%CI 0.11至0.31),EASI较低(四项研究,426名参与者,MD -4.0,95%CI -5.42至-2.57),但未达到MID(6.6)。报告不良事件的参与者数量无统计学差异(四项研究,430名参与者,RR 1.03,95%CI 0.79至1.33)。这些结局的证据质量中等。

与安慰剂相比,参与者报告含尿素乳膏改善皮肤的频率更高(一项研究,129名参与者,RR 1.28,95%CI 1.06至1.53;低质量证据),两组满意度相同(一项研究,38名参与者,低质量证据)。含尿素乳膏更频繁地改善了干燥情况(研究者评估)(一项研究,128名参与者,RR 1.40,95%CI 1.14至1.71;中等质量证据),皮疹发作较少(一项研究,44名参与者,RR 0.47,95%CI 0.24至0.92;低质量证据),但该组更多参与者报告了不良事件(一项研究,129名参与者,RR 1.65,95%CI 1.16至2.34;中等质量证据)。

三项研究比较了含甘油保湿剂与赋形剂或安慰剂。甘油组更多参与者注意到皮肤改善(一项研究,134名参与者,RR 1.22,95%CI 1.01至1.48;中等质量证据),该组研究者评估的SCORAD有所改善(一项研究,249名参与者,MD -2.20,95%CI -3.44至-0.96;高质量证据),但未达到MID。未涉及参与者满意度。报告不良事件的参与者数量无统计学显著差异(两项研究,385名参与者,RR 0.90,95%CI 0.68至1.19;中等质量证据)。

四项研究比较了含燕麦保湿剂与不治疗或赋形剂。在参与者评估的疾病严重程度(一项研究,50名参与者,RR 1.11,95%CI 0.84至1.46;低质量证据)、满意度(一项研究,50名参与者,RR 1.06,95%CI 0.74至1.52;极低质量证据)和研究者评估的疾病严重程度(三项研究,272名参与者,标准化均值差(SMD)-0.23,95%CI -0.66至0.21;低质量证据)方面,各研究组之间未报告显著差异。在燕麦组中,皮疹发作较少(一项研究,43名参与者,RR 0.31,95%CI 0.12至0.7;低质量证据),需要的外用皮质类固醇较少(两项研究,222名参与者,MD -9.30g,95%CI 15.3至-3.27;低质量证据),但报告的不良事件较多(一项研究,173名参与者;Peto比值比(OR)7.26,95%CI 1.76至29.92;低质量证据)。

上述所有保湿剂均与安慰剂、赋形剂或不使用保湿剂进行了比较。参与者认为保湿剂在减轻湿疹(五项研究,572名参与者,RR 2.46,95%CI 1.16至5.23;低质量证据)和瘙痒(七项研究,749名参与者,SMD -1.10,95%CI -1.83至-0.38)方面比对照组更有效。两个治疗组的参与者报告的满意度相当(三项研究,296名参与者,RR 1.35,95%CI 0.77至2.26;低质量证据)。保湿剂导致研究者评估的疾病严重程度较低(12项研究,1281名参与者,SMD -1.04,95%CI -1.57至-0.51;高质量证据),皮疹发作较少(六项研究,607名参与者,RR 0.33,95%CI 0.17至0.62;中等质量证据),但不良事件无差异(10项研究,1275名参与者RR 1.03,95%CI 0.82至1.30;中等质量证据)。

外用活性治疗联合保湿剂在降低研究者评估的疾病严重程度(三项研究,192名参与者,SMD -0.87,95%CI -1.17至-0.57;中等质量证据)和皮疹发作(一项研究,105名参与者,RR 0.43,95%CI 0.20至0.93)方面比单纯活性治疗更有效,且更受参与者青睐(均为低质量证据)。不良事件数量无统计学显著差异(一项研究,125名参与者,RR 0.39,95%CI 0.13至1.19;极低质量证据)。未涉及参与者评估的疾病严重程度。

作者结论

大多数保湿剂显示出一些有益效果,与活性治疗联合使用时效果更佳,可延长皮疹发作时间,减少皮疹发作次数以及实现类似湿疹严重程度降低所需的外用皮质类固醇用量。我们未找到可靠证据表明一种保湿剂优于另一种。

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