Department of Dermatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.
St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Cochrane Database Syst Rev. 2021 Oct 28;10(10):CD013870. doi: 10.1002/14651858.CD013870.pub2.
Atopic eczema (AE), also known as atopic dermatitis, is a chronic inflammatory skin condition that causes significant burden. Phototherapy is sometimes used to treat AE when topical treatments, such as corticosteroids, are insufficient or poorly tolerated.
To assess the effects of phototherapy for treating AE.
We searched the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and ClinicalTrials.gov to January 2021.
We included randomised controlled trials in adults or children with any subtype or severity of clinically diagnosed AE. Eligible comparisons were any type of phototherapy versus other forms of phototherapy or any other treatment, including placebo or no treatment.
We used standard Cochrane methodology. For key findings, we used RoB 2.0 to assess bias, and GRADE to assess certainty of the evidence. Primary outcomes were physician-assessed signs and patient-reported symptoms. Secondary outcomes were Investigator Global Assessment (IGA), health-related quality of life (HRQoL), safety (measured as withdrawals due to adverse events), and long-term control.
We included 32 trials with 1219 randomised participants, aged 5 to 83 years (mean: 28 years), with an equal number of males and females. Participants were recruited mainly from secondary care dermatology clinics, and study duration was, on average, 13 weeks (range: 10 days to one year). We assessed risk of bias for all key outcomes as having some concerns or high risk, due to missing data, inappropriate analysis, or insufficient information to assess selective reporting. Assessed interventions included: narrowband ultraviolet B (NB-UVB; 13 trials), ultraviolet A1 (UVA1; 6 trials), broadband ultraviolet B (BB-UVB; 5 trials), ultraviolet AB (UVAB; 2 trials), psoralen plus ultraviolet A (PUVA; 2 trials), ultraviolet A (UVA; 1 trial), unspecified ultraviolet B (UVB; 1 trial), full spectrum light (1 trial), Saalmann selective ultraviolet phototherapy (SUP) cabin (1 trial), saltwater bath plus UVB (balneophototherapy; 1 trial), and excimer laser (1 trial). Comparators included placebo, no treatment, another phototherapy, topical treatment, or alternative doses of the same treatment. Results for key comparisons are summarised (for scales, lower scores are better): NB-UVB versus placebo/no treatment There may be a larger reduction in physician-assessed signs with NB-UVB compared to placebo after 12 weeks of treatment (mean difference (MD) -9.4, 95% confidence interval (CI) -3.62 to -15.18; 1 trial, 41 participants; scale: 0 to 90). Two trials reported little difference between NB-UVB and no treatment (37 participants, four to six weeks of treatment); another reported improved signs with NB-UVB versus no treatment (11 participants, nine weeks of treatment). NB-UVB may increase the number of people reporting reduced itch after 12 weeks of treatment compared to placebo (risk ratio (RR) 1.72, 95% CI 1.10 to 2.69; 1 trial, 40 participants). Another trial reported very little difference in itch severity with NB-UVB (25 participants, four weeks of treatment). The number of participants with moderate to greater global improvement may be higher with NB-UVB than placebo after 12 weeks of treatment (RR 2.81, 95% CI 1.10 to 7.17; 1 trial, 41 participants). NB-UVB may not affect rates of withdrawal due to adverse events. No withdrawals were reported in one trial of NB-UVB versus placebo (18 participants, nine weeks of treatment). In two trials of NB-UVB versus no treatment, each reported one withdrawal per group (71 participants, 8 to 12 weeks of treatment). We judged that all reported outcomes were supported with low-certainty evidence, due to risk of bias and imprecision. No trials reported HRQoL. NB-UVB versus UVA1 We judged the evidence for NB-UVB compared to UVA1 to be very low certainty for all outcomes, due to risk of bias and imprecision. There was no evidence of a difference in physician-assessed signs after six weeks (MD -2.00, 95% CI -8.41 to 4.41; 1 trial, 46 participants; scale: 0 to 108), or patient-reported itch after six weeks (MD 0.3, 95% CI -1.07 to 1.67; 1 trial, 46 participants; scale: 0 to 10). Two split-body trials (20 participants, 40 sides) also measured these outcomes, using different scales at seven to eight weeks; they reported lower scores with NB-UVB. One trial reported HRQoL at six weeks (MD 2.9, 95% CI -9.57 to 15.37; 1 trial, 46 participants; scale: 30 to 150). One split-body trial reported no withdrawals due to adverse events over 12 weeks (13 participants). No trials reported IGA. NB-UVB versus PUVA We judged the evidence for NB-UVB compared to PUVA (8-methoxypsoralen in bath plus UVA) to be very low certainty for all reported outcomes, due to risk of bias and imprecision. There was no evidence of a difference in physician-assessed signs after six weeks (64.1% reduction with NB-UVB versus 65.7% reduction with PUVA; 1 trial, 10 participants, 20 sides). There was no evidence of a difference in marked improvement or complete remission after six weeks (odds ratio (OR) 1.00, 95% CI 0.13 to 7.89; 1 trial, 9/10 participants with both treatments). One split-body trial reported no withdrawals due to adverse events in 10 participants over six weeks. The trials did not report patient-reported symptoms or HRQoL. UVA1 versus PUVA There was very low-certainty evidence, due to serious risk of bias and imprecision, that PUVA (oral 5-methoxypsoralen plus UVA) reduced physician-assessed signs more than UVA1 after three weeks (MD 11.3, 95% CI -0.21 to 22.81; 1 trial, 40 participants; scale: 0 to 103). The trial did not report patient-reported symptoms, IGA, HRQoL, or withdrawals due to adverse events. There were no eligible trials for the key comparisons of UVA1 or PUVA compared with no treatment. Adverse events Reported adverse events included low rates of phototoxic reaction, severe irritation, UV burn, bacterial superinfection, disease exacerbation, and eczema herpeticum.
AUTHORS' CONCLUSIONS: Compared to placebo or no treatment, NB-UVB may improve physician-rated signs, patient-reported symptoms, and IGA after 12 weeks, without a difference in withdrawal due to adverse events. Evidence for UVA1 compared to NB-UVB or PUVA, and NB-UVB compared to PUVA was very low certainty. More information is needed on the safety and effectiveness of all aspects of phototherapy for treating AE.
特应性皮炎(AE),也称特应性湿疹,是一种慢性炎症性皮肤疾病,会导致严重的负担。当局部治疗(如皮质类固醇)不足或不耐受时,有时会使用光疗来治疗 AE。
评估光疗治疗 AE 的效果。
我们检索了 Cochrane 皮肤专题注册库、CENTRAL、MEDLINE、Embase 和 ClinicalTrials.gov,检索时间截至 2021 年 1 月。
我们纳入了任何类型的光疗与其他类型的光疗或任何其他治疗(包括安慰剂或不治疗)比较的成年或儿童的随机对照试验。纳入的比较包括任何类型的光疗与其他类型的光疗或任何其他治疗(包括安慰剂或不治疗)。
我们使用了标准的 Cochrane 方法。对于主要发现,我们使用 RoB 2.0 评估偏倚,使用 GRADE 评估证据的确定性。主要结果是医生评估的体征和患者报告的症状。次要结果是研究者全球评估(IGA)、健康相关生活质量(HRQoL)、安全性(因不良反应而退出的测量)和长期控制。
我们纳入了 32 项试验,共 1219 名随机参与者,年龄 5 至 83 岁(平均 28 岁),男女各占一半。参与者主要从二级皮肤科诊所招募,研究持续时间平均为 13 周(范围:10 天至 1 年)。我们对所有主要结局的风险偏倚评估为存在一些关注或高风险,原因是数据缺失、分析不当或信息不足,无法评估选择性报告。评估的干预措施包括:窄谱中波紫外线(NB-UVB);长波紫外线 A1(UVA1);广谱中波紫外线(BB-UVB);紫外线 AB(UVAB);补骨脂素加紫外线 A(PUVA);长波紫外线(UVA);未特指的中波紫外线(UVB);全光谱光(1 项试验);Saalmann 选择性紫外线光疗(SUP)舱(1 项试验);盐水浴加 UVB(光疗浴;1 项试验);和准分子激光(1 项试验)。对照包括安慰剂、不治疗、其他光疗、局部治疗或相同治疗的不同剂量。关键比较结果总结如下(对于量表,分数越低越好):NB-UVB 与安慰剂/不治疗:与安慰剂相比,NB-UVB 治疗 12 周后可能会导致医生评估的体征更大程度的改善(MD-9.4,95%置信区间(CI)-3.62 至-15.18;1 项试验,41 名参与者;量表:0 至 90)。两项试验报告 NB-UVB 与不治疗之间的差异很小(37 名参与者,治疗 4 至 6 周);另一项试验报告 NB-UVB 比不治疗改善体征(11 名参与者,治疗 9 周)。与安慰剂相比,NB-UVB 治疗 12 周后可能会增加报告瘙痒减轻的人数(RR 1.72,95%置信区间(CI)1.10 至 2.69;1 项试验,40 名参与者)。另一项试验报告 NB-UVB 对瘙痒严重程度的影响非常小(25 名参与者,治疗 4 周)。与安慰剂相比,NB-UVB 治疗 12 周后可能会有更多的参与者报告整体改善(RR 2.81,95%置信区间(CI)1.10 至 7.17;1 项试验,41 名参与者)。与安慰剂相比,NB-UVB 可能不会增加因不良反应而退出的人数。一项 NB-UVB 与安慰剂(18 名参与者,治疗 9 周)的试验报告没有因不良反应而退出的参与者。在 NB-UVB 与不治疗的两项试验中,每组各有一名参与者退出(71 名参与者,治疗 8 至 12 周)。我们认为所有报告的结果都支持低确定性证据,因为存在偏倚和不准确性。没有报告关于健康相关生活质量的结果。NB-UVB 与 UVA1:我们认为 NB-UVB 与 UVA1 相比的证据,由于偏倚和不准确性,所有结局的确定性都非常低。在 6 周时,我们没有证据表明医生评估的体征(MD-2.00,95%置信区间(CI)-8.41 至 4.41;1 项试验,46 名参与者;量表:0 至 108)或患者报告的瘙痒(MD 0.3,95%置信区间(CI)-1.07 至 1.67;1 项试验,46 名参与者;量表:0 至 10)有差异。两项分体型试验(20 名参与者,40 侧)也在 7 至 8 周时使用不同的量表测量了这些结果,他们报告说 NB-UVB 的分数较低。一项试验报告了 6 周时的健康相关生活质量(MD 2.9,95%置信区间(CI)-9.57 至 15.37;1 项试验,46 名参与者;量表:30 至 150)。一项分体型试验报告了 12 周内无因不良反应而退出的参与者(13 名参与者)。没有报告关于 IGA 的结果。NB-UVB 与 PUVA:我们认为 NB-UVB 与 PUVA(8-甲氧基补骨脂素在浴中加 UVA)相比的证据,由于偏倚和不准确性,所有报告的结果的确定性都非常低。在 6 周时,我们没有证据表明医生评估的体征有差异(NB-UVB 组的 64.1%的减少与 PUVA 组的 65.7%的减少;1 项试验,10 名参与者,20 侧)。在 6 周时,也没有证据表明明显改善或完全缓解有差异(OR 1.00,95%置信区间(CI)0.13 至 7.89;1 项试验,9/10 名参与者的两种治疗都有)。一项分体型试验报告了 6 周内无因不良反应而退出的参与者(10 名参与者)。试验没有报告患者报告的症状或健康相关生活质量。UVA1 与 PUVA:由于严重的偏倚和不准确性,我们有非常低确定性的证据表明,与 UVA1 相比,PUVA(口服 5-甲氧基补骨脂素加 UVA)在 3 周时减少了医生评估的体征(MD 11.3,95%置信区间(CI)-0.21 至 22.81;1 项试验,40 名参与者;量表:0 至 103)。试验没有报告患者报告的症状、IGA、健康相关生活质量或因不良反应而退出的情况。没有纳入与 NB-UVB 或 PUVA 相比不治疗的关键比较的试验。不良事件:报告的不良事件包括低水平的光毒性反应、严重的刺激、UV 灼伤、细菌继发感染、疾病恶化和疱疹性湿疹。
与安慰剂或不治疗相比,NB-UVB 可能在 12 周时改善医生评估的体征、患者报告的症状和 IGA,而不良反应退出的比例没有差异。与 NB-UVB 或 PUVA 相比,UVA1 的证据和 NB-UVB 与 PUVA 的证据均为非常低确定性。我们需要更多关于光疗治疗 AE 的所有方面的安全性和有效性的信息。