烧伤后瘙痒干预措施。
Interventions for postburn pruritus.
机构信息
Department of Comparative Biology and Experimental Medicine, University of Calgary, Calgary, Canada.
Departments of Clinical Neurosciences, Pediatrics and Surgery, University of Calgary, Calgary Firefighters' Burn Treatment Centre, Calgary, Canada.
出版信息
Cochrane Database Syst Rev. 2024 Jun 5;6(6):CD013468. doi: 10.1002/14651858.CD013468.pub2.
BACKGROUND
Postburn pruritus (itch) is a common and distressing symptom experienced on healing or healed burn or donor site wounds. Topical, systemic, and physical treatments are available to control postburn pruritus; however, it remains unclear how effective these are.
OBJECTIVES
To assess the effects of interventions for treating postburn pruritus in any care setting.
SEARCH METHODS
In September 2022, we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL Plus. We also searched clinical trials registries and scanned references of relevant publications to identify eligible trials. There were no restrictions with respect to language, publication date, or study setting.
SELECTION CRITERIA
Randomised controlled trials (RCTs) that enrolled people with postburn pruritus to compare an intervention for postburn pruritus with any other intervention, placebo or sham intervention, or no intervention.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence.
MAIN RESULTS
We included 25 RCTs assessing 21 interventions with 1166 randomised participants. These 21 interventions can be grouped into six categories: neuromodulatory agents (such as doxepin, gabapentin, pregabalin, ondansetron), topical therapies (such as CQ-01 hydrogel, silicone gel, enalapril ointment, Provase moisturiser, beeswax and herbal oil cream), physical modalities (such as massage therapy, therapeutic touch, extracorporeal shock wave therapy, enhanced education about silicone gel sheeting), laser scar revision (pulsed dye laser, pulsed high-intensity laser, fractional CO2 laser), electrical stimulation (transcutaneous electrical nerve stimulation, transcranial direct current stimulation), and other therapies (cetirizine/cimetidine combination, lemon balm tea). Most RCTs were conducted at academic hospitals and were at a high risk of performance, attrition, and detection bias. While 24 out of 25 included studies reported change in burn-related pruritus, secondary outcomes such as cost-effectiveness, pain, patient perception, wound healing, and participant health-related quality of life were not reported or were reported incompletely. Neuromodulatory agents versus antihistamines or placebo There is low-certainty evidence that doxepin cream may reduce burn-related pruritus compared with oral antihistamine (mean difference (MD) -2.60 on a 0 to 10 visual analogue scale (VAS), 95% confidence interval (CI) -3.79 to -1.42; 2 studies, 49 participants). A change of 2 points represents a minimal clinically important difference (MCID). Due to very low-certainty evidence, it is uncertain whether doxepin cream impacts the incidence of somnolence as an adverse event compared to oral antihistamine (risk ratio (RR) 0.64, 95% CI 0.32 to 1.25; 1 study, 24 participants). No data were reported on pain in the included study. There is low-certainty evidence that gabapentin may reduce burn-related pruritus compared with cetirizine (MD -2.40 VAS, 95% CI -4.14 to -0.66; 1 study, 40 participants). A change of 2 points represents a MCID. There is low-certainty evidence that gabapentin reduces the incidence of somnolence compared to cetirizine (RR 0.02, 95% CI 0.00 to 0.38; 1 study, 40 participants). No data were reported on pain in the included study. There is low-certainty evidence that pregabalin may result in a reduction in burn-related pruritus intensity compared with cetirizine with pheniramine maleate (MD -0.80 VAS, 95% CI -1.24 to -0.36; 1 study, 40 participants). A change of 2 points represents a MCID. There is low-certainty evidence that pregabalin reduces the incidence of somnolence compared to cetirizine (RR 0.04, 95% CI 0.00 to 0.69; 1 study, 40 participants). No data were reported on pain in the included study. There is moderate-certainty evidence that ondansetron probably results in a reduction in burn-related pruritus intensity compared with diphenhydramine (MD -0.76 on a 0 to 10 numeric analogue scale (NAS), 95% CI -1.50 to -0.02; 1 study, 38 participants). A change of 2 points represents a MCID. No data were reported on pain and adverse events in the included study. Topical therapies versus relevant comparators There is moderate-certainty evidence that enalapril ointment probably decreases mean burn-related pruritus compared with placebo control (MD -0.70 on a 0 to 4 scoring table for itching, 95% CI -1.04 to -0.36; 1 study, 60 participants). No data were reported on pain and adverse events in the included study. Physical modalities versus relevant comparators Compared with standard care, there is low-certainty evidence that massage may reduce burn-related pruritus (standardised mean difference (SMD) -0.86, 95% CI -1.45 to -0.27; 2 studies, 166 participants) and pain (SMD -1.32, 95% CI -1.66 to -0.98). These SMDs equate to a 4.60-point reduction in pruritus and a 3.74-point reduction in pain on a 10-point VAS. A change of 2 VAS points in itch represents a MCID. No data were reported on adverse events in the included studies. There is low-certainty evidence that extracorporeal shock wave therapy (ESWT) may reduce burn-related pruritus compared with sham stimulation (SMD -1.20, 95% CI -1.65 to -0.75; 2 studies, 91 participants). This equates to a 5.93-point reduction in pruritus on a 22-point 12-item Pruritus Severity Scale. There is low-certainty evidence that ESWT may reduce pain compared with sham stimulation (MD 2.96 on a 0 to 25 pressure pain threshold (PPT), 95% CI 1.76 to 4.16; 1 study, 45 participants). No data were reported on adverse events in the included studies. Laser scar revision versus untreated or placebo controls There is moderate-certainty evidence that pulsed high-intensity laser probably results in a reduction in burn-related pruritus intensity compared with placebo laser (MD -0.51 on a 0 to 1 Itch Severity Scale (ISS), 95% CI -0.64 to -0.38; 1 study, 49 participants). There is moderate-certainty evidence that pulsed high-intensity laser probably reduces pain compared with placebo laser (MD -3.23 VAS, 95% CI -5.41 to -1.05; 1 study, 49 participants). No data were reported on adverse events in the included studies.
AUTHORS' CONCLUSIONS: There is moderate to low-certainty evidence on the effects of 21 interventions. Most studies were small and at a high risk of bias related to blinding and incomplete outcome data. Where there is moderate-certainty evidence, practitioners should consider the applicability of the evidence for their patients.
背景
烧伤后瘙痒(瘙痒)是愈合或愈合烧伤或供体部位伤口时常见且令人痛苦的症状。有局部、全身和物理治疗方法可控制烧伤后瘙痒,但尚不清楚这些方法的效果如何。
目的
评估治疗各种治疗环境中烧伤后瘙痒的干预措施的效果。
检索方法
2022 年 9 月,我们检索了 Cochrane 伤口专业注册库、Cochrane 中央对照试验注册库(CENTRAL)、Ovid MEDLINE(包括正在进行和其他非索引引文)、Ovid Embase 和 EBSCO CINAHL Plus。我们还检索了临床试验注册处,并扫描了相关出版物的参考文献,以确定合格的试验。对语言、出版日期或研究环境没有任何限制。
入选标准
招募有烧伤后瘙痒的人,将干预措施用于烧伤后瘙痒的随机对照试验(RCT),比较干预措施与任何其他干预措施、安慰剂或假干预措施或无干预措施。
数据收集和分析
我们使用 Cochrane 预期的标准方法学程序。我们使用 GRADE 评估证据的确定性。
主要结果
我们纳入了 25 项 RCT,评估了 21 项干预措施,共纳入了 1166 名随机参与者。这些 21 项干预措施可以分为六类:神经调节药物(如多塞平、加巴喷丁、普瑞巴林、昂丹司琼)、局部治疗(如 CQ-01 水凝胶、硅凝胶、依那普利软膏、普罗瓦塞保湿霜、蜂蜡和草药油霜)、物理疗法(如按摩疗法、治疗性触摸、体外冲击波疗法、增强硅胶片使用教育)、激光瘢痕修整(脉冲染料激光、脉冲高强度激光、分秒 CO2 激光)、电刺激(经皮神经电刺激、经颅直流电刺激)和其他疗法(西替利嗪/西咪替丁联合、柠檬香脂茶)。大多数 RCT 都是在学术医院进行的,存在很高的偏倚风险,包括检测和失访偏倚。虽然 25 项研究中有 24 项报告了烧伤相关瘙痒的变化,但次要结果,如成本效益、疼痛、患者感知、伤口愈合和参与者的健康相关生活质量,并未报告或报告不完整。
神经调节药物与抗组胺药或安慰剂相比
低确定性证据表明,与口服抗组胺药相比,多塞平乳膏可能减轻烧伤相关瘙痒(0 到 10 视觉模拟量表(VAS)的平均差值(MD)-2.60,95%置信区间(CI)-3.79 至-1.42;2 项研究,49 名参与者)。2 分的变化代表了最小临床重要差异(MCID)。由于证据确定性低,尚不确定多塞平乳膏是否会影响与口服抗组胺药相比的困倦作为不良事件的发生率(风险比(RR)0.64,95%CI 0.32 至 1.25;1 项研究,24 名参与者)。在纳入的研究中,没有报告疼痛的数据。低确定性证据表明,与西替利嗪相比,加巴喷丁可能减轻烧伤相关瘙痒(MD-2.40 VAS,95%CI-4.14 至-0.66;1 项研究,40 名参与者)。2 分的变化代表了 MCID。低确定性证据表明,与西替利嗪相比,加巴喷丁降低了困倦的发生率(RR0.02,95%CI0.00 至 0.38;1 项研究,40 名参与者)。在纳入的研究中,没有报告疼痛的数据。低确定性证据表明,与西替利嗪和苯海拉明合用相比,普瑞巴林可能减轻烧伤相关瘙痒的强度(MD-0.80 VAS,95%CI-1.24 至-0.36;1 项研究,40 名参与者)。2 分的变化代表了 MCID。低确定性证据表明,与西替利嗪相比,普瑞巴林降低了困倦的发生率(RR0.04,95%CI0.00 至 0.69;1 项研究,40 名参与者)。在纳入的研究中,没有报告疼痛的数据。
与抗组胺药相比,昂丹司琼可能降低烧伤相关瘙痒的强度(MD-0.76 0 至 10 数字模拟量表(NAS),95%CI-1.50 至-0.02;1 项研究,38 名参与者)。2 分的变化代表了 MCID。在纳入的研究中,没有报告疼痛和不良反应的数据。
局部治疗与相关对照
中等确定性证据表明,与安慰剂相比,依那普利软膏可能降低烧伤相关瘙痒的平均强度(MD-0.70 在 0 到 4 瘙痒评分表上,95%CI-1.04 至-0.36;1 项研究,60 名参与者)。在纳入的研究中,没有报告疼痛和不良反应的数据。
物理疗法与相关对照
与标准护理相比,按摩可能降低烧伤相关瘙痒(标准均数差(SMD)-0.86,95%CI-1.45 至-0.27;2 项研究,166 名参与者)和疼痛(SMD-1.32,95%CI-1.66 至-0.98)的中等确定性证据。这些 SMD 相当于瘙痒的 4.60 分和疼痛的 3.74 分的降低。VAS 上瘙痒的 2 分变化代表了 MCID。在纳入的研究中,没有报告不良反应的数据。
低确定性证据表明,与假刺激相比,体外冲击波疗法(ESWT)可能减轻烧伤相关瘙痒(SMD-1.20,95%CI-1.65 至-0.75;2 项研究,91 名参与者)。这相当于 22 分 12 项瘙痒严重程度量表上瘙痒的 5.93 分降低。低确定性证据表明,与假刺激相比,ESWT 可能减轻疼痛(MD 2.96 0 至 25 压力疼痛阈值(PPT),95%CI 1.76 至 4.16;1 项研究,45 名参与者)。在纳入的研究中,没有报告不良反应的数据。
激光瘢痕修整与未治疗或安慰剂对照
中等确定性证据表明,与安慰剂激光相比,高强度脉冲激光可能降低烧伤相关瘙痒的强度(MD-0.51 在 0 至 1 瘙痒严重程度量表(ISS)上,95%CI-0.64 至-0.38;1 项研究,49 名参与者)。中等确定性证据表明,与安慰剂激光相比,高强度脉冲激光可能减轻疼痛(MD-3.23 VAS,95%CI-5.41 至-1.05;1 项研究,49 名参与者)。在纳入的研究中,没有报告不良反应的数据。
作者结论
有中等至低确定性证据表明 21 种干预措施的效果。大多数研究规模较小,且在盲法和不完整结局数据方面存在较高的偏倚风险。在具有中等确定性证据的情况下,从业者应考虑将证据的适用性应用于患者。