Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
EMERGING Research, Manchester Foundation Trust, Manchester, UK.
Cochrane Database Syst Rev. 2021 Jul 26;7(7):CD013397. doi: 10.1002/14651858.CD013397.pub2.
BACKGROUND: Leg ulcers are open skin wounds on the lower leg that can last weeks, months or even years. Most leg ulcers are the result of venous diseases. First-line treatment options often include the use of compression bandages or stockings. OBJECTIVES: To assess the effects of using compression bandages or stockings, compared with no compression, on the healing of venous leg ulcers in any setting and population. SEARCH METHODS: In June 2020 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 We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions by language, date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials that compared any types of compression bandages or stockings with no compression in participants with venous leg ulcers in any setting. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, and risk-of-bias assessment using the Cochrane risk-of-bias tool. We assessed the certainty of the evidence according to GRADE methodology. MAIN RESULTS: We included 14 studies (1391 participants) in the review. Most studies were small (median study sample size: 51 participants). Participants were recruited from acute-care settings, outpatient settings and community settings, and a large proportion (65.9%; 917/1391) of participants had a confirmed history or clinical evidence of chronic venous disease, a confirmed cause of chronic venous insufficiency, or an ankle pressure/brachial pressure ratio of greater than 0.8 or 0.9. The average age of participants ranged from 58.0 to 76.5 years (median: 70.1 years). The average duration of their leg ulcers ranged from 9.0 weeks to 31.6 months (median: 22.0 months), and a large proportion of participants (64.8%; 901/1391) had ulcers with an area between 5 and 20 cm. Studies had a median follow-up of 12 weeks. Compression bandages or stockings applied included short-stretch bandage, four-layer compression bandage, and Unna's boot (a type of inelastic gauze bandage impregnated with zinc oxide), and comparator groups used included 'usual care', pharmacological treatment, a variety of dressings, and a variety of treatments where some participants received compression (but it was not the norm). Of the 14 included studies, 10 (71.4%) presented findings which we consider to be at high overall risk of bias. Primary outcomes There is moderate-certainty evidence (downgraded once for risk of bias) (1) that there is probably a shorter time to complete healing of venous leg ulcers in people wearing compression bandages or stockings compared with those not wearing compression (pooled hazard ratio for time-to-complete healing 2.17, 95% confidence interval (CI) 1.52 to 3.10; I = 59%; 5 studies, 733 participants); and (2) that people treated using compression bandages or stockings are more likely to experience complete ulcer healing within 12 months compared with people with no compression (10 studies, 1215 participants): risk ratio for complete healing 1.77, 95% CI 1.41 to 2.21; I = 65% (8 studies with analysable data, 1120 participants); synthesis without meta-analysis suggests more completely-healed ulcers in compression bandages or stockings than in no compression (2 studies without analysable data, 95 participants). It is uncertain whether there is any difference in rates of adverse events between using compression bandages or stockings and no compression (very low-certainty evidence; 3 studies, 585 participants). Secondary outcomes Moderate-certainty evidence suggests that people using compression bandages or stockings probably have a lower mean pain score than those not using compression (four studies with 859 participants and another study with 69 ulcers): pooled mean difference -1.39, 95% CI -1.79 to -0.98; I = 65% (two studies with 426 participants and another study with 69 ulcers having analysable data); synthesis without meta-analysis suggests a reduction in leg ulcer pain in compression bandages or stockings, compared with no compression (two studies without analysable data, 433 participants). Compression bandages or stockings versus no compression may improve disease-specific quality of life, but not all aspects of general health status during the follow-up of 12 weeks to 12 months (four studies with 859 participants; low-certainty evidence). It is uncertain if the use of compression bandages or stockings is more cost-effective than not using them (three studies with 486 participants; very low-certainty evidence). AUTHORS' CONCLUSIONS: If using compression bandages or stockings, people with venous leg ulcers probably experience complete wound healing more quickly, and more people have wounds completely healed. The use of compression bandages or stockings probably reduces pain and may improve disease-specific quality of life. There is uncertainty about adverse effects, and cost effectiveness. Future research should focus on comparing alternative bandages and stockings with the primary endpoint of time to complete wound healing alongside adverse events including pain score, and health-related quality of life, and should incorporate cost-effectiveness analysis where possible. Future studies should adhere to international standards of trial conduct and reporting.
背景:下肢溃疡是小腿上的开放性皮肤伤口,可能持续数周、数月甚至数年。大多数下肢溃疡是静脉疾病的结果。一线治疗选择通常包括使用压缩绷带或长袜。 目的:评估与不使用压缩相比,使用压缩绷带或长袜对任何环境和人群的静脉性下肢溃疡愈合的影响。 检索方法:2020 年 6 月,我们检索了 Cochrane 伤口专科注册库、Cochrane 对照试验中心注册库(CENTRAL)、Ovid MEDLINE(包括正在处理和其他非索引引文)、Ovid Embase 和 EBSCO CINAHL Plus。我们还检索了正在进行和未发表研究的临床试验登记处,并扫描了相关纳入研究的参考文献以及综述、荟萃分析和卫生技术报告,以确定其他研究。我们没有对语言、发表日期或研究环境进行任何限制。 选择标准:我们纳入了将任何类型的压缩绷带或长袜与静脉性下肢溃疡患者的无压缩进行比较的随机对照试验。 数据收集和分析:至少两名综述作者使用预定的纳入标准独立评估了研究。我们进行了数据提取,并使用 Cochrane 偏倚风险工具评估了风险。我们根据 GRADE 方法评估了证据的确定性。 主要结果:我们综述了 14 项研究(1391 名参与者)。大多数研究规模较小(中位数研究样本量:51 名参与者)。参与者来自急性护理环境、门诊环境和社区环境,很大一部分(65.9%;917/1391)有慢性静脉疾病的病史或临床证据、慢性静脉功能不全的明确病因、或踝压/肱压比值大于 0.8 或 0.9。参与者的平均年龄范围为 58.0 至 76.5 岁(中位数:70.1 岁)。他们的腿部溃疡平均持续时间从 9.0 周到 31.6 个月(中位数:22.0 个月),很大一部分参与者(64.8%;901/1391)的溃疡面积在 5 至 20 厘米之间。研究的中位随访时间为 12 周。应用的压缩绷带或长袜包括短弹性绷带、四层压缩绷带和 Unna 靴(一种浸渍氧化锌的弹性纱布绷带),对照组包括“常规护理”、药物治疗、各种敷料以及一些参与者接受压缩(但不是常规)的各种治疗。在 14 项纳入的研究中,有 10 项(71.4%)的研究结果被认为整体偏倚风险较高。主要结局有中等确定性证据(因偏倚风险降低一次)(1)穿着压缩绷带或长袜的人比不穿压缩绷带的人完成静脉性下肢溃疡愈合的时间可能更短(汇总风险比为 2.17,95%置信区间(CI)为 1.52 至 3.10;I = 59%;5 项研究,733 名参与者);(2)与未接受压缩治疗的人相比,使用压缩绷带或长袜治疗的人在 12 个月内更有可能完全愈合溃疡(10 项研究,1215 名参与者):完全愈合的风险比为 1.77,95%CI 为 1.41 至 2.21;I = 65%(8 项有分析数据的研究,1120 名参与者);无 meta 分析的综合结果表明,与无压缩相比,使用压缩绷带或长袜的溃疡完全愈合的比例更高(2 项无分析数据的研究,95 名参与者)。使用压缩绷带或长袜与不使用压缩相比,不良事件的发生率是否存在差异尚不确定(非常低确定性证据;3 项研究,585 名参与者)。次要结局有中等确定性证据表明,与不使用压缩相比,使用压缩绷带或长袜的人可能疼痛评分较低(四项研究,859 名参与者,另一项研究 69 个溃疡):平均差异-1.39,95%CI-1.79 至-0.98;I = 65%(两项研究,426 名参与者和另一项研究,69 个溃疡有分析数据);无 meta 分析的综合结果表明,与不使用压缩相比,使用压缩绷带或长袜可减轻腿部溃疡疼痛(两项研究,433 名参与者无分析数据)。与不使用相比,压缩绷带或长袜可能改善疾病特异性生活质量,但在 12 周至 12 个月的随访期间,不一定改善一般健康状况(四项研究,859 名参与者;低确定性证据)。使用压缩绷带或长袜是否比不使用更具成本效益尚不确定(三项研究,486 名参与者;非常低确定性证据)。 作者结论:如果使用压缩绷带或长袜,静脉性下肢溃疡患者可能更快地完全愈合伤口,且更多的患者伤口完全愈合。使用压缩绷带或长袜可能减轻疼痛并可能改善疾病特异性生活质量。不良事件和成本效益方面的情况不确定。未来的研究应重点比较替代绷带和长袜,以完全愈合伤口的时间作为主要终点,同时比较包括疼痛评分和健康相关生活质量在内的不良事件,并尽可能纳入成本效益分析。未来的研究应遵循国际试验实施和报告标准。
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