Wellcome Trust Centre for Global Health Research, Brighton and Sussex Medical School, Brighton, UK.
Centre for Environmental and Developmental Studies, Addis Ababa University, Addis Ababa, Ethiopia.
Lancet Glob Health. 2018 Jul;6(7):e795-e803. doi: 10.1016/S2214-109X(18)30124-4. Epub 2018 May 15.
BACKGROUND: Podoconiosis (also known as endemic, non-filarial elephantiasis) affects about 4 million subsistence farmers in tropical Africa. Poor awareness of the condition and inadequate evidence for the efficacy of treatment mean that no government in an endemic country yet offers lymphoedema management for patients with podoconiosis. Among patients with filarial lymphoedema, trials suggest that limb care is effective in reducing the most disabling sequelae: episodes of acute dermatolymphangioadenitis. We aimed to test the hypothesis that a simple, inexpensive lymphoedema management package would reduce the incidence of acute dermatolymphangioadenitis in adult patients with podoconiosis in northern Ethiopia. METHODS: We did a pragmatic randomised controlled trial at health posts and health centres in 18 sub-districts of Aneded woreda (district) in Amhara, northern Ethiopia. Participants were adults aged 18 years and older, had a diagnosis of at least stage 2 podoconiosis (persistent lymphoedema) and a negative antigen test for filariasis, and intended to remain within Aneded woreda for the duration of the trial. Patients were randomly assigned (1:1) to either receive a package containing instructions for foot hygiene, skin care, bandaging, exercises, and use of socks and shoes, with support by lay Community Podoconiosis Agents at monthly meetings (intervention group) or to receive no intervention (control group). Participants were aware of their group assignment, but researchers doing all analyses were masked to treatment group. The primary outcome was incidence of acute dermatolymphangioadenitis episodes in the total period of observation of each participant, measured by use of validated patient self-reported pictorial diaries. This trial was registered with the International Standard Randomised Controlled Trials Number Register, number ISRCTN67805210. FINDINGS: Between Dec 1, 2014, and June 30, 2015, 1339 patients were screened, and 696 patients were enrolled and randomly allocated to treatment groups. We allocated 350 patients to the intervention group and 346 patients to the control group. 321 (92%) patients from the intervention group and 329 (95%) patients from the control group provided follow-up results at 12 months. During the 12 months of follow-up, 16 550 new episodes of acute dermatolymphangioadenitis occurred during 765·2 person-years. The incidence of acute dermatolymphangioadenitis was 19·4 episodes per person-year (95% CI 18·9-19·9) in the intervention group and 23·9 episodes per person-year (23·4-24·4) in the control group. The ratio of incidence rate in the intervention group to that of the control group was 0·81 (0·74 to 0·89; p<0·0001), with a rate difference of -4·5 (-5·1 to -3·8) episodes per person-year. No serious adverse events related to the intervention were reported. INTERPRETATION: A simple, inexpensive package of lymphoedema self-care is effective in reducing the frequency and duration of acute dermatolymphangioadenitis. We recommend its implementation by the governments of endemic countries. FUNDING: Joint Global Health Trials scheme (from the Wellcome Trust, the UK Medical Research Council, and UK Aid).
背景:足菌肿(也称为地方性、非丝虫性象皮病)影响着非洲热带地区约 400 万自给自足的农民。由于对这种疾病的认识不足,以及治疗效果的证据不足,因此没有一个流行国家的政府为患有足菌肿的患者提供淋巴水肿管理。在丝虫性淋巴水肿患者中,试验表明肢体护理可有效减少最具致残性的后遗症:急性皮肤淋巴管炎发作。我们旨在检验一个假设,即在埃塞俄比亚北部的阿尼达沃州的 18 个分区的卫生所和卫生中心进行的一项实用随机对照试验,一种简单、廉价的淋巴水肿管理方案是否会降低成人足菌肿患者急性皮肤淋巴管炎的发病率。
方法:我们在埃塞俄比亚北部阿尼达沃州的 18 个分区进行了一项实用随机对照试验。参与者为年龄在 18 岁及以上的成年人,患有至少 2 期足菌肿(持续性淋巴水肿),丝虫病抗原检测阴性,并且在试验期间打算留在阿尼达沃州。患者被随机分配(1:1)接受包含足部卫生、皮肤护理、包扎、运动以及使用袜子和鞋子的说明的方案,每月由非专业的社区足菌肿代理进行支持(干预组),或不接受干预(对照组)。参与者知道他们的分组情况,但进行所有分析的研究人员对治疗分组情况不知情。主要结局是每位参与者在整个观察期内急性皮肤淋巴管炎发作的发生率,通过使用经过验证的患者自我报告的图片日记来衡量。这项试验在国际标准随机对照试验号注册库中注册,注册号为 ISRCTN67805210。
发现:2014 年 12 月 1 日至 2015 年 6 月 30 日,对 1339 名患者进行了筛查,有 696 名患者入组并随机分配到治疗组。我们将 350 名患者分配到干预组,346 名患者分配到对照组。321 名(92%)来自干预组的患者和 329 名(95%)来自对照组的患者在 12 个月时提供了随访结果。在 12 个月的随访期间,在 765.2 人年中发生了 16550 例新的急性皮肤淋巴管炎发作。干预组的急性皮肤淋巴管炎发病率为 19.4 例/人年(95%CI 18.9-19.9),对照组为 23.9 例/人年(23.4-24.4)。干预组的发病率与对照组的比值为 0.81(0.74-0.89;p<0.0001),发病率差异为-4.5(-5.1 至-3.8)例/人年。未报告与干预相关的严重不良事件。
解释:一种简单、廉价的淋巴水肿自我护理方案可有效降低急性皮肤淋巴管炎的频率和持续时间。我们建议流行国家的政府实施该方案。
资助:全球联合健康试验计划(由惠康信托基金会、英国医学研究理事会和英国国际发展部资助)。
PLoS Negl Trop Dis. 2011-6-7
PLoS Negl Trop Dis. 2012-7-17
Bull World Health Organ. 2017-6-26
PLoS Negl Trop Dis. 2025-7-7
Wellcome Open Res. 2017-9-4
BMC Med. 2016-7-7
PLoS Negl Trop Dis. 2015-7-29