Complex decongestant therapy with use of alternative material to reduce and control lymphedema in patients with endemic area of filariasis: a clinical trial

ABSTRACT Lymphatic filariasis puts billions of people around the world at risk. Despite this, little is known about the impact of chronic disease morbidity, such as lymphedema. The complex decongestant therapy is a gold standard for treating lymphedemas, but there are no viable protocols for implementation in developing countries. The objective of this clinical trial was to evaluate the efficacy of this technique with the use of alternative material and compare its effects on quality of life, functionality and body weight. The intervention and control groups were evaluated using perimetry and limb volume calculation, the Whoqol-bref quality of life questionnaire, the Functional and Mobility test of the lower limbs Timed Up and Go, and body weight assessment. The intervention group received the complex decongestant therapy twice a week for ten weeks, using an alternative material for the bandaging, made with cambric tissue, which presents low cost in relation to the imported bands. The control group received a lecture with information about the disease and care and hygiene guidelines of the members. The sample consisted of thirty patients with a mean age of 50.8 ± 10 years, 52.9% of whom were women. In the statistical analysis, Student's t test, Multivariate analysis of variance, Wilcoxon test and Kolmogorov-Smirnov test were used. The significance was 5% (p<0.05). There was a significant reduction in lymphedema volume and perimetry in the intervention group, and increased in the control group. The functionality did not show significant improvement in the evaluation by the Timed Up and Go test. The quality of life had significant improvement in the physical and environmental domains in the intervention group. The effect of treatment on body weight was also significant, presenting reduction in the control group and intergroups. Complex decongestant therapy was effective in reducing and controlling lymphedema and positively impacted, increasing the numerical values of the physical and environmental aspects of the quality of life of the intervention group.

摘要 淋巴丝虫病（Lymphatic filariasis）使全球数十亿人面临感染风险。尽管如此，学界对淋巴水肿（lymphedema）这类慢性疾病相关不良健康结局的影响仍知之甚少。综合消肿治疗（complex decongestant therapy）是治疗淋巴水肿的金标准，但目前尚无适用于发展中国家的可行实施方案。本临床试验旨在评估采用替代材料开展该疗法的疗效，并对比其对患者生活质量、肢体功能与体重的影响。研究通过肢体周径测量与肢体体积计算、世界卫生组织生活质量量表简版（WHOQOL-BREF）、下肢定时起身行走测试（Timed Up and Go）以及体重评估，对干预组与对照组患者进行评价。干预组患者每周接受2次综合消肿治疗，持续10周，其绷带包扎采用细平布（cambric tissue）制作的替代材料，相较于进口绷带成本更低。对照组患者则接受关于疾病知识、护理与个人卫生规范的健康宣讲。本研究共纳入30例患者，平均年龄为50.8±10岁，其中女性占比52.9%。统计分析采用学生t检验（Student's t test）、多变量方差分析（Multivariate analysis of variance）、威尔科克森检验（Wilcoxon test）与科尔莫戈罗夫-斯米尔诺夫检验（Kolmogorov-Smirnov test），显著性水平设定为5%（P<0.05）。结果显示，干预组患者的淋巴水肿体积与肢体周径均出现显著降低，而对照组则有所上升；定时起身行走测试评估的肢体功能未出现显著改善。干预组患者的生活质量在生理领域与环境领域均得到显著提升。治疗对体重的影响同样具有统计学意义，对照组患者体重出现降低，且干预组与对照组间的体重变化存在显著差异。综合消肿治疗可有效减少并控制淋巴水肿，且对干预组患者生活质量的生理与环境维度量化评分提升产生了积极影响。