Candela-Zamora M D, Martín-Gómez M A, Solas-Gómez B, Fernández-Pérez C, Martín-González M, Manzanedo-Basilio L, Navarro-Gorjón S, González-Dugo R, Rodríguez-Sánchez S, Nuñez-Marugan M S G, Nosti del Valle C, García-Aceña T, Cano-Escudero S, del Prado-González N
Unidad de Hospitalización Geriátrica de Agudos y Media Estancia, Hospital Clínico San Carlos de Madrid, Madrid, España.
Enferm Clin. 2010 Jan-Feb;20(1):10-6. doi: 10.1016/j.enfcli.2009.07.013. Epub 2010 Feb 1.
To evaluate whether there is equivalence between two treatments for grade I ulcers with a base of hyperoxygenated fatty acids, AGHO and Mepentol: AGHO and phytotherapy.
A randomized, controlled, triple blind clinical trial was conducted with patients admitted at the Elderly Ward at San Carlos Hospital in Madrid between November 2006 and January 2008. There were two treatment groups: Experimental and control. A theoretical limit of 15% was determined between both groups. We took a random sample of patients admitted to the Elderly Ward, which produced a sample of 151 sores. The control group received treatment with Mepentol and the experimental group received AGHO. The assignment to the group was at random. The output variable was healing of erythema within the first 72h. We calculated the absolute difference in the incidence of healing between both treatments with a level of confidence of 95%.
The sample at the end of the study was 148 (72 control and 76 experimental). There was a healing incidence of 55.6% in the control group and 69.7% in the experimental group (p=0.074). The difference in the incidence of healing between both treatments was 14% (95% CI: 29% to -1%). The upper limit of the confidence interval of the difference is outside the margin of equivalence.
We cannot conclude that the treatment with AGHO fatty acids is equivalent to Mepentol treatment. With both treatments the healing is clinically significant.
评估两种以高氧脂肪酸为基础的I级溃疡治疗方法AGHO和Mepentol之间是否等效：AGHO与植物疗法。
对2006年11月至2008年1月期间入住马德里圣卡洛斯医院老年病房的患者进行了一项随机、对照、三盲临床试验。有两个治疗组：试验组和对照组。两组之间确定了15%的理论界限。我们从入住老年病房的患者中随机抽取样本，得到151个溃疡样本。对照组接受Mepentol治疗，试验组接受AGHO治疗。分组是随机的。输出变量是最初72小时内红斑的愈合情况。我们计算了两种治疗方法愈合发生率的绝对差异，置信水平为95%。
研究结束时的样本为148个（72个对照组和76个试验组）。对照组的愈合发生率为55.6%，试验组为69.7%（p = 0.074）。两种治疗方法愈合发生率的差异为14%（95%置信区间：29%至 -1%）。差异置信区间的上限超出了等效界限。
我们不能得出AGHO脂肪酸治疗等同于Mepentol治疗的结论。两种治疗方法的愈合在临床上都具有显著意义。
