Geffard Michel, Mangas Arturo, Coveñas Rafael
Institut pour le Développement de la Recherche en Pathologie Humaine et Thérapeutique, 33400 Talence, France.
Gemacbio, Research Department, Lieu dit Berganton, 33127 Saint Jean d'Illac, France.
Biomed Rep. 2017 Mar;6(3):307-313. doi: 10.3892/br.2017.857. Epub 2017 Feb 9.
Endotherapia (GEMSP) is a novel therapeutic approach for multiple sclerosis (MS). The aim of the present study was to demonstrate the efficiency of Endotherapia in the follow-up of 193 patients with MS. The efficiency coefficient that was evaluated was the Expanded Disability Status Scale (EDSS) score, which is a functional scale of MS progression. The evaluated score of each patient during follow-up visits was compared with the theoretical score of the disease progression without GEMSP. The evolution of the EDSS score was evaluated according to the inclusion score. The quantitative global study of the EDSS score highlighted a statistically significant difference between the final average scores of the treatment with GEMSP (M) and worldwide reference (R) groups. The improvement of the M group compared with the R group was 24.5%. According to the final EDSS scores, the study highlighted a difference in favor of the M group with 62.0% for scores ≤3, 7.8% for scores between 3 and 6 and 19.6% for scores ≥6. According to the qualitative evolution of the EDSS scores, the improvements in favor of group M were 49.3% for scores ≤3, 79.1% for scores between 3 and 6 and 19.5% for scores ≥6. The qualitative study of the EDSS score showed a statistically significant success percentage; the success percentages were between 59.1 and 90.0%. In a larger population of MS patients, the data confirm the beneficial effects of GEMSP that were previously reported in pre-clinical and clinical studies. In addition, 78% of patients showed an improvement or deceleration of the disease.
内热疗法(GEMSP)是一种用于治疗多发性硬化症(MS)的新型治疗方法。本研究的目的是在193例MS患者的随访中证明内热疗法的有效性。所评估的有效性系数是扩展残疾状态量表(EDSS)评分,它是MS进展的功能量表。将每位患者在随访期间的评估得分与无GEMSP时疾病进展的理论得分进行比较。根据纳入时的得分评估EDSS评分的变化。对EDSS评分的定量整体研究突出显示,GEMSP治疗组(M)和全球参考组(R)的最终平均得分之间存在统计学上的显著差异。与R组相比,M组的改善率为24.5%。根据最终的EDSS评分,研究突出显示M组更具优势,得分≤3的患者占62.0%,得分在3至6之间的患者占7.8%,得分≥6的患者占19.6%。根据EDSS评分的定性变化,得分≤3的患者中,M组的改善率为49.3%,得分在3至6之间的患者中为79.1%,得分≥6的患者中为19.5%。对EDSS评分的定性研究显示成功率具有统计学意义;成功率在59.1%至90.0%之间。在更大规模的MS患者群体中,数据证实了先前在临床前和临床研究中报道的GEMSP的有益效果。此外,78%的患者病情出现改善或进展减缓。