RESUMO
La Esclerosis Múltiple (EM) es una enfermedad crónica del sistema nervioso central, para la cual aún no hay una cura definitiva; sin embargo, existe una diversa variedad de terapias con el objetivo de modificar el curso natural de la enfermedad, que promueve la inclusión constante de nuevas estrategias terapéuticas. Objetivo: La Sociedad Peruana de Neurología, por encargo del Ministerio de Salud, convocó a un comité de expertos con el objetivo de elaborar una guía de práctica clínica para el diagnóstico y tratamiento de EM. Método: Se realizó una búsqueda y evaluación de guías de práctica clínica bajo la metodología AGREE II, escogiendo como modelo la Guía de Práctica Clínica Catalana. Las preguntas clínicas no concernientes al tratamiento fueron resueltas a través de revisión sistemática. Las preguntas clínicas de tratamiento se diseñaron bajo el formato PICO y se resolvieron con un meta-análisis de ensayos clínicos disponibles hasta agosto del 2017, tomando en consideración las terapias aprobadas por DIGEMID hasta enero del 2017. Las recomendaciones finales fueron elaboradas mediante el método Delphi modificado con un consenso de al menos 80% de los miembros de su comité. Finalmente se realizó una revisión externa del manuscrito por expertos internacionales en EM. Resultados: Se formularon 18 preguntas clínicas y 21 recomendaciones para el manejo, incluyendo algoritmos terapéuticos.
Multiple Sclerosis (MS) is a chronic disease of the central nervous system, for which there is still no definitive cure; but there is a diverse variety of therapies with the objective of modifying the course of the disease, which promotes the constant inclusion of new therapeutic strategies. Objective: The Peruvian Society of Neurology, as requested by the Peruvian Health Ministry, convened a committee of experts with the purpose of elaborating a clinical practice guideline for the diagnosis and treatment of MS. Method: Clinical practice guidelines were searched and evaluated according to the AGREE II methodology, choosing the Catalan Clinical Practice Guide as a model. The clinical questions not related to treatment were solved through a systematic review. The clinical treatment questions were assessed under the PICO format and were solved with a meta-analysis of clinical trials available until August 2017, considering the therapies approved by DIGEMID until January 2017. The final recommendations were elaborated using the modified Delphi method with a consensus of at least 80% of the members of its committee. Finally, an external revision of the manuscript was made by international experts in MS. Results: Eighteen clinical questions and twenty-one recommendations for management were developed, including therapeutic algorithms.
RESUMO
BACKGROUND AND PURPOSE: The NeuroThera Effectiveness and Safety Trial-1 (NEST-1) study evaluated the safety and preliminary effectiveness of the NeuroThera Laser System in the ability to improve 90-day outcomes in ischemic stroke patients treated within 24 hours from stroke onset. The NeuroThera Laser System therapeutic approach involves use of infrared laser technology and has shown significant and sustained beneficial effects in animal models of ischemic stroke. METHODS: This was a prospective, intention-to-treat, multicenter, international, double-blind, trial involving 120 ischemic stroke patients treated, randomized 2:1 ratio, with 79 patients in the active treatment group and 41 in the sham (placebo) control group. Only patients with baseline stroke severity measured by National Institutes of Health Stroke Scale (NIHSS) scores of 7 to 22 were included. Patients who received tissue plasminogen activator were excluded. Outcome measures were the patients' scores on the NIHSS, modified Rankin Scale (mRS), Barthel Index, and Glasgow Outcome Scale at 90 days after treatment. The primary outcome measure, prospectively identified, was successful treatment, documented by NIHSS. This was defined as a complete recovery at day 90 (NIHSS 0 to 1), or a decrease in NIHSS score of at least 9 points (day 90 versus baseline), and was tested as a binary measure (bNIH). Secondary outcome measures included mRS, Barthel Index, and Glasgow Outcome Scale. Primary statistical analyses were performed with the Cochran-Mantel-Haenszel rank test, stratified by baseline NIHSS score or by time to treatment for the bNIH and mRS. Logistic regression analyses were conducted to confirm the results. RESULTS: Mean time to treatment was >16 hours (median time to treatment 18 hours for active and 17 hours for control). Time to treatment ranged from 2 to 24 hours. More patients (70%) in the active treatment group had successful outcomes than did controls (51%), as measured prospectively on the bNIH (P=0.035 stratified by severity and time to treatment; P=0.048 stratified only by severity). Similarly, more patients (59%) had successful outcomes than did controls (44%) as measured at 90 days as a binary mRS score of 0 to 2 (P=0.034 stratified by severity and time to treatment; P=0.043 stratified only by severity). Also, more patients in the active treatment group had successful outcomes than controls as measured by the change in mean NIHSS score from baseline to 90 days (P=0.021 stratified by time to treatment) and the full mRS ("shift in Rankin") score (P=0.020 stratified by severity and time to treatment; P=0.026 stratified only by severity). The prevalence odds ratio for bNIH was 1.40 (95% CI, 1.01 to 1.93) and for binary mRS was 1.38 (95% CI, 1.03 to 1.83), controlling for baseline severity. Similar results held for the Barthel Index and Glasgow Outcome Scale. Mortality rates and serious adverse events (SAEs) did not differ significantly (8.9% and 25.3% for active 9.8% and 36.6% for control, respectively, for mortality and SAEs). CONCLUSIONS: The NEST-1 study indicates that infrared laser therapy has shown initial safety and effectiveness for the treatment of ischemic stroke in humans when initiated within 24 hours of stroke onset. A larger confirmatory trial to demonstrate safety and effectiveness is warranted.