RESUMEN
OBJECTIVE: To examine whether the combination of Naoxintong Capsule with standard care could further reduce the recurrence of ischemic stroke without increasing the risk of severe bleeding. METHODS: A total of 23 Chinese medical centers participated in this trial. Adult patients with a history of ischemic stroke were randomly assigned in a 1:1 ratio using a block design to receive either Naoxintong Capsule (1.2 g orally, twice a day) or placebo in addition to standard care. The primary endpoint was recurrence of ischemic stroke within 2 years. Secondary outcomes included myocardial infarction, death due to recurrent ischemic stroke, and all-cause mortality. The safety of drugs was monitored. Results were analyzed using the intention-to-treat principle. RESULTS: A total of 2,200 patients were enrolled from March 2015 to March 2016, of whom 143 and 158 in the Naoxintong and placebo groups were lost to follow-up, respectively. Compared with the placebo group, the recurrence rate of ischemic stroke within 2 years was significantly lower in the Naoxintong group [6.5% vs. 9.5%, hazard ratio (HR): 0.665, 95% confidence interval (CI): 0.492-0.899, P=0.008]. The two groups showed no significant differences in the secondary outcomes and safety, including rates of severe hemorrhage, cerebral hemorrhage and subarachnoid hemorrhage (P>0.05). CONCLUSION: The combination of Naoxintong Capsule with standard care reduced the 2-year stroke recurrence rate in patients with ischemic stroke without increasing the risk of severe hemorrhage in high-risk patients. (Trial registration No. NCT02334969).
Asunto(s)
Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Adulto , Humanos , Prevención Secundaria/métodos , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular/prevención & control , Hemorragia Cerebral/tratamiento farmacológico , Hemorragia Cerebral/complicaciones , Método Doble Ciego , Inhibidores de Agregación PlaquetariaRESUMEN
OBJECTIVE: The primary aim of this study was to investigate the effects of two different patterns of rehabilitation training on movement and balance function in patients with idiopathic Parkinson disease. DESIGN: Forty patients with Parkinson disease were randomized into the tai chi group (n = 20) or the multimodal exercise training group (n = 20). Outcome measures were assessed at baseline and after 12 wks of exercise. Balance was assessed using the Berg Balance Scale, and movement was assessed by the Unified Parkinson's Disease Rating Scale-Motor Examination, stride length, gait velocity, and Timed Up and Go Test. RESULTS: The multimodal exercise training group improved significantly in movement from baseline, and a reduction in balance impairment was observed for the multimodal exercise training group. The questionnaire results after training showed that the multimodal exercise training is easy to learn and adhere to. No major adverse events were noted in both groups. CONCLUSIONS: This multimodal exercise training could improve motion function and benefit balance function in patients with Parkinson disease. The multimodal exercise training is easy to learn and practice.