Naoxintong Capsule for Secondary Prevention of Ischemic Stroke: A Multicenter, Randomized, and Placebo-Controlled Trial.

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).

[Protective effects of Chinese herbal medicine Naoshuantong on neurovascular unit in rats with cerebral ischemia/reperfusion injury].

OBJECTIVE: To investigate the protective effects of Naoshuantong, a compound traditional Chinese herbal medicine, on the main components of neurovascular unit in rats with cerebral ischemia/reperfusion injury. METHODS: A total of 30 male Sprague-Dawley rats were randomly divided into sham-operated, ischemia/reperfusion, and ischemia/reperfusion plus Naoshuantong groups. The cerebral ischemia was induced by 1.5 h of middle cerebral artery occlusion, followed by unlocking the thread to induce reperfusion injury. After 24 h of reperfusion, neurological functional deficits were assessed, apoptosis of main components of neurovascular unit was determined by terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate-biotin nick end-labeling combined with neuronal nuclei antigen, glial fibrillary acidic protein or CD31 immunofluorescence double staining. RESULTS: Naoshuantong significantly reduced neurological functional deficits, and reduced neuron, astrocyte and vascular endothelium cell apoptosis induced by ischemia/reperfusion injury in the border zone of ischemic cortex. CONCLUSION: Naoshuantong is effective in protecting the neurovascular unit including neurons, astrocytes and vascular endothelium cells against cerebral ischemia/reperfusion-induced apoptosis.