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OBJECTIVE: To investigate whether Naoxueshu Oral Liquid (NXS) could promote hematoma absorption in post-craniotomy hematoma (PCH) patients. METHODS: This is an open-label, multicenter, and randomized controlled trial conducted at 9 hospitals in China. Patients aged 18-80 years with post-craniotomy supratentorial hematoma volume ranging from 10 to 30 mL or post-craniotomy infratentorial hematoma volume less than 10 mL, or intraventricular hemorrhage following cranial surgery were enrolled. They were randomly assigned at a 1:1 ratio to the NXS (10 mL thrice daily for 15 days) or control groups using a randomization code table. Standard medical care was administered in both groups. The primary outcome was the percentage reduction in hematoma volume from day 1 to day 15. The secondary outcomes included the percentage reduction in hematoma volume from day 1 to day 7, the absolute reduction in hematoma volume from day 1 to day 7 and 15, and the change in neurological function from day 1 to day 7 and 15. The safety was closely monitored throughout the study. Moreover, subgroup analysis was performed based on age, gender, history of diabetes, and etiology of intracerebral hemorrhage (ICH). RESULTS: A total of 120 patients were enrolled and randomly assigned between March 30, 2018 and April 15, 2020. One patient was lost to follow-up in the control group. Finally, there were 119 patients (60 in the NXS group and 59 in the control group) included in the analysis. In the full analysis set (FAS) analysis, the NXS group had a greater percentage reduction in hematoma volume from day 1 to day 15 than the control group [median (Q1, Q3): 85% (71%, 97%) vs. 76% (53%, 93%), P<0.05]. The secondary outcomes showed no statistical significance between two groups, either in FAS or per-protocol set (P>0.05). Furthermore, no adverse events were reported during the study. In the FAS analysis, the NXS group exhibited a higher percentage reduction in hematoma volume on day 15 in the following subgroups: male patients, patients younger than 65 years, patients without diabetes, or those with initial cranial surgery due to ICH (all P<0.05). CONCLUSIONS: The administration of NXS demonstrated the potential to promote the percentage reduction in hematoma volume from day 1 to day 15. This intervention was found to be safe and feasible. The response to NXS may be influenced by patient characteristics. (Registration No. ChiCTR1800017981).
RESUMO
BACKGROUND AND PURPOSE: Little information is available on the effects of age on health care and outcomes of ischemic stroke (IS) in China. Our aim was to evaluated risk factors, health care, and outcomes among age groups including ≤ 45, 46-65, 66-79, and ≥ 80 years and to find whether the outcome was affected by age and health care. METHODS: CNSR is a nationwide prospective registry for patients admitted with acute stroke and prospectively followed up 12-month outcomes. Demographics, socioeconomics, risk factors, health care, and outcomes were analyzed among age groups, and multivariate regression analysis was used to determine the association of outcome and age and health care. RESULTS: We identified 12,415 acute IS patients for analysis. Of 1179 (9.50%) were aged ≥ 80 years. In terms of risk factors, cardiac diseases were significantly more frequent in patients ≥ 80 years, behavioral risk factors were more common in younger patients, and hypertension, hyperlipidemia, and diabetes were more seen in 46-79 patients. The use of health care varied among groups and was significantly lower in ≥ 80 years especially in secondary prevention. The very old patients had the worst outcomes even after adjusting by prognostic factors; however, adjusting forward by health care, the extent of differences decreased. CONCLUSIONS: In CNSR, differences in stroke clinic characteristics and health care were observed among various age groups, and the old patients, receiving lower levels of stroke care, had the worst outcomes. Knowledge of the age differences in ischemic stroke may be helpful to appropriately allocate the limited health resources and to improve stroke outcomes.