Background and Purpose—
Previous clinical studies suggested benefit for poststroke recovery when MLC601 was administered between 2 weeks and 6 months of stroke onset. The Chinese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study tested the hypothesis that MLC601 is superior to placebo in acute, moderately severe ischemic stroke within a 72-hour time window.
Methods—
This multicenter, double-blind, placebo-controlled trial randomized 1100 patients with a National Institutes of Health
Stroke
Scale score 6 to 14, within 72 hours of onset, to trial medications for 3 months. The primary outcome was a shift in the modified Rankin Scale. Secondary outcomes were modified Rankin Scale dichotomy, National Institutes of Health
Stroke
Scale improvement, difference in National Institutes of Health
Stroke
Scale total and motor scores, Barthel index, and mini-mental state examination. Planned subgroup analyses were performed according to age, sex, time to first dose, baseline National Institutes of Health
Stroke
Scale, presence of cortical signs, and antiplatelet use.
Results—
The modified Rankin Scale shift analysis–adjusted odds ratio was 1.09 (95% confidence interval, 0.86–1.32). Statistical difference was not detected between the treatment groups for any of the secondary outcomes. Subgroup analyses showed no statistical heterogeneity for the primary outcome; however, a trend toward benefit in the subgroup receiving treatment beyond 48 hours from stroke onset was noted. Serious and nonserious adverse events rates were similar between the 2 groups.
Conclusions—
MLC601 is statistically no better than placebo in improving outcomes at 3 months when used among patients with acute ischemic stroke of intermediate severity. Longer treatment duration and follow-up of participants with treatment initiated after 48 hours may be considered in future studies.
Clinical Trial Registration—
URL:
http://www.clinicaltrials.gov
. Unique identifier: NCT00554723.
Background: The CHInese Medicine NeuroAiD Efficacy on Stroke recovery (CHIMES) study was an international randomized double-blind placebo-controlled trial of MLC601 (NeuroAiD) in subjects with cerebral infarction of intermediate severity within 72 h. CHIMES-E (Extension) aimed at evaluating the effects of the initial 3-month treatment with MLC601 on long-term outcome for up to 2 years. Methods: All subjects randomized in CHIMES were eligible for CHIMES-E. Inclusion criteria for CHIMES were age ≥18, baseline National Institute of Health Stroke Scale of 6-14, and pre-stroke modified Rankin Scale (mRS) ≤1. Initial CHIMES treatment allocation blinding was maintained, although no further study treatment was provided in CHIMES-E. Subjects received standard care and rehabilitation as prescribed by the treating physician. mRS, Barthel Index (BI), and occurrence of medical events were ascertained at months 6, 12, 18, and 24. The primary outcome was mRS at 24 months. Secondary outcomes were mRS and BI at other time points. Results: CHIMES-E included 880 subjects (mean age 61.8 ± 11.3; 36% women). Adjusted OR for mRS ordinal analysis was 1.08 (95% CI 0.85-1.37, p = 0.543) and mRS dichotomy ≤1 was 1.29 (95% CI 0.96-1.74, p = 0.093) at 24 months. However, the treatment effect was significantly in favor of MLC601 for mRS dichotomy ≤1 at 6 months (OR 1.49, 95% CI 1.11-2.01, p = 0.008), 12 months (OR 1.41, 95% CI 1.05-1.90, p = 0.023), and 18 months (OR 1.36, 95% CI 1.01-1.83, p = 0.045), and for BI dichotomy ≥95 at 6 months (OR 1.55, 95% CI 1.14-2.10, p = 0.005) but not at other time points. Subgroup analyses showed no treatment heterogeneity. Rates of death and occurrence of vascular and other medical events were similar between groups. Conclusions: While the benefits of a 3-month treatment with MLC601 did not reach statistical significance for the primary endpoint at 2 years, the odds of functional independence defined as mRS ≤1 was significantly increased at 6 months and persisted up to 18 months after a stroke.
Fat embolism syndrome (FES) is a life-threatening complication in patients with orthopedic trauma, especially long bone fractures. The diagnosis of fat embolism is made by clinical features alone with no specific laboratory findings. FES has no specific treatment and requires supportive care, although it can be prevented by early fixation of bone fractures. Here, we report a case of FES in a patient with right femoral neck fracture, which was diagnosed initially by Gurd's criteria and subsequently confirmed by typical appearances on magnetic resonance imaging (MRI) of the brain. The patient received supportive management and a short course of intravenous methylprednisolone.
BackgroundThe difficult intubation is associated with failure of emergency tracheal intubation. This study aimed to develop and validate a model for predicting difficult intubation in emergency department (ED).MethodsA cross-sectional study was conducted in the ED. We collected data from all consecutive adult patients who underwent emergency tracheal intubation. Patients were excluded if they were intubated by low experience intubator. The difficult intubation was defined by grade III or IV of Cormack and Lehane classification. We used multivariable regression model to identify significant predictors of difficult intubation and weighted points proportional to the beta coefficient values. The ability to discriminate was quantified by using the area under receiver operating characteristics curve (AuROC). The bootstrapping method was used to validate the performance.ResultsA total of 1,212 intubations were analyzed. One hundred and fifty-seven intubations were enrolled in difficult intubation group. Five independence predictors were identified, and each was assigned a number of points proportional to its beta coefficient: male gender (one), large tongue (two), limit mouth opening (two), poor neck mobility (two), and presence of obstructed airway (three). Intubation assessment score model was created and applied to all subjects. The AuROC was 0.81 (95% confidence interval (CI): 0.77 - 0.85) for the development dataset, and 0.80 (95% CI: 0.76 - 0.85) for the validation dataset. We defined three risk groups: low risk (zero to one points), intermediate risk (two to three points), and high risk (above three points), and the difficult intubation rate was 4.7%, 22.5%, and 53.6%, respectively.ConclusionsIntubation assessment score model was constructed from patients’ simple characteristics and performed well in predicting difficult intubation and can discriminate between with and without difficult intubation.
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