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Objective:To confirm the efficacy and safety of cinepazide maleate injection in acute ischemic stroke patients with obvious motor function deficit.Methods:This study is a subgroup analysis of multi-center, randomized, double-blind, placebo-controlled phase Ⅳ clinical trial. A total 812 patients of acute ischemic stroke with obvious limb motor deficit [motor function of limbs score in National Institutes of Health Stroke Scale (NIHSS) ≥4] were enrolled in this subgroup analysis. Patients received either cinepazide maleate injection or placebo. The treatment period was 14 days and follow-up was 90 days. The efficacy endpoints included the proportions of patients with a modified Rankin Scale (mRS) score ≤2, mRS score ≤1 and Barthel Index <95 on day 90. Safety was evaluated by recording all adverse events, monitoring vital signs, laboratory parameters and electrocardiogram.Results:A total of 732 patients were involved in the final efficacy analysis (361 in cinepazide maleate group and 371 in control group). The baseline limb motor function score of NIHSS was 5.23±1.43 in the cinepazide maleate group whereas 5.20±1.36 in the control group. Logistic regression analysis showed that following treatment for 90 days, the proportion of patients with a mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group [56.0% (202/361) vs 44.2% (164/371), OR=0.60, 95% CI 0.44-0.82, P=0.002]. The proportion of patients with a mRS score ≤1 was higher in the cinepazide maleate group than in the control group [43.3% (139/361) vs 35.2% (118/371), OR=0.69, 95% CI 0.50-0.97, P=0.031]. The proportion of patients with a Barthel Index <95 on day 90 was significantly lower in the cinepazide maleate group than in the control group [45.2% (145/361) vs 55.2% (185/371), OR=0.64, 95% CI 0.46-0.88, P=0.007]. During the treatment and follow-up period, the incidence of the most common adverse events in the cinepazide maleate group was 50.4% (199/395). Constipation and abnormal liver function were more common, but there were no statistically significant differences between the two groups. Conclusion:Cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery and safe in patients with acute ischemic stroke with obvious limb motor deficit.
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Objective:To investigate the association between plaque vulnerability characteristics and infarction sub-types in patients with acute unilateral anterior circulation cerebral infarction due to intracranial atherosclerotic disease.Methods:A total of 58 eligible patients who underwent intracranial high-resolution magnetic resonance imaging (HRMRI) were finally enrolled in the retrospective study from December 2018 to December 2020. In the current study, all patients were classified into the group with artery-to-artery (A-to-A) embolic infarction ( n=32) and the group without ( n=26), according to infarction sub-types on diffusion-weighted imaging. Baseline information, the presence/absence of hyperintense plaque, irregular plaque surface, remodeling pattern and quadrant distribution by HRMRI were collected and evaluated. Multivariate Logistic regression analysis was performed to determine the relationship between plaque vulnerability and infarction sub-types. Furthermore, the analysis of interaction between hyperintense plaque and positive remodeling in response to A-to-A embolism was visualized by Sankey diagram. Results:The presence of hyperintense plaque ( OR=3.90, 95% CI 1.21-12.59, P=0.023) and arterial remodeling patterns (positive remodeling vs intermediate state, OR=4.32, 95% CI 0.86-21.49, P for trend=0.027) were the strong independent predictors for A-to-A embolism. Importantly, a significantly positive synergy between the remodeling pattern and hyperintense plaque in response to infarction sub-types was found by Sankey diagram ( Wald=10.044, P for interaction=0.007). Similarly, in receiver operating characteristic curve analysis, the discrimination of hyperintense plaque combined with positive remodeling for A-to-A embolism was significantly superior to that of either biomarker alone (area under the curve=0.710, 95% CI 0.576-0.845, P=0.006). Conclusion:A synergistic effect between positive remodeling and hyperintense plaque can promote plaque vulnerability, suggesting a potential target sub-population may benefit from stroke prevention with intensive antithrombotic therapy, although this must be confirmed in future.
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Objective:To investigate the blood pressure change in patients with acute ischemic stroke (AIS) and hypertension treated with cinepazide maleate injection.Methods:This was a subgroup analysis of post-marketing clinical confirmation study of cinepazide maleate injection for acute ischemic stroke: a randomized, double-blinded, multicenter, placebo-parallel controlled trial, which conducted in China from August 2016 to February 2019. Eligible patients fulfilled the inclusive criteria of acute anterior circulation ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores of 7-25. The primary endpoints were mean blood pressure of AIS patients treated with cinepazide maleate or control, which were assessed during the treatment period (14 days), and the proportion of the patients with normal blood pressure was analyzed after the treatment period. Furthermore, a subgroup analysis was performed to investigate a possible effect of the history of hypertension on outcomes.Results:This analysis included 809 patients with hypertension. There was no significant difference in patients blood pressure and the proportion of patients with normal blood pressure (60.5% vs. 59.0%, P>0.05) between cinepazide maleate group and control group. Conclusion:Administration of cinepazide maleate injection does not affect the management of clinical blood pressure in patients with AIS.
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Objective:To assess the efficacy and safety of cinepazide maleate injection in the treatment of patients with acute ischemic stroke.Methods:A multicenter, randomized, double-blind, placebo-controlled phase Ⅳ clinical trial, led by Peking Union Medical College Hospital, was conducted in 65 Hospitals in China. The efficacy of cinepazide maleate injection in patients with acute anterior circulation cerebral infarction with onset time of ≤48 hours, 7≤National Institute of Health stroke scale (NIHSS) score ≤25 was assessed from August 2016 to February 2019, using the proportion of modified Rankin scale (mRS) score≤1 and Barthel index (BI) score≤95 on day 14 as efficacy endpoint. The patients were divided into treatment group who were treated with cinepazide maleate injection and control group who were treated with placebo.Results:A total 937 patients were involved in the final efficacy analysis (466 in treatment group and 471 in control group). The proportion of subjects with mRS score≤1 on day 14 after treatment were higher in the treatment group than that in the control group (102/466(21.89%) vs76/471(16.14%)). Logistic regression analysis showed that patients treated with cinepazide maleate were significantly more likely to have a favorable outcome (mRS score≤1) than patients treated with placebo on day 14 ( OR=0.677, 95% CI 0.484-0.948 , P=0.023), and patients treated with cinepazide maleate were more likely to reach independence in activities of daily living (Barthel Index ≥95) than those treated with placebo on day 14 (125/466(26.82%) vs 91/471(19.32%); OR=0.632, 95% CI0.459-0.869, P=0.005). The rate of adverse events was similar between the treatment and control groups. Conclusion:The 14-day treatment with cinepazide maleate injection could reduce the degree of disability whereas did not increase the risk of adverse events.
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Objective:To investigate the value of net water uptake (NWU) in predicting malignant edema (ME) in large hemispheric infarction (LHI).Methods:Fifty-six patients suffering from LHI in the General Hospital of Northern Theater Command from September 2017 to July 2018 were retrospectively analyzed, and their NWU was calculated separately. Patients were divided into two groups according to the occurrence of ME, which was defined as space-occupying infarct requiring decompressive craniectomy or death resulting from cerebral hernia in seven days from onset. The clinical characteristics were analyzed, and receiver operating characteristic (ROC) curve and respective area under curve (AUC) were used to assess the value of NWU and other factors.Results:After adjusting for atrial fibrillation, National Institutes of Health Stroke Scale scores at admission, and time from onset to imaging, multivariable analysis showed that NWU was an independent predictor of ME ( OR=1.226，95% CI 1.040-1.446, P=0.015). According to the ROC curve, NWU≥13.08% identified ME with great predictive power (AUC=0.813;sensitivity 0.64, specificity 0.94). Conclusions:NWU is an important predictor of ME in patients with LHI. It can help identify patients at risk of ME.
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Objective To investigate the clinical manifestations,imaging features,and etiological classification in patients with isolated midbrain infarction. Methods From December 2013 to January 2017,40 consecutive patients with isolated midbrain infarction admitted to the Department of Neurology, General Hospital of Shenyang Military Command were enrolled retrospectively. The general data,clinical and imaging data of the patients were analyzed retrospectively. According to the vascular control range and MRI characteristics,the midbrain infarcts were divided into anteromedial,anterolateral,lateral and dorsal infarcts . The differences of baseline data,clinical manifestation and etiological typing of various types of patients were analyzed. Results In the 40 patients,23 were anteriomedial infarction,14 were anterolateral infarction, 1 was lateral infarction,and 2 were mixed location infarction,0 was dorsal infarction. The common signs were dysarthria in 23 cases (57. 5%),limb and／or gait ataxia in 18 cases (45. 0%),oculomotor disturbances and／or ptosis in 15 cases (37. 5%),and limb movement disorders in 14 cases (35. 0%). The differences were statistically significant in central facial paralysis and／or lingual paralysis (3／23 vs. 8／17 ),oculomotor disturbances (15／23 vs. 0 ),and etiological types between the patients with anterior medial infarction and those infarction at other sites (all P＜0. 05). Of the 40 patients,38 had a short-term good prognosis (95. 0%)and 2 had poor prognosis (5. 0%). Conclusions Isolated midbrain infarcts mainly manifested as dysarthria,ataxia,and oculomotor disturbances. Oculomotor disturbances occurred in anteromedial infarction. The common causes of anteromedial infarction are large atherosclerosis and small vascular lesions,while the cause of infarction in other sites is often large atherosclerosis.
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AIM: To explore the relationship between the expression of transforming growth factor-?1 (TGF-?1) and the pathogenesis of lung carcinoma, and the influence of radiotherapy on plasma TGF-?1 level of patients with lung carcinoma. METHODS: By immunohistochemical method, the expression of TGF-?1 was examined. An enzyme-linked immunoadsorbent assay (ELISA) was used to quantify the plasma TGF-?1 levels in different time as before radiotherapy, at the end of radiotherapy, and at the time of follow-up 6 months after radiotherapy, respectively. The changes of quantity of TGF-?1 in different time above were analysed statistically. RESULTS: There was a significant increase in TGF-?1 expression in the carcinoma compared with normal lung tissue. The mean TGF-?1 level in the 39 lung carcinoma patients before radiotherapy was (11 0?1 5) ?g/L, which was significantly higher than control group (3 8?0 2 ?g/L) ( P 0 05). At the time of follow-up 6 months, the patients of lung carcinoma had a significantly higher plasma TGF-?1 level (11 3?1 2 ?g/L) compared with the level at the end of radiotherapy ( P 0 05). Not significant difference was found in TGF-?1 levels among different histologic types. CONCLUSION: These data demonstrated that TGF-?1 was associated with the pathogenesis of lung carcinoma, and it may be a useful tumor marker in patients with lung carcinoma. [
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12 cases of severe pulmonary infection were treated with ceftizoxime, one of cepha-losporins of the third generation. Clinical observation and pharmacokinetics were carried out. The result showed that intravenous infusion was the best route of drug administration. It had the advantages of high serum concentration and prolonged maintenance of serum level. 1 gram of ceftizoxi-me, two times a day, was enough for most pathogens except Pseudomonas aeruginosa.