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      Safety and Efficacy of Atorvastatin for Chronic Subdural Hematoma in Chinese Patients : A Randomized ClinicalTrial

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          Abstract

          Chronic subdural hematoma (CSDH) is a trauma-associated condition commonly found in elderly patients. Surgery is currently the treatment of choice, but it carries a significant risk of recurrence and death. Nonsurgical treatments remain limited and ineffective. Our recent studies suggest that atorvastatin reduces hematomas and improves the clinical outcomes of patients with CSDH.

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          Most cited references27

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          The ABCs of Measuring Intracerebral Hemorrhage Volumes

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            Chronic subdural hematoma in the elderly: not a benign disease.

            Chronic subdural hematoma (CSDH) is perceived to be a "benign," easily treated condition in the elderly, but reported follow-up periods are brief, usually limited to acute hospitalization. The authors conducted a retrospective review of data obtained in a prospectively identified consecutive series of adult patients admitted to their institution between September 2000 and February 2008 and in whom there was a CT diagnosis of CSDH. Survival data were compared to life-table data. Of the 209 cases analyzed, 63% were men and the mean age was 80.6 years (range 65-96 years). Primary surgical interventions performed were bur holes in 21 patients, twist-drill closed-system drainage in 44, and craniotomies in 72. An additional 72 patients were simply observed. Reoperations were recorded in 5 patients-4 who had previously undergone twist-drill drainage and 1 who had previously undergone a bur hole procedure (p = 0.41, chi-square analysis). Thirty-five patients (16.7%) died in hospital, 130 were discharged to rehabilitation or a skilled care facility, and 44 returned home. The follow-up period extended to a maximum of 8.3 years (median 1.45 years). Six-month and 1-year mortality rates were 26.3% and 32%, respectively. In the multivariate analysis (step-wise logistic regression), the sole factor that predicted in-hospital death was neurological status on admission (OR 2.1, p = 0.02, for each step). Following discharge, the median survival in the remaining cohort was 4.4 years. In the Cox proportional hazards model, only age (hazard ratio [HR] 1.06/year, p = 0.02) and discharge to home (HR 0.24, p = 0.01) were related to survival, whereas the type of intervention, whether surgery was performed, size of subdural hematoma, amount of shift, bilateral subdural hematomas, and anticoagulant agent use did not affect the long- or short-term mortality rate. Comparison of postdischarge survival and anticipated actuarial survival demonstrated a markedly increased mortality rate in the CSDH group (median survival 4.4 vs 6 years, respectively; HR 1.94, p = 0.0002, log-rank test). This excess mortality rate was also observed at 6 months postdischarge with evidence of normalization only at 1 year. In this first report of the long-term outcome of elderly patients with CSDH the authors observed persistent excess mortality up to 1 year beyond diagnosis. This belies the notion that CSDH is a benign disease and indicates it is a marker of other underlying chronic diseases similar to hip fracture.
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              Intravenous magnesium sulphate for aneurysmal subarachnoid hemorrhage (IMASH): a randomized, double-blinded, placebo-controlled, multicenter phase III trial.

              Pilot clinical trials using magnesium sulfate in patients with acute aneurysmal subarachnoid hemorrhage have reported trends toward improvement in clinical outcomes. This Phase III study aimed to compare intravenous magnesium sulfate infusion with saline placebo among such patients. We recruited patients with aneurysmal subarachnoid hemorrhage within 48 hours of onset from 10 participating centers. The patients were randomly assigned to magnesium sulfate infusion titrated to a serum magnesium concentration twice the baseline concentration or saline placebo for 10 to 14 days. Patients and assessors were blinded to treatment allocation. The study is registered at www.strokecenter.org/trials (as Intravenous Magnesium Sulphate for Aneurysmal Subarachnoid Hemorrhage [IMASH]) and www.ClinicalTrials.gov (NCT00124150). Of the 327 patients recruited, 169 were randomized to receive treatment with intravenous magnesium sulfate and 158 to receive saline (placebo). The proportions of patients with a favorable outcome at 6 months (Extended Glasgow Outcome Scale 5 to 8) were similar, 64% in the magnesium sulfate group and 63% in the saline group (OR, 1.0; 95% CI, 0.7 to 1.6). Secondary outcome analyses (modified Rankin Scale, Barthel Index, Short Form 36, and clinical vasospasm) also showed no significant differences between the 2 groups. Predefined subgroups included age, admission World Federation of Neurological Surgeons grade, pre-existing hypertension, intracerebral hematoma, intraventricular hemorrhage, location of aneurysm, size of aneurysm, and mode of aneurysm treatment. In none of the subgroups did the magnesium sulfate group show a better outcome at 6 months. The results do not support a clinical benefit of intravenous magnesium sulfate infusion over placebo infusion in patients with acute aneurysmal subarachnoid hemorrhage.
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                Author and article information

                Journal
                JAMA Neurology
                JAMA Neurol
                American Medical Association (AMA)
                2168-6149
                November 01 2018
                November 01 2018
                : 75
                : 11
                : 1338
                Affiliations
                [1 ]Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China
                [2 ]Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin, China
                [3 ]Department of Neurosurgery, Peking Union Medical College Hospital, Beijing, China
                [4 ]Department of Neurosurgery, Southwest Hospital, Chongqing, China
                [5 ]Department of Neurosurgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
                [6 ]Department of Neurosurgery, Qilu Hospital of Shandong University, Jinan, China
                [7 ]Department of Neurosurgery, Huashan Hospital Fudan University, Shanghai, China
                [8 ]Department of Neurosurgery, Xiangya Hospital of Central South University, Changsha, China
                [9 ]Department of Neurosurgery, Xijing Hospital, Xian, China
                [10 ]Department of Neurosurgery, Beijing TianTan Hospital, the Capital Medical University, Beijing, China
                [11 ]Department of Neurosurgery, General Hospital of Chinese People’s Liberation Army, Beijing, China
                [12 ]Division of Neurosurgery, Department of Surgery, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, Hong Kong
                [13 ]Department of Neurosurgery, Linyi People’s Hospital, Linyi, China
                [14 ]Department of Neurosurgery, Jiangsu Provincial Hospital, Nanjing Medical University First Affiliated Hospital, Nanjing, China
                [15 ]Department of Neurosurgery, First Affiliated Hospital of Fujian Medical University, Fuzhou, China
                [16 ]Department of Neurosurgery, General Hospital of Ningxia Medical University, Yinchuan, China
                [17 ]Department of Neurosurgery, Second Affiliated Hospital of Hebei Medical University, Shijiazhuang, China
                [18 ]Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
                [19 ]Department of Neurosurgery, Affiliated Hospital of Xuzhou Medical College, Xuzhou, China
                [20 ]Department of Neurosurgery, Central Hospital of Erdos, Erdos, China
                [21 ]Department of Neurosurgery, Xi'an Tangdu Hospital of the fourth Military Medical University, Xian, China
                [22 ]Department of Neurosurgery, First Affiliated Hospital of Shanxi Medical University, Taiyuan, China
                [23 ]Department of Neurosurgery, Provincial People’s Hospital of Inner Mongolia, Huhehot, China
                [24 ]Department of Neurosurgery, Cangzhou Central Hospital, Cangzhou, China
                [25 ]Department of Neurosurgery, Second Affiliated Hospital of Nanchang University, Nanchang, China
                [26 ]Department of Neurosurgery, Shanghai Changzheng Hospital, Shanghai, China
                [27 ]Department of Neurosurgery, 117th Hospital of Chinese People’s Liberation Army, Hangzhou, China
                [28 ]Laboratory of Neuro-Trauma and Neurodegenerative Disorders, Tianjin Geriatrics Institute, Tianjin Medical University General Hospital, Tianjin, China
                [29 ]Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin, China
                [30 ]Bloodworks Research Institute, Division of Hematology, Department of Medicine, University of Washington School of Medicine, Seattle
                Article
                10.1001/jamaneurol.2018.2030
                6248109
                30073290
                95152d9b-08da-4e45-897b-397f60f1a6fc
                © 2018
                History

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