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Treatment of chronic subdural hematoma with atorvastatin combined with low-dose dexamethasone: phase II randomized proof-of-concept clinical trial

Wang, Dong, Gao, Chuang, Xu, Xin, Chen, Tao ORCID:, Tian, Ye, Wei, Huijie, Zhang, Shu, Quan, Wei, Wang, Yi, Yue, Shuyuan, Wang, Zengguang, Lei, Ping, Anderson, Craig, Dong, Jing-Fei, Zhang, Jianning and Jiang, Rongcai (2020) 'Treatment of chronic subdural hematoma with atorvastatin combined with low-dose dexamethasone: phase II randomized proof-of-concept clinical trial'. Journal of Neurosurgery, Vol 134, Issue 1.

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The authors sought to test the hypothesis that adding dexamethasone (DXM) to atorvastatin (ATO) potentiates the effects of ATO on chronic subdural hematoma (CSDH).
Sixty patients with CSDH underwent 5 weeks of treatment with an additional 7-week follow-up. Patients were randomized to receive a 5-week regimen of ATO 20 mg daily or ATO 20 mg daily plus a DXM regimen (ATO+DXM). The 5-week DXM regimen was 2.25 mg daily for 2 consecutive weeks, followed by 0.75 mg twice daily for 2 weeks and 0.75 mg once daily for 1 week. The primary endpoint was hematoma reduction assessed by neuroimaging at baseline and at 5 weeks of follow-up. Secondary outcomes included neurological improvement assessed by using the Markwalder’s Grading Scale and Glasgow Coma Scale (MGS-GCS).
The mean patient age was 66.6 years, and 25% of patients were women. The patients who were treated with ATO+DXM had more obvious hematoma reduction at the 5th week (between-groups difference 18.37 ml; 95% CI 8.17–28.57; p = 0.0005). This reduction started from the 2nd week (14.51 ml; 95% CI 4.31–24.71; p = 0.0056) of treatment and persisted until the 12th week (17.50 ml; 95% CI 7.30–27.70; p = 0.0009). Complete recovery of neurological function (MGS-GCS grade 0) at 5 weeks was achieved in 83.33% and 32.14% of patients in the ATO+DXM and ATO groups, respectively. At the 5th week, patients receiving ATO+DXM had significantly lower levels of T cells and higher levels of regulatory T cells and endothelial progenitor cells in their peripheral blood.
ATO+DXM was more effective than ATO alone in reducing hematoma and improving neurological function in patients with CSDH. These results require further confirmation in a randomized placebo-controlled trial.

Item Type: Article
Subjects: QV Pharmacology > Drug Standardization. Pharmacognosy. Medicinal Plants > QV 771 Standardization and evaluation of drugs
WB Practice of Medicine > WB 102 Clinical medicine
WB Practice of Medicine > WB 102.5 Clinical medicine - evidence-based practice
WH Hemic and Lymphatic Systems > Hematologic Diseases. Immunologic Factors. Blood Banks > WH 312 Hemorrhagic disorders (General)
WK Endocrine System > WK 20 Research (General)
WL Nervous System > WL 200 Meninges. Blood-brain barrier
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):
Depositing User: Christine Bradbury
Date Deposited: 03 Feb 2020 13:37
Last Modified: 06 Apr 2021 14:34


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