Dong Wang1,2, Chuang Gao1,2, Xin Xu1,2, Tao Chen3, Ye Tian1,2, Huijie Wei1,2, Shu Zhang2, Wei Quan1,2, Yi Wang1,2, Shuyuan Yue1,2, Zengguang Wang1,2, Ping Lei4, Craig Anderson5, Jingfei Dong6, Jianning Zhang1,2, Rongcai Jiang1,2. 1. 1Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin. 2. 2Key Laboratory of Post-Neuroinjury Neuro-repair and Regeneration in the Central Nervous System, Ministry of Education, Tianjin Medical University, Tianjin Key Laboratory of Injury and Regenerative Medicine of Nervous System, Tianjin Neurological Institute, Tianjin, China. 3. 3Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom. 4. 4Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin, China. 5. 5George Institute China at Peking University Health Science Center China and George Institute for International Health, University of Sydney, Australia; and. 6. 6Bloodworks Research Institute, Bloodworks Northwest and Department of Medicine, University of Washington School of Medicine, Seattle, Washington.
Abstract
OBJECTIVE: The authors sought to test the hypothesis that adding dexamethasone (DXM) to atorvastatin (ATO) potentiates the effects of ATO on chronic subdural hematoma (CSDH). METHODS: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). RESULTS: 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. CONCLUSIONS: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.Clinical trial registration no.: ChiCTR-IPR-14005573 (http://www.chictr.org.cn/index.aspx).
RCT Entities:
OBJECTIVE: The authors sought to test the hypothesis that adding dexamethasone (DXM) to atorvastatin (ATO) potentiates the effects of ATO on chronic subdural hematoma (CSDH). METHODS: 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). RESULTS: 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. CONCLUSIONS: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.Clinical trial registration no.: ChiCTR-IPR-14005573 (http://www.chictr.org.cn/index.aspx).
Entities:
Keywords:
ADL = activities of daily living; ADL-BI = ADL according to the modified Barthel Index; ATO = atorvastatin; CSDH = chronic subdural hematoma; DXM = dexamethasone; EPC = endothelial progenitor cell; FACS = fluorescence-activated cell sorting; FITC = fluorescein isothiocyanate; GOSE = Glasgow Outcome Scale–Extended; HV = hematoma volume; LOCF = last observation carried forward; MGS-GCS = Markwalder’s Grading Scale and Glasgow Coma Scale; PE = phycoerythrin; Treg = regulatory T cell; atorvastatin; chronic subdural hematoma; dexamethasone; endothelial progenitor cells; regulatory T cells; trauma
Authors: F Al-Mufti; G Kaur; K Amuluru; J B Cooper; K Dakay; M El-Ghanem; J Pisapia; C Muh; R Tyagi; C Bowers; C Cole; S Rosner; J Santarelli; S Mayer; C Gandhi Journal: AJNR Am J Neuroradiol Date: 2021-03-04 Impact factor: 3.825
Authors: Rong Cai Jiang; Dong Wang; Shi Guang Zhao; Ren Zhi Wang; De Zhi Kang; Xin Gen Zhu; Zong Mao Zhao; Jun Ji Wei; Ying Huang; Yan Qu; Xiao Chuan Sun; Hong Ming Ji; Xiao Chun Jiang; Jin Fang Liu; Xi De Zhu; Jian Jun Wang; Ye Tian; Chuang Gao; Hui Jie Wei; Shu Zhang; Wei Quan; Shu Yuan Yue; Ping Lei; Xian Li; Li Li Song; Craig S Anderson; Jian Ning Zhang Journal: Trials Date: 2021-12-11 Impact factor: 2.279