Wang Dong, Gao Chuang, Xu Xin, Chen Tao, Tian Ye, Wei Huijie, Zhang Shu, Quan Wei, Wang Yi, Yue Shuyuan, Wang Zengguang, Lei Ping, Anderson Craig, Dong Jingfei, Zhang Jianning, Jiang Rongcai
1Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin.
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.
J Neurosurg. 2020 Jan 31;134(1):235-243. doi: 10.3171/2019.11.JNS192020. Print 2021 Jan 1.
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.Clinical trial registration no.: ChiCTR-IPR-14005573 (http://www.chictr.org.cn/index.aspx).
作者试图验证以下假设，即阿托伐他汀（ATO）联合地塞米松（DXM）可增强ATO对慢性硬膜下血肿（CSDH）的治疗效果。
60例CSDH患者接受为期5周的治疗，并进行7周的随访。患者被随机分为两组，分别接受为期5周的每日20mg阿托伐他汀治疗或每日20mg阿托伐他汀联合地塞米松治疗（ATO+DXM）。地塞米松的5周治疗方案为：连续2周每日2.25mg，随后2周每日0.75mg，分两次服用，最后1周每日0.75mg，一次服用。主要终点是通过基线及随访5周时的神经影像学评估血肿缩小情况。次要结局包括使用马克瓦尔德分级量表和格拉斯哥昏迷量表（MGS-GCS）评估的神经功能改善情况。
患者平均年龄为66.6岁，25%为女性。接受ATO+DXM治疗的患者在第5周时血肿缩小更明显（组间差异18.37ml；95%可信区间8.17 - 28.57；p = 0.0005）。这种缩小从治疗第2周（14.51ml；95%可信区间4.31 - 24.71；p = 0.0056）开始，并持续至第12周（17.50ml；95%可信区间7.30 - 27.70；p = 0.0009）。在第5周时，ATO+DXM组和ATO组分别有83.33%和32.14%的患者神经功能完全恢复（MGS-GCS 0级）。在第5周时，接受ATO+DXM治疗的患者外周血中T细胞水平显著降低，调节性T细胞和内皮祖细胞水平升高。
在CSDH患者中，ATO+DXM在减少血肿和改善神经功能方面比单独使用ATO更有效。这些结果需要在随机安慰剂对照试验中进一步证实。临床试验注册号：ChiCTR-IPR-14005573（http://www.chictr.org.cn/index.aspx）。
