Poulsen Frantz Rom, Munthe Sune, Søe Morten, Halle Bo
Department of Neurosurgery, Odense University Hospital, DK-5000 Odense , Denmark; OPEN Odense Patient Data Explorative Network, Odense University Hospital, DK-5000 Odense, Denmark; Institute of Clinical Research, University of Southern Denmark, DK-5000 Odense, Denmark.
Department of Neurosurgery, Odense University Hospital, DK-5000 Odense , Denmark; Institute of Clinical Research, University of Southern Denmark, DK-5000 Odense, Denmark.
Clin Neurol Neurosurg. 2014 Aug;123:4-8. doi: 10.1016/j.clineuro.2014.05.003. Epub 2014 May 14.
Recurrence rates of between 5% and 25% have been reported following surgery for chronic subdural hematoma (CSH). A previous study showed that the treatment with angiotensin converting enzyme (ACE) inhibitors decreases the risk of recurrence. To test the effects of ACE inhibitors on the recurrence CSH and CSH remnant six weeks after surgery, we conducted a prospective double-blinded randomized controlled clinical trial on patients with CSHs from July 2009 until October 2012.
Patients eligible for burr hole surgery for CSH were randomized into either an ACE inhibitor perindopril 5mg or placebo treatment daily for three months prior to surgery. Cerebral CT scans were performed after six weeks, and clinical follow-ups were performed three months after surgery. Additionally, a retrospective analysis of the data and CT scans from all nonrandomized patients from the same time period was performed.
Forty-seven patients were included in the randomized study. The patients' preoperative Glasgow Coma Scale scores were 15. None of the patients in the randomized group developed a recurrence after surgery. Measurements of the sizes of the CSH before and six weeks after surgery revealed no difference between the placebo and perindopril-treated groups. In the retrospective group (245 patients), there was no correlation between the risk of recurrence and ACE inhibitor treatment.
Our data suggest that perindopril does not diminish the size of residual CSHs six weeks after burr hole surgery and that ACE inhibitors do not decrease the risk of CSH recurrence.
据报道，慢性硬膜下血肿（CSH）手术后的复发率在5%至25%之间。先前的一项研究表明，使用血管紧张素转换酶（ACE）抑制剂进行治疗可降低复发风险。为了测试ACE抑制剂对CSH复发及术后六周CSH残余物的影响，我们于2009年7月至2012年10月对CSH患者进行了一项前瞻性双盲随机对照临床试验。
符合CSH钻孔手术条件的患者被随机分为两组，一组术前三个月每天服用5mg ACE抑制剂培哚普利，另一组服用安慰剂。六周后进行脑部CT扫描，术后三个月进行临床随访。此外，对同一时期所有非随机分组患者的数据和CT扫描进行了回顾性分析。
47名患者纳入随机研究。患者术前格拉斯哥昏迷量表评分为15分。随机分组的患者术后均未复发。安慰剂组和培哚普利治疗组术后六周CSH大小的测量结果无差异。在回顾性分析组（245名患者）中，复发风险与ACE抑制剂治疗之间无相关性。
我们的数据表明，培哚普利不会减小钻孔手术后六周残余CSH的大小，且ACE抑制剂不会降低CSH复发风险。
