The Effect of Goreisan on the Prevention of Chronic Subdural Hematoma Recurrence: Multi-Center Randomized Controlled Study
The Effect of Goreisan on the Prevention of Chronic Subdural Hematoma Recurrence: Multi-Center Randomized Controlled Study
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DOI：
10.1089/neu.2017.5407
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发表时间：
2018-07-01
影响因子：
4.2
通讯作者：
Ohkuma, Hiroki
中科院分区：
文献类型：
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作者：
Katayama, Kosuke;Matsuda, Naoya;Ohkuma, Hiroki
慢性硬膜下血肿（CSDH）术后复发率较高是一个值得关注的问题。Goreisan是一种草药，通过抑制水通道蛋白的表达表现出利尿作用，并且其在预防术后CSDH复发中的功效已被几个病例试验所证实。这项多中心前瞻性随机对照试验旨在研究goreisan对术后CSDH复发的预防作用。本研究入组了60岁以上接受钻孔手术的症状性CSDH患者。将患者随机分为对照组和goreisan组，口服goreisan（7.5g/d），持续12周。主要终点是术后12周的复发率，次要终点是12周时计算机断层扫描显示的血肿体积减少率。不仅对60岁以上的所有年龄段的患者进行了分析，还对75岁以上或75岁以下的患者进行了分析。对180例患者进行了随访和分析（对照组，n=88; goreisan组，n=92）。考虑到所有年龄段的患者和75岁以下的患者，Goreisan组的复发率相对较低，但无显著差异。血肿体积缩小率无显著差异。根据目前的研究结果，未来需要进行更大规模的研究，包括更多的病例，以确认Goreisan的疗效。
The relatively high rate of post-operative recurrence in the treatment of chronic subdural hematoma (CSDH) is a significant problem. Goreisan is an herbal medicine that exhibits a hydragogue effect by inhibiting the expression of aquaporins, and its efficacy in preventing post-operative CSDH recurrence has been suggested by several case trials. This multi-center prospective randomized controlled trial was performed to investigate the preventative effect of goreisan on post-operative CSDH recurrence. Patients with symptomatic CSDH over 60 years old undergoing burr hole surgery were enrolled in this study. The patients were randomly allocated to the control group or the goreisan group, in which oral administration of goreisan (7.5g daily) was continued for 12 weeks. The primary end-point was the post-operative recurrence rate at 12 weeks and the secondary end-point was hematoma volume reduction rates on computed tomography scan at 12 weeks. The analyses were performed not only on patients of all ages older than 60 years, but also on patients divided into those over or under 75 years old. One hundred and eighty patients were followed and analyzed (the control group, n=88; the goreisan group, n=92). The recurrence rates considering patients of all ages and patients under 75 years old were relatively low in the goreisan group but without a significant difference. The hematoma volume reduction rates showed no significant difference. Based on the results of the present study, a larger-scale study including more cases is necessary in future to confirm the efficacy of goreisan.