目的：探讨脑血舒口服液(NXS)是否能促进开颅血肿(PCH)术后血肿的吸收。
方法：这是一个开放标签，多中心，在中国9家医院进行的随机对照试验。年龄18-80岁的患者，开颅术后幕上血肿体积在10-30mL范围内或开颅术后幕下血肿体积小于10mL，纳入颅骨手术后或脑室内出血.他们以1：1的比例随机分配到NXS（每天10mL三次，持续15天）或对照组。两组均进行标准医疗护理。主要结果是第1天至第15天血肿体积减少的百分比。次要结果包括第1天至第7天血肿体积减少的百分比，第1天至第7天和第15天血肿体积的绝对减少，以及第1天至第7天和第15天神经功能的变化。在整个研究过程中密切监测安全性。此外，根据年龄进行亚组分析，性别,糖尿病史,和脑出血（ICH）的病因。
结果：在2018年3月30日至2020年4月15日期间，共纳入120例患者并随机分配。对照组中有一名患者失访。最后,纳入分析的患者有119例(NXS组60例,对照组59例).在完整分析集(FAS)分析中，与对照组相比，NXS组在第1天至第15天的血肿体积减少百分比更大[中位数（Q1，Q3）：85％（71％，97%）与76%(53%，93%），P<0.05]。两组的次要结果无统计学意义，无论是在FAS还是按方案组(P>0.05)。此外，研究期间未报告不良事件.在FAS分析中，在以下亚组中，NXS组在第15天表现出更高的血肿体积减少百分比：男性患者，65岁以下的患者，没有糖尿病的病人,或因ICH而进行初次颅骨手术的患者（均P＆lt;0.05）。
结论：从第1天到第15天，NXS的给药显示出促进血肿体积百分比减少的潜力。这种干预被认为是安全可行的。对NXS的反应可能受患者特征的影响。(登记号ChiCTR1800017981)。
OBJECTIVE: To investigate whether Naoxueshu Oral Liquid (NXS) could promote hematoma absorption in post-craniotomy hematoma (PCH) patients.
METHODS: This is an open-label, multicenter, and randomized controlled
trial conducted at 9 hospitals in China. Patients aged 18-80 years with post-craniotomy supratentorial hematoma volume ranging from 10 to 30 mL or post-craniotomy infratentorial hematoma volume less than 10 mL, or intraventricular hemorrhage following cranial surgery were enrolled. They were randomly assigned at a 1:1 ratio to the NXS (10 mL thrice daily for 15 days) or control groups using a randomization code table. Standard medical care was administered in both groups. The primary outcome was the percentage reduction in hematoma volume from day 1 to day 15. The secondary outcomes included the percentage reduction in hematoma volume from day 1 to day 7, the absolute reduction in hematoma volume from day 1 to day 7 and 15, and the change in neurological function from day 1 to day 7 and 15. The safety was closely monitored throughout the
study. Moreover, subgroup analysis was performed based on age, gender, history of diabetes, and etiology of intracerebral hemorrhage (ICH).
RESULTS: A total of 120 patients were enrolled and randomly assigned between March 30, 2018 and April 15, 2020. One patient was lost to follow-up in the control group. Finally, there were 119 patients (60 in the NXS group and 59 in the control group) included in the analysis. In the full analysis set (FAS) analysis, the NXS group had a greater percentage reduction in hematoma volume from day 1 to day 15 than the control group [median (Q1, Q3): 85% (71%, 97%) vs. 76% (53%, 93%), P<0.05]. The secondary outcomes showed no statistical significance between two groups, either in FAS or per-protocol set (P>0.05). Furthermore, no adverse events were reported during the
study. In the FAS analysis, the NXS group exhibited a higher percentage reduction in hematoma volume on day 15 in the following subgroups: male patients, patients younger than 65 years, patients without diabetes, or those with initial cranial surgery due to ICH (all P<0.05).
CONCLUSIONS: The administration of NXS demonstrated the potential to promote the percentage reduction in hematoma volume from day 1 to day 15. This intervention was found to be safe and feasible. The response to NXS may be influenced by patient characteristics. (Registration No. ChiCTR1800017981).
