脑血疏口服液加速患者开颅术后血肿吸收：一项开放标签、多中心、随机对照试验

HE Qiu; LIN Fu-xin; SU Jin-ye; ZHUO Ling-yun; ZHU Qing; SUN Xiao-chuan; JIANG Rong-cai; YAO Zhi-gang; WANG Lei; DANG Yan-wei; LIU De-zhong; LIU Yang; FANG Wen-hua; WANG Fang-yu; LIN Yuan-xiang; WANG An-xin; WANG Deng-liang; KANG De-zhi

doi:10.1007/s11655-024-3902-6

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脑血疏口服液加速患者开颅术后血肿吸收：一项开放标签、多中心、随机对照试验

Original Article | Updated：2024-07-22

- 脑血疏口服液加速患者开颅术后血肿吸收：一项开放标签、多中心、随机对照试验
- Naoxueshu Oral Liquid Accelerates Post-Craniotomy Hematoma Absorption in Patients: An Open-Label, Multicenter, and Randomized Controlled Trial
- 中国结合医学杂志（英文版） 2024年30卷第8期页码：675-683
- Affiliations：
  
  1.Department of Neurosurgery, Neurosurgery Research Institute, The First Affiliated Hospital of Fujian Medical University, Fuzhou(350004), China
  2.Department of Neurosurgery, Binhai Branch of National Regional Medical Center, The First Affiliated Hospital, Fujian Medical University, Fuzhou (350209), China
  3.Clinical Research and Translation Center, The First Affiliated Hospital of Fujian Medical University, Fuzhou (350004), China
  4.Fujian Clinical Research Center for Neurological Diseases, The First Affiliated Hospital of Fujian Medical University, Fuzhou (350004), China
  5.Fujian Provincial Institutes of Brain Disorders and Brain Sciences, The First Affiliated Hospital of Fujian Medical University, Fuzhou (350004), China
  6.Department of Neurosurgery, The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province (215000), China
  7.Department of Neurosurgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing (400000), China
  8.Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin (300000), China
  9.Department of Neurosurgery, The Third Hospital of Shijiazhuang, Shijiazhuang (050000), China
  10.Department of Neurosurgery, The First College of Clinical Medical Science, China Three Gorges University, Yichang, Hubei Province (443000), China
  11.Department of Neurosurgery, Yichang Central People's Hospital, Yichang, Hubei Province(443000), China
  12.Department of Neurosurgery, Xiangyang No. 1 People's Hospital Affiliated to Hubei University of Medicine, Xiangfan, Hubei Province (441100), China
  13.Department of Neurosurgery, Zhoukou Central Hospital, Zhoukou, Henan Province(466000), China
  14.Department of Neurosurgery, The Third Hospital of Mianyang, Mianyang, Sichuan Province (621000), China
  15.Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing (100000), China
  16.China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing (100000), China
  17.Department of Clinical Epidemiology and Clinical Trial, Capital Medical University, Beijing (100000), China
  18.Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing (100000), China
- Author bio：
  
  Dr. KANG De-zhi, E-mail: kdz99988@vip.sina.com
- Funds：
  
  the Technology Platform Construction Project of Fujian Province(2021Y2001;2020Y2003)
- DOI：10.1007/s11655-024-3902-6
  中图分类号：
- 纸质出版日期：2024-08，
  
  网络出版日期：2024-04-04，
  
  录用日期：2023-11-15
- Accepted：
Scan for full text
脑血疏口服液加速患者开颅术后血肿吸收：一项开放标签、多中心、随机对照试验[J]. 中国结合医学杂志（英文版）, 2024,30(8):675-683.

HE Qiu, LIN Fu-xin, SU Jin-ye, et al. Naoxueshu Oral Liquid Accelerates Post-Craniotomy Hematoma Absorption in Patients: An Open-Label, Multicenter, and Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2024,30(8):675-683.
脑血疏口服液加速患者开颅术后血肿吸收：一项开放标签、多中心、随机对照试验[J]. 中国结合医学杂志（英文版）, 2024,30(8):675-683. DOI： 10.1007/s11655-024-3902-6.

HE Qiu, LIN Fu-xin, SU Jin-ye, et al. Naoxueshu Oral Liquid Accelerates Post-Craniotomy Hematoma Absorption in Patients: An Open-Label, Multicenter, and Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2024,30(8):675-683. DOI： 10.1007/s11655-024-3902-6.

摘要

目的:

探究脑血疏口服液 (NXS) 对开颅术后血肿 (PCH) 患者血肿吸收的促进作用.

方法:

这是一项开放标签、多中心、随机对照试验

在中国的9家医院开展. 患者年龄18–80岁

开颅术后幕上血肿体积为10–30 mL

或术后幕下血肿体积小于10 mL

或术后脑室内出血. 采用随机数字表法将入组患者按照1:1的比例随机分配到NXS组 (每次10 mL

每日3次

共15天) 或对照组. 两组患者均给予标准医疗护理. 主要结局指标为从第1天到第15天血肿体积减少的百分比. 次要结局指标包括从第1天到第7天血肿体积减少的百分比

从第1天到第7天和第15天血肿体积减少的绝对值

以及从第1天到第7天和第15天神经功能的变化. 在整个研究过程中

对药物的安全性进行密切监测. 此外

根据年龄、性别、糖尿病史和脑出血 (ICH) 病因进行亚组分析.

结果:

在2018年3月30日至2020年4月15日期间

共有120例患者入组并随机分配. 对照组有1例患者失访

最终共有119例患者纳入分析 (NXS组60例

对照组59例) . 在全分析集 (FAS) 分析中

NXS组患者从第1天到第15天血肿体积减少的百分比显著高于对照组 [中位数 (Q1

Q3) : 85% (71%

97%)

. 76% (53%

93%)

0.05

]

. 无论是FAS还是符合方案集分析

两组次要结局指标比较

差异无统计学意义 (

0.05) . 此外

研究期间无不良事件的报告. 在FAS分析中

在以下亚组中

NXS组在第15天的血肿体积减少的百分比更高: 男性患者、65岁以下患者、无糖尿病患者或因ICH而首次行开颅手术的患者 (均

0.05) .

结论:

NXS具有促进PCH患者从第1天到第15天血肿体积减少百分比的潜力; 其疗效是安全且有效的. 但NXS的疗效同时可能受患者特征的影响. (临床试验注册号: ChiCTR1800017981)

Abstract

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%)

. 76% (53%

93%)

0.05

]

. The secondary outcomes showed no statistical significance between two groups

either in FAS or per-protocol set (

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

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)

关键词

开颅术后血肿脑血疏口服液血肿吸收随机对照试验中医

Keywords

post-craniotomy hematomaNaoxueshu Oral Liquidhematoma absorptionrandomized controlled trialChinese medicine

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