首页|Naoxueshu Oral Liquid Accelerates Post-Craniotomy Hematoma Absorption in Patients:An Open-Label,Multicenter,and Randomized Controlled Trial

Naoxueshu Oral Liquid Accelerates Post-Craniotomy Hematoma Absorption in Patients:An Open-Label,Multicenter,and Randomized Controlled Trial

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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 than65 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.ChiCTR1 800017981)

post-craniotomy hematomaNaoxueshu Oral Liquidhematoma absorptionrandomized controlled trialChinese medicine

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

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Department of Neurosurgery,Neurosurgery Research Institute,The First Affiliated Hospital of Fujian Medical University,Fuzhou(350004),China

Department of Neurosurgery,Binhai Branch of National Regional Medical Center,The First Affiliated Hospital,Fujian Medical University,Fuzhou(350209),China

Clinical Research and Translation Center,The First Affiliated Hospital of Fujian Medical University,Fuzhou(350004),China

Fujian Clinical Research Center for Neurological Diseases,The First Affiliated Hospital of Fujian

Department of Neurosurgery,The Second Affiliated Hospital of Soochow University,Suzhou,Jiangsu Province(215000),China

Department of Neurosurgery,The First Affiliated Hospital of Chongqing Medical University,Chongqing(400000),China

Department of Neurosurgery,Tianjin Medical University General Hospital,Tianjin 300000,China

Department of Neurosurgery,The Third Hospital of Shijiazhuang,Shijiazhuang(050000),China

Department of Neurosurgery,The First College of Clinical Medical Science,China Three Gorges University,Yichang,Hubei Province(443000),China

Department of Neurosurgery,Yichang Central People's Hospital,Yichang,Hubei Province(443000),China

Department of Neurosurgery,Xiangyang No.1 People's Hospital Affiliated to Hubei University of Medicine,Xiangfan,Hubei Province(441100),China

Department of Neurosurgery,Zhoukou Central Hospital,Zhoukou,Henan Province(466000),China

Department of Neurosurgery,The Third Hospital of Mianyang,Mianyang,Sichuan Province(621000),China

Department of Neurology,Beijing Tiantan Hospital,Capital Medical University,Beijing(100000),China

China National Clinical Research Center for Neurological Diseases,Beijing Tiantan Hospital,Capital Medical University,Beijing(100000),China

Department of Clinical Epidemiology and Clinical Trial,Capital Medical University,Beijing(100000),China

Beijing Municipal Key Laboratory of Clinical Epidemiology,Beijing(100000),China

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Technology Platform Construction Project of Fujian ProvinceTechnology Platform Construction Project of Fujian Province

2021Y20012020Y2003

2024

10.1007/s11655-024-3902-6

中国结合医学杂志(英文版)
中国中西医结合学会 中国中医研究院

中国结合医学杂志(英文版)

CSTPCD
影响因子：1.056
ISSN：1672-0415
年,卷(期)：2024.30(8)