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

作     者:HE Qiu LIN Fu-xin SU Jin-ye ZHUO Ling-yunn 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 

作者机构:Department of NeurosurgeryNeurosurgery Research InstituteThe First Affiliated Hospital of Fujian Medical UniversityFuzhou350004China Department of NeurosurgeryBinhai Branch of National Regional Medical CenterThe First Affiliated HospitalFujian Medical UniversityFuzhou350209China Clinical Research and Translation CenterThe First Affiliated Hospital of Fujian Medical UniversityFuzhou350004China Fujian Clinical Research Center for Neurological DiseasesThe First Affiliated Hospital of Fujian Medical UniversityFuzhou350004China Fujian Provincial Institutes of Brain Disorders and Brain SciencesThe First Affiliated Hospital of Fujian Medical UniversityFuzhou350004China Department of NeurosurgeryThe Second Affiliated Hospital of Soochow UniversitySuzhouJiangsu Province215000China Department of NeurosurgeryThe First Affiliated Hospital of Chongqing Medical UniversityChongqing400000China Department of NeurosurgeryTianjin Medical University General HospitalTianjin300000China Department of NeurosurgeryThe Third Hospital of ShijiazhuangShijiazhuang050000China Department of NeurosurgeryThe First College of Clinical Medical ScienceChina Three Gorges UniversityYichangHubei Province443000China Department of NeurosurgeryYichang Central People’s HospitalYichangHubei Province443000China Department of NeurosurgeryXiangyang No.1 People’s Hospital Affiliated to Hubei University of MedicineXiangfanHubei Province441100China Department of NeurosurgeryZhoukou Central HospitalZhoukouHenan Province466000China Department of NeurosurgeryThe Third Hospital of MianyangMianyangSichuan Province621000China Department of NeurologyBeijing Tiantan HospitalCapital Medical UniversityBeijing100000China China National Clinical Research Center for Neurological DiseasesBeijing Tiantan HospitalCapital Medical UniversityBeijing100000China Department of Clinical Epidemiology and Clinical TrialCapital Medical UniversityBeijing100000China Beijing Municipal Key Laboratory of Clinical EpidemiologyBeijing100000China 

出 版 物:《Chinese Journal of Integrative Medicine》 (中国结合医学杂志(英文版))

年 卷 期:2024年第30卷第8期

页      面:675-683页

核心收录:

学科分类:1002[医学-临床医学] 100210[医学-外科学(含:普外、骨外、泌尿外、胸心外、神外、整形、烧伤、野战外)] 10[医学] 

基  金:Supported by the Technology Platform Construction Project of Fujan Province(No.2021Y2001 and 2020Y2003) 

主  题:post-craniotomy hematoma Naoxueshu Oral Liquid hematoma absorption randomized controlled trial Chinese medicine 

摘      要:Objective To investigate whether Naoxueshu Oral Liquid(NXS)could promote hematoma absorption in post-craniotomy hematoma(PCH)*** This is an open-label,multicenter,and randomized controlled trial conducted at 9 hospitals in *** 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 *** 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 *** medical care was administered in both *** primary outcome was the percentage reduction in hematoma volume from day 1 to day *** 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 *** safety was closely monitored throughout the ***,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,*** patient was lost to follow-up in the control ***,there were 119 patients(60 in the NXS group and 59 in the control group)included in the *** 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%),P0.05).Furthermore,no adverse events were reported during the *** 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 yea

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