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

作者全名："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"

作者地址："[He, Qiu; Lin, Fu-xin; Su, Jin-ye; Zhuo, Ling-yun; Fang, Wen-hua; Wang, Fang-yu; Lin, Yuan-xiang; Wang, Deng-liang; Kang, De-zhi] Fujian Med Univ, Neurosurg Res Inst, Affiliated Hosp 1, Dept Neurosurg, Fuzhou 350004, Peoples R China; [He, Qiu; Lin, Fu-xin; Su, Jin-ye; Zhuo, Ling-yun; Fang, Wen-hua; Wang, Fang-yu; Lin, Yuan-xiang; Wang, Deng-liang; Kang, De-zhi] Fujian Med Univ, Affiliated Hosp 1, Binhai Branch Natl Reg Med Ctr, Dept Neurosurg, Fuzhou 350209, Peoples R China; [Lin, Fu-xin; Zhuo, Ling-yun; Fang, Wen-hua; Wang, Fang-yu; Lin, Yuan-xiang; Wang, Deng-liang; Kang, De-zhi] Fujian Med Univ, Affiliated Hosp 1, Clin Res & Translat Ctr, Fuzhou 350004, Peoples R China; [Lin, Fu-xin; Zhuo, Ling-yun; Fang, Wen-hua; Wang, Fang-yu; Lin, Yuan-xiang; Wang, Deng-liang; Kang, De-zhi] Fujian Med Univ, Affiliated Hosp 1, Fujian Prov Clin Res Ctr Neurol Dis, Fuzhou 350004, Peoples R China; [Lin, Fu-xin; Zhuo, Ling-yun; Fang, Wen-hua; Wang, Fang-yu; Lin, Yuan-xiang; Wang, Deng-liang; Kang, De-zhi] Fujian Med Univ, Fujian Prov Inst Brain Disorders & Brain Sci, Affiliated Hosp 1, Fuzhou 350004, Peoples R China; [Zhu, Qing] Soochow Univ, Dept Neurosurg, Affiliated Hosp 2, Suzhou 215000, Jiangsu, Peoples R China; [Sun, Xiao-chuan] Chongqing Med Univ, Dept Neurosurg, Affiliated Hosp 1, Chongqing, Peoples R China; [Jiang, Rong-cai] Tianjin Med Univ Gen Hosp, Dept Neurosurg, Tianjin 300000, Peoples R China; [Yao, Zhi-gang] Third Hosp Shijiazhuang, Dept Neurosurg, Shijiazhuang 050000, Hebei, Peoples R China; [Wang, Lei] China Three Gorges Univ, Coll Clin Med Sci 1, Dept Neurosurg, Yichang 443000, Hubei, Peoples R China; [Wang, Lei] Yichang Cent Peoples Hosp, Dept Neurosurg, Yichang, Hubei, Peoples R China; [Dang, Yan-wei] Hubei Univ Med, Xiangyang Peoples Hosp 1, Dept Neurosurg, Xiangfan 441053, Hubei, Peoples R China; [Liu, De-zhong] Zhoukou Cent Hosp, Dept Neurosurg, Zhoukou 466000, Henan, Peoples R China; [Liu, Yang] Third Hosp MianYang, Dept Neurosurg, Mianyang 621000, Sichuan, Peoples R China; [Wang, An-xin] Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing 100000, Peoples R China; [Wang, An-xin] Capital Med Univ, Beijing Tiantan Hosp, China Natl Clin Res Ctr Neurol Dis, Beijing 100000, Peoples R China; [Wang, An-xin] Capital Med Univ, Dept Clin Epidemiol & Clin Trial, Beijing 100000, Peoples R China; [Wang, An-xin] Beijing Municipal Key Lab Clin Epidemiol, Beijing 100000, Peoples R China"

通信作者："Kang, DZ (通讯作者)，Fujian Med Univ, Neurosurg Res Inst, Affiliated Hosp 1, Dept Neurosurg, Fuzhou 350004, Peoples R China.; Kang, DZ (通讯作者)，Fujian Med Univ, Affiliated Hosp 1, Binhai Branch Natl Reg Med Ctr, Dept Neurosurg, Fuzhou 350209, Peoples R China.; Kang, DZ (通讯作者)，Fujian Med Univ, Affiliated Hosp 1, Clin Res & Translat Ctr, Fuzhou 350004, Peoples R China.; Kang, DZ (通讯作者)，Fujian Med Univ, Affiliated Hosp 1, Fujian Prov Clin Res Ctr Neurol Dis, Fuzhou 350004, Peoples R China.; Kang, DZ (通讯作者)，Fujian Med Univ, Fujian Prov Inst Brain Disorders & Brain Sci, Affiliated Hosp 1, Fuzhou 350004, Peoples R China."

来源：CHINESE JOURNAL OF INTEGRATIVE MEDICINE

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001196129500001

JCR分区：Q2

影响因子：2.2

年份：2024

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：post-craniotomy hematoma; Naoxueshu Oral Liquid; hematoma absorption; randomized controlled trial; Chinese medicine

摘要："ObjectiveTo investigate whether Naoxueshu Oral Liquid (NXS) could promote hematoma absorption in post-craniotomy hematoma (PCH) patients. MethodsThis 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). ResultsA 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). ConclusionsThe 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)"

基金机构："Technology Platform Construction Project of Fujian Province [2021Y2001, 2020Y2003]"

基金资助正文：Supported by the Technology Platform Construction Project of Fujian Province (No. 2021Y2001 and 2020Y2003).