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

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Chinese Journal of Integrative Medicine Aims and scope Submit manuscript

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%) 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)

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Acknowledgments

We would like to express our gratitude to the patients enrolled, as well as the nurses, clinical staff, and staff of the clinical research coordinator, clinical research associate for their valuable support and contributions to the study.

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Authors and Affiliations

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

    Qiu He, Fu-xin Lin, Jin-ye Su, Ling-yun Zhuo, Wen-hua Fang, Fang-yu Wang, Yuan-xiang Lin, Deng-liang Wang & De-zhi Kang

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

    Qiu He, Fu-xin Lin, Jin-ye Su, Ling-yun Zhuo, Wen-hua Fang, Fang-yu Wang, Yuan-xiang Lin, Deng-liang Wang & De-zhi Kang

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

    Fu-xin Lin, Ling-yun Zhuo, Wen-hua Fang, Fang-yu Wang, Yuan-xiang Lin, Deng-liang Wang & De-zhi Kang

  4. Fujian Clinical Research Center for Neurological Diseases, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350004, China

    Fu-xin Lin, Ling-yun Zhuo, Wen-hua Fang, Fang-yu Wang, Yuan-xiang Lin, Deng-liang Wang & De-zhi Kang

  5. Fujian Provincial Institutes of Brain Disorders and Brain Sciences, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350004, China

    Fu-xin Lin, Ling-yun Zhuo, Wen-hua Fang, Fang-yu Wang, Yuan-xiang Lin, Deng-liang Wang & De-zhi Kang

  6. Department of Neurosurgery, The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, 215000, China

    Qing Zhu

  7. Department of Neurosurgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China

    Xiao-chuan Sun

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

    Rong-cai Jiang

  9. Department of Neurosurgery, The Third Hospital of Shijiazhuang, Shijiazhuang, 050000, China

    Zhi-gang Yao

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

    Lei Wang

  11. Department of Neurosurgery, Yichang Central People’s Hospital, Yichang, Hubei Province, 443000, China

    Lei Wang

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

    Yan-wei Dang

  13. Department of Neurosurgery, Zhoukou Central Hospital, Zhoukou, Henan Province, 466000, China

    De-zhong Liu

  14. Department of Neurosurgery, The Third Hospital of Mianyang, Mianyang, Sichuan Province, 621000, China

    Yang Liu

  15. Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100000, China

    An-xin Wang

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

    An-xin Wang

  17. Department of Clinical Epidemiology and Clinical Trial, Capital Medical University, Beijing, 100000, China

    An-xin Wang

  18. Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100000, China

    An-xin Wang

Authors
  1. Qiu He
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  2. Fu-xin Lin
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  3. Jin-ye Su
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  4. Ling-yun Zhuo
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  5. Qing Zhu
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  6. Xiao-chuan Sun
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  7. Rong-cai Jiang
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  8. Zhi-gang Yao
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  9. Lei Wang
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  10. Yan-wei Dang
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  11. De-zhong Liu
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  12. Yang Liu
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  13. Wen-hua Fang
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  14. Fang-yu Wang
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  15. Yuan-xiang Lin
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  16. An-xin Wang
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  17. Deng-liang Wang
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  18. De-zhi Kang
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Contributions

Wang AX, Wang DL and Kang DZ contributed to conceptualizing and designing the trial; He Q, Lin FX, Su JY, and Zhuo LY cleaned, analyzed, and interpreted the data; Lin FX and He Q wrote the manuscript; Zhu Q, Sun XC, Jiang RC, Yao ZG, Wang L, Dang YW, Liu DZ, Liu Y, Fang WH, Wang FY, and Lin YX recruited the patients and collected data. All authors have approved the final manuscript as submitted and have agreed to be accountable for all aspects of the work.

Corresponding author

Correspondence to De-zhi Kang.

Ethics declarations

All authors have declared that they have no conflict of interest.

Additional information

Supported by the Technology Platform Construction Project of Fujian Province (No. 2021Y2001 and 2020Y2003)

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He, Q., Lin, Fx., Su, Jy. et al. Naoxueshu Oral Liquid Accelerates Post-Craniotomy Hematoma Absorption in Patients: An Open-Label, Multicenter, and Randomized Controlled Trial. Chin. J. Integr. Med. (2024). https://doi.org/10.1007/s11655-024-3902-6

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  • DOI: https://doi.org/10.1007/s11655-024-3902-6

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