Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial

Jing-ya Li; Li-xin Yuan; Gen-ming Zhang; Li Zhou; Ying Gao; Qing-bin Li; Che Chen

doi:10.1007/s11655-016-2467-7

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Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial

Updated：2021-08-27

- Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial
- Chinese Journal of Integrative Medicine Vol. 22, Issue 5, Pages: 328-334(2016)
- Affiliations：
  
  1. Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Beijing,China
  2. Tongzhou Traditional Chinese Medicine Hospital of Beijing,Beijing,China
- Author bio：
- Funds：
  
  Supported by the Beijing Committee on Science and Technology, Project on Research on Two Standards of Traditional Chinese Medicine Treatment for Stroke (No. D101107049310003)
- DOI：10.1007/s11655-016-2467-7
  CLC：
- Published：2016，
  
  Published Online：30 April 2016，
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Li, Jy., Yuan, Lx., Zhang, Gm. et al. Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial., Chin. J. Integr. Med. 22, 328–334 (2016). https://doi.org/10.1007/s11655-016-2467-7

Jing-ya Li, Li-xin Yuan, Gen-ming Zhang, et al. Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial. [J]. Chinese Journal of Integrative Medicine 22(5):328-334(2016)
Li, Jy., Yuan, Lx., Zhang, Gm. et al. Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial., Chin. J. Integr. Med. 22, 328–334 (2016). https://doi.org/10.1007/s11655-016-2467-7 DOI：

Jing-ya Li, Li-xin Yuan, Gen-ming Zhang, et al. Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial. [J]. Chinese Journal of Integrative Medicine 22(5):328-334(2016) DOI： 10.1007/s11655-016-2467-7.

摘要

To investigate the efficacy and safety of the Chinese herbal therapeutic regimen of activating blood circulation (TRABC) in treatment of hypertensive intracerebral hemorrhage (HICH). This was a multi-center prospective randomized open-label blinded-endpoint (PROBE) trial with HICH admitted to 12 hospitals. Totally 240 participants were randomized to the treatment group treated with TRABC in addition to conventional Western treatment or the control group with conventional Western treatment equally for 3 months. Primary outcome was degree of disability as measured by modified Rankin Scale (mRS). Secondary outcomes were the absorption of hematoma and edema

National Institutes of Health Stroke Scale (NIHSS) scores and patient-reported outcome measures for stroke and Barthel activities of daily living index. Adverse events and mortality were also recorded. After 3 months of treatment

the rate of mRS 0-1 and mRS 0-2 in the treatment group was 72.5% and 80.4%

respectively

and in the control group 48.1% and 63.9%

respectively

with a significant difference between groups (P<0.01). Hematoma volume decreased significantly at day 7 of treatment in the treatment group than the control group (P=0.038). Average Barthel scores in the treatment group after treatment was 89.11±19.93

and in the control group 82.18±24.02 (P=0.003). NIHSS scores of the two groups after treatment decreased significantly compared with before treatment (P=0.001). Patient-reported outcomes in the treatment group were lower than the control group at day 21 and 3 months of treatment (P<0.05). There were 4 deaths

2 in each group

and 11 adverse events

6 in the treatment group and 5 in the control group. The integrative therapy combined TRABC with conventional Western treatment for HICH could promote hematoma absorption thus minimize neurologic impairment

without increasing intracerebral hematoma expansion and re-bleeding.

Abstract

the rate of mRS 0-1 and mRS 0-2 in the treatment group was 72.5% and 80.4%

respectively

and in the control group 48.1% and 63.9%

respectively

2 in each group

and 11 adverse events

without increasing intracerebral hematoma expansion and re-bleeding.

关键词

hypertensive intracerebral hemorrhageactivating blood circulation to remove stasisChinese herbsprospective randomized open-label blinded-endpoint trial

Keywords

hypertensive intracerebral hemorrhageactivating blood circulation to remove stasisChinese herbsprospective randomized open-label blinded-endpoint trial

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Henan University of Chinese Medicine

The First Affiliated Hospital of Henan University of Chinese Medicine

College of Fundamental Medicine, Chengdu University of Traditional Chinese Medicine

The First Affiliated Hospital of Soochow University

The Hospital of Traditional Chinese Medicine of Jiangsu Province

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