| BackgroundRen Jixue, the maste of national physician, initiated the method that using herbs with the effect of removing blood stasis for patients with intracranial hemaorrhage. It is proved a useful method for acute intracranial hemorrhage patients through dacades of clinical practice, with the effects of reducing intracranial pressure, relieving cerebral edema, protectiving blood-brain barrier, improving the microcirculation around the hematoma and protectiving neurons. It is proved safe that removing blood stasis method for patients with intracranial hemaorrhage after 24 hours. Whether it is safe and effective when using in hyperacute intracranial hemaorrhage stage is not kwnown.ObjectivesTo find Whether using removing blood stasis method in hyperacute intracranial hemaorrhage stage can lead to hematoma enlargement and its clinical efficacy and explore the related factors of hematoma enlargement.MehtodsIt was a multicenter prospective randomized double-blind placebo-controlled clinical studies. We recruited patients presenting at less than 6 h from symptom onset to hospital. All the patients were randomised divided into group A, group B and group C, with conventional therapy plus investigational product, and the three groups were allocated according to 1:1:1. Each group needed 95 patients. All the there kinds of investigational product consists 8 kinds of Chinese herb medicines. Among them, one investigational product consisits of the original formula mading up by 8 kinds of Chinese herb medicines;One is formd by 6 kinds of Chinese herb medicines as the same as group A when it removes 2 herbs which can remove blood stasis, and 2 corresponding herb placebo. The last one is made up by 8 kinds of corresponding herb placebo. The primary outcome is the mobidity of hematoma enlargement among the three group. Secondary outcomes were neurologic deficits, the ability of daily activity of life and disability rate in 90+3 day. We also explore the relative factors of hematoma enlargement.ResultsFrom Octomber 2013 through March 2015, a total 80 participants were enrolled at the 8 hospitals. Four patients were excluded for without conducting the second CT. Between 24h to 10 days,4 patients were withdrawn for hematoma enlargement,2 patients died and one patient was suspended by the researcher for chest congestion symptom after taking the medicine.69 patients complete the study by 3 months follow up.12 patients (15.8%)occurred hematoma enlargement within 24 hours. Threr are 3 patients(11.5%) in Group A,4 patients(16.0%) in Group B, and 3 patients (20%) in Group C whose hematoma were enlarged. The mobidity of hematoma enlargement among the three groups has no difference with eath other (P>0.05). There are also no difference in the change of homatma volume by 24h and tenth day and NIHSS, BI and disability mobidity among the three groups in 90±3 days. Univariate analysis find the time from symptom onset to hospital (OR:0.48;95%CI:0.28-0.84;P=0.010), and the level of HDL (OR:0.025;95%CI:0.0014-0.42; P=0.011) are associated with hematoma enlargement. Irregular shape (OR:3.0;95%CI:0.85-10.6;P=0.089) and small hematoma volume (OR:0.9;95%CI:0.8-1.0;P=0.084) may increase the risk of hematoma enlargement., Multivariate analysis indicates that the time from symptom onset to hospital (OR:0.544;95%CI:0.308-0.962;P=0.036) and HDL (OR:0.027;95%CI:0.001-0.529;P=0.017) is relative independent with hematoma enlargement.Conclusion1. It may be safe using removing blood stasis method in hyperacute intracranial hemaorrhage stage and can not increase the risk of hematoma enlargement.2. Multivariate analysis indicated that the shorter the time from symptom onset to hospital, the higher mobidity of hematoma enlargement, and low level of HDL can increase the risk of hematoma enlargement.3. Univariate analysis shows that irregular shape of hematoma may increase the risk of hematoma enlargement and small volume of ICH in basal ganglia can also occur hematoma enlargement. |
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