OBJECTIVETo observe the clinical effect and safety of blood activating stasis removing method (BASRM) on intracerebral hemorrhage patients.

METHODSA multi-center, prospective, randomized, open, controlled and blinded endpoint design was adopted. Totally 228 intracerebral hemorrhage patients were assigned to the treatment group and the control group, 114 in each group by center randomized method. All patients received basic treatment of Western internal medicine. Patients in the treatment group received intravenous infusion with Xingnaojing Injection (XI) from the 1st day of grouping, 20 mL per day for 14 days. Then they took or were nasally fed with Chinese medical granules (by syndrome typing as complicated with wind syndrome, fire syndrome, and phlegm syndrome) for 21 days. Finally they took Naoxueshu Oral Liquid (NOL), 10 mL each time, 3 times per day till the 3rd month of incidence. Patients' disability degree, activities of daily living, neurological impairment, the effective rate, physiologic functions, mental status, social relationship, and degree of treatment satisfaction were assessed using Modified Rankin Scale (MRS), Barthel index (BI), National Institute of Health Stroke Scale (NIHSS), and patient reported outcome (PRO). Head CT was performed to evaluate the absorption of hematoma at the 1st and 7th day of grouping. The safety was also assessed.

RESULTSTotally 108 patients in the treatment group and 112 patients in the control group completed the trial. There was no statistical difference in the total effective rate between the two groups after 3 months of treatment (P>0.05). The MRS score was obviously lower in the treatment group than in the control group (P<0.01) at month 3 after attack (P<0.01). There was statistical difference in the difference between pre-post hematoma volume between the two groups after 7-day treatment (P<0.05). The NIHSS score of two groups at the 7th, 14th, 21st day, and 3rd month decreased significantly (P<0.05). Compared with the control group, the decremenit of NIHSS score decreased more obviously in the treatment group at day 7, 21, and 3rd month (P<0.05). Compared with the control group, the BI increased (P<0.01); physiologic fupctions, social relationship, treatment satisfaction and total score in PRO scale were all lower in the treatment group than in the control group (P<0.05, P<0.01). The incidence of adverse events occurred in 7 cases (6.14%) in the treatment group and 5 cases (4.39%) in the control group, with no statistical difference (P>0.05).

CONCLUSIONBASRM could lower the deformity rate of intracerebral hemorrhage patients at month 3, effectively promote hematoma absorption within 7 days, improve neurologic impairment, and elevate living abilities at month 3 of onset.