Efficacy And Safety Of The Method Of Breaking Blood And Removing Blood (BBRB) Stasis In The Treatment Of Acute Hypertensive Cerebral Hemorrhage(HICH)

Objective1.To evaluate the result of the method of BBRB stasis in the treatment of AICH from 6 to 72 hour time window.2.To evaluate the safety of the method of BBRB stasis in the treatment of AICH from 6 to 72 hour time window.MethodsThis study was a randomized,controlled,double-blind study conducted in multiple centers.The stratified area group was selected randomly and the opaque envelope method was used.The subjects were randomly divided into three groups according to the same proportion.On the basis of conventional western medicine treatment,they were given placebo,traditional Chinese medicine compound for BBRB stasis and traditional Chinese medicine compound for removing BBRB stasis respectively.The formulation of the test drug is granule.One package for each time,one time in the morning and one time in the evening.The course of treatment is 10 days.The conscious person takes orally,and the unconscious person or the person with dysphagia is fed by nasal feeding.They are followed up within 90 days.The main outcome was hematoma enlargement rate.Secondary outcome measures included 10-14 day mortality,90 day disability rate and disability degree,neurological deficit,daily living ability and hematoma volume change.The safety index are adverse event rates and the occurrence of serious adverse events.ResultsFrom April 2018 to December 2019,124 patients with hypertensive cerebral hemorrhage were enrolled and randomly assigned.Then opened the blind firstly,there are 40 cases of group A,42 cases of group B and 42 cases of group C.For intention to treat principle,2 cases which did not meet the inclusion criteria and had no intervention data were excluded.Finally,122 cases were finally included in the full analysis set(FAS)which is the main analysis set.Excluding poor compliance,withdrawal and death cases,103 cases were included in Per Protocol Set(PPS).The study suggests that there was no significant difference in hematoma expansion rate between the three groups at 24 hours and 10th day(P>0.05).There were no death within 10th-14th days.And there were no significant difference in 90th day disability rate and degree among the three groups(P>0.05).Besides,there are no difference in change of NIHSS score,Barthel Index as well(P>0.05).The safety evaluation shows no significant difference in adverse event rate among the three groups.There is one case of possible serious adverse events.Conclusion1.It may be safe using BBRB stasis in acute intracerebral hemorrhage which does not increase the incidence of hematoma expansion and total adverse events.6-72 hours may be a safe time window for the treatment of acute hypertensive cerebral hemorrhage with the compound of breaking blood and removing blood stasis.2.It may not reduce the occurrence of disability for 90th days,and there is no evidence that it can promote the absorption of hematoma and improve the prognosis of neurological function with BBRB stasis treatment.