| Objective: This study tried to investigate the clinical effect of early inte-nsive blood pressure reduction in the acute intracerebral hemorrhage (ICH)patients through a randomized controlled trial. The main purpose of thisresearch was to examine the effect of early intensive blood pressure reductionon the rate of mortality and invalidism, and life quality of patients with acuteICH respectively at different follow-up points-days7,28and90.The sec-ondary purpose of this research was to assess the effect of early intensiveblood pressure reduction on neural function and conscious level of patients inthe short-term (within7days); this research also aimed at measure theinfluence of early intensive blood pressure reduction on hematoma enlarge-ement or hemorrhage from various causes in acute ICH patients within24hours.Methods: First, the acute ICH patients, who have been confirmed by CTwithin6hours after onset, were selected. After getting the patients' informedconsent, we collected and recorded patients' baseline data, including thepatient's age, gender, blood pressure, heart rate, body temperature, GCS score,NIHSS scores; head CT, routine blood, hepatic function, renal function,electrolyte, blood sugar levels, mRS and EQ-5D score, past medical historyand always drug therapy history.).Using an independent telephone random-ization system, patients were randomly assigned to a control group or anexperimental group. The control group were treated according to the Americanheart association (AHA) guidelines, and there was a threshold of venousantihypertensive treatment (systolic blood pressure(SBP)≥180mmHg) in thefirst7days after assignment. The long-term goal of blood pressure treatmentwas to lower BP to below140/90mmHg. In the experimental group, patients'SBP was controlled between130-140mmHg within1hour after assignment to treatment, and it remained during the whole experimental process. The venousantihypertensive treatment was preferred, however, once circumstances perm-itted, it was changed to oral medication as soon as possible. Same as thecontrol group, the long-term goal of blood pressure treatment was also BPlower than140/90mmHg. During the90days follow-up, the blood pressurelevel, drug treatment information, and other medical data were carefully reco-rded according to the pre-designed experimental procedure. All patients in theexperimental group were required head CT within24hours after joining in thegroup, and then patients' hematoma volume change and incidence of recurrentbleeding were compared. NIHSS scores, GCS score, revised Rankin scale andEurope quality of life score (EuroQOL) were used to assess the efficiency atthe follow-up pointsStatistical analysis was performed with the Statistical Package for theSocial Sciences (SPSS, version13.0) software, Categorical data were expre-ssed as percentage of basal values and analyzed with chi-square test. Measu-rement data of baseline data were expressed as mean±SD and analyzed witht-test. GCS score, NIHSS scores and EuroQOL score were expressed as mean±SD and analyzed with the analysis of variance(ANOVA).The difference wasconsidered significant with P <0.05.Results:108cases were enrolled, of which55were assigned to thecontrol group and53were assigned to the experimental group. There were nostatistical differences between the two groups in all the baseline data. Theevaluation of intervention showed that the utilization ratio of venous antihy-pertensive treatment of experimental group was significantly higher than thatof the control group (p <0.05), and the blood pressure levels of experimentalgroup also significantly lower than those of the control group. There wassignificantly difference between the two groups in terms of the main eval-uation index-the rate of mortality and invalidism.(useing mRS) Specifically,on day7, the rate of mortality and invalidism of experimental group was60.4%and that of the control group was74.5%, which had a statistical diff-erence between the two groups (p <0.05). On day28, the rate of experimental group was30.2%, and that of control group was45.4%, which also had astatistical difference (p <0.05). On day90, the rate of experimental group was20.8%, and that of control group was31.0%, with a significantly difference (p<0.05). At each of the follow-up point, the rate of mortality and invalidism forexperimental group was lower than that for the control group. In addition,EuroQOL scores between the two groups had statistical difference as well (p <0.05). Both on days28and90, EuroQOL scores of the experimental groupwere higher than those of the control group. As for the secondary evaluationindex-The improvement of conscious level, there was no statistical differencefound between the two groups (p>0.05). In terms of the improvement ofneural function, on day1, there was no significantly difference found, but onday7a significantly difference was found between the two groups (p <0.05).Further subgroup analysis showed that neither between experimental groupand baseline data, nor between control group and the baseline data, could wedetect a statistical difference of NIHSS scores on day1. With respect to othersecondary evaluation indices-hematoma enlargement or hemorrhage with vari-ous causes within24hours, the average increase rate of hematoma enlarge-ement in experimental group was5.66%, while11.1%in the control group,with a statistical difference (p <0.05).Conclusion: Treating the ICH patients with standard antihypertensivetherapy in the acute phase, can reduce the rate of mortality and invalidism inpatients enhance their life quality, improve their neurological recovery, andreduce hematoma enlargement and the risk of recurrent bleeding. But we havenot found that positive antihypertensive therapy can improve patients' consci-ousness level. Further research with large sample size is needed to fullydetermine whether or not there is a relationship between positive antihyperten-sive therapy and patients' consciousness level. |
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