| Objective:To investigate the efficacy and safety of butylphthalide in the treatment of delayed encephalopathy after carbon monoxide poisoning.Methods:In this study,a multicenter,randomized controlled clinical research method was adopted,and inpatients from 21 sub centers in China were included.The inclusion criteria met the diagnostic criteria for delayed encephalopathy after carbon monoxide poisoning in the guidelines for clinical treatment of carbon monoxide poisoning-Ⅳ in 2013.The computer central random system was used to randomly divide the patients into experimental group and control group according to the ratio of 1:1.In addition to routine treatment,the experimental group was given butylphthalide sodium chloride injection,100ml each time,twice a day,intravenous drip for 14 days,and then changed to butylphthalide soft capsule,0.2g each time,three times a day,oral administration for 76 days.The control group received hyperbaric oxygen therapy,improved circulation drugs,energy mixture and other routine treatment.The two groups of patients were scored with MMSE,Barthel index rating scale(BI)and European five dimensional health scale(EQ-5D)before treatment and on the 14th,30th and 90th days of treatment to evaluate the changes of cognitive function,ability of daily living and quality of life before and after treatment.EQ-5D was only evaluated before treatment and on the 30th day of treatment.Before treatment,the imaging data of T1 weighted MRI,T2 weighted MRI,T2 weighted MRI liquid attenuated inversion recovery sequence(T2-FLAIR)scanning on the 30th and 90th days of treatment were collected.The demyelination volume of white matter was segmented and calculated by ITK-SANP(a software application for segmenting three-dimensional medical image structure).Main outcome measures:the effective rate on the 90th day of treatment.In this study,the degree of cognitive impairment was judged according to MMSE score.The efficacy was divided into:cured(27≤MMSE≤30),significantly effective(20≤MMSE≤26),effective(10≤MMSE≤19)and ineffective(MMSE<10).The effective rate was defined as:effective rate=(cured+significantly effective+effective)/the number of all cases.Secondary efficacy indicators included:EQ-5D utility value score on the 30th day of treatment,MMSE score and Bi score on the 90th day of treatment relative to the change before treatment,and the change of white matter demyelination volume of head MRI before and after treatment.Safety indicators include:adverse events,vital signs,laboratory test values.The study adopted the intention to treat(ITT)principle and spss 20.0(SPSS Inc,Chicago,USA)software.Results:Finally,68 patients were included in the analysis,35 in the experimental group and 33 in the control group.In terms of cognitive function,after 90 days of treatment,the MMSE scores of the test group and the control group increased by 12.0(4.0,17.0)points compared with those before treatment,and that of the control group increased by 6.0(0.0,12.0).There was significant difference between the two groups after treatment(p=0.021).After 90 days of treatment,the effective rate of the test group was higher than that of the control group,28(82.4%)and 22(78.3%)respectively,but there was no statistical significance between the two groups(p=0.263).In terms of quality of life,after 30 days of treatment,the utility value integral of EQ-5D score in the test group and the control group increased by 0.3(0.0,0.6)points compared with that before treatment,and that in the control group increased by 0.1(0.0,0.2).The difference in the change value between the two groups after treatment was statistically significant(p=0.032).There were also differences in white matter demyelination of magnetic resonance imaging.After 90 days of treatment,the volume of white matter demyelination in the experimental group and the control group decreased significantly compared with that before treatment.The volume of white matter demyelination in the experimental group decreased more significantly than that in the control group(P<0.05).During the treatment,there were 6 deaths unrelated to drugs(test group:control group=1:5).The incidence of adverse events in the test group and the control group were 2.9%(1/35)and 27.3%(9/33)respectively,with a statistically significant difference(p=0.012).Conclusion:1.Butylphthalide can significantly improve the cognitive function and quality of life of patients with delayed encephalopathy after carbon monoxide poisoning,and promote the recovery of demyelination of brain white matter.2.During the treatment of butylphthalide,there was no hepatic and renal insufficiency.Compared with the control group,the incidence of adverse events was low and safe. |
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