| Objective To investigate the effect of butylphthalide on delayed encephalopathy after carbon monoxide poisoning(DEACMP)and its effect on MRI white matter lesions,so as to provide basis for the treatment of DEACMP patients.Methods 1.Research object:This study is a prospective,multicenter,randomized controlled clinical study,involving 25 sub centers in total.After calculation,444samples are needed in the experimental group and the control group.This is the initial experiment of this study.Patients hospitalized in each sub center and diagnosed as DEACMP from June 2018 to December 2019 are selected.Inclusion criteria:(1)the inpatients voluntarily participated in the experiment and signed the informed consent form by themselves or their families;(1)when they joined the group,they met the diagnostic criteria of delayed encephalopathy in 2013 clinical treatment guide for carbon monoxide poisoning-IV,i.e.the patients with acute carbon monoxide poisoning had a"false recovery period"of about 2-60 days after the recovery of consciousness disorder.Any of the following clinical manifestations can be diagnosed:1)mental and consciousness disorders,dementia,delirium or cortical state,2)extrapyramidal nervous disorders,and Parkinson’s disease,3)pyramidal nervous damage,such as hemiplegia,positive pathological reflex or incontinence in urination,4)focal cerebral dysfunction,such as aphasia,blindness,etc.,or Secondary epilepsy;(3)18 years old≤age≤80 years old;(4)the course of disease from onset to enrollment<1 month.Exclusion criteria:(1)Acute cerebrovascular disease and other causes of encephalopathy;(2)mixed poisoning;(3)previous dementia or mental disorders;(4)burn or trauma;(5)serious heart,lung,liver,kidney and blood system diseases and hematopoietic system diseases;(6)gastrointestinal diseases or gastrointestinal hand surgery may affect gastrointestinal absorption;(7)severe infection uncontrolled;(8)Lactation or pregnancy patients;(9)those who have a history of hypersensitivity to celery or butylphthalide;(10)those who have concurrent cancer or are undergoing anti-tumor treatment;(11)those who have taken butylphthalide within 3 months before the date of informed consent;(12)those who are not considered suitable for this clinical study by the researchers.2.Research methods:the patients were randomly assigned into the control group and the experimental group by the central random system,and the baseline data(age,gender,history of hypertension,history of diabetes,history of coronary heart disease,history of smoking,history of drinking,false recovery period and whether acute carbon monoxide poisoning causes coma)were collected.The control group was given hyperbaric oxygen,jinnado,energy mixture,etc Symptomatic treatment,On the basis of the same treatment method as the control group,100ml(including 25mg of butylphthalide)of butylphthalide injection was used twice a day in the experimental group for 14 days,and then 0.2g of butylphthalide capsule was used three times a day for 76 days.The patients in the two groups were assessed with MMSE and Barthel index rating scale before treatment,1 month and 3 months after treatment,the modified Ashworth grading standard were used to score,and the imaging data of T1weighted,T2 weighted and T2 weighted MR fluid attenuated inversion recovery sequence(T2-FLAIR)were collected to analyze and calculate the volume of white matter demyelination.Researchers from all sub centers fill in the CRF and upload the collected data to the database created by Yunshu Pharmaceutical Technology Co.,Ltd.3.Statistics:spss19.0 software was used for statistical analysis of the above indicators.Measurement data conforming to the normal distribution were tested by t-test,counting data were tested byχ~2test,and Fisher accurate probability method was used when necessary,P<0.05,with statistical significance.Results as of December 2019,40 DEACMP patients were enrolled in the group(4 cases in the control group were not perfect,so they were excluded),and the remaining 36 cases were 21 cases in the test group and 15 cases in the control group.There was no significant difference in baseline data,MMSE score,Barthel index score and Ashworth grade before treatment.The MRI data of 7 patients in the experimental group before treatment,1 month after treatment and 3 months after treatment were collected.The MRI data of 6 patients in the control group before treatment and 1 month after treatment were collected,but the MRI data of 3 months after treatment were not collected.1.Comparison within the group:MMSE and Barthel Index scores in the experimental group were significantly improved after one month of treatment compared with that before treatment,with statistical significance(P<0.05).MMSE and Barthel Index scores and improved Ashworth grades in the experimental group and the control group were significantly improved after three months of treatment compared with that before treatment,with statistical significance(P<0.05).The demyelination volume of white matter in the experimental group decreased significantly after 3 months of treatment(P<0.05).2.Comparison between groups:after 1 month of treatment,the modified Ashworth grade of the experimental group was significantly improved compared with that of the control group(P<0.05);after 3 months of treatment,the MMSE,BI score and the modified Ashworth grade of the experimental group were significantly improved compared with that of the control group(P<0.05).3.The effective rate of the experimental group and the control group after 3 months treatment was statistically significant(P<0.05).Conclusion This study is in the stage of inclusion and follow-up.After summarizing the initial data,the research shows that:1.Butylphthalide is better than conventional treatment in promoting the recovery of neural function,improving the cognitive function and self-care ability of daily life of patients with DEACMP.2.DEACMP is a reversible process.3.Butylphthalide may promote the recovery of demyelination of white matter in DEACMP patients. |
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