Clinical Study On Ketogenic Diet Therapy In Children With Refractory Epilepsy

PurposeTo observe clinical efficacy, retention rates, adverse reaction,electroencephalogram(EEG) changes and their effects on cognitive function of theketogenic diet (ketogenic diet, KD) on children with refractory epilepsy, and tocompare the clinical efficacy and retention rates of outpatient group and inpatientgroup. And to explore more suitable KD programs for the treatment of Chinesechildren with refractory epilepsy.MethodsThis study enrolled36patients with refractory epilepsy who had received KDtherapy in Rehabilitation Center for Children with Cerebral Palsy of the thirdaffiliated hospital of Zhengzhou University from May2012to October2013, itincluded20inpatient patients and16outpatient patients. The ages of inpatientpatients ranged from8to63months, and the median age was41months, the durationranged from6to57months before they received KD therapy, the median durationwas42months, inpatient group received classic KD therapy which started withfasting, and then changed to lipid-to-nonlipid4:1; The ages of outpatient patientsranged from10to58months, and the median age was40months, the duration ranged from9to50months before they received KD therapy, the median duration was43.6months, they didn’t need fasting, and lipid-to-nonlipid ratio gradually increased to4:1.Seizure types in both treatment groups includes typical absence seizures, atypicalabsence seizes, epileptic seizures, myoclonic seizures, tonic seizures, clonic seizures,tonic-clonic seizures, and partial seizures. Each of the children had one or more typesof seizures. The type and dosage of antiepileptic drug remain unchanged in3months.Seizure frequency before therapy was set as the baseline, to evaluate the clinicalefficiency, seizure frequency, type, degree, the duration and changes in the degree ofeach episode were recorded during KD therapy, and Gesell Developmental Scaleassessment were respectively performed prior to KD therapy, and3,6,12monthsafter KD therapy. Patients should review in outpatient1,2,3,6,12months after KDtherapy, and urinary tract ultrasonography, blood lipids and liver and kidney functionshould review,24h video electroencephalogram (24h V-EEG) examination and GesellDevelopmental Scale assessment(including total developmental quotient and fivedevelopment quotients) were respectively performed prior to KD therapy, and3,6,12months after KD therapy.Results1.The total effective rates in inpatient group were respectively60%、45%、40%after3,6,12months treatment, the retention rates were respectively80%,55%,40%,and the complete control rate was30%; while the total effective rates in outpatientgroup were respectively37.5%、25%、18.8%after3,6,12months treatment, theretention rates were respectively62.5%、37.5%、18.8%, and the complete control ratewas12.5%;2.The clinical efficacy difference between inpatient treatment group andoutpatient treatment group was statistically significant（P<0.05）, the retention ratedifference was not statistically significant(P>0.05).3.Short-term adverse reactions in inpatient group were: five cases ofgastrointestinal reactions (25%), three cases of hypoglycemia(15%), two cases offever(10%), long-term adverse effects were one case of kidney stones(5%), one case of acute infection(5%); adverse reactions in outpatient group were minor:2cases ofgastrointestinal reactions (13%),1case of fever(6%);4.10(27.8%) of the36patients had24h V-EEG improvement, including8cases(22.2%) of clinically effective children (patients who reached a, b, c grade wererespectively1case,3cases, and4cases) and two cases(5.6%) of clinically ineffectivechildren (patients who reached b, c grade were both1case), and7(19.4%) of themwere in inpatient group, and3(8.3%) of them were in outpatient group;5.9(25%) patient had cognitive improvement, including6(16.7%) inpatientpatients and3(8.3%) outpatient patients, the main improved areas were gross motorand adaptability.Conclusions1.KD therapy for children with refractory epilepsy are safe and effective in bothoutpatient and inpatient group;2.inpatient group have better efficiency, the two groups had no significantdifference in retention rate;3. to improve patient compliance is still an important factor for the success ofKD therapy;4.KD therapy can improve children24h V-EEG(including children withclinically effective and clinically ineffective), the longer the treatment was, and themore obvious EEG improvement was, and EEG improvement was more obvious inclinically effective patients;5. KD therapy can improve cognitive function of children with refractoryepilepsy, improvements were mainly gross motor and adaptability in short terms.