| Background and Objective: Infantile spasms (IS) is a refractory epilepsysyndrome by internationally recognized with poor outcome. Since Sorel andDusaucy-Bauloye reported the effectiveness of adrenocorticotropic hormone (ACTH)in stopping the spasms and improving the EEG in some patients with IS in1958, wehave always used ACTH as a first-line agent for most children with IS. However, theincidence of adverse effects of ACTH is higher, which is also difficult to be availablein our country. In addition, the traditional or new antiepileptic drugs(AEDs) are pooroutcome for IS. However, oral high-dose prednisolone was equivalent to syntheticACTH(70vs76%seizure free, P=0.61) after14days in the UKISS study, andanother study performed by Kossoff et al also suggested that high-dose prednisolonewas more effective and less expensive than ACTH. The objective of this study is toevaluate the clinical efficacy and safety of different doses prednisone combined withtopiramate (TPM) in the treatment of IS, and to provide a new choice of the therapyof IS.Methods: Fifty-six cases were collected in the Department of Neurology ofJiangxi Children’s Hospital from May in2011to December in2012, with approvalfrom their guardians or parents. They were randomly divided into two groups: controlgroup and trial group. The control group took prednisone tablet of1mg/kg two timesa day for2weeks and the trial group took prednisone tablet of10mg four times a dayfor2weeks. In addition, TPM was combined in both groups by initial dose1mg/kgper day or two times a day, and then was gradually increased to3~5mg/kg per daywithin2weeks. For those children in whom the spasms seizure completely ceasedafter2weeks, prednisone was then reduced by degrees to be discontinued for a7week course (extending to four weeks with the initial doses if spasms continued after2weeks). All patients underwent the assessment of spasms seizure and a3~12hvideo-electroencephalogram (VEEG) monitoring including wake and sleep states,which were performed before treatment, after two weeks and the end of the courses (7or9weeks after treatment), respectively. Meanwhile, we recorded the side effects of the drugs during the treatment. The developmental quotient (DQ) tests of children with complete cessation of spasms more than six months were performed before treatment and after six months. All patients have been followed-up for2～18months.Results:(1) After2weeks of the therapy, the rate of cessation of spasms were75.00%and28.57%in the trial group and the control group, respectively. And in the same term, the rate of complete resolution of hypsrrhythmia were60.71%and21.43%, respectively. At the end of treatment, the rate of cessation of spasms were67.86%and35.71%in the trial group and control group, respectively. And in the mean time, the rate of complete resolution of hypsrrhythmia were57.14%and14.29%, respectively. No matter after2weeks or at the end of treatment, there were significant differences between two groups (χ112=12.087, P11=0.001;χ122=5.793, P=0.016; χ212=8.928, P21=0.003; χ222=11.200, P=0.001).(2) Weight gain and increased appetite were the most frequent side effects in our study. The incidence of side effects were82.14%and67.86%in the trial group and control group, respectively. There was no significant differences between them(χ2=1.524, P=0.217). However, the incidence of hypertension was higher in the trial group than the control group. No death occurred in this clinical trail and no one discontinued the treatment protocol as result of the adverse events.(3) Up to the time of my writing this paper, the recurrence rate of the trial group and the control group were31.82%and72.73%, respectively. And there was significant differences between them (P=0.026). In the trial group there were9cases with cessation of spasms more than six months, whose the average DQ values were compared through self-matching test, which were no significant differences between them (t=2.271,P=0.053)Conclusions:(1) The efficacy of the trial group was significantly better than the control group.(2) After a follow-up of2～18months, The recurrence rate of the trial group was significantly lower than the control group.(3) The incidence of side effects in the trial group was similar to the control group. No one discontinued the treatment protocol as result of the adverse events. |
