Efficacy and safety of different doses of prednisone combined with topiramate for the children with infantile spasms / 中华实用儿科临床杂志

ABSTRACT

Objective To evaluate the clinical efficacy and safety of different doses of prednisone combined with topiramate(TPM) in the treatment of infantile spasms(IS),in order to provide a new choice of the therapy of IS.Methods Fifty-six cases were collected in the Department of Neurology of Jiangxi Children's Hospital from May.2011 to Dec.2012.They were randomly divided into 2 groupscontrol group and trial group.The patients in control group took prednisone tablet of 1 mg/kg,2 times a day for 2 weeks;and the patients in trial group took prednisone tablet of 10 mg/ d,4 times a day for 2 weeks.In addition,TPM was used in both groups by initial dose 1 mg/(kg · d) or 2 times a day,and then was gradually increased to 3-5 mg/(kg · d) within 2 weeks.For those children in whom the spasms seizure completely ceased after 2 weeks,prednisone was then reduced by degrees to be discontinued for a 7-weeks course(extending to 4 weeks with the initial doses if spasms continued after 2 weeks).All patients underwent the assessment of spasms seizure and a 3-12 h video-electroencephalogram monitoring including wake and sleep states,which were performed before treatment,after 2 weeks and the end of the courses (7 or 9 weeks after treatment),respectively.Meanwhile,the side effects of the drugs during the treatment were recorded.The developmental quotient (DQ) tests of children with complete cessation of spasms more than 6 months were performed before treatment and after 6 months.All patients had been followed up for 2-18 months.Results 1.After 2 weeks of the therapy,the rate of cessation of spasms were 75.00％ (21/28 cases) and 28.57％ (8/28 cases) in the trial group and the control group,respectively,there was significant difference (x2 =12.087,P =0.001).And in the same term,the rate of complete resolution of hypsrrhythmia were 60.71％ (17/28 cases) and 21.43 ％ (6/28 cases),respectively,there was significant difference (x2 =8.928,P =0.003).At the end of treatment,the rate of cessation of spasms were 67.86％ (19/28 cases) and 35.71％ (10/28 cases) in the trial group and control group,respectively,there was significant difference (x2 =5.793,P =0.016).And in the mean time,the rate of complete resolution of hypsrrhythmia were 57.14％ (16/28 cases) and 14.29％ (4/28 cases),respectively,there was significant difference (x2 =11.200,P =0.001).2.Weight gain and increased appetite were the most frequent side effects.The incidence of side effects were 82.14％ (23/28 cases) and 67.86％ (19/28 cases) in the trial group and control group,respectively,there was no significant difference between the 2 groups (x2 =1.524,P =0.217).No death occurred in this clinical trail and no one discontinued the treatment protocol as result of the adverse events.3.The recurrence rate in the trial group and the control group were 31.82％ and 72.73％,respectively.And there was significant difference between the 2 groups (x2 =4.950,P =0.026).In the trial group,there were 9 cases with cessation of spasms more than 6 months,whose average business development values had no significant difference before and after treatment (t =2.271,P =0.053).Conclusion The efficacy of large-dose prednisone combined with TPM for IS was significantly better than that of conventional dose prednisone combined with TPM.