بررسي اثر تك درماني لووتيراستام در مقايسه با سديم والپروات به روش كارآزمايي باليني تصادفي در درمان كودكان مبتلا به صرع ژنراليزه يا فوكال

Evaluation of the Effect of Levetiracetam Monotherapy in Comparison with Sodium Valproate in the Treatment of Children with Generalized or Focal Epilepsy in a Randomized Clinical Trial

ﺳﺎﺑﻘﻪ و ﻫﺪف: ﺻﺮع ﯾﮏ ﺑﯿﻤﺎري ﻣﺰﻣﻦ اﺳﺖ ﮐﻪ ﺗﺄﺛﯿﺮات ﻣﺘﻔﺎوﺗﯽ ﺑﺮ ﻋﻤﻠﮑﺮد دارد. ﮐﻨﺘﺮل ﺗﺸﻨﺞ در ﮐﻮﺗﺎهﺗﺮﯾﻦ زﻣﺎن ﻣﻤﮑﻦ ﺑﺎ داروﻫﺎﯾﯽ ﺑﺎ ﮐﻤﺘﺮﯾﻦ ﻋﻮارض ﺟﺎﻧﺒﯽ ﻣﻬﻢ اﺳﺖ. در ارﺗﺒﺎط ﺑﺎ اﺛﺮﺑﺨﺸﯽ و ﻋﻮارض ﺟﺎﻧﺒﯽ داروﻫﺎي ﻧﺴﻞ ﺟﺪﯾﺪ در ﻣﻘﺎﯾﺴﻪ ﺑﺎ داروﻫﺎي ﻗﺪﯾﻤﯽ و ﺧﻂ اول ﺑﺤﺚﻫﺎي زﯾﺎدي وﺟﻮد دارد. در اﯾﻦ ﻣﻄﺎﻟﻌﻪ اﺛﺮﺑﺨﺸﯽ و ﻋﻮارض ﺟﺎﻧﺒﯽ دو داروي ﺳﺪﯾﻢ واﻟﭙﺮوات )ﺑﻪﻋﻨﻮان داروي ﻧﺴﻞ اول( و ﻟﻮوﺗﯿﺮاﺳﺘﺎم )ﺑﻪﻋﻨﻮان داروي ﻧﺴﻞ دوم( ﻣﻘﺎﯾﺴﻪ ﺷﺪ. ﻣﻮاد و روشﻫﺎ: ﺗﻤﺎم ﮐﻮدﮐﺎن ﺑﯿﺸﺘﺮ از 2 ﺳﺎل و ﮐﻤﺘﺮ از 18 ﺳﺎل ﺑﺎ ﺗﺸﺨﯿﺺ ﺟﺪﯾﺪ ﺻﺮع ﻋﻤﻮﻣﯽ و ﮐﺎﻧﻮﻧﯽ ﮐﻪ ﻣﻌﯿﺎرﻫﺎي ورود و رﺿﺎﯾﺖ ﺷﺨﺼﯽ را ﺑﺮاي ورود ﺑﻪ ﻣﻄﺎﻟﻌﻪ داﺷﺘﻨﺪ، ﺑﻪﻃﻮر ﺗﺼﺎدﻓﯽ وارد ﻣﻄﺎﻟﻌﻪ ﺷﺪﻧﺪ. ﺑﯿﻤﺎران ﺑﻪ دو ﮔﺮوه ﺗﻘﺴﯿﻢ ﺷﺪﻧﺪ؛ ﯾﮏ ﮔﺮوه ﺑﺎ واﻟﭙﺮوات ﺳﺪﯾﻢ و ﮔﺮوه دﯾﮕﺮ ﺑﺎ ﻟﻮوﺗﯿﺮاﺳﺘﺎم ﺗﺤﺖ درﻣﺎن ﻗﺮار ﮔﺮﻓﺘﻨﺪ. ﻓﺮاواﻧﯽ ﺗﺸﻨﺞﻫﺎي ﻣﮑﺮر در ﺑﯿﻤﺎران و ﻋﻮارض ﺑﻌﺪ از ﻣﺼﺮف داروﻫﺎ ﺑﺎ ﭘﯿﮕﯿﺮي ﺑﻪ ﻣﺪت ﺷﺶ ﻣﺎه ﺑﻪﻃﻮر دﻗﯿﻖ ﺛﺒﺖ ﺷﺪ. ﯾﺎﻓﺘﻪﻫﺎ: ﻧﺘﺎﯾﺞ ﻧﺸﺎن داد ﺑﯿﻦ ﺳﻦ، ﺟﻨﺲ و ﺳﺎﺑﻘﻪ ﺧﺎﻧﻮادﮔﯽ ﺗﺸﻨﺞ در ﺑﯿﻤﺎران ﻫﺮ دو ﮔﺮوه ﺑﺎ ﻣﯿﺰان ﻣﻮﻓﻘﯿﺖ در ﮐﻨﺘﺮل ﺗﺸﻨﺞ ﺗﻔﺎوت ﻣﻌﻨﯽداري وﺟﻮد ﻧﺪارد. ﻫﻤﭽﻨﯿﻦ ﺑﯿﻦ ﻧﻮع داروي ﻣﺼﺮﻓﯽ )واﻟﭙﺮوات ﺳﺪﯾﻢ و ﻟﻮوﺗﯿﺮاﺳﺘﺎم( و ﻧﻮع ﺗﺸﻨﺞ )ﮐﺎﻧﻮﻧﯽ و ﻋﻤﻮﻣﯽ( ﺑﺎ ﻣﻮﻓﻘﯿﺖ در درﻣﺎن )ﻣﻬﺎر ﺗﺸﻨﺞ( ﺑﯿﻦ دو ﮔﺮوه ﺗﻔﺎوت ﻣﻌﻨﯽداري وﺟﻮد ﻧﺪاﺷﺖ. ﻧﺘﺎﯾﺞ ﻧﺸﺎن داد ﮔﺮوه ﺗﺤﺖ درﻣﺎن ﺑﺎ واﻟﭙﺮوات ﺳﺪﯾﻢ ﻋﻮارض ﺟﺎﻧﺒﯽ ﺑﯿﺸﺘﺮي ﻧﺴﺒﺖ ﺑﻪ ﮔﺮوه ﻟﻮوﺗﺮاﺳﺘﺎم داﺷﺘﻨﺪ )P<0/05(. ﻧﺘﯿﺠﻪﮔﯿﺮي: ﺑﺎ ﺗﻮﺟﻪ ﺑﻪ ﻧﺘﺎﯾﺞ ﻣﻄﺎﻟﻌﻪ ﺣﺎﺿﺮ، واﻟﭙﺮوات ﺳﺪﯾﻢ و ﻟﻮوﺗﺮاﺳﺘﺎم در ﮐﻨﺘﺮل ﺗﺸﻨﺞ ﻣﺆﺛﺮ ﻫﺴﺘﻨﺪ. ﺑﺮاي ﺑﺮداﺷﺘﻦ ﻣﺮاﺣﻞ ﻣﺆﺛﺮ ﺑﺮاي ﮐﻨﺘﺮل ﻫﺰﯾﻨﻪﻫﺎ و ﻋﻮارض درﻣﺎن ﺿﺪﺗﺸﻨﺞ، ﭘﯿﮕﯿﺮي ﺑﯿﺸﺘﺮ و ﻣﻄﺎﻟﻌﺎت ﺑﯿﺸﺘﺮ ﻻزم اﺳﺖ.

Background and Objectives: Epilepsy is a chronic disease with different effects on performance. It is important to control seizures in the shortest possible time using medications with the least side effects. There are controversies regarding the effectiveness and side effects of new generation medications, compared to old and first-line therapeutic agents. Therefore, this study aimed to compare the effectiveness and side effects of two medications, including sodium valproate (as a first-generation medication) and levetiracetam (as a second-generation medication). Materials and Methods: All children over two and under 18 years old with a new diagnosis of generalized and focal epilepsy who met the inclusion criteria and were willing to enter the study were enrolled randomly. They were then divided into two groups of treatment with sodium valproate and levetiracetam. The frequency of recurrent seizures in patients and complications after taking the medications were accurately recorded with a six-month follow-up. Results: The results showed no significant difference of age, gender, and family history of seizures in the patients of both groups with the success rate in seizure control. Moreover, there was no significant difference between the two groups regarding the type of medication (sodium valproate and levetiracetam), type of seizure (focal and generalized), and success in treatment (seizure inhibition). Additionally, the group treated with sodium valproate revealed more significant side effects, compared to the levetiracetam group (P<0.05). Conclusions: According to the results of the present study, both sodium valproate and levetiracetam have been effective in controlling seizures. More follow-up and further studies are required to take effective steps to control the costs and complications of anticonvulsant therapy.