بررسي تاثير ايبوپروفن خوراكي در بسته شدن مجراي شرياني نوزادان رسيده

The effect of oral ibuprofen in ductus arteriosus closure of full-term neonates

هدف از اين مطالعه ارزيابي اثر‌بخشي و امنيت استفاده از ايبوپروفن خوراكي با دوز بالا نسبت به دوز معمولي، در درمان PDA در نوزادان رسيده بود. نوزادان رسيده (هفته تولد 42-37) با سن بيشتر از سه روز با تشخيص PDA وارد اين مطالعه شدند. از اكوكارديوگرافي جهت تعيين قطر مجراي شرياني، فشار گراديانت و نسبت قطر La/Ao استفاده شد. روش بررسي:‌ اين مطالعه كارآزمايي باليني با حجم نمونه 60 نفر نوزاد از مرداد 1392 تا مرداد 1394، به‌صورت كاملا تصادفي‌ به يكي از دو گروه تخصيص داده شدند جمع‌آوري گرديد كه گروه اول سه دوز ايبوپروفن خوراكي (mg/kg و 5 و 105 به فاصله 24 ساعت) و گروه دوم يك دوز mg/kg 20، ايبوپروفن خوراكي و سپس دو دوز mg/kg 10 پس از 24 و 48 ساعت گرفتند. تست پيگيري اكو 48 ساعت و دو هفته پس از درمان توسط كارديولوژيست كه از دسته‌بندي گروه‌ها آگاه نبود انجام شد. همچنين از نظر تغييرات‌ تعداد پلاكت، BUN و CR و عارضه‌ها بين دو گروه با استفاده ازتحليل‌هاي آماري مقايسه انجام شد. يافته‌ها: مجراي شرياني در 73% بيماران گروه اول و 76% گروه دوم پس از 48 ساعت اول بسته شد، كه تفاوت آماري معنادار نداشت (1/000=P). عارضه جدي درماني در هيچ‌يك از گرو‌ه‌ها ديده نشد. نتيجه‌گيري: نتيجه اين بود كه دوز بالاتر ايبوپروفن خوراكي (Mg/kg 20 و 10و10) نتايج بهتري در بسته شدن PDA در نوزادان ترم نداشت. عارضه كليوي يا گوارشي در هر دو گروه ديده نشد.

This study aimed to assess the efficacy and safety of the oral use of ibuprofen suspension in various doses in the treatment of PDA (Patent ductus arteriosus) in mature babies. Mature babies (37-42 weeks) aged more than 3 days who had been diagnosed with PDA were involved in this study. For the measurement of the ratio of left atrial to aortic root diameters (La/Ao) Color, pressure gradient and the internal ductal diameter, Doppler echocardiography (ECHO) was performed. This clinical trial was performed on 60 infants born born between August 2013 to August 2015. Methods: This clinical trial study was performed on 60 infants were randomly born between August 2013 to August 2015 which Randomly divided into two groups: The first group, received oral ibuprofen in three doses (5, 5, 10 mg/kg at 24-hour intervals) and the second group received an early dose of OIS, in two doses of 10 mg/kg after 24 and 48 hours (totally 20 mg/kg). A follow-up ECHO was performed 48 hours and 2 weeks after treatment by the same pediatric cardiologist who was not aware of the study groups. Evaluation of changes in platelet count, blood urea nitrogen, creatinine and complications of thrombocytopenia, evaluation of elevated serum creatinine, and complications of gastrointestinal bleeding were compared between the two groups using statistical analysis. Results: Seventy-three percent (73%) patients in the first group and seventy-six (76%) patients in the second group had successful PDA closure in the first 48 hrs. No statistically significant difference between the two groups (P=0.0001) was obtained and the highest response time was observed in the first 48 hours of treatment. After 2 weeks, the PDA closure in both groups was completely successful (100%). No specific side effects were observed between the two groups. Conclusion: We conclude that higher doses of ibuprofen (20 and 2×510 mg/kg) do not show better results for PDA closure without renal or gastrointestinal complications.