临床研究与生物伦理学杂志

抽象的

Randomized Controlled Trial on the Use of Intravenous Immune Globulin in Acute Pediatric Myocarditis

Sonia Ali El-Saiedi

Background: Myocardial damage in myocarditis is mediated, in part, by immunological mechanisms. This prospective placebo controlled trial was designed to determine whether Intravenous Immune Globulin (IVIG) improves Left Ventricular Fractional Shortening (LVFS) and decrease left ventricular end diastolic volume (LVED) in children with acute onset dilated cardiomyopathy or myocarditis.

Methods: 86 patients were enrolled in the study all presenting with recent onset dilated cardiomyopathy duration less than 6 months. They were randomized to 2 g/kg IVIG over two consecutive days or placebo. All underwent echocardiographic examination before admission then one month and six months after randomization. Each time the left ventricular end diastolic dimension (LVEDD) and fractional shortening (FS) were recorded.

Results: At baseline the LVEDD and FS did not differ significantly between those treated with IVIG and those treated with Placebo. Over the period of six months follow-up the patients in both groups became better. Patients treated with conventional therapy continued to have a mean end diastolic dimensions significantly larger than treated children, with no evidence of regression.

Conclusion: The results suggest that for young patients with recent onset dilated cardiomyopathy, IVIG does not augment the improvement in left ventricular FS. However, in this overall cohort, left ventricular FS improved significantly with time during follow up.