Efficacy and safety of montelukast as monotherapy in children with mild persistent asthma.

OBJECTIVE: To study the efficacy and tolerability of montelukast as monotherapy in the treatment of mild persistent bronchial asthma. DESIGN: Open, non-comparative, prospective, 12-month study. SETTING: Asthma clinic in urban multi-speciality trust hospital. METHODS: Children (age 3-11 yrs) with mild persistent asthma, not on any prophylactic drugs were enrolled consecutively (from January to December 2003) and started on 4 mg (2-4 yrs) or 5mg (<4 yrs) montelukast for a period of 12 weeks. Efficacy was assessed by improvements in clinical score, peak expiratory flow rates (PEFR), spirometry measurements and reduction in reliever drug requirement after 4 and 12 weeks of therapy. Side effects were also judged after 12 weeks of therapy. RESULTS: 50 children (mean age 5.41 +/-2.11 years) completed the study. There was association with positive family history (92%), allergic rhinitis (64%), exercise induced asthma (40%), cough variant asthma (24%), seasonal asthma (80%) and high IgE (12%) levels. Clinical scores, viz, activity, wheeze and cough, improved effectively from (1.64 +/-0.5253) at baseline to (0.7 +/-0.7071) and (1.72 +/-0.701) to (0.92 +/-0.6952) and (1.5 +/-0.6145) to (0.88 +/-0.8241) respectively after 12 weeks of therapy. Significant clinical improvement (p >0.001) was also noted after 4 weeks of therapy. Peak expiratory flow rates (done in 19 cases) documented improvement from (120.21 +/-12.23) at baseline to (135.41 +/-23.34) after 12 weeks. FEV1 / FVC (done in 11 cases) improved from (71.44 +/-1.35%) to (87.10 +/-8.34%) after 12 weeks. Mean improvement in all the parameters demonstrated P value less than >.001. A total of 19 of 50 cases showed mild side-effects as anorexia (16%), elevated liver function tests (18%) and headache (10%). CONCLUSION: The clinical outcome showed significant improvement (p < 0.01) after 4 and 12 weeks.

Umbilical cord blood TSH levels in term neonates: a screening tool for congenital hypothyroidism.

This study was conducted to find normative values for thyroid stimulating hormone (TSH) in 1200 cord blood samples of term babies whose mothers were not on any thyroid medications. TSH was estimated within 24 hrs by enzyme immunoassay. A full thyroid profile, viz, T3, T4, TSH, fT3 and fT4 was done at 7-10 days of age in all babies with cord TSH >20 mIU/L. The mean, median and standard deviation for the TSH values for the cohort were 6.13 mIU/L, 5.8 mIU/L and 4.523 respectively. 22 babies with TSH values >20 mIU/L were given repeat tests. Hypothyroidism was confirmed in two of these babies. We conclude that a cut off value of TSH >20 mIU/L is adequate for neonatal thyroid screening in Indian settings.