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PURPOSE: Lamotrigine (LTG), vigabatrin (VGB) and gabapentin (GBP) are three anti-epileptic drugs (AEDs) used in the treatment of children with epilepsy for which long-term retention rates are not currently well known. This study examines the efficacy, long-term survival and adverse event profile of these three agents used as add-on therapy in children with refractory epilepsy over a 10-year period. METHODS: Three separate audits were conducted between February 1996 and September 2000. All children studied had epilepsy refractory to other AEDs. Efficacy was confirmed if a patient became seizure free or achieved >50% reduction in seizure frequency for 6 months or more after starting therapy. Adverse events and patient survival for each drug were recorded at the end of the study period. RESULTS: Between September 1990 and February 1996, 132 children received LTG, 80 VGB and 39 GBP. At the 10-year follow-up audit, 33% of the children on LTG had a sustained beneficial effect on their seizure frequency in contrast to 19% for VGB and 15% for GBP. No significant difference in efficacy was found in children with partial seizures. Children with epileptic encephalopathy (EE) including myoclonic-astatic epilepsy and Lennox-Gastaut Syndrome (LGS) achieved a more favorable response to LTG. The main reasons for drug withdrawal were lack of efficacy for VGB, apparent worsening of seizures for GBP and the development of a rash for LTG. CONCLUSIONS: Lamotrigine is a useful add-on therapy in treating children with epilepsy. It has a low adverse event profile and a sustained beneficial effect in children with intractable epilepsy.

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We conducted a two-year prospective audit to review the paediatric management of Convulsive Status Epilepticus (CSE) in Ireland. Our audit showed that there is considerable variability in the management of CSE in this country. In order to provide optimum care for this potentially life-threatening condition a uniform management strategy is required. We propose a protocol for the treatment of CSE, which should ensure uniform management and optimum care and also provide a template for further study and audit of this important disorder.

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OBJECTIVE: To evaluate the distribution of Thyroxin (T4) and Thyroid Stimulating Hormone (TSH) values in children of various age groups attending our hospital. METHOD: We have retrospectively reviewed the T4, TSH levels recorded at our hospital in children from birth to 5 years and evaluated the reference intervals for T4 TSH amongst different ages. Non parametric methods were used to establish a 97.5th, 95th, 50th, 5th and 2.5th centiles. RESULTS: In T4 (n=1148) and TSH (n=1142) samples reviewed a TSH surge following delivery showed a sharp decline in the first 4 days of life. This was followed by a more gradual downward trend. Data on T4 estimations showed a similar but more gradual downward trend in advancing age groups. The 5th-95th centile reference range for TSH showed values between 1.7-22.5 (0-4 days; n=992), 0.6-13.3 (5-7 days; n=38), 0.9-14.0 (1 week-1 month; n=38), 0.5-13.6 (1 month-1 year, n=38) and 0.4-12.8 (1-5 years; n=38) microlU/mL. The 5th-95th centile reference range for T4 showed values between 10.7-25.0 (0-4 days; n=995), 6.5-20.4 (5-7 days; n=35), 8.0-18.1 (1 week-1 month; n=38), 6.0-16.1 (1 month-1 year; n=41), 6.9-15.3 (1-5 years; n=39) micro gm/dl. CONCLUSION: We recommend using separate T4 and TSH reference values for children in different age groups. Further large-scale studies should be done in Pakistan to establish these reference values within age groups. A national center for neonatal thyroid screening is highly recommended.

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OBJECTIVE: To evaluate the results of T4, TSH analysis and pattern of presentation in babies born at our hospital. METHOD: We retrospectively reviewed the data collected from T4, TSH screening on all babies delivered at our Hospital, where the blood was drawn within the first 4 days of life. Period under evaluation was from October 1995 to October 1998. Shifa Reference values were used. RESULTS: Blood sample were collected from 997 babies within 4 days of birth. Nine hundred and forty nine (95.2%) were evaluated after 24 hours. and 48(4.8%) in less than 24 hours of age. A high TSH was reported on 166 (16.8%) babies and a low T4 was reported on 78 (7.9%) babies. Statistical analysis showed a similar sensitivity for T4 and TSH (100%) but a higher specificity for T4 (93.1%) as compared to TSH (86%). A high-TSH with a low T4 was reported in 5 (0.5%) babies out of which 1 case was confirmed as congenital hypothyroidism requiring permanent thyroxin replacement and one case manifested a picture consistent with transient hypothyroidism. A low TSH with a low T4 was seen in 2 cases, however, they were all premature babies on antibiotics. CONCLUSION: Congenital hypothyroidism may be more frequent in our population and for the purpose of screening babies T4 values would carry a higher positive predictive value than TSH. Combining T4 TSH assays would however reduce the call back rate quite significantly but may prove to be a bit more expensive.

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PURPOSE: To evaluate the efficacy and safety of Cefaclor in respiratory tract infections amongst Pakistani children. PATIENTS AND METHODS: Multicenter, open label and non-comparative study was done to evaluate the response in terms of symptoms (In vivo) and bacterial cultures (In Vitro) to Cefaclor amongst children with respiratory tract infection between the ages 2 months to 12 years. Each patient was asked to visit the doctor on three occasions i.e., Day 0 (Initial evaluation prior to commencement of study), Day 4 (During therapy assessment and confirmation of compliance) and Day 10 (End of therapy assessment and compliance evaluation). Representative swab specimens (Throat swabs, Ear swabs or Sputum) were collected from the infected site on day 0 and day 10 for culture and sensitivity. Patients were also assessed by the evaluators on each visit in terms of clinical symptomatic response and information collected was documented on a prescribed data base form. RESULTS: A total of 160 patients were enrolled in the study, of whom 15 were lost to follow-up between the first and second visit and a further 38 were lost by the 3rd visit. Thus 107 patients completed the study as per protocol. Otitis media and Upper respiratory tract infection were the predominant ailments amongst the cases enrolled. One or more bacteria were isolated in 75 (46%) instances, the maximum number of isolates being from ear swabs of Otitis media patients. Beta haemolytic Streptococcus (group A,C,F,G) seen in 18 cases was the most common pathogen reported followed by Staphylococcus aureus, H. influenzae and Streptococcus pneumoniae in 13,12 and 11 cases respectively. Sensitivity of Cefaclor for bacteria commonly seen in the respiratory tract was greater than 90% in most of the cases. Evaluation of the 42 culture proven cases for patients who completed the study showed that Cefaclor had a 93% efficacy for indicated bacteria and 54% for non-indicated bacteria. In Vivo analysis of Cefaclor (i.e. on the basis of symptomatic response) showed that 96% cases had a symptomatic response by the second visit, which improved to 97% by the third visit. Only 15 non-serious adverse events were observed in 160 patients, none of the cases necessitated discontinuation of drug. Mild gastrointestinal symptom was the most common adverse event reported. CONCLUSION: Cefaclor was found to be a safe and efficacious drug in the treatment of bacterial respiratory tract infections amongst Pakistani children.

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