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SUMMARY A double‐blind study of the antiepileptic effect and side effects of carbamazepine (CARB) and diphenylhydantoin (DPH) was undertaken in 38 patients with psychomotor epilepsy and without grand mal epilepsy except for a single previous seizure. The patients were treated with CARB and DPH only, each in periods of 16 weeks and with a crossover of 4 weeks. The initial dosage of 6 mg/kg DPH or 15 mg/kg CARB was corrected according to the serum values aiming at therapeutic intervals of 8–16 mg/1 DPH and 6–10 mg/1 CARB. The trial had to be discontinued in 12 patients. The effect of the two drugs in preventing psychomotor seizures was the same. Some patients, however, had considerably fewer seizures while on CARB; others had fewer seizures on DPH. It seems advisable, therefore, to try both drugs separately before proceeding to combined medication. During CARB treatment the selected therapeutic interval was more easily reached and maintained than during DPH. During the latter treatment, one‐third of the monthly serum value determinations were below the level in spite of dosage corrections. Side effects were equally mild and occurred as often during DPH as during CARB treatment. RESUMEN Se ha realizado un estudio doble ciego para valorar los efectos antiepilépticos y los signos tóxicos de la carbamazepina (CARB) y de la difenilhidantoina (DPH) en 38 enfermos con epilepsía psicomotora y sin epilepsía gran mal con la excepción de una sola convulsión previa. Los enfermos fueron tratados exclusivamente con CARB y DPH durante periodos de 16 semanas cada uno con 4 semanas de tratamiento cruzado. La dosis inicial de 6 mg/Kg de DPH o 15 mg/Kg de CARB fué corregida según los nivelés séricos y tendiendo a alcanzar intervales terapéuticos de 8 a 16 mg/L de DPH y 6 a 10 mg/L de CARB. Este estudio tuvo que ser interrumpido en 12 enfermos. El efecto de ambas medicaciones fué el mismo en lo que se refiere a la prevención de los ataques. Sin embargo algunos enfermos tuvieron muchos menos episodios con la CARB y otros con la DPH. Por esta razón es aconsejable ensayar ambas drogas por separado antes de proceder a la combinación medica‐mentosa. Los intervalos terapeúticos se alcanzaron y se mantuvieron con mas facilidad durante el tratamiento con CARB que con la DPH. Durante el tratamiento con DPH, un tercio de las determinaciones mensuales de los valores séricos resultaron inferiores al valor deseado a pesar de las correcciones de las dosis. Los efectos tóxicos fueron poco intensos e igualmente frecuentes durante los dos tratamientos. ZUSAMMENFASSUNG Doppelblindstudie der antiepileptischen Wirkung und der Nebenwirkungen von Carbamazepin (CARB) und Diphenylhydantoin (DPH) an 38 Pa tien ten mit psychomotorischer Epilepsie aber ohne Grand‐Mal‐Anfäile mit Ausnahme eines einzelnen früheren Anfalls. Die Patienten wurden nur mit CARB und DPH behandelt; jedes Medikament wurde in Perioden von 16 Wochen mit einem cross‐over von 4 Wochen verabfolgt. Die Initialdosis von 6 mg/kg DPH oder 15 mg/kg CARB wurde entsprechend den Serumspiegeln angepasst, um therapeutische Bereiche von 8–16 mg/1 DPH und 6–10 mg/1 CARB zu erzielen. Bei 12 Patienten musste der Versuch abgebrochen werden. Beide Medikamente waren hinsichtlich der Vermeidung psychomotorischer Anfälle gleichermassen wirksam. Einige Patienten hatten jedoch beträchtlich weniger Anfälle unter Carbamazepin, einige unter DPH. Es scheint daher ratsam, jedes Medikament getrennt zu versuchen, ehe eine kombinnerte Behandlung eingeleitet wird. Der therapeutische Dosierungsbereich wurde während CARB Behandlung leichter erreicht und aufrechterhalten als mit DPH. Unter der DPH‐Behandlung lag 1/3 der monatlichen Serumbestimmungen unterhalb des ange‐strebten Spiegels trotz entsprechenden Dosi‐erungskorrekturen. Die Nebenwirkungen waren geringfügig und traten ebenso häufig bei DPH und unter CARB auf.
Epilepsia – Wiley
Published: Jun 1, 1976
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