Manreza M L, Gherpelli J L, Machado-Haertel L R, Pedreira C C, Heise C O, Diament A
Serviço de Neurologia Infantil, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (FMUSP), Brasil.
Arq Neuropsiquiatr. 1997 Dec;55(4):757-61. doi: 10.1590/s0004-282x1997000500012.
Fifty children, 24 female and 26 male, with ages varying from 6 to 72 months (mean = 23.7 m.) that experienced at least one febrile seizure (FS) entered a prospective study of intermittent therapy with clobazam. Cases with severe neurological abnormalities, progressive neurological disease, afebrile seizures, symptomatic seizures of other nature, or seizures during a central nervous system infection were excluded. Seizures were of the simple type in 25 patients, complex in 20 and unclassified in 5. The mean follow-up period was 7.9 months (range = 1 to 23 m.), and the age at the first seizure varied from 5 to 42 months (mean = 16.8 m.). Clobazam was administered orally during the febrile episode according to the child's weight: up to 5 kg, 5 mg/day; from 5 to 10 kg, 10 mg/day; from 11 to 15 kg, 15 mg/day, and over 15 kg, 20 mg/day. There were 219 febrile episodes, with temperature above 37.8 degrees C, in 40 children during the study period. Twelve children never received clobazam and 28 received the drug at least once. Drug efficacy was measured by comparing FS recurrence in the febrile episodes that were treated with clobazam with those in which only antipyretic measures were taken. Ten children (20%) experienced a FS during the study period. Of the 171 febrile episodes treated with clobazam there were only 3 recurrences (1.7%), while of the 48 episodes treated only with antipyretic measures there were 11 recurrences (22.9%), a difference highly significant (p < 0.0001). Adverse effects occurred in 10/28 patients (35.7%), consisting mainly in vomiting, somnolence and hyperactivity. Only one patient had recurrent vomiting which lead to drug interruption. These effects did not necessarily occurred in every instance the drug was administered, being present in one febrile episode and not in the others. We conclude that clonazepam is safe and efficacious in preventing FS recurrence. It may be an alternative to diazepam in the intermittent treatment of FS recurrence.
50名儿童（24名女性，26名男性），年龄在6至72个月之间（平均23.7个月），经历过至少一次热性惊厥（FS），进入了一项氯巴占间歇治疗的前瞻性研究。排除有严重神经异常、进行性神经疾病、无热惊厥、其他性质的症状性惊厥或中枢神经系统感染期间惊厥的病例。25例患者的惊厥为单纯型，20例为复杂型，5例未分类。平均随访期为7.9个月（范围1至23个月），首次惊厥时的年龄在5至42个月之间（平均16.8个月）。在发热期根据儿童体重口服氯巴占：5千克及以下，5毫克/天；5至10千克，10毫克/天；11至15千克，15毫克/天；超过15千克，20毫克/天。研究期间，40名儿童出现219次体温高于37.8摄氏度的发热发作。12名儿童从未接受过氯巴占治疗，28名儿童至少接受过一次该药物治疗。通过比较接受氯巴占治疗的发热发作与仅采取退热措施的发热发作中FS的复发情况来衡量药物疗效。10名儿童（20%）在研究期间经历了一次FS。在171次接受氯巴占治疗的发热发作中，仅有3次复发（1.7%），而在48次仅采取退热措施的发作中有11次复发（22.9%），差异非常显著（p<0.0001）。10/28例患者（35.7%）出现不良反应，主要包括呕吐、嗜睡和多动。只有1例患者反复呕吐导致药物中断。这些不良反应并非每次用药时都会出现，在一次发热发作中出现而在其他发作中未出现。我们得出结论，氯硝西泮在预防FS复发方面安全有效。在FS复发的间歇治疗中，它可能是地西泮的替代药物。
