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[大学生论坛]:大麻二酚在Dravet综合征的耐药性发作试验

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CCC 发表于 2017-12-30 19:51:01 | 显示全部楼层 |阅读模式
BACKGROUND:
The Dravet syndrome is a complex childhood epilepsy disorder that is associated with drug-resistant seizures and a high mortality rate. We studied cannabidiol for the treatment of drug-resistant seizures in the Dravet syndrome.
背景:
Dravet综合症是一种复杂的伴有耐药性癫痫发作,死亡率高的儿童癫痫疾病。我们研究了大麻二酚这一治疗Dravet综合征的耐药性癫痫发作的药物。


METHODS:
In this double-blind, placebo-controlled trial, we randomly assigned 120 children and young adults with the Dravet syndrome and drug-resistant seizures to receive either cannabidiol oral solution at a dose of 20 mg per kilogram of body weight per day or placebo, in addition to standard antiepileptic treatment. The primary end point was the change in convulsive-seizure frequency over a 14-week treatment period, as compared with a 4-week baseline period.
方法:
在此双盲安慰剂对照试验中,我们随机分配了患有Dravet综合症并伴有耐药性癫痫发作的120名儿童和年轻人。除了标准抗癫痫治疗,参与者会服用20毫克(每日体重每千克的标准)的大麻二酚口服液或安慰剂。此试验的主要终点指标是在此后14周治疗期中,惊厥发作频率与4周的基线期相比发生变化。


RESULTS:
The median frequency of convulsive seizures per month decreased from 12.4 to 5.9 with cannabidiol, as compared with a decrease from 14.9 to 14.1 with placebo (adjusted median difference between the cannabidiol group and the placebo group in change in seizure frequency, -22.8 percentage points; 95% confidence interval [CI], -41.1 to -5.4; P=0.01). The percentage of patients who had at least a 50% reduction in convulsive-seizure frequency was 43% with cannabidiol and 27% with placebo (odds ratio, 2.00; 95% CI, 0.93 to 4.30; P=0.08). The patient's overall condition improved by at least one category on the seven-category Caregiver Global Impression of Change scale in 62% of the cannabidiol group as compared with 34% of the placebo group (P=0.02). The frequency of total seizures of all types was significantly reduced with cannabidiol (P=0.03), but there was no significant reduction in nonconvulsive seizures. The percentage of patients who became seizure-free was 5% with cannabidiol and 0% with placebo (P=0.08). Adverse events that occurred more frequently in the cannabidiol group than in the placebo group included diarrhea, vomiting, fatigue, pyrexia, somnolence, and abnormal results on liver-function tests. There were more withdrawals from the trial in the cannabidiol group.
结果:
使用的患者每周抽搐发作的中位频率从12.4降低到了5.9,而使用安慰剂患者的频率从14.9降低到了14.1(大麻二酚组与安慰剂组的癫痫发作频率变化的矫正的中位差为-22.8个百分点;95% 置信区间[CI],-41.1至-5.4;P = 0.01)。在惊厥发作频率至少降低50%的患者中,服用大麻二酚的占43%,服用安慰剂的占27%(优势比2.00;;95%CI,0.93至4.30; P = 0.08)。与占34%的安慰剂组患者相比,占62%的大麻二酚组的患者的整体状况在CaGI量表7类中至少提高了1类(P=0.02)。服用大麻二酚后所有类型的癫痫发作频率均明显减少(P = 0.03),但非惊厥发作没有明显减少。在癫痫不再发作的患者中,服用大麻二酚的占5% ,服用安慰剂的占 0%(P=0.08)。
与安慰剂组相比,大麻二酚组的患者更频繁地出现了一些不良反应(腹泻,呕吐,乏力,发热,嗜睡,以及肝功能检查结果异常)。大麻二酚组患者中有更多人从试验中退出。


CONCLUSIONS:
Among patients with the Dravet syndrome, cannabidiol resulted in a greater reduction in convulsive-seizure frequency than placebo and was associated with higher rates of adverse events.
结论:
对Dravet综合症患者来说,大麻二酚大大降低了抽搐发作的频率(与安慰剂相比),但是其不良反应发生率高。



Source: N Engl J Med.
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