Schierhout G, Roberts I
Department of Epidemiology and Public Health, Institute of Child Health, University College London, UK.
J Neurol Neurosurg Psychiatry. 1998 Jan;64(1):108-12. doi: 10.1136/jnnp.64.1.108.
To determine the effectiveness and safety of prophylactic antiepileptic agents in the management of acute traumatic head injury.
Systematic review of randomised controlled trials identified using MEDLINE, EMBASE, CINAHL, Dewent Biotechnology abstracts, and specialised databases of randomised controlled trials, by searching reference lists and contacting investigators.
Ten eligible randomised controlled trials were identified, including 2036 patients. The pooled relative risk (RR) for early seizure prevention was 0.34 (95% confidence interval (95%CI) 0.21-0.54); based on this estimate, for every 100 patients treated, 10 would be kept seizure free in the first week. Seizure control in the acute phase was not accompanied by a reduction in mortality (RR=1.15; 95% CI 0.89-1.51), a reduction in death and neurological disability (RR=1.49; 95% CI 1.06-2.08 for carbamazepine and RR=0.96; 95% CI 0.72-1.26 for phenytoin) or a reduction in late seizures (pooled RR=1.28; 95% CI 0.90-1.81). The pooled relative risk for skin rashes was 1.57 (95% CI 0.90-2.75).
Prophylactic antiepileptic drugs are effective in reducing early seizures, but there is no evidence that treatment with such drugs reduces the occurrence of late seizures, or has any effect on death and neurological disability. Insufficient evidence is available to establish the net benefit of prophylactic treatment at any time after injury.
确定预防性抗癫痫药物在急性创伤性脑损伤治疗中的有效性和安全性。
通过检索MEDLINE、EMBASE、CINAHL、德温特生物技术文摘以及随机对照试验的专业数据库,并查阅参考文献列表和联系研究者,对随机对照试验进行系统评价。
共纳入10项符合条件的随机对照试验,涉及2036例患者。预防早期癫痫发作的合并相对危险度(RR)为0.34(95%置信区间(95%CI)0.21 - 0.54);据此估计,每治疗100例患者,在第一周可使10例患者无癫痫发作。急性期癫痫控制并未使死亡率降低(RR = 1.15;95%CI 0.89 - 1.51),也未使死亡和神经功能障碍减少(卡马西平的RR = 1.49;95%CI 1.06 - 2.08,苯妥英钠的RR = 0.96;95%CI 0.72 - 1.26),或晚期癫痫发作减少(合并RR = 1.28;95%CI 0.90 - 1.81)。皮疹的合并相对危险度为1.57(95%CI 0.90 - 2.75)。
预防性抗癫痫药物在减少早期癫痫发作方面有效,但没有证据表明此类药物治疗可降低晚期癫痫发作的发生率,或对死亡和神经功能障碍有任何影响。尚无足够证据确定伤后任何时间预防性治疗的净效益。