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目的系统评价左乙拉西坦添加治疗难治性部分性发作癫癎的疗效和药物安全性。方法计算机检索1998年1月-2010年12月Cochrane图书馆、MEDLINE、EMbase、社会科学引文索引、维普中文科技期刊、中国知网中国期刊全文数据库和中国生物医学文献数据库,并手工检索相关杂志,由两名研究者独立进行质量评价及数据分析,RevMan 5.0统计软件进行Meta分析。结果根据Cochrane5.0.2版随机对照临床试验质量评价标准,纳入11项随机对照临床试验共1981例受试者(左乙拉西坦组1192例、安慰剂对照组789例)。Meta分析结果显示,左乙拉西坦组每周部分性癫癎发作频率减少≥50%的病例数高于对照组(1000 mg/d:OR=2.990,P=0.000;2000 mg/d:OR=3.870,P=0.000;3000 mg/d:OR=3.440,P=0.000);每周发作频率减少≥75%的病例明显高于对照组(1000 mg/d:OR=3.130,P=0.000;2000 mg/d:OR=5.060,P=0.000;3000 mg/d:OR=4.730,P=0.000);完全不发作病例明显高于对照组(1000 mg/d:OR=5.080,P=0.001;2000 mg/d:OR=4.420,P=0.050;3000 mg/d:OR=4.150,P=0.000)。左乙拉西坦组失访率与安慰剂对照组之间差异无统计学意义(P>0.05)。治疗期间常见药物不良反应包括嗜睡、头晕、乏力、鼻咽炎、精神行为异常等,两组精神行为不良反应方面存在异质性(P=0.360,I~2=8.000%)。结论现有证据显示,左乙拉西坦添加治疗难治性部分性发作癫癎的疗效与安慰剂组相比效果显著,保留率高;药物安全性应注意其所引起的精神行为异常。
Objective To evaluate the efficacy and safety of levetiracetam in the treatment of refractory and partial seizures. METHODS: The Cochrane Library, MEDLINE, EMbase, Social Science Citation Index, VIP Chinese Science and Technology Journal, China Knowledge Online Chinese Journal Full-text Database and Chinese Biomedical Literature Database were searched by computer from January 1998 to December 2010. Two researchers independently conducted quality evaluation and data analysis, and RevMan 5.0 statistical software for meta-analysis. RESULTS: A total of 1981 randomized controlled clinical trials of 1981 subjects (1192 in the levetiracetam group and 789 in the placebo-controlled group) were included in the Cochrane version 5.0.2 randomized controlled clinical trial. Meta-analysis showed that the weekly incidence of partial epileptic seizures in levetiracetam group was higher than that of the control group (1000 mg / d: OR = 2.990, P = 0.000; 2000 mg / d: OR = 3.870, P = 0.000; 3000 mg / d: OR = 3.440, P = 0.000). The frequency of weekly seizure frequency reduction ≥75% was significantly higher than that of the control group (1000 mg / d; OR = 5.060, P = 0.000; 3000 mg / d: OR = 4.730, P = 0.000). The number of cases without complete attack was significantly higher than that of the control group (1000 mg / d: 2000 mg / d: OR = 4.420, P = 0.050; 3000 mg / d: OR = 4.150, P = 0.000). No difference was found between the rate of follow-up in the levetiracetam group and the placebo group (P> 0.05). Common adverse drug reactions during treatment include drowsiness, dizziness, fatigue, nasopharyngitis, mental and behavioral abnormalities, and there was heterogeneity in the adverse reactions of both groups (P = 0.360, I ~ 2 = 8.000%). Conclusion The available evidence shows that the efficacy of levetiracetam in the treatment of refractory partial seizures is significant compared with placebo and the retention rate is high. The safety of drugs should be paid attention to its mental and behavioral abnormalities.