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目的系统评价普罗加比(progabide,PGB)治疗难治性癫痫的有效性及安全性。方法计算机检索PubMed、EMbase、e Cochrane Central Register of Controlled Trial(s CENTRAL)、CNKI、VIP和CBM等电子数据库,查找PGB治疗难治性癫痫的随机对照试验(RCT),检索时间均从建库至2011年7月。对符合纳入标准的RCT,由两位评价员按Cochrane系统评价的方法,独立进行资料提取、质量评价并交叉核对后,采用RevMan 5.1软件进行Meta分析。结果共纳入7个研究,合计231例患者。Meta分析结果显示,在常规治疗基础上,与安慰剂相比,PGB对单纯难治性部分性癫痫无效[OR=1.76,95%CI(0.40,7.65),P=0.45];对难治性部分性+全面性癫痫的有效率高于安慰剂组[OR=4.46,95%CI(2.06,9.65),P=0.000 1]。PGB的主要不良反应为嗜睡、头晕、头痛等,但表现多轻微、短暂,减少剂量多可恢复正常,仅少数患者需停药。结论现有研究证据显示,PGB可能对难治性部分性+全面性癫痫具有较好的疗效,但对单纯性难治性癫痫的疗效尚不确定。PGB不良反应多轻微。但由于纳入研究的方法学质量存在中度选择性偏倚的可能性,可能影响结果的真实性,因此上述结论还有待开展更多高质量大样本的随机双盲临床对照试验来验证。
Objective To evaluate the efficacy and safety of progabide (PGB) in the treatment of refractory epilepsy. Methods The electronic databases of PubMed, EMbase, eCochrane Central Register of Controlled Trial (s CENTRAL), CNKI, VIP and CBM were searched for randomized controlled trials (RCTs) of PGB for treatment of refractory epilepsy. July 2011. The eligible RCTs were evaluated by two reviewers according to the Cochrane systematic review. After independent data extraction, quality evaluation and cross-check, the RevMan 5.1 software was used for meta-analysis. Results A total of 7 studies were included, with a total of 231 patients. Meta-analysis showed that, on the basis of routine treatment, PGB was not effective in patients with simple refractory partial epilepsy compared with placebo [OR = 1.76, 95% CI (0.40, 7.65), P = 0.45] Partial + comprehensive epilepsy was more effective than placebo [OR = 4.46, 95% CI (2.06, 9.65), P = 0.0001]. The main adverse reactions of PGB are drowsiness, dizziness, headache, etc., but the performance is slight and short, and the dosage can be reduced to return to normal. Only a few patients need to be discontinued. Conclusion The available evidence shows that PGB may have a better curative effect for refractory partial + comprehensive epilepsy, but the curative effect on simple refractory epilepsy is uncertain. PGB adverse reactions mild. However, due to the possibility of moderate selectivity bias in the methodological quality of the included studies, which may affect the authenticity of the results, the above conclusions have yet to be validated in more randomized, double-blind, controlled clinical trials of large, high-quality samples.