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目的探讨左乙拉西坦(LEV)作为添加治疗对部分性癫癎患者认知功能及生活质量的影响。方法研究分两个阶段进行。第一阶段,采用随机、双盲、安慰剂对照的方法,为期16周;第二阶段为开放性试验,为期24周。在入组时、试验的16周末和24周末分别检测患者认知功能,并进行生活质量量表评价。结果 (1)第16周末,LEV 组威斯康星卡片分类测验(WCST)操作时间与入组时基线的差值分别为-110.3和-122.9,延迟逻辑记忆与基线差值为3.4,与入组时比较差异有统计学意义(P<0.01);与健康相关的生活质量(HRQOL)中认知功能及社会功能均有改善(P<0.01)。(2)第40周末,与入组时比较,LEV 组与安慰剂组连线测验 A 型、B 型时间与基线的差值分别为-13.3、～20.5和-5.2、-15.2,较入组时缩短,WCST 持续错误数减少,操作时间减少,延迟视觉记忆增加(P<0.05),HRQOL 中综合 QOL、总体健康水平、认知功能、社会功能均有改善(P<0.05)。结论 LEV 作为添加治疗在控制癫癎发作的同时可以部分改善癫癎患者认知功能和生活质量。
Objective To investigate the effect of levetiracetam (LEV) as a supplement therapy on cognitive function and quality of life in patients with partial epilepsy. Method research is carried out in two stages. The first phase, a randomized, double-blind, placebo-controlled approach for a period of 16 weeks; the second phase of the open-label trial for a period of 24 weeks. At enrollment, cognitive function was measured at the 16th and 24th weeks of the trial, and the quality of life scale was evaluated. Results (1) At the end of the 16th week, the differences between WCST operation time and baseline in the LEV group were -110.3 and -122.9 respectively, and the difference between the delayed logic memory and the baseline was 3.4. The difference was statistically significant (P <0.01). The cognitive and social functions of health-related quality of life (HRQOL) were improved (P <0.01). (2) At the end of the 40th week, the differences between the LEV group and the placebo group in type A and type B time-baseline were -13.3, -20.5 and -5.2, -15.2, respectively (P <0.05). The integrated QOL, overall health status, cognitive function and social function were all improved in HRQOL (P <0.05). Conclusion LEV as an add-on therapy can partly improve the cognitive function and quality of life in patients with epilepsy while controlling epileptic seizures.