UNASSIGNED: Patients included in the study were randomly assigned to either flexible-dose pregabalin treatment group or carbamazepine treatment group. The primary efficacy variable was face visual analog scale (F-VAS), the second efficacy assessment was used to assess the effect of treatment on mental health by Hamilton anxiety scale (HAMA) and Hamilton depression scale (HAMD).
UNASSIGNED: The mean baseline pain score F-VAS was 6.47 in the pregabalin group and 6.58 in carbamazepine treatment group. F-VAS was significantly lower in the pregabalin group (1.64) than (3.94) carbamazepine treatment group after treatment. Pregabalin was significantly superior to carbamazepine in endpoint assessments on the HAMA and HAMD after treatment. F-VAS and HAMD were showed efficacy as early as week 2 and maintained for whole duration of the study. The average pregabalin dose in the 12-week study was 214.6 (150-375) mg/day. The mean dose (range) of carbamazepine received by the patients was 275.0 (200-400) mg/day. Mild or moderate, typically transient, somnolence and dizziness were the most common adverse events (AES). The differences of the side effects between the two groups were not significant.
UNASSIGNED: Pregabalin, but not carbamazepine, may be effective in improving F-VAS, HAMA and HAMD in patients with CPSP.
■纳入研究的患者被随机分配到灵活剂量普瑞巴林治疗组或卡马西平治疗组。主要疗效变量是面部视觉模拟量表(F-VAS),第二次疗效评估采用汉密尔顿焦虑量表(HAMA)和汉密尔顿抑郁量表(HAMD)评估治疗对心理健康的影响。
普瑞巴林组的平均基线疼痛评分F-VAS为6.47,卡马西平治疗组为6.58。治疗后普瑞巴林组(1.64)的F-VAS显著低于卡马西平治疗组(3.94)。在治疗后的HAMA和HAMD终点评估中,普瑞巴林明显优于卡马西平。F-VAS和HAMD早在第2周就显示出功效,并在整个研究期间保持。12周研究中的平均普瑞巴林剂量为214.6(150-375)mg/天。患者接受卡马西平的平均剂量(范围)为275.0(200-400)mg/天。轻度或中度,通常是瞬态的,嗜睡和头晕是最常见的不良事件(AES)。两组之间的副作用差异无统计学意义。
■普瑞巴林,但卡马西平不是,可能有效改善F-VAS,CPSP患者的HAMA和HAMD。