Mosolov S N, Kostiukova E G, Kapiletti S G, Belen'kaia D V, Shafarenko A A, Fedotov D D
Moskovskiĭ NII psikhiatrii, Moskva.
Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(11):47-52.
One hundred and twenty-five patients (49 men and 76 women, mean age 38,0+/-12,5 years) were randomized in two groups. One group (64 patients) was treated with valproate sodium and another group (61 patients) received lithium carbonate. Monotherapy was administered with the mean dose of valproate 20 mg/kg/day (serum valproate concentration between 70 and 125 ?g/ml) and the mean dose of lithium 800 mg/day (between 600 and 900 mg/day; serum lithium concentration 0,8-1,2 mmol/L) during 12 weeks. Clinical effectiveness was assessed using YMRS, CGI-BP and MADRS at 0, 5th, 10th, 21st , 84th days of treatment. The number of responders (50% reduction in YMRS scores) was 51,7% (30 patients) in lithium group and 56,7% (34 patients) in valproate group by the 21st day (p=0,59).The mean reduction in YMRS scores was 11,6 in patients treated with lithium and 12,3 in patients treated with valproate. By the 84th day (LOCF), the number of responders reached 85% (51 patients) in lithium group and 90,3% (56 patients) in valproate group (p=0,37). The mean reduction in YMRS scores was 19,4 in patients treated with lithium and 19,6 in patients treated with valproate. The average reduction in MADRS scores was -1,4 (p=0,08) and -2,2 (p=0,001) in lithium group; -1,6 (p=0,002) and -1,4 (p=0,019) in valproate group on the 21st and 84th days. Adverse effects were observed in 8 (13,1%) patients who received lithium and 3 patients (4,7%) who received valproate (p=0,12). The most common of them were tremor, nausea, dry mouth. There were no clinically significant abnormalities in laboratory values, vital functions and EEG. In conclusion, the results demonstrated equal therapeutic efficacy, tolerability and safety of valproate and lithium in the treatment of manic episodes in patients with bipolar disorder.
125例患者（49例男性，76例女性，平均年龄38.0±12.5岁）被随机分为两组。一组（64例患者）接受丙戊酸钠治疗，另一组（61例患者）接受碳酸锂治疗。在12周内，丙戊酸钠的平均剂量为20mg/kg/天（血清丙戊酸浓度在70至125μg/ml之间），碳酸锂的平均剂量为800mg/天（在600至900mg/天之间；血清锂浓度0.8 - 1.2mmol/L）进行单药治疗。在治疗的第0、5、10、21、84天，使用杨氏躁狂量表（YMRS）、临床总体印象-双相障碍版（CGI-BP）和蒙哥马利-艾斯伯格抑郁量表（MADRS）评估临床疗效。到第21天，碳酸锂组的有效率（YMRS评分降低50%）为51.7%（30例患者），丙戊酸钠组为56.7%（34例患者）（p = 0.59）。接受碳酸锂治疗的患者YMRS评分平均降低11.6，接受丙戊酸钠治疗的患者为12.3。到第84天（末次观察结转），碳酸锂组的有效率达到85%（51例患者），丙戊酸钠组为90.3%（56例患者）（p = 0.37）。接受碳酸锂治疗的患者YMRS评分平均降低19.4，接受丙戊酸钠治疗的患者为19.6。在第21天和第84天，碳酸锂组MADRS评分的平均降低值分别为-1.4（p = 0.08）和-2.2（p = 〈0.001〉）；丙戊酸钠组分别为-1.6（p = 〈0.002〉）和-1.4（p = 〈0.019〉）。接受碳酸锂治疗的8例（13.1%）患者和接受丙戊酸钠治疗的3例（4.7%）患者观察到不良反应（p = 0.12）。最常见的不良反应是震颤、恶心、口干。实验室检查值、生命功能和脑电图均无临床显著异常。总之，结果表明丙戊酸盐和锂盐在双相情感障碍患者躁狂发作治疗中的疗效、耐受性和安全性相当。
