丙戊酸治疗躁狂症及其血药浓度的临床对照研究

The Serum Concentration of Valproic Acid in the Treatment of Mania

目的探讨丙戊酸治疗躁狂症的临床疗效、血药浓度及药物不良反应。方法60例躁狂症患者分别接受丙戊酸钠缓释剂及丙戊酸镁治疗6周，并于服药后1，2，4，6周末使用高效液相色谱法检测丙戊酸血药浓度，以Bech—Rafaelsen躁狂量表（BRMS）和不良反应量表（TESS）观察临床疗效和药物不良反应。结果观察组有效率为80．00％，对照组有效率为76．67％，两组疗效无明显差异，有效病例的血药浓度平均为（77．58±14．45）μg·mL^-1，治疗窗范围为50～100μg·mL^-1之间。结论丙戊酸能有效治疗躁狂症，血药浓度监测有助于临床安全有效用药。

OBJECTIVE To explore the relationship between serum concentration and clinical efficacy of valproic acid in the treatment of patients with mania. METHODS Sixty patients of mania were divided into two equal number groups, the treatment group was given depakine ehrono （ 1 000 mg ·d^ 1 ） and the control group was given magnesium valproate （ 1 000-1 200 mg · d^ -1 ） for 6 weeks. At the 1st, 2nd, 4th and 6th weekends of treatment, the serum concentration of valproie acid were determined with HPLC and the clinical efficacy were assessed with the BRMS and TESS. RESULTS The response rates were 80% in treatment group and 76.67% in control group. There was no significant difference （ P 〉 0.05）. The serum concentration averaged （77.58 - 14.45 ） μg · mL^-1 , the therapeutic window was 50-100 μg ·mL^-1. CONCLUSION The results suggest that it is effective of valproie acid in treatment of mania. The clinical efficacy was related to its serum concentration. It is helpful to monitoring serum concentration of valproie acid in treatment of mania.