双相Ⅰ型障碍患者丙戊酸钠血药浓度监测的应用与初步评价

Application and Primary Evaluation of Sodium Valproate Blood Concentration in Treatment of BipolarⅠ Disorder Patients

目的:探讨丙戊酸钠治疗双相障碍I型躁狂或混合性发作患者的血药浓度与临床疗效和安全性的关系。方法:共入组30例患者,接受丙戊酸钠治疗,丙戊酸钠实施个体化药物剂量调整方案。于基线时、治疗第1、2、3、4、6、8、10、12、16周末,分别采用临床总体印象疾病总体严重度量表-双相障碍版(CGI-BP)、Young躁狂评定量表(YMRS)、简明精神病量表(BPRS)、汉密尔顿抑郁评定量表(HAMD-21)、功能总体评定量表评定(GAS)评定疗效和测定丙戊酸钠血浓度。在基线状态、治疗第4、8、12、16周时,进行血生化、血常规、尿常规、ECG检查以及药物治疗副反应量表(TESS)评定,以评价安全性。结果:(1)自治疗1周末CGI-BP(5.0±0.4)和YMRS(26.7±3.7)得分较治疗前[(5.3±0.5)vs.(30.4±1.5)]有明显下降(P<0.05),自治疗第4周起,社会功能也较基线时有显著改善。治疗16周末,缓解率为93.3%,不良反应的发生率为40%。(2)丙戊酸钠的有效治疗血浓度范围为(84～125)μg/ml,有效维持血浓度范围为(77～98)μg/ml。结论:丙戊酸钠治疗双相I型障碍的疗效与血浓度存在相关,监测血药浓度对临床药物剂量调整有较好的帮助。

Objective： To evaluate the relation of the clinical efficacy and safety with the plasma drug concentration of sodium valproate in treatment of the patients with bipolar Ⅰ disorder and mixed episodes. Methods： The eligible patients （ n = 30 ） received sodium valproate treatment, and the dosages of sodium valproate were individualized. The patients were assessed with the Clinical Global Impress Scale-bipolar Disorder （ CGI-BP）, Young Mania Rating Scale （ YMRS）, Brief Psychiatric Rating Scale （ BPRS）, Hamilton Depression Scale （ HAMD-21）, Global Assessment Scale, and the plasma concentrations of sodium valproate were assayed at the baseline, and at the end of the 1, 2, 3, 4, 6, 8, 10, 12, 16th week after treatment. Blood biochemistry and routine, urine routine and electrocardiogram were examined, and treatment emergent symptoms scale （ TESS） was assessed for safety evaluation, at the baseline, and the 4, 8, 12, 16th week after treatment. Results： （ 1 ） The scores of CGI-BP [ （5.0 ±0. 4） vs. （5.3± 0. 5 ） ] and YMRS [ （ 26. 7 ± 3.7 ） vs. （ 30. 4 ± 1.5 ） ] after 1 week treatment were significantly decreased compared with the baseline （ all P 〈 0. 05 ） . The social function was significantly improved since the 4th week. At the end of 16th week, the effective rates were 93%, and the rate of observable side effects was 40%. （2） The plasma effective concentration of Sodrum valproate was （84 ± 125） μg/ml, the effective maintainable concentration was （77 ± 98） μg/ml. Conclusion： Sodium valproate has good efficacy on the treatment of bipolar I disorder, which is correlated with plasma drug concentration.