阿立哌唑治疗精神分裂症的血药浓度与临床效应关系研究

目的:研究阿立哌唑治疗精神分裂症的血药浓度与临床效应之间关系,探索阿立哌唑血药浓度的治疗窗。方法:采用前瞻性研究方法,应用非固定剂量药物治疗8周。以高效液相色谱仪测定阿立哌唑的谷浓度,阳性和阴性症状量表(PANSS)、临床总体印象-病情严重程度量表(CGI-SI)评定疗效,治疗时出现的症状量表(TESS)评定不良反应。采用受试者运筹特征曲线(ROC曲线)获得血药浓度的最佳截断值,结合四分位间距法推测阿立哌唑血药浓度的治疗窗。并分析血药浓度与药物剂量、临床疗效、不良反应等之间的相关性。结果:入组80例患者,治疗有效47例、无效29例,另外4例脱落。总的不良反应发生率为32.5%。阿立哌唑血药浓度与药物剂量、PANSS减分率及TESS分值间呈正相关,与CGI-SI分值呈负相关。药物剂量与疗效无相关性。最低有效血药浓度为363μg/L,发生不良反应的血药浓度阈值为540μg/L。有效组血药浓度的四分位间距为348～623μg/L。血药浓度在350～540μg/L的范围内疗效较好,副反应较轻。结论:阿立哌唑治疗精神分裂症的血药浓度与临床效应之间存在相关性,较适宜的治疗窗是350～540μg/L。

Relationship between serum concentration and clinical efficacy of aripiprazole in the treatment of patients with schizophrenia

AIM : To explore the relationship between serum concentration and clinical efficacy of aripiprazole in the treatment of patients with schizophrenia,and the suitable therapeutic window of aripiprazole. METHODS : Prospective study method was adopted.The dosages of aripiprazole were unfixed for eight weeks.The trough serum concentrations were determined by high performance liquid chromatography(HPLC).The clinical efficacy was evaluated with the Positive and Negative Syndrome Scale(PANSS) and the Clinical Globa...