不同剂型文拉法辛治疗女性抑郁症患者的血药浓度与临床疗效的关系(英文)  

Relationship between blood levels and clinical efficacy of two different formulations of venlafaxine in female patients with depression

作　　者：宋宝华[1] 范振国[1] 沈卫民[1] 钱敏才[1] 陈海支[1] 戴红[1] 王世锴[1] 

机构地区：[1]浙江省湖州市第三人民医院精神科,313000

出　　处：《上海精神医学》2011年第6期338-344,共7页Shanghai Archives of Psychiatry

基　　金：supported by the Third People's Hospital of Huzhou,it did not received funds from any pharmaceutical company

摘　　要：背景不同剂型的药物在体内的解离和释放速度存在差异,因此其起效和作用时间也有所不同,并可能会进一步影响其疗效和不良反应。目的探讨不同剂型的文拉法辛治疗女性抑郁症患者的血药浓度与药物临床疗效和不良反应间的关系。方法将60例女性抑郁症住院患者以单纯随机的方式分别编入文拉法辛缓释剂组(怡诺思组)及文拉法辛速释剂组(博乐欣组),进行为期6周的对照研究。怡诺思组患者每日晨起一次顿服药物,日平均剂量(标准差)为168(32)mg;博乐欣组患者每日分3次服用药物,日平均剂量(标准差)为160(67)mg。在研究第1、2、4、6周末以高效液相色谱法测定文拉法辛及其活性代谢产物氧去甲基文拉法辛浓度,以汉密尔顿抑郁量表(Hamilton Depression Rating Scale,HAMD)和治疗时出现的症状量表(Treatment Emergent Symptoms Scale,TESS)评定临床疗效和药物不良反应,HAMD评分减分率≥50%为有效。结果两组均未见有严重的药物不良反应。在各研究时点两组HAMD评分组间差异均无统计学意义。治疗6周后两组HAMD评分均明显下降;缓释剂组的有效率为65.6%,速释剂组的有效率为69.2%(χ2=0.77,p=0.380)。治疗前后HAMD评分的改变与氧去甲基文拉法辛(rs=-0.10,p=0.470)及文拉法辛(rs=-0.11,p=0.403)血药浓度呈较弱的负相关。结论两种剂型的文拉法辛对女性抑郁症患者均显示了良好的临床疗效和耐受性,但文拉法辛与氧去甲基文拉法辛血药浓度未与临床疗效密切相关,所以此两项指标不适合用来判定文拉法辛的临床疗效。Background： Different formulations of the same medication can have distinct dissociation profiles and release rates resulting in different onset times and durations of action; these differences may influence the clinical efficacy and adverse reactions of the medication. Objective： Assess the relationship between the plasma concentrations and the clinical efficacy and adverse reaction profile of two formulations of venlafaxine （VL） in female patients with major depression. Methods： Sixty female patients hospitalized for depression were randomly assigned to use EFFEXOR XR, the extendedrelease formulation of venlafaxine （hereafter, the XR group）, or Bolexin, the immediate-release formulation of venlafaxine （hereafter, the IR Group）, for six weeks. The mean （SD） total daily dose in the XR group was 168 （32） mg/d administered in one oral dose in the morning and that in the IR group was 160 （67） mg/day administered in three oral doses over the day. At the end of the first, second, fourth and sixth week of treatment the plasma concentrations of VL and its active metabolite, O-desmethylvenlafaxine （ODV）, were determined using high-performance liquid chromatography and the clinical efficacy and adverse reactions were accessed using the Hamilton Depression Rating Scale （HAMD） and the Treatment Emergent Symptoms Scale （TESS）. A reduction in the baseline HAMD score of 50% or greater was deemed remission. Results： No serious adverse reactions were observed. There were no significant differences in the mean HAMD scores between the two groups at any of the time points evaluated. Mean HAMD scores after six weeks of treatment were significantly lower in both treatment groups; the overall remission rate was 65.6% in the XR group and 69.2% in the IR group 0（2=0.77, p=0.380）. Changes in the HAMD scores from baseline were only weakly correlated with changes in the plasma concentrations of ODV （rs=-0.10, p=0.470） and VL （r,=-0.11, p=0.403）. Conclusion： Both the extended-release

关 键 词：抑郁症 文拉法辛 氧去甲基文拉法辛 高效液相色谱法 

分 类 号：R749.4[医药卫生—神经病学与精神病学]