课件：度洛西汀药理机制和临床疗效.pptVIP

* KEY POINTS 已证实：度洛西汀对血压的影响没有显著临床意义。在临床研究中，度洛西汀治疗(40-120mg/d)导致收缩压平均增加2mmHg，舒张压平均增加0.5mmHg。但血压抬高2mmHg是相对于安慰剂组的，如果与基线相比仅增加了0.8mmHg。 度洛西汀治疗(40-120mg/d)9周会引起平均心率增加2bpm，尽管这种变化有统计学差异，但几乎没有临床意义。 度洛西汀对QTc也没有具临床意义的影响 由于数据仅反映了血压变化的平均值，因此用度洛西汀治疗的患者应在治疗开始时及治疗中定期检查血压。 Key Points: Duloxetine has demonstrated no clinically significant effects on blood pressure. There also was no clinically significant effects on pulse or QTc. Because the data reflect a change in mean blood pressure, patients on duloxetine should have their blood pressure taken at initiation of and periodically while on therapy. One patient in each group (duloxetine and paroxetine) met criteria for PCS values QTcF intervals as compared with none in the placebo group. PCS criteria ( 450 ms for men; and 470 ms for women with an increase in QTcF of ms from baseline. BACKGROUND The electrocardiogram/QTc data are from MDD clinical trials of 321 patients treated with duloxetine and 169 placebo-treated patients. The heart rate, blood pressure, and sustained hypertension data are from 8 placebo-controlled MDD studies of duloxetine 40-120 mg/day. REFERENCE Hudson JI, Wohlreich MM, Kajdasz DK, et al., Safety and tolerability of duloxetine in the treatment of major depressive disorder: analysis of pooled data from eight placeco-controlled clinical trials. Hum Psychopharmacol Clin Exp. 2005; 20:327-341. Thase ME, Tran PV, Wiltse C , et al., Cardiovascular Profile of Duloxetine, a Dual Reuptake Inhibitor of Serotonin and Norepinephrine. J Clin Psychopharmacol 2005;25(2):132-140. Data on file, Lilly Research Laboratories: CY, CY, CY. Studies: F1J-MC-HMAQa, F1J-MC-HMAQb, F1J-MC-HMATa, F1J-MC-HMATb, F1J-MC-HMAYa, F1J-MC-HMAYb, F1J-MC-HMBHa, F1J-MC-HMBHb * Key Points: 这张片子展示了在安慰剂对照研究中接受不同剂量度洛西汀治疗的患者发生持续性高血压的比例。 在8-9周急性治疗期，度洛西汀组的持续性高血压发生率与安慰剂组相比没有显著差异。 在26周的治疗期内，度洛西汀组的持续性高血压发生率与安慰剂组也没有显著差异(80mg/day: 120mg/day: Placebo=5.7%: 7.1%: 6.2%) This slide shows the incidence of sustained hypertension b