Morales Knashawn, Wittink Marsha, Datto Catherine, DiFilippo Suzanne, Cary Mark, TenHave Thomas, Katz Ira R
Center for Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
J Am Geriatr Soc. 2006 Jan;54(1):70-6. doi: 10.1111/j.1532-5415.2005.00542.x.
To test for simvastatin-induced changes in affect and affective processes in elderly volunteers.
Randomized, clinical trial.
The Geriatric Behavioral Psychopharmacology Laboratory at the University of Pennsylvania.
Eighty older volunteers, average age 70, with high normal/mildly elevated serum cholesterol.
Simvastatin up to 20 mg/d or placebo for 15 weeks.
Daily diary records of positive and negative affects and of events and biweekly measures of depressive symptoms. Affect ratings were obtained using the Lawton positive and negative affect scales; independent raters coded the valences of events.
Thirty-one of 39 subjects assigned to placebo and 33 of 41 receiving simvastatin completed the study. During biweekly assessments, four subjects on simvastatin and one on placebo experienced depressive symptoms, as manifest by Center for Epidemiological Studies Depression scale scores greater than 16 (exact P=.36). Diary data demonstrated significant effects on affective processes. For positive affect, there was a significant medication-by-time interaction that reflected decreases in positive affect in subjects receiving simvastatin, greatest in those patients whose final total cholesterol levels were below 148 mg/dL. For negative affect, there were significant medication-by-event, and medication-by-event-by-time interactions, reflecting a time-limited increase in the apparent effect of negative events.
Simvastatin has statistically significant effects on affect and affective processes in elderly volunteers. The decrease in positive affect may be significant clinically and relevant to the quality of life of many patients.
检测辛伐他汀对老年志愿者情感及情感过程的影响。
随机临床试验。
宾夕法尼亚大学老年行为心理药理学实验室。
80名老年志愿者,平均年龄70岁,血清胆固醇处于高正常/轻度升高水平。
给予辛伐他汀每日最高剂量20mg,或安慰剂,持续15周。
每日记录积极和消极情绪以及事件,并每两周测量一次抑郁症状。使用劳顿积极和消极情绪量表获得情绪评分;由独立评估者对事件的效价进行编码。
分配至安慰剂组的39名受试者中有31名,接受辛伐他汀治疗的41名受试者中有33名完成了研究。在每两周一次的评估中,4名服用辛伐他汀的受试者和1名服用安慰剂的受试者出现了抑郁症状,以流行病学研究中心抑郁量表得分大于16为表现(确切P = 0.36)。日记数据显示对情感过程有显著影响。对于积极情绪,存在显著的药物×时间交互作用,这反映了接受辛伐他汀治疗的受试者积极情绪下降,在最终总胆固醇水平低于148mg/dL的患者中下降最为明显。对于消极情绪,存在显著的药物×事件以及药物×事件×时间交互作用,反映了消极事件的明显影响在时间上有限的增加。
辛伐他汀对老年志愿者的情感及情感过程具有统计学上的显著影响。积极情绪的下降在临床上可能具有重要意义,并且与许多患者的生活质量相关。