Tamoxifen and depression: More evidence from the National Surgical Adjuvant Breast and Bowel Project's Breast Cancer Prevention (P-1) randomized study
Tamoxifen and depression: More evidence from the National Surgical Adjuvant Breast and Bowel Project's Breast Cancer Prevention (P-1) randomized study
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DOI：
10.1093/jnci/93.21.1615
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发表时间：
2001-11-07
期刊：
影响因子：
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通讯作者：
Costantino, JP
中科院分区：
文献类型：
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作者：
Day, R;Ganz, PA;Costantino, JP
背景：他莫昔芬可能与抑郁症有关，这一点已经引起关注。为了调查这个问题，我们研究了他莫昔芬治疗对乳腺癌预防的心理影响，这些妇女参加了国家外科辅助乳腺和肠道项目的乳腺癌预防（P-1）研究，具有不同程度的临床抑郁症风险。研究方法：在P-1研究中，共有11064名妇女被随机分配接受为期5年的每日剂量为20 mg的他莫昔芬或安慰剂，这是一项多中心，双盲，安慰剂对照的化学预防试验。根据基线检查时收集的病史项目，前瞻性评估每位女性的抑郁风险，并将其分为高、中、低风险组。每6个月，共36个月，参与者通过完成流行病学调查中心抑郁症（CES-D）问卷来评估抑郁症状。16分或更高的分数表明情感困扰发作。通过logistic回归分析风险组和治疗组之间的差异。所有统计学检验均为双侧检验。结果如下：高风险抑郁症组的女性更有可能在CES-D中得分16或更高（随访检查评分≥ 16分的百分比：高危组= 35.7%，95%置信区间[CI] = 32.5%~ 38.9%;中危组= 19.2%，95% CI = 18.1%~ 20.3%;和低风险组= 8.7%，95%CI = 8.3至9.1%），并比低风险组的妇女更频繁地进行这些评分，持续时间更长。在每个抑郁风险组中，按治疗分配（他莫昔芬与安慰剂），得分16分或更高的女性比例没有差异（比值比= 0.98; 95%CI = 0.93至1.02）。锄后分析表明，缺乏他莫昔芬效应不是差异缺失数据的结果。结论：医生不必过分担心他莫昔芬治疗会增加女性抑郁症的风险或加剧现有的抑郁症。尽管如此，医生应该继续筛查和治疗或转介在常规临床实践中遇到的潜在抑郁症病例。
Background: Concerns have been raised that tamoxifen may be associated with depression. To investigate this question, we examined the psychological effects of tamoxifen treatment for breast cancer prevention on women at different levels of risk for clinical depression who were enrolled in the National Surgical Adjuvant Breast and Bowel Project's Breast Cancer Prevention (P-1) Study. Methods: A total of 11 064 women were randomly assigned to receive for 5 years daily doses of 20 mg of tamoxifen or placebo in the P-1 study, a multicenter, double-blind, placebo-controlled chemoprevention trial. Each woman was prospectively assessed for depression risk on the basis of medical history items collected at the baseline examination and placed in a high-, medium-, or low-risk group. Every 6 months, for a total of 36 months, the participants were assessed for depressive symptoms by completing the Center for Epidemiological Studies-Depression (CES-D) questionnaire. Scores of 16 or higher were indicative of an episode of affective distress. Differences between the risk groups and treatment arms were analyzed by logistic regression. All statistical tests were two-sided. Results: Women in the higher risk depression groups were more likely to score 16 or higher on the CES-D (percent follow-up examinations with a score of greater than or equal to 16: highrisk group = 35.7%, with 95% confidence interval [CI] = 32.5% to 38.9%; medium-risk group = 19.2%, with 95% CI = 18.1% to 20.3%; and low-risk group = 8.7%, with 95% CI = 8.3 to 9.1 %) and to have these scores more frequently and for longer periods than women in the lower risk groups. Within each depression risk group, there was no difference in the proportion of women scoring 16 or higher by treatment assignment (tamoxifen versus placebo) (odds ratio = 0.98; 95% CI = 0.93 to 1.02). A post-hoe analysis indicated that the lack of a tamoxifen effect was not a result of differential missing data. Conclusions: Physicians need not be overly concerned that treatment with tamoxifen will increase the risk for or exacerbate existing depression in women. Nevertheless, physicians should continue to screen for and treat or refer potential cases of depression encountered in routine clinical practice.