氟伏沙明治疗妇科恶性肿瘤患者心理困扰的临床研究。

Clinical study on the efficacy of fluvoxamine for psychological distress in gynecologic cancer patients.

机构信息

Department of Obstetrics and Gynecology, St Marianna University School of Medicine, Kanagawa, Japan.

出版信息

Int J Gynecol Cancer. 2011 Aug;21(6):1143-9. doi: 10.1097/IGC.0b013e3181ffbeb9.

DOI:10.1097/IGC.0b013e3181ffbeb9

PMID:21792017

Abstract

BACKGROUND

Diagnosis of cancer causes psychological distress. The present study investigated the safety and efficacy of fluvoxamine therapy in gynecologic cancer patients with either adjustment disorder or major depression after cancer was diagnosed.

METHODS

Screening with the Hospital Anxiety and Depression Scale (HADS) was conducted at least 2 weeks after notification of the diagnosis of cancer in 214 gynecologic cancer patients hospitalized between January 2007 and December 2008. The HADS cutoff score was set at 11 points or greater. Informed consent to the study was obtained from 10 patients, and fluvoxamine was administered for 8 weeks. As primary end points, the safety and efficacy of fluvoxamine were evaluated using the HADS and the SF-36. As a secondary end point, the Clinical Global Impression was determined.

RESULTS

The total HADS score, the anxiety score, and the depression score were significantly reduced after 6, 4, and 6 weeks of treatment, respectively. The SF-36 revealed significant improvement in vitality, mental health, and role (emotional) after 8 weeks of treatment. In the 5 patients with adjustment disorder, only the HADS anxiety score was significantly reduced after 4 weeks. In the 5 patients with major depression, the total HADS score, the anxiety score, and the depression score were significantly reduced after 6, 8, and 6 weeks, respectively. According to the SF-36, the adjustment-disorder groups showed significant improvement in mental health after 8 weeks of treatment, whereas the major-depression group showed significant improvement in vitality and role (emotional) after 8 weeks. No adverse events occurred in any subject. Assessment of the Clinical Global Impression suggested that fluvoxamine improved psychological distress in all 10 subjects.

CONCLUSIONS

The present findings suggest that fluvoxamine is useful for alleviating psychological distress, including adjustment disorder and major depression, in gynecologic cancer patients. Management of psychological distress after diagnosis of cancer is important.

摘要

背景

癌症的诊断会导致心理困扰。本研究调查了氟伏沙明治疗妇科癌症患者在癌症确诊后出现适应障碍或重度抑郁症的安全性和疗效。

方法

2007 年 1 月至 2008 年 12 月期间，对 214 名住院妇科癌症患者进行了至少 2 周的医院焦虑抑郁量表（HADS）筛查，该量表在癌症确诊后进行。HADS 的截断值设为 11 分或更高。10 名患者同意参加本研究，并接受氟伏沙明治疗 8 周。主要终点为 HADS 和 SF-36 评估氟伏沙明的安全性和疗效。次要终点为临床总体印象的确定。

结果

治疗后 6、4 和 6 周，HADS 总分、焦虑评分和抑郁评分分别显著降低。治疗 8 周后，SF-36 显示活力、心理健康和角色（情感）显著改善。在 5 名适应障碍患者中，仅在治疗 4 周后 HADS 焦虑评分显著降低。在 5 名重度抑郁症患者中，治疗 6、8 和 6 周后 HADS 总分、焦虑评分和抑郁评分分别显著降低。根据 SF-36，适应障碍组在治疗 8 周后心理健康显著改善，而重度抑郁症组在治疗 8 周后活力和角色（情感）显著改善。所有患者均未出现不良反应。临床总体印象评估表明氟伏沙明改善了所有 10 名患者的心理困扰。