Double-blind, multicenter comparison of sertraline and amitriptyline in elderly depressed patients.
Double-blind, multicenter comparison of sertraline and amitriptyline in elderly depressed patients.
复制标题
舍曲林和阿米替林治疗老年抑郁症的双盲、多中心比较。
DOI：
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发表时间：
1990
影响因子：
5.3
通讯作者：
A. Lautin
中科院分区：
文献类型：
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作者：
C. Cohn;R. Shrivastava;J. Mendels;J. Cohn;L. Fabre;J. Claghorn;E. Dessain;T. Itil;A. Lautin
241例老年抑郁症患者进入这项平行组、多中心研究的8周双盲期; 161例患者随机接受舍曲林（50-200 mg/天），80例患者随机接受阿米替林（50-150 mg/天）。在可评价患者中，治疗组之间的任何主要疗效变量均无统计学显著性差异：汉密尔顿抑郁量表（HAM-D）总评分的变化（17项）、HAM-D评分的百分比变化、HAM-D第1项的变化、临床总体应激（CGI）严重程度评分的变化、56项霍普金斯症状检查表的抑郁因子的变化，以及最后一次访视时的CGI改善评分。使用所有患者的数据获得了类似的结果（意向治疗分析），除了阿米替林在HAM-D总分方面上级（p = 0.044）。这两种药物产生了相似程度的反应：根据HAM-D标准，69.4%的舍曲林患者和62.5%的阿米替林患者有反应，根据CGI标准，79.5%的舍曲林患者和73.4%的阿米替林患者有反应。28%的舍曲林患者因为治疗相关的副作用而退出研究，2.5%（4）的患者因为实验室异常而退出研究。相比之下，35%的阿米替林患者因为治疗相关的副作用而退出。舍曲林与嗜睡、口干、便秘、共济失调和疼痛的发生率在统计学上较低，与恶心、厌食、腹泻/稀便和失眠的发生率较高相关;因此，舍曲林的抗胆碱能作用较不常见，胃肠道作用较阿米替林常见。（250字处删节）
Two hundred forty-one elderly depressed patients entered the 8-week, double-blind phase of this parallel-group, multicenter study; 161 patients were randomized to receive sertraline (50-200 mg/day) and 80 were randomized to receive amitriptyline (50-150 mg/day). Among evaluable patients, there were no statistically significant differences between treatments in any of the primary efficacy variables: change in total Hamilton Rating Scale for Depression (HAM-D) score (17 items), percentage change in HAM-D score, change in HAM-D Item 1, change in Clinical Global Impressions (CGI) Severity score, change in the Depression Factor of the 56-item Hopkins Symptom Checklist, and the CGI Improvement score at the last visit. Similar results were obtained using data from all patients (intention-to-treat analysis), except that amitriptyline was superior in HAM-D Total score (p = .044). The two drugs produced a similar degree of response: on the basis of the HAM-D criterion, 69.4% of sertraline patients and 62.5% of amitriptyline patients responded, and, on the basis of CGI criterion, 79.5% of sertraline and 73.4% of amitriptyline patients responded. Twenty-eight percent of the sertraline patients withdrew from the study because of a treatment-related side effect and 2.5% (4) because of a laboratory abnormality. In comparison, 35% of the amitriptyline patients withdrew because of treatment-related side effects. Sertraline was associated with a statistically lower frequency of somnolence, dry mouth, constipation, ataxia, and pain and a higher frequency of nausea, anorexia, diarrhea/loose stools, and insomnia; thus, anticholinergic effects were less common and gastrointestinal effects were more common with sertraline than with amitriptyline.(ABSTRACT TRUNCATED AT 250 WORDS)