Thase M E, Fava M, Halbreich U, Kocsis J H, Koran L, Davidson J, Rosenbaum J, Harrison W
Department of Psychiatry, University of Pittsburgh School of Medicine, USA.
Arch Gen Psychiatry. 1996 Sep;53(9):777-84. doi: 10.1001/archpsyc.1996.01830090023004.
Despite the high prevalence of dysthymia and its associated morbidity, few controlled trials have evaluated the efficacy of antidepressant medication for this disorder. A 12-week, double-blind, placebo-controlled, randomized, multicenter trial was performed to evaluate the safety and efficacy of sertraline hydrochloride and imipramine hydrochloride in treating dysthymia.
A total of 416 outpatients (271 women and 145 men) aged 25 to 65 years with DSM-III-R-defined, early-onset, primary dysthymia without concurrent major depression were randomized to 12 weeks of treatment with sertraline, imipramine, or placebo.
Both active treatments resulted in significantly reduced scores on the 17-item Hamilton Rating Scale for Depression (P = .04 and P = .01 for sertraline and imipramine vs placebo, respectively), the Montgomery-Asberg Depression Rating Scale (P = .01 and P = .003 vs placebo, respectively), Hopkins Symptom Checklist (P < .05), and the self-rated version of the Inventory of Depressive Symptoms (P < .05). With the use of a Clinical Global impressions improvement score of 1 or 2 (very much or much improved) to define response, response rates were 59% for sertraline, 64% for imipramine, and 44% for placebo (P = .02 for sertraline vs placebo and P < .001 for imipramine vs placebo). A significantly greater proportion of patients receiving imipramine than those receiving sertraline or placebo discontinued treatment because of adverse events (P = .001 and P < .001, respectively).
Pharmacotherapy provides considerable relief from the symptoms of dysthymia in patients suffering from this chronic affective disorder, with both sertraline and imipramine being more effective than placebo. The greater tolerability of sertraline is an important consideration because of the chronicity of dysthymia, which may require prolonged treatment with antidepressant medication.
尽管心境恶劣障碍患病率高且伴有发病，但很少有对照试验评估抗抑郁药物对该疾病的疗效。进行了一项为期12周的双盲、安慰剂对照、随机、多中心试验，以评估盐酸舍曲林和盐酸丙咪嗪治疗心境恶劣障碍的安全性和疗效。
总共416例年龄在25至65岁之间、符合DSM-III-R定义的早发性、原发性心境恶劣障碍且无并发重度抑郁的门诊患者（271名女性和145名男性）被随机分配接受12周的舍曲林、丙咪嗪或安慰剂治疗。
两种活性治疗均使17项汉密尔顿抑郁评定量表评分显著降低（舍曲林和丙咪嗪分别与安慰剂相比，P = 0.04和P = 0.01）、蒙哥马利-阿斯伯格抑郁评定量表评分（分别与安慰剂相比，P = 0.01和P = 0.003）、霍普金斯症状清单评分（P < 0.05）以及抑郁症状量表自评版评分（P < 0.05）。使用临床总体印象改善评分为1或2（明显改善或改善很多）来定义反应，舍曲林的反应率为59%，丙咪嗪为64%，安慰剂为44%（舍曲林与安慰剂相比，P = 0.02；丙咪嗪与安慰剂相比，P < 0.001）。因不良事件而停药的接受丙咪嗪治疗的患者比例显著高于接受舍曲林或安慰剂治疗的患者（分别为P = 0.001和P < 0.001）。
药物治疗能为患有这种慢性情感障碍的心境恶劣障碍患者的症状提供显著缓解，舍曲林和丙咪嗪均比安慰剂更有效。由于心境恶劣障碍具有慢性特点，可能需要长期使用抗抑郁药物治疗，因此舍曲林具有更高的耐受性是一个重要的考虑因素。
