Keller M B, McCullough J P, Klein D N, Arnow B, Dunner D L, Gelenberg A J, Markowitz J C, Nemeroff C B, Russell J M, Thase M E, Trivedi M H, Zajecka J
Department of Psychiatry, Brown University, Providence, RI 02906, USA.
N Engl J Med. 2000 May 18;342(20):1462-70. doi: 10.1056/NEJM200005183422001.
Patients with chronic forms of major depression are difficult to treat, and the relative efficacy of medications and psychotherapy is uncertain.
We randomly assigned 681 adults with a chronic nonpsychotic major depressive disorder to 12 weeks of outpatient treatment with nefazodone (maximal dose, 600 mg per day), the cognitive behavioral-analysis system of psychotherapy (16 to 20 sessions), or both. At base line, all patients had scores of at least 20 on the 24-item Hamilton Rating Scale for Depression (indicating clinically significant depression). Remission was defined as a score of 8 or less at weeks 10 and 12. For patients who did not have remission, a satisfactory response was defined as a reduction in the score by at least 50 percent from base line and a score of 15 or less. Raters were unaware of the patients' treatment assignments.
Of the 681 patients, 662 attended at least one treatment session and were included in the analysis of response. The overall rate of response (both remission and satisfactory response) was 48 percent in both the nefazodone group and in the psychotherapy group, as compared with 73 percent in the combined-treatment group. (P<0.001 for both comparisons). Among the 519 subjects who completed the study, the rates of response were 55 percent in the nefazodone group and 52 percent in the psychotherapy group, as compared with 85 percent in the combined-treatment group (P<0.001 for both comparisons). The rates of withdrawal were similar in the three groups. Adverse events in the nefazodone group were consistent with the known side effects of the drug (e.g., headache, somnolence, dry mouth, nausea, and dizziness).
Although about half of patients with chronic forms of major depression have a response to short-term treatment with either nefazodone or a cognitive behavioral-analysis system of psychotherapy, the combination of the two is significantly more efficacious than either treatment alone.
患有慢性重度抑郁症的患者难以治疗，药物治疗和心理治疗的相对疗效尚不确定。
我们将681名患有慢性非精神病性重度抑郁症的成年人随机分配接受为期12周的门诊治疗，治疗方式包括服用奈法唑酮（最大剂量为每日600毫克）、认知行为分析系统心理治疗（16至20次疗程）或两者结合。在基线时，所有患者在24项汉密尔顿抑郁评定量表上的得分至少为20分（表明临床上有显著抑郁症状）。缓解定义为在第10周和第12周时得分8分或更低。对于未缓解的患者，满意反应定义为得分较基线至少降低50%且得分15分或更低。评估者不知道患者的治疗分配情况。
在681名患者中，662名至少参加了一次治疗疗程并被纳入反应分析。奈法唑酮组和心理治疗组的总体反应率（缓解和满意反应）均为48%，而联合治疗组为73%。（两项比较P均<0.001）。在完成研究的519名受试者中，奈法唑酮组的反应率为55%，心理治疗组为52%，联合治疗组为85%（两项比较P均<0.001）。三组的退出率相似。奈法唑酮组的不良事件与该药物已知的副作用一致（如头痛、嗜睡、口干、恶心和头晕）。
虽然约一半患有慢性重度抑郁症的患者对短期服用奈法唑酮或认知行为分析系统心理治疗有反应，但两者结合比单独任何一种治疗都显著更有效。
