Koran L M, Gelenberg A J, Kornstein S G, Howland R H, Friedman R A, DeBattista C, Klein D, Kocsis J H, Schatzberg A F, Thase M E, Rush A J, Hirschfeld R M, LaVange L M, Keller M B
Stanford University Medical Center, CA, USA.
J Affect Disord. 2001 Jun;65(1):27-36. doi: 10.1016/s0165-0327(00)00272-x.
Chronic depressions are common, disabling and under-treated, and long-term treatment is little studied. We report the continuation phase results from a long-term treatment study.
After 12 weeks of acute phase treatment in a double-blind, randomized, parallel-group, multi-center trial of sertraline or imipramine, patients with chronic depression (> or = 2 years in major depression, or major depression superimposed on dysthymia) continued study drug for 16 weeks. Initially, 635 patients were randomized to sertraline or imipramine in a 2:1 ratio. Nonresponders after 12 weeks entered a 12-week double-blind crossover trial of the alternate medication. Entry into continuation treatment required at least a satisfactory response (partial remission) to initial or crossover treatment.
Of 239 acute or crossover responders to sertraline, 60% entered continuation in full remission and 40% with a partial remission. These proportions were identical for imipramine patients (n = 147). For both drug groups, over two-thirds of those entering in full remission retained it. For those entering in partial remission, over 40% achieved full remission. Patients requiring crossover treatment were less likely to maintain or improve their response during continuation treatment. The two drugs did not differ significantly in response distribution, drop out rates or discontinuation due to side effects during continuation treatment.
The absence of a placebo group constrains interpretation of our results, but chronic depressions have low placebo response rates.
Most chronic depression patients who remit with 12 weeks of sertraline or imipramine treatment maintain remission during 16 weeks of continuation treatment. Most patients with a satisfactory therapeutic response (partial remission) after 12 weeks of treatment maintain it or further improve. Patients treated with imipramine experienced more side effects, but both drugs were well tolerated.
慢性抑郁症常见、致残且治疗不足，长期治疗的研究较少。我们报告一项长期治疗研究的延续期结果。
在一项舍曲林或丙咪嗪的双盲、随机、平行组、多中心急性期治疗12周的试验中，慢性抑郁症患者（重度抑郁症≥2年，或重度抑郁症叠加心境恶劣）继续服用研究药物16周。最初，635名患者以2:1的比例随机分配至舍曲林或丙咪嗪组。12周后无反应者进入为期12周的另一种药物双盲交叉试验。进入延续治疗要求对初始或交叉治疗至少有满意反应（部分缓解）。
在239名对舍曲林有急性或交叉反应者中，60%进入延续期时完全缓解，40%部分缓解。丙咪嗪患者（n = 147）的这些比例相同。对于两个药物组，进入完全缓解的患者中超过三分之二维持了缓解状态。对于进入部分缓解的患者，超过40%实现了完全缓解。需要交叉治疗的患者在延续治疗期间维持或改善反应的可能性较小。两种药物在延续治疗期间的反应分布、脱落率或因副作用停药方面无显著差异。
缺乏安慰剂组限制了对我们结果的解释，但慢性抑郁症的安慰剂反应率较低。
大多数在12周舍曲林或丙咪嗪治疗后缓解的慢性抑郁症患者在16周的延续治疗期间维持缓解状态。大多数在12周治疗后有满意治疗反应（部分缓解）的患者维持或进一步改善。接受丙咪嗪治疗的患者副作用更多，但两种药物耐受性均良好。
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