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首页> 外文期刊>The journal of clinical psychiatry >Controlled double-blind trial of phenytoin vs. fluoxetine in major depressive disorder.
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Controlled double-blind trial of phenytoin vs. fluoxetine in major depressive disorder.

机译：苯妥英钠与氟西汀治疗重度抑郁症的对照双盲试验。

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BACKGROUND: Phenytoin was the first non-sedative anticonvulsant introduced and is still the anticonvulsant most widely used worldwide in neurology. Given the efficacy of the anticonvulsant lamotrigine in the depressed phase of bipolar disorder, a critical theoretical question is whether other anticonvulsants used in treating bipolar disorder might be similarly effective. We therefore undertook a controlled trial of phenytoin versus fluoxetine in major depressive disorder. METHOD: Data were collected from July 2001 to July 2003. Thirty-three subjects entered the study. All patients met DSM-IV criteria for major depressive disorder and scored a minimum of 18 on the 24-item Hamilton Rating Scale for Depression (HAM-D) at baseline. After a 3-day washout of any previous medications, patients were randomly assigned to fluoxetine or phenytoin in identical capsules. Each capsule contained phenytoin 100 mg or fluoxetine 7 mg plus cornstarch. Patients started with 1 tablet daily and increased every other day until they were taking 1 tablet 3 times daily with meals. Blood phenytoin levels were taken after 1 week, 3 weeks, and 6 weeks, and dosage was adjusted to achieve blood levels of 10 to 20 microg/mL, to a maximum dose of 4 capsules per day or a minimum dose of 2 capsules per day. Fluoxetine patients were assigned dummy blood phenytoin levels by the control psychiatrist such that the treating physician would raise the number of capsules to at least 3 per day (20 mg of fluoxetine). RESULTS: Thirty-three patients entered the study, and 28 (N = 14 in each treatment group) completed at least 3 weeks and were included in the data analysis. Patients who dropped out after week 3 (3 patients) were included in the study as last value carried forward. There was no difference between treatment groups in overall rate of response or speed of response. CONCLUSION: The absence of a placebo arm in our study allows for the possibility that neither treatment was more effective than placebo. However, the exclusion of past fluoxetine nonresponders and the minimum HAM-D score at baseline of 18 make this possibility unlikely.
机译：背景：苯妥英钠是第一个被引入的非镇静抗惊厥药，仍然是全世界神经病学中使用最广泛的抗惊厥药。考虑到抗惊厥药拉莫三嗪在双相情感障碍的抑郁症中的功效，一个关键的理论问题是用于治疗双相情感障碍的其他抗惊厥药是否可能同样有效。因此，我们进行了苯妥英钠与氟西汀在重度抑郁症中的对照试验。方法：收集2001年7月至2003年7月的数据。33名受试者进入研究。所有患者均符合重度抑郁症的DSM-IV标准，并且在基线的24项汉密尔顿抑郁量表（HAM-D）中得分至少18。经过3天的任何以前的药物冲洗后，患者被随机分配在相同的胶囊中接受氟西汀或苯妥英钠治疗。每个胶囊含苯妥英100毫克或氟西汀7毫克加玉米淀粉。患者开始每天服用1片，然后每隔一天增加一次，直到他们每天3次进餐时服用1片。在1周，3周和6周后取血中苯妥英水平，并调整剂量以达到10至20微克/毫升的血液水平，最大剂量为每天4粒胶囊或每天最小剂量为2粒胶囊。对照精神病医生为氟西汀患者分配了假血苯妥英水平，以使治疗医生将胶囊的数量提高到每天至少3粒（氟西汀20 mg）。结果：33例患者进入研究，其中28例（每个治疗组N = 14）完成了至少3周的时间，并纳入了数据分析。在第3周后退学的患者（3例患者）被作为最后的结转值纳入研究。治疗组之间的总缓解率或缓解速度没有差异。结论：我们的研究中没有安慰剂组，这两种治疗方法均没有比安慰剂更有效的可能性。但是，排除过去的氟西汀无反应者和基线时HAM-D最低分数18是不可能的。

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