金丝桃提取物 WS 5570 与帕罗西汀用于中重度抑郁症发作恢复后的持续治疗比较：一项随机多中心研究的结果

Comparison of Hypericum extract WS 5570 and paroxetine in ongoing treatment after recovery from an episode of moderate to severe depression: results from a randomized multicenter study.

作者信息

Anghelescu I G, Kohnen R, Szegedi A, Klement S, Kieser M

机构信息

Department of Psychiatry and Psychotherapy, Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.

出版信息

Pharmacopsychiatry. 2006 Nov;39(6):213-9. doi: 10.1055/s-2006-951388.

DOI:10.1055/s-2006-951388

PMID:17124643

Abstract

OBJECTIVE

To test and compare the efficacy and safety of Hypericum extract WS 5570 to paroxetine, a potent SSRI, in patients suffering from moderate or severe depression according to DSM-IV criteria.

METHODS

In a multicenter, randomized, double-blind phase III study, the changes in moderate to severe major depression DSM-IV; 17-item Hamilton Depression Rating Scale (HAM-D total>or=22) after an acute treatment with Hypericum extract WS 5570 or paroxetine were analyzed in a 16-week continuation phase for relapse prevention. Patients with a HAM-D total score decrease of >or=50% during the 6 weeks of acute treatment were asked to continue the treatment for another 4 months. One-hundred and thirty-three adult out-patients who received maintenance doses of 900 (n=33) or 1800 mg/d (n=38) of WS 5570 and 20 (n=28) or 40 mg/d (n=34) of paroxetine, respectively, were included. The relevant dosage was already fixed during the acute treatment.

RESULTS

Between baseline of the acute phase and end of continuation treatment the HAM-D total score decreased from 25.3+/-2.5 (mean+/-SD) to 4.3+/-6.2 points for WS 5570 and from 25.3+/-2.6 to 5.2+/-5.5 points for paroxetine (p=0.49, two-sided t-test; median relative decrease: 92.0 and 85.5%, respectively). During maintenance treatment alone (day 154-day 42), 61.6% of the patients randomized to WS 5570 and 54.6% treated with paroxetine showed an additional reduction (p=0.59) with respect to the HAM-D total score. Remission (HAM-D endpoint total score below 8) occurred in 81.6% (31 patients) of the patients for WS 5570 and in 71.4% (30 patients) for paroxetine (p=0.29). Three patients in the WS 5570 group and 2 patients in the paroxetine group showed a HAM-D increase>5 points during continuation treatment. In the continuation phase there were 0.006 adverse events per day of exposure for WS 5570 and 0.007 events for paroxetine.

CONCLUSION

This study showed that WS 5570 and paroxetine were similarly effective in preventing relapse in a continuation treatment after recovery from an episode of moderate to severe depression and point therefore to an important alternative treatment option for long-term relapse-prevention.

摘要

目的

根据《精神疾病诊断与统计手册》第四版（DSM-IV）标准，测试并比较金丝桃提取物 WS 5570 与强效选择性 5-羟色胺再摄取抑制剂（SSRI）帕罗西汀治疗中度或重度抑郁症患者的疗效和安全性。

方法

在一项多中心、随机、双盲的 III 期研究中，分析了金丝桃提取物 WS 5570 或帕罗西汀急性治疗后，中度至重度重度抑郁症（DSM-IV）；17 项汉密尔顿抑郁量表（HAM-D 总分≥22）在 16 周持续治疗期预防复发的变化情况。在急性治疗 6 周期间 HAM-D 总分下降≥50%的患者被要求继续治疗 4 个月。纳入了 133 名成年门诊患者，他们分别接受 900（n = 33）或 1800 mg/d（n = 38）的 WS 5570 维持剂量以及 20（n = 28）或 40 mg/d（n = 34）的帕罗西汀维持剂量。相关剂量在急性治疗期间已确定。

结果

在急性期基线至持续治疗结束时，WS 5570 组的 HAM-D 总分从 25.3±2.5（均值±标准差）降至 4.3±6.2 分，帕罗西汀组从 25.3±2.6 降至 5.2±5.5 分（p = 0.49，双侧 t 检验；中位数相对下降分别为 92.0%和 85.5%）。仅在维持治疗期间（第 154 天至第 42 天），随机分配至 WS 5570 组的 61.6%患者和接受帕罗西汀治疗的 54.6%患者的 HAM-D 总分进一步下降（p = 0.59）。WS 5570 组 81.6%（31 例患者）和帕罗西汀组 71.4%（30 例患者）达到缓解（HAM-D 终点总分低于 8）（p = 0.29）。WS 5570 组 3 例患者和帕罗西汀组 2 例患者在持续治疗期间 HAM-D 增加>5 分。在持续治疗阶段，WS 5570 组每日暴露的不良事件发生率为 0.006，帕罗西汀组为 0.007。