预测接受金丝桃提取物 WS 5570/5572 治疗的重度抑郁症患者的稳定治疗反应。

Predicting stable treatment response in patients with major depression treated with hypericum extract WS 5570/5572.

作者信息

Kieser M, Szegedi A

机构信息

Dr. Willmar Schwabe Pharmaceuticals, P O Box 410925, 76209 Karlsruhe, Germany.

出版信息

Pharmacopsychiatry. 2005 Sep;38(5):194-200. doi: 10.1055/s-2005-873153.

DOI:10.1055/s-2005-873153

PMID:16189745

Abstract

OBJECTIVE

Recent research with several synthetic antidepressants indicates that early improvement during the initial weeks of treatment may be a highly sensitive predictor of therapeutic success in major depression. We investigated whether early improvement is sensitive and specific in predicting sustained response and non-response to antidepressant treatment with Hypericum extract WS(R) 5570/5572 and whether the results reported for synthetic antidepressants apply to these Hypericum extracts as well.

METHODS

We analyzed original data of 3 double-blind, randomized trials including a total of 594 adult out-patients suffering from major depression according to DSM-IV criteria, who received well-characterized Hypericum extract preparations WS(R) 5570, WS(R) 5572, WS(R) 5573 or placebo for 6 weeks. The main outcome measure was the prediction of a sustained > or = 50 % decrease of the Hamilton Depression Scale (HAM-D) total score versus baseline ('sustained response') by the presence of > or =20 % HAM-D total score improvement after 1 and 2 weeks of treatment ('early improvement').

RESULTS

For Hypericum extract, early improvement had a sensitivity of 87 % (95 % confidence interval [CI], 82-93 %) and a specificity of 54 % (95 % CI, 45-62 %) at day 14, and a sensitivity of 43 % (95 % CI, 35-51 %) and a specificity of 86 % (95 % CI, 80-92 %) at day 7 for predicting sustained response. After 2 weeks of treatment, 78 % (95 % CI, 69-87 %) of the patients who failed to improve did not show sustained response later during treatment.

CONCLUSION

A substantial fraction of the patients treated with Hypericum extracts WS(R) 5570/5572 showed a meaningful reduction of depressive symptoms during the first two weeks of treatment (early improvement), which was found to be a sensitive predictor of sustained response. The results determined for the herbal extracts were comparable to those for effective synthetic antidepressants investigated previously.

摘要

目的

近期对几种合成抗抑郁药的研究表明，治疗最初几周内的早期改善可能是重度抑郁症治疗成功的高度敏感预测指标。我们调查了早期改善对于预测金丝桃提取物WS(R) 5570/5572抗抑郁治疗的持续反应和无反应是否敏感且特异，以及合成抗抑郁药的相关研究结果是否也适用于这些金丝桃提取物。

方法

我们分析了3项双盲、随机试验的原始数据，这些试验共纳入了594名符合DSM-IV标准的成年门诊重度抑郁症患者，他们接受了特征明确的金丝桃提取物制剂WS(R) 5570、WS(R) 5572、WS(R) 5573或安慰剂治疗6周。主要结局指标是通过治疗1周和2周后汉密尔顿抑郁量表（HAM-D）总分改善≥20%（“早期改善”）来预测HAM-D总分较基线持续降低≥50%（“持续反应”）。

结果

对于金丝桃提取物，在第14天，早期改善预测持续反应的敏感性为87%（95%置信区间[CI]，82 - 93%），特异性为54%（95% CI，45 - 62%）；在第7天，敏感性为43%（95% CI，35 - 51%），特异性为86%（95% CI，80 - 92%）。治疗2周后，未改善的患者中有78%（95% CI，69 - 87%）在后续治疗中未出现持续反应。