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教育、药物治疗及支持对患者预后的影响:一项关于文拉法辛缓释剂治疗重度抑郁症门诊患者的研究

Patient outcomes with education, drug therapy, and support: a study of venlafaxine ER-treated outpatients with major depressive disorder.

作者信息

Lobello Kasia, Reddy Sujana, Musgnung Jeff, Pedersen Ronald, Ninan Philip T

机构信息

Pfizer Inc, Collegeville, PA, USA.

出版信息

Psychopharmacol Bull. 2010;43(2):28-44.

Abstract

OBJECTIVE

Dialogues Time to Talk (Dialogues) is a care management program that provides additional follow-up care and patient education for outpatients with major depressive disorder (MDD) starting venlafaxine extended release (ER) therapy. This study examined the effect of the Dialogues program on patient treatment satisfaction.

METHODS

In this 6-month, open-label study, primary care patients with MDD received usual care and were randomly assigned to venlafaxine ER (75 to 225 mg/d) either alone or in combination with the Dialogues program (venlafaxine ER + D). The primary outcome was patient treatment satisfaction on day 112, measured by the 10- point Satisfaction with Depression Care Scale (SDCS). Secondary efficacy outcomes included the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score, response (≥50% decrease from baseline HAM-D17 score), and remission (HAM-D17 ≤ 7).

RESULTS

The modified intent-to-treat population included 263 patients in the venlafaxine ER group and 257 in the venlafaxine ER+D group. The percentage of patients with an SDCS "very satisfied" score (≥8) at day 112 was not significantly different in the venlafaxine ER and venlafaxine ER+D groups (63% and 58%, respectively; P = 0.22). No significant differences were found on any secondary outcomes.

CONCLUSION

Among primary care patients starting venlafaxine ER for MDD, participation in the Dialogues program did not have a statistically significant effect on patient treatment satisfaction.

摘要

目的

“对话:交流时间”(Dialogues)是一项护理管理项目,为开始接受文拉法辛缓释(ER)治疗的重度抑郁症(MDD)门诊患者提供额外的随访护理和患者教育。本研究考察了Dialogues项目对患者治疗满意度的影响。

方法

在这项为期6个月的开放标签研究中,患有MDD的初级护理患者接受常规护理,并被随机分配单独接受文拉法辛ER(75至225毫克/天)治疗或联合Dialogues项目(文拉法辛ER + D)治疗。主要结局是在第112天的患者治疗满意度,通过10分制的抑郁护理满意度量表(SDCS)进行测量。次要疗效结局包括17项汉密尔顿抑郁评定量表(HAM-D17)总分、反应(HAM-D17评分较基线降低≥50%)和缓解(HAM-D17≤7)。

结果

改良意向性治疗人群包括文拉法辛ER组的263例患者和文拉法辛ER + D组的257例患者。在第112天,SDCS“非常满意”评分(≥8)的患者百分比在文拉法辛ER组和文拉法辛ER + D组中无显著差异(分别为63%和58%;P = 0.22)。在任何次要结局上均未发现显著差异。

结论

在开始使用文拉法辛ER治疗MDD的初级护理患者中,参与Dialogues项目对患者治疗满意度没有统计学上的显著影响。

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