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首页> 外文期刊>The journal of sexual medicine >Validity of the patient-reported Clinical Global Impression of Change as a measure of treatment response in men with premature ejaculation.
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Validity of the patient-reported Clinical Global Impression of Change as a measure of treatment response in men with premature ejaculation.

机译：患者报告的临床总体变化印象作为早泄男性治疗反应的量度的有效性。

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INTRODUCTION: The Clinical Global Impression of Change (CGIC) measures have high utility in clinical practice. However, it is unknown whether the CGIC is valued for assessing premature ejaculation (PE) symptoms and/or the relationship between CGIC and other validated PE patient-reported measures. AIM: The study aims to assess the validity of the patient-reported CGIC measure in men with PE and to examine the relationship between CGIC ratings and assessments of control, satisfaction, personal distress, and interpersonal difficulty. METHODS: Data from a randomized, double-blind, 24-week phase 3 trial in 1,162 men with PE who received dapoxetine (30 mg or 60 mg) or placebo on demand provided the basis for the analysis. Patients were >/=18 years, in a stable monogamous relationship for >/=6 months, met the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision criteria for PE for >/=6 months, and had an intravaginal ejaculatory latency time (IELT) /=75% of intercourse episodes. MAIN OUTCOME MEASURES: The CGIC asked patients to rate improvement or worsening of their PE compared with the start of the study using a 7-point response scale; other patient-reported measures were control over ejaculation, satisfaction with sexual intercourse, interpersonal difficulty, and personal distress related to ejaculation. Stopwatch-measured IELT was recorded. Associations between CGIC and change in other measures at study end point were assessed. RESULTS: The magnitude of IELT increased for each category of improvement on the CGIC: 1.63, 4.03, and 7.15 minutes for slightly better, better, and much better, respectively. Higher CGIC ratings were correlated with greater improvement in control (r = 0.73), satisfaction (r = 0.62), greater reduction in distress (r = -0.52), and interpersonal difficulty (r = -0.39). Total variance accounted for was 57.4%: control (48.7%), satisfaction (4.5%), IELT (2.8%), and distress (1.15%). CONCLUSIONS: The analyses support the validity of the CGIC measure in men with PE. The CGIC can provide clinicians in practice with a valid and brief outcome assessment of their patient's condition.
机译：简介：临床整体变化印象（CGIC）措施在临床实践中具有很高的实用性。但是，尚不清楚CGIC是否可用于评估早泄（PE）症状和/或CGIC与其他经过验证的PE患者报告的措施之间的关系。目的：该研究旨在评估患者报告的CGIC措施在PE男性中的有效性，并检查CGIC评分与控制，满意度，个人困扰和人际关系困难评估之间的关系。方法：来自一项随机，双盲，为期24周的3期临床试验，该试验在1,162名按需接受达泊西汀（30 mg或60 mg）或安慰剂的PE男性患者中进行了分析，为分析提供了基础。患者≥18岁，一夫一妻关系稳定，≥6个月，符合《精神障碍诊断和统计手册》-第四版-PE文本修订标准≥6个月，并且有阴道内射精延迟时间（IELT） / = 75％。主要观察指标：CGIC要求患者使用7点反应量表评估与研究开始相比其PE的改善或恶化。患者报告的其他措施包括控制射精，对性交的满意度，人际交往困难以及与射精有关的个人困扰。记录秒表测量的IELT。在研究终点评估了CGIC与其他措施变化之间的关联。结果：CGLT上每种改进类别的IELT幅度都增加了：分别为1.63、4.03和7.15分钟，分别略好，更好和好得多。较高的CGIC评分与控制能力的改善（r = 0.73），满意度的改善（r = 0.62），痛苦的减轻程度（r = -0.52）和人际交往困难（r = -0.39）相关。总方差占57.4％：对照（48.7％），满意度（4.5％），雅思（2.8％）和困扰（1.15％）。结论：这些分析支持CGIC措施在PE男性中的有效性。 CGIC可以为实践中的临床医生提供对其患者状况的有效且简短的结果评估。

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