Matthys Heinrich, Lizogub Victor G, Funk Petra, Malek Fathi A
Medizinischer Direktor emeritus, Universitätsklinik Freiburg, Freiburg, Germany.
Wien Med Wochenschr. 2010 Dec;160(21-22):564-70. doi: 10.1007/s10354-010-0847-5.
Health-related quality of life (HRQL) and patient-reported outcome (PRO) have become important outcome parameters for the evaluation of medical treatment within clinical trials and, furthermore, to evaluate efficiency in clinical practice. We therefore report further exploratory results of an already reported dose-finding study with EPs 7630 tablets, now focussing on HRQL and PRO. A total of 406 adults with acute bronchitis were randomly assigned to one of four parallel treatment groups (placebo, 30 mg, 60 mg or 90 mg EPs 7630 daily). HRQL and PRO were assessed by questionnaires as secondary outcome measures at each study visit or daily in the patient's diary. At day 7, the patient-reported outcome measures were significantly more improved in all the three EPs 7630 groups compared to placebo (EQ-5D and EQ VAS, SF-12: physical score, impact of patient's sickness, duration of activity limitation, patient-reported treatment outcome, satisfaction with treatment). In conclusion, a statistically significant and clinically relevant improvement of HRQL/PRO compared to placebo was shown in all the three EPs 7630 groups.
健康相关生活质量（HRQL）和患者报告结局（PRO）已成为临床试验中评估医学治疗以及进一步评估临床实践效率的重要结局参数。因此，我们报告一项已报道的关于EPs 7630片剂剂量探索研究的进一步探索性结果，现在重点关注HRQL和PRO。共有406名患有急性支气管炎的成年人被随机分配到四个平行治疗组之一（安慰剂组、每日30毫克、60毫克或90毫克EPs 7630组）。在每次研究访视时或患者日记中每日通过问卷评估HRQL和PRO作为次要结局指标。在第7天，与安慰剂组相比，所有三个EPs 7630组的患者报告结局指标均有显著改善（EQ - 5D和EQ VAS、SF - 12：身体评分、患者疾病影响、活动受限持续时间、患者报告的治疗结局、对治疗的满意度）。总之，所有三个EPs 7630组与安慰剂相比，HRQL/PRO均有统计学显著且临床相关的改善。
