Lukacs B, Leplège A, Thibault P, Jardin A
Department of Urology, Tenon Hospital, Paris, France.
Urology. 1996 Nov;48(5):731-40. doi: 10.1016/S0090-4295(96)00302-0.
To investigate in men with benign prostatic hyperplasia (BPH) treated in the general practitioner setting (1) the magnitude and durability of symptom score improvement with alfuzosin; (2) the effect on patients perceived health-related quality of life (HRQL) and sexuality, (3) adverse outcomes and treatment failure; and (4) progression to acute urinary retention and prostate surgery.
A large, open outcome study was undertaken in the general practitioner setting in France, and a cohort of men with symptomatic BPH who received alfuzosin for 12 months was established. A total of 5849 patients (mean age 66.7 years) were enrolled by 1508 general practitioners in France. Men were examined at baseline and at 3 months, 6 months, and 1 year. To produce standardized outcome measures of disease-specific health status, under the conditions of routine care in the community, patients in the study completed a self-administered symptom questionnaire (score range 0 to 40) and a new, validated BPH-specific HRQL questionnaire (score range 0 to 200). Questionnaires were completed at baseline and during follow-up at 3, 6, and 12 months.
Alfuzosin was effective in reducing symptoms; 98% (420) of severely and 85% (2479) of moderately symptomatic patients experienced improvement. At 3 months, the global symptom score was reduced by 9.49 +/- 0.08 (-53%), and this reduction persisted for the remainder of the study (-9.76 +/- 0.11). In contrast to the global reduction of symptom scores, there was a time-dependent improvement (+18.41 +/- 0.32 [+30%], +18.45 +/- 0.54 [+37%], and +23.42 +/- 0.57 [+43%] at 3, 6, and 12 months, respectively), in patients' perception of HRQL status. The magnitude of the improvement in HROL status was significantly more pronounced for those patients who had moderate or severe nocturia and daytime frequency at baseline than for those who had mild levels of the same symptoms. Sexuality score at baseline was significantly related to age and was significantly (P < 0.0001) higher in patients less than 70 years old than in older patients. Improvement in patients' perceived sexuality was significant at 12 months (P < 0.0001) and was correlated with age.
The results of this large cohort study demonstrate the effectiveness of alfuzosin in reducing symptom severity and improving HRQL status over a 12-month period in men with BPH. It also suggests that HQRL and symptom severity are different and complementary entities. The results of the present study highlight the improvement in HRQL and patients' perceived sexuality that can be achieved in symptomatic patients with BPH receiving a 12-month course of alfuzosin therapy.
在全科医生诊所接受治疗的良性前列腺增生（BPH）男性患者中，研究（1）阿夫唑嗪治疗后症状评分改善的幅度和持久性；（2）对患者感知的健康相关生活质量（HRQL）和性功能的影响；（3）不良结局和治疗失败情况；以及（4）急性尿潴留和前列腺手术的进展情况。
在法国的全科医生诊所进行了一项大型开放性结局研究，建立了一组接受阿夫唑嗪治疗12个月的有症状BPH男性患者队列。法国的1508名全科医生共招募了5849名患者（平均年龄66.7岁）。在基线、3个月、6个月和1年时对男性患者进行检查。为了在社区常规护理条件下产生针对特定疾病健康状况的标准化结局指标，研究中的患者完成了一份自我管理的症状问卷（评分范围0至40）和一份新的、经过验证的BPH特异性HRQL问卷（评分范围0至200）。问卷在基线以及随访的3个月、6个月和12个月时完成。
阿夫唑嗪在减轻症状方面有效；98%（420例）重度症状患者和85%（2479例）中度症状患者症状得到改善。在3个月时，总体症状评分降低了9.49±0.08（-53%），并且在研究的剩余时间内持续降低（-9.76±0.11）。与总体症状评分降低相反，患者对HRQL状况的感知有随时间的改善（分别在3个月、6个月和12个月时为+18.41±0.32[+30%]、+18.45±0.54[+37%]和+23.42±0.57[+43%]）。对于那些在基线时有中度或重度夜尿症和日间尿频的患者，HRQL状况改善的幅度明显比对那些有相同症状轻度水平的患者更为显著。基线时的性功能评分与年龄显著相关，并且70岁以下患者的评分显著高于（P<0.0001）老年患者。患者对性功能的改善在12个月时显著（P<0.0001），并且与年龄相关。
这项大型队列研究的结果表明，阿夫唑嗪在12个月期间对减轻BPH男性患者的症状严重程度和改善HRQL状况有效。这也表明HRQL和症状严重程度是不同且互补的实体。本研究结果突出了接受12个月阿夫唑嗪治疗疗程的有症状BPH患者在HRQL和患者感知的性功能方面的改善。
