一项前瞻性、观察性分组分析，旨在评估曲普瑞林对晚期前列腺癌患者下尿路症状的影响。
A prospective, observational grouped analysis to evaluate the effect of triptorelin on lower urinary tract symptoms in patients with advanced prostate cancer.
机构信息
Department of Urology, Institute Jules Bordet - Université Libre de Bruxelles, Brussels, Belgium.
Ipsen Pharma, Paris, France.
出版信息
Ther Adv Urol. 2015 Jun;7(3):116-24. doi: 10.1177/1756287215574480.
OBJECTIVES
Few studies have assessed the effect of gonadotropin-releasing hormone (GnRH) agonists, such as triptorelin, on lower urinary tract symptoms (LUTS) in patients with advanced prostate cancer. Therefore, multiple, national observational, noninterventional studies were initiated to assess the effectiveness of triptorelin in reducing moderate or severe LUTS [International Prostate Symptom Score (IPSS) >7] in men with prostate cancer starting triptorelin therapy in clinical practice.
METHODS
Prospective, noninterventional, multicentre studies of LUTS located in Algeria, Belgium, China, Hungary, Romania and South Korea, in patients who were scheduled to receive triptorelin (3-month extended release or 1-month formulation) in clinical practice. The primary effectiveness endpoint was the proportion of patients with moderate or severe LUTS after 48 weeks as assessed by IPSS. Secondary endpoints included the distribution of IPSS categories, total IPSS and prostate-specific antigen (PSA) levels at baseline, 24 and 48 weeks.
RESULTS
In total, 2461 patients were recruited in the studies; 1282 patients had moderate or severe LUTS at baseline (IPSS > 7), received triptorelin and had follow-up IPSS. Mean total IPSS was reduced from 18.2 [95% confidence interval (CI) 17.8-18.5] at baseline to 11.9 (95% CI 11.5-12.3; p < 0.001) and 10.6 (95% CI 10.2-11.0; p < 0.001) at weeks 24 and 48, respectively. Mean PSA levels were reduced from 117.9 ng/ml (95% CI 93.8-141.9) at baseline to 8.5 ng/ml (95% CI 5.2-11.7) and 16.6 ng/ml (95% CI 7.4-25.8) at weeks 24 and 48, respectively. There was a significant correlation between total IPSS change from baseline and PSA change from baseline at weeks 24 and 48 (ρ = 0.3 and 0.2, p < 0.001).
CONCLUSIONS
The improvement in LUTS in men with locally advanced or metastatic prostate cancer after 24-48 weeks suggests that triptorelin is effective in improving LUTS in this subgroup of patients.
目的
很少有研究评估促性腺激素释放激素（GnRH）激动剂（如曲普瑞林）对晚期前列腺癌患者下尿路症状（LUTS）的影响。因此，开展了多项全国性、非干预性、观察性研究，以评估曲普瑞林在临床实践中降低开始曲普瑞林治疗的前列腺癌患者中中重度 LUTS（国际前列腺症状评分（IPSS）>7）的有效性。
方法
这些位于阿尔及利亚、比利时、中国、匈牙利、罗马尼亚和韩国的前瞻性、非干预性、多中心 LUTS 研究纳入了计划在临床实践中接受曲普瑞林（3 个月延长释放或 1 个月制剂）治疗的患者。主要有效性终点是通过 IPSS 评估的 48 周后中重度 LUTS 患者的比例。次要终点包括基线时、24 周和 48 周时 IPSS 类别分布、总 IPSS 和前列腺特异性抗原（PSA）水平。
结果
研究共纳入 2461 例患者；1282 例基线时（IPSS>7）有中重度 LUTS，接受了曲普瑞林治疗并随访了 IPSS。总 IPSS 从基线时的 18.2[95%置信区间（CI）17.8-18.5]降至 24 周时的 11.9（95%CI 11.5-12.3；p<0.001）和 48 周时的 10.6（95%CI 10.2-11.0；p<0.001）。PSA 水平从基线时的 117.9ng/ml（95%CI 93.8-141.9）降至 24 周时的 8.5ng/ml（95%CI 5.2-11.7）和 48 周时的 16.6ng/ml（95%CI 7.4-25.8）。24 周和 48 周时，总 IPSS 从基线的变化与 PSA 从基线的变化之间呈显著相关性（ρ=0.3 和 0.2，p<0.001）。
结论
在 24-48 周后，局部晚期或转移性前列腺癌男性的 LUTS 得到改善，表明曲普瑞林在这一亚组患者中可有效改善 LUTS。
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