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我们能否利用基线特征来评估哪些有进展风险的中度症状性良性前列腺增生男性患者将从治疗中获益?一项对来自为期2年的CONDUCT研究数据的事后分析。

Can we use baseline characteristics to assess which men with moderately symptomatic benign prostatic hyperplasia at risk of progression will benefit from treatment? A post hoc analysis of data from the 2-year CONDUCT study.

作者信息

Roehrborn Claus G, Oyarzabal Perez Igor, Roos Erik P M, Calomfirescu Nicolae, Brotherton Betsy, Palacios Juan Manuel, Vasylyev Averyan, Manyak Michael J

机构信息

Department of Urology, UT Southwestern Medical Center, 5323 Harry Hines Blvd, J8 142, Dallas, TX, 75390-9110, USA.

Department of Urology, Mendaro Hospital, Mendaro, Gipuzkoa, Spain.

出版信息

World J Urol. 2017 Mar;35(3):421-427. doi: 10.1007/s00345-016-1884-5. Epub 2016 Jun 22.

Abstract

PURPOSE

To investigate (in a post hoc analysis of the 2-year CONDUCT study) the characteristics and clinical outcomes of men with moderately symptomatic benign prostatic hyperplasia (BPH) at risk of progression who benefitted from lifestyle changes alone.

METHODS

Patients were given lifestyle advice and randomized to a fixed-dose combination (FDC) of dutasteride and tamsulosin or watchful waiting (WW) and followed for 24 months. Patients in the WW group were escalated to tamsulosin if any follow-up International Prostate Symptom Score (IPSS) was equal or greater than the baseline value. Improvements in symptoms (change in IPSS) and quality of life [measured by BPH Impact Index (BII) and question 8 of the IPSS (IPSS-Q8)] were analysed in the FDC group, men who initiated tamsulosin (WW-TAM) and men who received no medical intervention (WW-no treatment) and the impact of baseline variables on IPSS determined.

RESULTS

The adjusted mean decrease in IPSS, BII and IPSS-Q8 at each post-baseline visit over 24 months appeared greater in the FDC (n = 369) and WW-no treatment groups (n = 144) than in the WW-TAM group (n = 229). IPSS improvements appeared similar in the FDC group and WW-no treatment subgroup, except in patients with the greatest degree of bother at baseline (BII 7-13).

CONCLUSION

BII at baseline may be a more relevant indicator than symptom severity as to whether a patient with moderate symptoms should receive medical therapy or not.

摘要

目的

(在一项针对2年CONDUCT研究的事后分析中)调查仅通过生活方式改变受益的有疾病进展风险的中度症状性良性前列腺增生(BPH)男性的特征和临床结局。

方法

给予患者生活方式建议,并随机分为度他雄胺和坦索罗辛固定剂量组合(FDC)组或观察等待(WW)组,随访24个月。如果WW组患者的任何一次随访国际前列腺症状评分(IPSS)等于或高于基线值,则升级为坦索罗辛治疗。分析FDC组、开始使用坦索罗辛的男性(WW-TAM)和未接受药物干预的男性(WW-未治疗)的症状改善情况(IPSS变化)和生活质量[通过BPH影响指数(BII)和IPSS的问题8(IPSS-Q8)测量],并确定基线变量对IPSS的影响。

结果

在24个月的每次基线后随访中,FDC组(n = 369)和WW-未治疗组(n = 144)的IPSS、BII和IPSS-Q8调整后平均下降幅度似乎大于WW-TAM组(n = 229)。FDC组和WW-未治疗亚组的IPSS改善情况相似,但基线时困扰程度最高的患者(BII 7-13)除外。

结论

对于中度症状患者是否应接受药物治疗,基线BII可能比症状严重程度更具相关性指标。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1716/5332489/80434791e25e/345_2016_1884_Fig1_HTML.jpg

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