Hegarty Josephine, Beirne Paul V, Walsh Ella, Comber Harry, Fitzgerald Tony, Wallace Kazer Meredith
School of Nursing and Midwifery, University College Cork, Brookfield Health Sciences Complex, College Road, Cork, Ireland.
Cochrane Database Syst Rev. 2010 Nov 10(11):CD006590. doi: 10.1002/14651858.CD006590.pub2.
The lack of evidence regarding the effectiveness of treatment options for clinically localised prostate cancer continues to impact on clinical decision-making. Two such options are radical prostatectomy (RP) and watchful waiting (WW). WW involves providing no initial treatment and monitoring the patient with the intention of providing palliative treatment if there is evidence of disease progression.
To compare the beneficial and harmful effects of RP versus WW for the treatment of localised prostate cancer.
MEDLINE, EMBASE, The Cochrane Library, ISI Science Citation Index, DARE and LILACS were searched through 30 July 2010.
Randomised or quasi-randomised controlled trials comparing the effects of RP versus WW for clinically localised prostate cancer.
Data extraction and quality assessment were carried out independently by two authors.
Two trials met the inclusion criteria. Both trials commenced prior to the widespread availability of prostate-specific antigen (PSA) screening; hence the results may not be applicable to men with PSA-detected disease.One trial (N = 142), conducted in the US, was judged to be of poor quality. All cause (overall) mortality was not significantly different between RP and WW groups after fifteen years of follow up (Hazard Ratio (HR) 0.9 (95% Confidence Interval (CI) 0.56 to 1.43).The second trial (N = 695), conducted in Scandinavia, was judged to be of good quality. After 12 years of follow up, the trial results were compatible with a beneficial effect of RP on the risks of overall mortality, prostate cancer mortality and distant metastases compared with WW but the precise magnitude of the effect is uncertain as indicated by the width of the confidence intervals for all estimates (risk difference (RD) -7.1% (95% CI -14.7 to 0.5); RD -5.4% (95% CI -11.1 to 0.2); RD -6.7% (95% CI -13.2 to -0.2), respectively). Compared to WW, RP increased the absolute risks of erectile dysfunction (RD 35% (95% CI 25 to 45)) and urinary leakage (RD 27% (95% CI 17 to 37)). These estimates must be interpreted cautiously as they are derived from data obtained from a self-administered questionnaire survey of a sample of the trial participants (N = 326), no baseline quality of life data were obtained and nerve-sparing surgery was not routinely performed on trial participants undergoing RP.
AUTHORS' CONCLUSIONS: The existing trials provide insufficient evidence to allow confident statements to be made about the relative beneficial and harmful effects of RP and WW for patients with localised prostate cancer. The results of ongoing trials should help to inform treatment decisions for men with screen-detected localised prostate cancer.
关于临床局限性前列腺癌治疗方案有效性的证据不足，这继续影响着临床决策。两种这样的方案是根治性前列腺切除术（RP）和观察等待（WW）。WW包括不进行初始治疗并对患者进行监测，目的是在有疾病进展证据时提供姑息治疗。
比较RP与WW治疗局限性前列腺癌的有益和有害影响。
检索了截至2010年7月30日的MEDLINE、EMBASE、Cochrane图书馆、ISI科学引文索引、DARE和LILACS。
比较RP与WW对临床局限性前列腺癌影响的随机或半随机对照试验。
由两位作者独立进行数据提取和质量评估。
两项试验符合纳入标准。两项试验均在前列腺特异性抗原（PSA）筛查广泛应用之前开始；因此，结果可能不适用于PSA检测出疾病的男性。一项在美国进行的试验（N = 142），质量被判定为较差。随访15年后，RP组和WW组的全因（总体）死亡率无显著差异（风险比（HR）0.9（95%置信区间（CI）0.56至1.43）。第二项试验（N = 695）在斯堪的纳维亚进行，质量被判定为良好。随访12年后，试验结果表明与WW相比，RP对总体死亡率、前列腺癌死亡率和远处转移风险有有益影响，但所有估计值的置信区间较宽，表明确切的影响程度不确定（风险差（RD）-7.1%（95%CI -14.7至0.5）；RD -5.4%（95%CI -11.1至0.2）；RD -6.7%（95%CI -13.2至-0.2））。与WW相比，RP增加了勃起功能障碍（RD 35%（95%CI 25至45））和尿失禁（RD 27%（95%CI 17至37））的绝对风险。这些估计值必须谨慎解释，因为它们来自对试验参与者样本（N = 326）进行的自我管理问卷调查获得的数据，未获得基线生活质量数据，并且在接受RP的试验参与者中未常规进行保留神经的手术。
现有试验提供的证据不足，无法就RP和WW对局限性前列腺癌患者的相对有益和有害影响做出有把握的陈述。正在进行的试验结果应有助于为筛查发现的局限性前列腺癌男性患者的治疗决策提供信息。
