Bouza Carmen, López Teresa, Magro Angeles, Navalpotro Lourdes, Amate José María
Agency for Health Technology Assessment, Ministry of Health & Consumers Affairs, Sinesio Delgado 4, 28029 Madrid, Spain.
BMC Urol. 2006 Jun 21;6:14. doi: 10.1186/1471-2490-6-14.
Benign prostatic hyperplasia (BPH) constitutes a major clinical problem. Minimally invasive therapies for the treatment of symptomatic BPH include Transurethral Needle Ablation (TUNA), but it is unclear what impact this technique has on the disease and its role among other currently available therapeutic options. The objective of this study is to ascertain the efficacy and safety of TUNA in the treatment of BPH.
Systematic review of the literature until January 2005 and meta-analysis of clinical studies assessing TUNA in symptomatic BPH. Studies were critically appraised. Estimates of effect were calculated according to the random-effects model.
35 studies (9 comparative, 26 non-comparative) were included. Although evidence was limited by methodological issues, the analysis of relevant outcomes indicates that while TUNA significantly improves BPH parameters with respect to baseline, it does not reach the same level of efficacy as TURP in respect to all subjective and objective variables. Further, its efficacy declines in the long-term with a rate of secondary-treatment significantly higher than of TURP [OR: 7.44 (2.47, 22.43)]. Conversely, TUNA seems to be a relatively safe technique and shows a lower rate of complications than TURP [OR:0.14 (0.05, 0.14)] with differences being particularly noteworthy in terms of postoperative bleeding and sexual disorders. Likewise, TUNA has fewer anesthetic requirements and generates a shorter hospital stay than TURP [WMD: -1.9 days (-2.75, -1.05)]. Scarce data and lack of replication of comparisons hinder the assessment of TUNA vs. other local therapies. No comparisons with medical treatment were found.
The body of evidence on which TUNA has been introduced into clinical practice is of only moderate-low quality. Available evidence suggest that TUNA is a relatively effective and safe technique that may eventually prove to have a role in selected patients with symptomatic BPH. TUNA significantly improves BPH parameters with respect to baseline values, but it does not reach the same level of efficacy and long-lasting success as TURP. On the other hand, TUNA seems to be superior to TURP in terms of associated morbidity, anesthetic requirements and length of hospital stay. With respect to the role of TUNA vis-à-vis other minimally invasive therapies, the results of this review indicate that there are insufficient data to define this with any degree of accuracy. Overall cost-effectiveness and the role of TUNA versus medical treatment need further evaluation.
良性前列腺增生(BPH)是一个主要的临床问题。治疗有症状BPH的微创疗法包括经尿道针刺消融术(TUNA),但尚不清楚该技术对疾病有何影响以及它在其他现有治疗选择中的作用。本研究的目的是确定TUNA治疗BPH的疗效和安全性。
对截至2005年1月的文献进行系统综述,并对评估TUNA治疗有症状BPH的临床研究进行荟萃分析。对研究进行严格评价。根据随机效应模型计算效应估计值。
纳入35项研究(9项比较性研究,26项非比较性研究)。尽管证据受到方法学问题的限制,但对相关结果的分析表明,虽然TUNA相对于基线显著改善了BPH参数,但在所有主观和客观变量方面,其疗效未达到经尿道前列腺切除术(TURP)的水平。此外,其长期疗效下降,二次治疗率显著高于TURP [比值比(OR):7.44(2.47,22.43)]。相反,TUNA似乎是一种相对安全的技术,并发症发生率低于TURP [OR:0.14(0.05, 0.14)],在术后出血和性功能障碍方面的差异尤为显著。同样,与TURP相比,TUNA的麻醉需求更少,住院时间更短 [加权均数差(WMD):-1.9天(-2.75,-1.05)]。数据稀缺以及缺乏对照研究的重复阻碍了对TUNA与其他局部治疗方法的评估。未找到与药物治疗的比较。
将TUNA引入临床实践所依据的证据质量仅为中低水平。现有证据表明,TUNA是一种相对有效且安全的技术,最终可能被证明在某些有症状BPH患者中发挥作用。TUNA相对于基线值显著改善了BPH参数,但其疗效和长期成功率未达到TURP的水平。另一方面,TUNA在相关发病率、麻醉需求和住院时间方面似乎优于TURP。关于TUNA相对于其他微创疗法的作用,本综述结果表明,尚无足够数据准确界定这一点。总体成本效益以及TUNA与药物治疗的比较需要进一步评估。