Zhang H L, Huang Z G, Qiu Y, Cheng X, Zou X Q, Liu T T
Department of Pharmacy, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Department of Pharmacy, Women &Infants Hospital of Zhengzhou, Zhengzhou, China.
Int J Impot Res. 2017 Jul;29(4):148-156. doi: 10.1038/ijir.2017.12. Epub 2017 Apr 20.
Tamsulosin has been used for the off-label treatment of lower urinary tract symptoms (LUTS) in women. Over the past few years, several randomized controlled trials (RCTs) have reported the clinical effectiveness and safety of tamsulosin for LUTS in women. Therefore, the aim of the present study was to perform a meta-analysis to evaluate the safety and efficacy of tamsulosin in treating LUTS in women, which may resolve some of the current controversies over use of the drug and provide more reliable evidence for the use of tamsulosin. A literature review was performed to identify all published RCTs of tamsulosin for the treatment of LUTS in women. The search included the following databases: PUBMED, EMBASE, the Cochrane Controlled Trail Register of Controlled Trials, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Chinese Science and Technique Journals Database (VIP) and Wanfang Database. A systematic review and meta-analysis were conducted. Six RCTs studies involving 764 female participants were included in the analysis. Four out of the six RCTs compared tamsulosin with placebo, one RCT compared tamsulosin with prazosin and the other study compared tamsulosin with tamsulosin combined with tolterodine. Two RCTs evaluated total International Prostate Symptom Score (IPSS) and improved total IPSS compared with the placebo (standardized mean difference=-4.08, 95% confidence interval=-5.93 to -2.23, P<0.00001). IPSS (storage symptom score), IPSS (voiding symptom score) and quality-of-life score also showed the similar effects. In addition, tamsulosin improved the Overactive Bladder Questionnaire score when compared with placebo in only one RCT. For urodynamic parameters, tamsulosin improved the average flow rate and the post-void residual volume when compared with prazosin and tolterodine combined with tamsulosin, respectively. Beyond that, the other parameters showed no significant difference between the treatment and control groups. On the basis of the present evidence, tamsulosin is an effective treatment for the relief of LUTS in women when compared with placebo. However, the safety of the tamsulosin remains unknown. Further, well-conducted trials that examine long-term outcomes are required.
坦索罗辛已被用于女性下尿路症状（LUTS）的非标签治疗。在过去几年中，多项随机对照试验（RCT）报告了坦索罗辛治疗女性LUTS的临床有效性和安全性。因此，本研究的目的是进行一项荟萃分析，以评估坦索罗辛治疗女性LUTS的安全性和疗效，这可能解决目前关于该药物使用的一些争议，并为坦索罗辛的使用提供更可靠的证据。进行了文献综述，以确定所有已发表的关于坦索罗辛治疗女性LUTS的RCT。检索包括以下数据库：PUBMED、EMBASE、Cochrane对照试验注册库、中国生物医学文献数据库、中国知网、维普中文科技期刊数据库和万方数据库。进行了系统评价和荟萃分析。分析纳入了6项涉及764名女性参与者的RCT研究。6项RCT中有4项将坦索罗辛与安慰剂进行比较，1项RCT将坦索罗辛与哌唑嗪进行比较，另一项研究将坦索罗辛与坦索罗辛联合托特罗定进行比较。2项RCT评估了总国际前列腺症状评分（IPSS），与安慰剂相比，总IPSS有所改善（标准化平均差=-4.08，95%置信区间=-5.93至-2.23，P<0.00001）。IPSS（储尿症状评分）、IPSS（排尿症状评分）和生活质量评分也显示出类似的效果。此外，在仅1项RCT中，与安慰剂相比，坦索罗辛改善了膀胱过度活动症问卷评分。对于尿动力学参数，与哌唑嗪和坦索罗辛联合托特罗定相比，坦索罗辛分别改善了平均尿流率和排尿后残余尿量。除此之外，治疗组和对照组之间的其他参数没有显著差异。基于目前的证据，与安慰剂相比，坦索罗辛是治疗女性LUTS的有效药物。然而，坦索罗辛的安全性仍然未知。此外，需要进行精心设计的试验来研究长期结果。
