Azis Abdul, Syarif Syarif, Makkaraka Moh Anfasa Giffari, Zainal Ahmad Taufik Fadillah, Rahmat Saidah, Fakhri Muhammad
Urology Division of Surgery Department, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia.
Hasanuddin University Teaching Hospital, Makassar, Indonesia.
Cent European J Urol. 2025;78(2):165-176. doi: 10.5173/ceju.2024.0219. Epub 2025 May 7.
Over the last few years, trends in managing benign prostatic hyperplasia (BPH) have improved, advancing from reliance on surgery to satisfactory medical therapies. However, the efficacy and safety of combination therapies, including silodosin and tadalafil, are not well established compared to monotherapy for treating lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO).
A systematic search was conducted in PubMed, ScienceDirect, Cochrane Library, and Scopus up to April 1, 2024. The quality of the studies was assessed using The Cochrane Risk of Bias (RoB) Tools 2 and Risk of Bias in Non-randomized Studies of Exposures (ROBINS-E). Meta-analysis was conducted using RevMan 5.4.
A total of 1,300 records were screened, resulting in 7 final studies. Our meta-analyses showed that international prostate symptom score (IPSS), maximum urine flow rate (Q), and post-void residual volume (PVR) led to considerably greater improvements with the combination of silodosin and tadalafil compared to using either as monotherapy. However, combination therapy notably exhibited higher rates of adverse events (AE). On the other hand, as monotherapy, silodosin demonstrated a statistically significant improvement in Q (p = 0.006) and PVR (p = 0.02) over tadalafil but with higher rates of total AE, discontinuation, and risk of retrograde ejaculation.
Silodosin and tadalafil are effective for treating LUTS in men due to BPO, especially when used in combination. However, with concerns about safety, tadalafil as monotherapy offers an advantage for patients with fertility desires due to its favorable side effect profile.
在过去几年中，良性前列腺增生（BPH）的管理趋势有所改善，从依赖手术发展到令人满意的药物治疗。然而，与用于治疗良性前列腺梗阻（BPO）引起的下尿路症状（LUTS）的单一疗法相比，包括西洛多辛和他达拉非在内的联合疗法的疗效和安全性尚未得到充分证实。
截至2024年4月1日，在PubMed、ScienceDirect、Cochrane图书馆和Scopus中进行了系统检索。使用Cochrane偏倚风险（RoB）工具2和暴露非随机研究中的偏倚风险（ROBINS-E）评估研究质量。使用RevMan 5.4进行荟萃分析。
共筛选了1300条记录，最终纳入7项研究。我们的荟萃分析表明，与单一疗法相比，西洛多辛和他达拉非联合使用在国际前列腺症状评分（IPSS）、最大尿流率（Q）和排尿后残余尿量（PVR）方面有显著更大的改善。然而，联合治疗的不良事件（AE）发生率明显更高。另一方面，作为单一疗法，西洛多辛在Q（p = 0.006）和PVR（p = 0.02）方面比他达拉非有统计学显著改善，但总AE、停药和逆行射精风险更高。
西洛多辛和他达拉非对治疗男性因BPO引起的LUTS有效，尤其是联合使用时。然而，出于安全性考虑，他达拉非作为单一疗法因其良好的副作用谱为有生育愿望的患者提供了优势。
