关键词: 下尿路症状, 勃起功能障碍, 他达拉非, 坦索罗辛, Meta分析, 系统评价

Abstract: Background　Tamsulosin and tadalafil（TAD）have been widely used for the treatment of lower urinary tract symptoms（LUTS）and erectile dysfunction（ED）．However，the efficacy and safety of the combination therapy of these two medicines for LUTS and ED in men is still controversial．Objective　To systematically investigate the efficacy and safety of TAD plus tamsulosin compared with TAD monotherapy in treating men with LUTS and ED．Methods　PubMed，EMBase，Cochrane Central Register of Controlled Trials，SinoMed，CNKI，WanFang Data Service Platform，and CQVIP databases were searched extensively from inception to February 29，2020 to obtain eligible studies comparing the efficacy and safety of TAD plus tamsulosin and TAD monotherapy in treating men with LUTS and ED．Data were extracted，such as the name（s）of the first author（s），year of publication，geographical location（country）of the research setting，types of research，sample size，age and BMI of the subjects，interventions，dosage，follow-up time and outcome indicators 〔total International Prostate Symptom Score（IPSS）score，IPSS storage subscore，IPSS voiding subscore，quality of life score，maximum urinary flow rate，post-void residual urine volume and International Index of Erectile Function-5（IIEF-5）score〕，incidence of adverse events（including total incidence of adverse events，incidence of headache，myalgia，back pain，dizziness，nasopharyngitis and ejaculation dysfunction），and rate of treatment discontinuation due to adverse events．Revman 5.3.0 was used for data evaluation and statistical analysis．Results　Six studies were included，all were assessed with high methodological quality，involving 776 cases，394 in the combination group and 382 in the TAD group．The results of the meta-analysis indicated that compared with the TAD group，the combination group obtained more benefits from treatment in aspects of total IPSS score 〔MD=-2.67，95%CI（-3.82，-1.50），P<0.001〕，IPSS storage subscore 〔MD=-0.55，95%CI（-0.85，-0.26），P=0.000 2〕，IPSS voiding subscore 〔MD=-0.97，95%CI（-1.43，-0.51），P<0.001〕，quality of life score 〔MD=-0.37，95%CI（-0.51，-0.23），P<0.001〕，and maximum urinary flow rate 〔MD=1.45，95%CI（0.90，1.99），P<0.000 01〕．However，there were no significant differences in post-void residual urine volume 〔MD=-4.22，95%CI（-12.82，4.39），P=0.34〕，IIEF-5 score 〔MD=0.44，95%CI（-0.23，1.11），P=0.19〕，the incidence of adverse events 〔OR=1.43，95%CI（0.98，2.08），P=0.06〕，the incidence of headache 〔OR=1.34，95%CI（0.66，2.72），P=0.42〕，myalgia 〔OR=1.56，95%CI（0.64，3.82），P=0.33〕，back pain 〔OR=1.45，95%CI（0.40，5.22），P=0.57〕，dizziness 〔OR=1.14，95%CI（0.27，4.76），P=0.86〕，nasopharyngitis 〔OR=0.47，95%CI（0.10，2.21），P=0.34〕，ejaculatory dysfunction 〔OR=3.81，95%CI（0.44，32.97），P=0.22〕，and the rate of treatment discontinuation due to adverse events 〔OR=1.44，95%CI（0.88，2.35），P=0.15〕 between the two groups．Conclusion　Both therapies have similar beneficial effects on ED and similar safety，but the combination of TAD plus tamsulosin is more effective for the improvement of the LUTS．Hence，the combination therapy may be recommended as a suitable option for men with both LUTS and ED．However，due to limited evidence，high-quality randomized controlled trials are required to further confirm these findings．

Key words: Lower urinary tract symptoms, Erectile dysfunction, Tadalafil, Tamsulosin, Meta-analysis, Systematic review