ABSTRACT
Objective To verify the short and medium term effect of dutasteride in the treatment of lower urinary tract symptoms ( LUTS) secondary to benign prostatic hyperplasia( BPH) with prostate volume≥40 ml.Methods One hundred and seven patients diagnosed as BPH accompanying moderate-to-severe LUTS who met the inclusion/exclusion criteria were enrolled from July 2013 to September 2014.After 12 weeks of treatment with dutasteride 0.5 mg/d, the primary outcome was international prostate symptom score (IPSS) change from baseline at Week 12, and the secondary outcome was Quality of Life (QOL) score before and after the treatment, maximun flow rate ( Qmax ) , and the change in residual urine volume. Comparing with baseline, patients with the rate of IPSS decline ≥30% ( effective group) continued taking dutasteride for another 4 weeks then undergoing the prostate volume and PSA measurement.In addition, patients with the rate of IPSS decline <30% were administered combination therapy with dutasteride and tamsulosin (0.2mg/d), their IPSS at Week 16 were compared with that at Week 12, and their prostate volume and PSA level were followed up until Week 20.The prostate volume and PSA changing were followed up.Results Compared with baseline, after 12 weeks of treatment with dutasteride, patients'IPSS decreased 5.54 points ( P <0.01 ) , including 59 patients ( 55.14%) with IPSS decline rate ≥30%, QOL score decreased 1.56 points (P<0.01), Qmax increased 1.07 ml /s (P=0.049), and residual urine decreased 6.46 ml (P=0.107).IPSS declined ≥30% in 42 patients at Week 12, whose prostate volume reduced 14.15%at Week 16 follow-up, with PSA declining of 0.68 ng /ml in 32 tested cases ( P=0.008).IPSS declining <30%in 36 patients at Week 12 was followed up to Week 20, and their prostate volume reduced 11.89%, with PSA declining of 0.18 ng/ml ( P=0.589) in 33 tested patients.Conclusions Dutasteride can improve the lower urinary tract symptom in patients who are diagnosed as BPH accompanying moderate-to-severe LUTS with prostate volume ≥ 40 ml significantly.Tamsulosin add-on treatment benefited most patients.