The Clinical Study Of Naftopidil In The Treatment Of Benign Prostatic Hyperplasia

Objectives: To evaluate the clinical efficacy and safety of naftopidil in treating benign prostatic hyperplasia(BPH) and in order to construct the best subtype-selective α₁-AR antagonist in treating BPH.Methods: A randomized, parallel-controlled clinical study was conducted in 72 patients with BPH. Patients of treatment group received naftopidil (25mg, once a day) and the controls received tamsulosin (0.2mg, once a day). Evaluation of the efficacy was done by the changes of the indexes including international prostate symptom score (IPSS), voiding symptoms score, storage symptoms score, maximum urinary flow rate (Qmax) and quality of life (QOL), residual urine (RU) and the clinical adverse event rate.Results: After 4-weeks therapy, IPSS, Qmax, QOL were significantly improved both in naftopidil group and tamsulosin group. In naftopidil group, IPSS was averagely decreased by 10.76 (p<0.001); QOL was averagely decreased by 1.77 (pO.OOl); Qmax was averagely increased by 2.67 ml/s (p<0.001). While in tamsulosin group, IPSS and QOL were decreased by 9.77 (p<0.001) and 1.33 (p<0.001), respectively; Qmax was increased by 2.78ml/s (pO.OOl). There was no significant difference between the two groups (p>0.05). The storage symptom score, the voiding symptom score and RU were decreased by 69.7%, 37.8% and 18.1%, respectively in the naftopidil group; While in the tamsulosin group, they were 37.8%, 54.8% and -3.24%, respectively. But there was significant difference between the two groups (p<0.05 ) . The clinical adverse event rate was 8.3% in naftopidil group, which was significantly lower than that in tamsulosin group (12.5%).Conclusions: Naftopidil was safe and effective in treating BPH. It can improve lower urinary tract symptoms (LUTS) associated with BPH. And naftopidil is more superior in improving the storage symptom than tamsulosin.