Gao Zhong-Wei, Xin Shi-Yong, Zhang Jian-Guo, Ren Xiao-Qiang, Shang Ya-Feng, Zhang Wei, Li Hui-Bing, Xiao Fei, Shao Chang-Shuai
Zhonghua Nan Ke Xue. 2014 Mar;20(3):239-43.
To evaluate the efficacy and safety of the combination therapy of tamsulosin and solifenacin for mild and moderate benign prostatic hyperplasia (BPH) with overactive bladder (OAB).
We randomly divided 166 patients with BPH and concomitant OAB into a mild obstruction symptom group (n = 88) and a moderate obstruction symptom group (n =78), 48 of the former group treated with 0. 2 mg tamsulosin + 5 mg solifenacin and the other 40 with 0. 2 mg tamsulosin; 36 of the latter group treated with 0. 2 mg tamsulosin + 5 mg solifenacin and the other 42 with 0. 2 mg tamsulosin, all administered once daily for 12 weeks. We obtained the International Prostate Symptom Score (IPSS), urine storage period symptom score (USPSS), voiding symptom score (VSS), Qmax, residual urine volume, OAB symptom score (OABSS) and adverse reactions, and compared them among different
Among the patients with mild obstruction symptoms, the combination of tamsulosin and solifenacin achieved remark-groups. able improvement in IPSS, USPSS, Qmax and OABSS as compared with the baseline (P < 0.05), but made no significant difference in the residual urine volume (P > 0. 05) , while tamsulosin improved IPSS only (P < 0.05). The combination therapy exhibited an obvious superiority over tamsulosin alone in improving IPSS (9.7 micro 3.0 vs 15.8 micro 3.3), USPSS (8. 1 micro 1.7 vs 12.3 micro 3.1), Qmax ([18.6 micro 2.3] ml/s vs [14.2 micro 2.3] ml/s ), and OABSS (5.3micro 1.3 vs 9.7 micro 2.7) (P < 0.05), but there were no obvious differences in residual urine, urine routine test results and adverse events between the two therapies ( P > 0. 05). In those with moderate obstruction symptoms, the combination therapy significantly improved IPSS, VSS, Qmax and OABSS (P < 0.05) but not the residual urine (P > 0. 05) in comparison with the baseline. The tamsulosin therapy achieved obvious improvement in IPSS, VSS, Qmax, OABSS and residual urine. The combination therapy showed a better effect than tamsulosin only in OABSS (4. 8 +/-1.5 vs 6.5 +/-2.5, P < 0.05), but no significant differences from the latter in IPSS, Qmax, VSS, routine urine test results, and adverse
Combination therapy of tamsulosin and solifenacin is obviously safe and efficacious in the treatment (P > 0.05). events of both mild and moderate BPH with concomitant OAB, and it is superior to tamsulosin alone.
评估坦索罗辛与索利那新联合治疗轻、中度良性前列腺增生(BPH)合并膀胱过度活动症(OAB)的疗效和安全性。
将166例BPH合并OAB患者随机分为轻度梗阻症状组(n = 88)和中度梗阻症状组(n = 78),前一组中48例接受0.2mg坦索罗辛 + 5mg索利那新治疗,另40例接受0.2mg坦索罗辛治疗;后一组中36例接受0.2mg坦索罗辛 + 5mg索利那新治疗,另42例接受0.2mg坦索罗辛治疗,均每日给药1次,持续12周。获取国际前列腺症状评分(IPSS)、储尿期症状评分(USPSS)、排尿症状评分(VSS)、最大尿流率(Qmax)、残余尿量、OAB症状评分(OABSS)及不良反应,并在不同组间进行比较。
在轻度梗阻症状患者中,与基线相比,坦索罗辛与索利那新联合治疗在IPSS、USPSS、Qmax和OABSS方面取得了显著改善(P < 0.05),但在残余尿量方面无显著差异(P > 0.05),而坦索罗辛仅改善了IPSS(P < 0.05)。联合治疗在改善IPSS(9.7±3.0 vs 15.8±3.3)、USPSS(8.1±1.7 vs 12.3±3.1)、Qmax([18.6±2.3]ml/s vs [14.2±2.3]ml/s)和OABSS(5.3±1.3 vs 9.7±2.7)方面明显优于单独使用坦索罗辛(P < 0.05),但两种治疗在残余尿量、尿常规检查结果及不良事件方面无明显差异(P > 0.05)。在中度梗阻症状患者中,与基线相比,联合治疗显著改善了IPSS、VSS、Qmax和OABSS(P < 0.05),但未改善残余尿量(P > 0.05)。坦索罗辛治疗在IPSS、VSS、Qmax、OABSS和残余尿量方面取得了明显改善。联合治疗仅在OABSS方面比单独使用坦索罗辛效果更好(4.8±1.5 vs 6.5±2.5,P < 0.05),但在IPSS、Qmax、VSS、尿常规检查结果及不良事件方面与后者无显著差异(P > 0.05)。
坦索罗辛与索利那新联合治疗轻、中度BPH合并OAB明显安全有效,且优于单独使用坦索罗辛。