前列欣胶囊联合盐酸坦洛新缓释胶囊治疗湿热瘀阻型前列腺增生疗效观察

Clinical Observation on Qian Lie Xin Capsule plus Tamsulosin Hydrochloride Sustained Release Capsules in the Treatment of Benign Prostatic Hyperplasia with Shi Re Yu Zu Syndrome

目的通过小样本的随机对照试验观察前列欣胶囊联合盐酸坦洛新缓释胶囊(齐索)治疗湿热瘀阻型前列腺增生的临床疗效。方法将符合要求的63例患者随机分为治疗组和对照组。治疗组33例给予前列欣胶囊加盐酸坦洛新缓释胶囊,对照组30例给予盐酸坦洛新缓释胶囊,两组的疗程均为4周,观察两组患者的中医症候评分、IPSS评分、残余尿、最大尿流率、前列腺体积的变化情况,并监测不良反应。结果治疗后,两组患者的中医症候评分、IPSS评分、残余尿、最大尿流率和治疗前相比都有明显改善,差异均有统计学意义(P<0.05)。而两组患者前列腺体积没有改善,差异无统计学意义(P>0.05)。治疗后治疗组患者各项改善明显优于对照组,具有统计学意义(P<0.05),治疗组对于患者中医症状评分的改善显著优于对照组(P<0.001)。结论前列欣胶囊联合盐酸坦洛新胶囊对于改善湿热瘀阻型前列腺增生患者症状作用显著,耐受性好,尤其是对于患者中医证侯评分的改善,明显优于单药(齐索)治疗方案。

Objective To evaluate the effect of the Qian Lie Xin Capsule plus Tamsulosin Hydrochloride Sustained Release Capsules(Qi Suo) in the Treatment of Benign Prostatic Hyperplasia with Shi Re Yu Zu Syndrome in TCM through a randomized controlled trial of small-sized samples.Methods Sixty-three subjects met the designed criteria were randomized into a treatment group and a control group.The treatment group,33 cases,was administered Qian Lie Xin Capsule plus Tamsulosin Hydrochloride Sustained Release Capsules(Qi Suo),while the control group,30 cases,was administered Tamsulosin Hydrochloride Sustained Release Capsules(Qi Suo).Both groups were treated for 4 weeks.Changes in TCM symptoms score,IPSS,residual urine,uroflowmetry,volume of prostate were observed,and the adverse events were monitored in whole study.Results After treatment,TCM symptoms score,IPSS,residual urine,uroflowmetry were improved in both groups(P<0.05)and the volume of prostate were not improved in both groups.the two groups for prostate volume reduction had similar degree,no significant difference(P>0.05).The effect of the treatment group was better than control group in Changes in TCM symptoms score,IPSS,residual urine,uroflowmetry(P<0.05),especially in the aspect of the improvement of TCM symptoms score(P<0.001).Conclusion Qian Lie Xin Capsule plus Tamsulosin Hydrochloride Sustained Release Capsules(Qi Suo) is effective and tolerable for treating Benign Prostatic Hyperplasia with Shi Re Yu Zu Syndrome in TCM,especially in the aspect of the improvement of TCM symptoms score.Joint solutions is superior to single drug(Qi Suo)programme.