癃闭舒胶囊联合甲磺酸多沙唑嗪片治疗良性前列腺增生症的临床研究

Treatment of Benign Prostatic Hyperplasia by Longbishu Capsule Combined Doxazosin Mesylate Tablet

目的观察癃闭舒胶囊联合甲磺酸多沙唑嗪片治疗良性前列腺增生症的疗效及安全性。方法将360例肾虚血瘀型良性前列腺增生症患者随机分为A、B、C组,每组120例。A组给予癃闭舒胶囊安慰剂联合甲磺酸多沙唑嗪片,B组给予癃闭舒胶囊联合甲磺酸多沙唑嗪片,C组给予癃闭舒胶囊联合甲磺酸多沙唑嗪片安慰剂。癃闭舒胶囊(0.3g/粒),每次3粒,每日2次口服;甲磺酸多沙唑嗪片(2 mg/片),每次1片,每日1次口服;各组均治疗12个月。纳入FAS分析A组为113例,B组为115例,C组为116例。观察各组主要疗效指标[国际前列腺症状评分(international prostate symptom score,IPSS)、最大尿流率(maximum urinary flow rate,Qmax)、生活质量(quality of life,QOL)评分]及次要疗效指标[残余尿量(postvoid residual urine volume,PVR)、前列腺体积(prostate volume,PV)、中医症状评分]。以受试者平均年龄(66岁)作为分层因素(年龄段是50岁≤年龄≤66岁和66岁<年龄≤80岁),进行疗效分析。结果与本组治疗前比较,治疗后A、B、C组IPSS、QOL评分和中医症状积分均降低,Qmax增大,B组和C组PVR减少,差异均有统计学意义(P<0.01);各组治疗后组间比较,主要疗效和次要疗效指标比较,差异均无统计学意义(P>0.05)。治疗后临床疗效比较,差异无统计学意义(P>0.05);年龄>66岁受试者的临床疗效比较,B组优于A和C组,差异有统计学意义(P<0.05)。结论单独运用癃闭舒胶囊或甲磺酸多沙唑嗪片及两药联合治疗BPH均安全有效。伴有残余尿异常或年龄超过66岁的良性前列腺增生症患者适合选择两药联合治疗。

Objective To observe the efficacy and safety of Longbishu Capsule（LBS）combined Doxazosin Mesylate Tablet（DMT）in treating benign prostatic hyperplasia（BPH）.Methods Totally 360 BPH with Shen deficiency blood stasis syndrome（SDBSS）were randomly assigned to group A,B,and C,120 cases in each group.Patients in Group A took LBS placebos combined DMT.Those in Group B took LBS combined DMT.Those in Group C took LBS combined DMT placebos.The dose for LBS was 3 pills each time,0.3 g/pill,twice per day.The dose of DMT was 1tablet each time,2 mg/tablet,once per day.The therapeutic course for all was 12 months.A total of 113 cases in Group A were recruited in FAS analysis,115 cases in Group B,and116 cases in Group C.Main efficacy indi-cators[International Prostate Symptom Score（IPSS）,maximum urinary flow rate（Qmax）,Quality of Life（QOL）],and secondary efficacy indicators[postvoid residual urine volume（PVR）and prostate volume（PV）,symptoms scores of Chinese medicine（CM）]were observed in each group.The efficacy was analyzed in the three groups by taking average age of subjects（66 years）as the hierarchy factor（50≤age≤66 and 66age≤80）.Results Compared with before treatment in the same group,IPSS,QOL score,and symptoms scores of CM all decreased,and Qmax increased in Group A,B,and C after treatment;PVR decreased in Group B and C（all P0.01）.There was no statistical difference in main efficacy indicators or secondary efficacy indicators among post-treatment groups（P0.05）.There was no statistical difference in clinical efficacy among post-treatment groups（P0.05）.The efficacy in subjects more than 66 years old of Group B was superior to that of Group A and C with statistical difference（P0.05）.Conclusions LBS,DMT,or LBS combined DMT was safe and effective for treating BPH.LBS combined DMT was suitable for patients complicated with abnormal PVR or aged over 66 years.