克癃胶囊治疗良性前列腺增生的临床研究

目的观察克癃胶囊治疗良性前列腺增生的有效性和安全性。方法将240例BPH患者随机分组后分别给予相应治疗,疗程4周,分析比较试验组和对照组治疗前后中医症状、国际前列腺症状评分、最大尿流率、前列腺体积和剩余尿量等疗效指标变化差异,并作相应安全性评价。结果两组中医证候疗效比较差异有统计学意义(P<0.05)。两组治疗后的国际前列腺症状评分、前列腺体积、最大尿流率和剩余尿量与治疗前比较,差异均有统计学意义(P<0.01)。治疗后两组的中医证侯积分、国际前列腺症状评分、最大尿流率比较差异均有统计学意义(P<0.01或P<0.05);而前列腺体积、剩余尿量比较差异则无统计学意义(P>0.05)。两组均无明显不良反应发生。结论克癃胶囊治疗良性前列腺增生疗效显著,且未见与药物有关的不良事件。

Clinical Study of KELONG Capsule in Treating Benign Prostatic Hyperplasia

Objective To observe effectiveness and safety of KELONG Capsule in treating benign prostatic hyperplasia(BPH).Methods The 240 cases of BPH were randomly divided into two groups and with the appropriate four-week course of treatment respectively.The TCM symptoms,International Prostate Symptom Score(I-PSS),maximum flow rate(Qmax),prostate volume,residual urine(RU) and other efficacy indicators of the treatment group and the control group were analyzed and compared before and after treatment,the safety assessment was also made.Results There was significant difference between the two groups in clinical effects of The TCM symptoms(P < 0.05).There exists a significant difference between the two groups before and after the treatment,in the integration of Chinese syndrome(P < 0.01 or P < 0.05),IPSS(P <0.05),the Qmax rate(P <0.05).But there was no significant difference in prostate volume and RU(P > 0.05).There was no drug-related adverse event in two groups.Conclusion The KELONG capsule is significantly effective in treating BPH,and no drug-related adverse event is observed.