【摘要】 目的:观察癃开颗粒治疗肾虚瘀阻证型良性前列腺增生症(BPH)的疗效和安全性。方法:遵循随机、双盲双模拟、阳性药物平行对照的原则,将BPH肾虚瘀阻证自愿者485例随机分成治疗和对照组。339例治疗组患者服用癃开颗粒1袋,每日3次,146例对照组患者服用隆必舒胶囊3粒,每日2次,检测和评判连续服用4周的临床疗效。结果:治疗组总有效率79.1%,总显效率42.2%;对照组总有效率60.3%,总显效率为17.1%,差异有显著性(P<0.05);治疗组在改善患者肾虚瘀阻证的主要症状、提高最大尿流率、降低残余尿量、降低I-PSS分值和改善患者生活质量指数等方面,疗效优于对照组(P<0.05)。87例临床控制和显效病例随访3个月,疗效稳定。治疗组连续服用30日,肝、肾功,血、尿常规,血压,心电图,PSA等指标均未见有明显的变化。结论:癃开颗粒对肾虚瘀阻证型BPH具有显著的疗效,且安全无明显毒副反应。更多还原

【Abstract】 AIM: To observe the efficacy and safety of Longkai Granule(LKG) in the treatment of benign prostatic hyperplasia(BPH) under ’Kidney-deficiency and blood-stasis syndrome’ in clinic trial. METHODS: According to the principle of the random,double blind,double-simulant and parallel-controlled,485 patients with BPH were randomly divided into two groups.Patients in curative group(n=339) were given orally LKG(1 bag,Tid),and patients in control group(n=146) were given orally Longbishu Capsule(3 granules, Bid) respectively for 4 weeks.And then the international prostatic symptom score(I-PSS),life quality index,prostate volume,maximum flow rate of urine and residual urine in bladder were detected before and after treatment in the two groups.(RESULTS:) The total effective rate and the total significant effective rate were 79.1% and 42.2% respectively in the curative group,while being 60.3% and 17.1% in the control group respectively,in which there was significant difference between the two groups(P<(0.05)).The curative group was notably better than the control group in the aspects of improving the main symptoms of Kidney-deficiency and blood-stasis syndrome,raising maximum flow rate of urine,reducing residual urine volume in bladder and the value of I-PSS in pantients(P<(0.05)).The curative effects were steady in all 87 cases received clinic control and significant effect during the 3 months follow-up.There were no significant differences in the liver and kidney function,blood and urinary routine,blood pressure, electro-Cardio-Gram and prostatic specific antigen in serum after oral administration of LKG for consecutive 30 d.(CONCLUSION:) The therapeutic effect of LKG on BPH is satisfactory with no serious toxicity and side effect.更多还原