【作者】 谢家骏； 殷海波； 贾金铭； 周智恒； 许得盛； 刘树硕； 乔正东； 周小初；

【Author】 Xie,jiajun1 Yin,haibo2 Jia,jinming2 Zhou,zhiheng3 Xu,desheng4 Liu,shushuo5 Qiao,zhengdong1 Zhou,xiaochu1(1.Shanghai Institute of Chinese Materia Medica,Shanghai 201203;2.Guang’anmen Hospitall,China Academy of Chinese Medical Scinces,Beijing 100053;3.Longhua Hospital,shanghai university of traditional chinese medicine,Shanghai 200032;4.Huashan Hospital,Fudan University,Shanghai 200040;5.The Affiliated Hospital of Zhejiang TCM Medical College,Hangzhou 310006

【机构】 上海市中药研究所； 中国中医科学院广安门医院； 上海中医药大学附属龙华医院； 复旦大学附属华山医院； 浙江中医学院附属医院；

【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两组。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LS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】 Objective:To observe the eficacy and safety of Longkai Granule(LKG)in the treatment of the benign prostatic hyperplasia(BPH)under’Kidney-deficiency and blood-stasis Syndrome’(a term of TCM)in clinic.Methods:According to the principle of the random,double blind,double-simulant and parallel-controlled,485 patients with BPH were randomly divided into tow groups.Patients in curative group(n=339)were given orally LKG(1bag,Tid),and patients in control group(n=339)were given orally LS Capsule(3 granules,Bid)respectively for 4 weeks.And then the international prostatic symptom score,life quality index,prostate volume,maximum flow rate of urine and residual urine in bladder etc.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<O.O5).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 International prostate symptom score(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(ECG)and prostatic specific antigen(PSA)in serum after oral administration of LKG for 30 days continuously.Conclusion:The therapeutic effect of LKG on BPH was satisfactory with no serious toxicity and side effect.更多还原