癃开颗粒治疗肾瘀阻证型良性前列腺增生症的临床研究.doc

癃开颗粒治疗肾虚瘀阻证型良性前列腺增生症的临床研究 谢家骏1 殷海波2 贾金铭2 周智恒3 许得盛4 刘树硕5 乔正东1 周小初1 (1.上海市中药研究所，上海 201203；2.中国中医科学院广安门医院，北京 100053；3.上海中医药大学附属龙华医院，上海200032；4.复旦大学附属华山医院，上海 200040；5.浙江中医学院附属 医院，杭州 310006） 关键词：良性前列腺增生症（BPH）；肾虚瘀阻证；癃开颗粒；临床治疗 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(P0.05)；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(P0.05)。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。 所属专业：老年药学（治疗老年性疾病新药研发及临床研究） 作者简介：谢家骏（1959～），男，教授级高级工程师。研究方向：药理毒理研究及中药新药开发。电话：021 Clinical Treatment of the benign prostatic hyperplasia with Longkai Granules 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 Key words：Benign prostatic hyperplasia(BPH); Kidney-deficiency and blood-stasis Syndrome; Longkai Granules(LKG); clinical study 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 s