前列泌尿栓治疗慢性前列腺炎多中心双盲阳性药对照试验的研究.docVIP

前列泌尿栓治疗慢性前列腺炎多中心双盲阳性药对照试验的研究 　　【摘要】目的：评价前列泌尿栓治疗慢性前列腺炎的有效性和安全性。方法：多中心、随机、双盲、阳性药对照临床试验设计。480例湿热瘀血蕴阻型慢性前列腺炎患者按3∶1的比例随机分为治疗组、阳性对照组。治疗组360例，应用前列泌尿栓，肛内给药，1粒/次，1次/d。安慰剂对照组120例，应用前列安栓，肛内给药，1粒/次，1次/d。疗程为4周。以美国国立卫生院前列腺炎症状评分（NIH-CPSI）、慢性前列腺炎中医证候评分作为主要疗效评价指标。结果：（1）治疗4周后，治疗组和对照组CPSI评分分别为（11.88±5.28）分和（13.79±5.68）分，各组相对于基线的变化均有统计学意义（P0.05）；治疗组和对照组治疗前后差值分别为（9.32±5.12）和（8.93±5.23），治疗组降幅与对照组比较无统计学差异（P0.05）。（3）治疗组愈显率为49.17%，对照组为34.17%，扣除中心效应，总愈显率治疗组疗效优于对照组（P0.05）。结论：前列泌尿栓治疗慢性前列腺炎安全、有效。 　　【关键词】 前列泌尿栓；慢性前列腺炎；临床疗效评价；NIH-CPSI；中医证候评分 　　The efficacy and safety of Qianlie Miniao suppository in the treatment of chronic prostatitis： a multi-center， randomized， double-blind， positive-controlled clinical trialGAO Xiaosong1，GAO Wenxi2， HE Juqiao3， DUAN Kejie4， LI Lanqun5， ZHANG Yaqiang1△. 1. Urology Department，Guang’anmen Hospital of China Academy of Chinese Medical Sciences， Beijing 100053， China； 2.Urology Department， Hubei Traditional Chinese Medicine Hospital， Wuhan 430061， Hubei， China； 3. Department of Surgery of Traditional Chinese Medicine， The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine， Changsha 410007， Hunan， China； 4. Urology Department，The First Affiliated Hospital of Traditional Chinese Medicine， Tianjin 300052， China； 5. Andrology Department，China-Japan Friendship Hospital， Beijing 100029， China 　　【Abstract】Objectives： To evaluate the efficacy and safety of Qianlie Miniao suppository in the treatment of chronic prostatitis. Methods： A multi-central， randomized double-blind， positive-controlled clinical trial was conducted. A total of 480 patients diagnosed as chronic prostatitis with the type of damp-heat blood stasis were divided into 2 groups with the ratio of 3/1： the trial group treated with Qianlie Miniao suppository for 4 weeks （anal，1 grains ， once a day） and the control group given Qianliean suppository in the same way. The efficacy was evaluated by the NIH chronic prostatitis symptom index （NIH-CPSI） and the syndrome index of Chines