高筱松 高文喜 贺菊乔 段客杰 李兰群 张亚强

【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（P<0.05）。治疗组和对照组治疗前后CPSI评分差值分别为（9.17±5.59）和（7.58±5.16），治疗组降幅大于对照组（P<0.05）。治疗组降低NIH-CPSI评分疗效优于对照组。（2）治疗4周后，治疗组和对照组中医证候评分分别为（8.12±4.78）分和（9.04±4.52）分，治疗组与对照组比较无统计学差异（P>0.05）；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（P>0.05）。（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（P<0.05）。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，Guanganmen 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 Chinese medicine for prostatitis （SI-CM）. Results： ① After 4 weeks of treatment， the CPSI scores in treatment group and the control group were （11.88±5.28） and （13.79±5.68） respectively， which were significantly decreased compared to the baseline （P<0.05）. The difference in CPSI scores between post-treatment and baseline in treatment group and control group were （9.17±5.59） and （7.58±5.16）， more significant in the treatment group. ②=2＼*GB3 After 4 weeks of treatment， syndrome index of Chinese medicine in treatment group and the control group were （8.12±4.78） and （9.04±4.52） respectively. No significant difference was found between two groups （P>0.05）. The difference in syndrome index of Chinese medicine between post-treatment and baseline in treatment group and control group were （9.32±5.12） and （8.93±5.23） respectively， without significant difference between the two groups （P>0.05）. ③ The cured and significant improvement rate was 49.17% in treatment group， which was significant higher that the 34.17% in control group （P<0.05）. Conclusions： Qianlie Miniao suppository is effective and safe in the treatment of chronic prostatitis.

【Key words】Qianlie Miniao suppository； Chronic prostatitis； Clinical evaluation； NIH chronic prostatitis symptom index （NIH-CPSI）； The syndrome index of Chinese medical for prostatitis （SI-CM）

【中图分类号】R697+.33【文献标志码】A

慢性前列腺炎是男性泌尿生殖系统的常见病，国外报道的发病率为2%～16%[1]，国内约为6%～32%[2]，高于国外水平。这可能与人种、环境、教育程度等有关[3]。男性中约有50%的人在不同时期受到这种疾病的困扰[4]。由于本病发病率高，病因不明，症状多样，病程迁延，给男性的身体及心理健康都带来很大的危害，严重影响患者的生活质量[5]。为使前列泌尿栓治疗慢性前列腺炎的安全性和有效性得到进一步评价，我们在广安门医院、中日友好医院、湖北中医学院一附院、天津中医学院一附院、湖南中医学院一附院5所医院同时进行了前列泌尿栓治疗慢性前列腺炎的多中心、随机、双盲、与前列安栓对照的临床研究，结果报告如下。